Chronic Pain, Musculoskeletal Pain
Conditions
Keywords
Musculoskeletal pain, Chronic pain, Patient centered outcomes research, Physician patient relationship, Mobile applications
Brief summary
Chronic musculoskeletal pain is an important problem, and treatments are often prescribed in a trial and error fashion. Clinicians prescribe a treatment to a patient and then wait and see if the treatment is successful. If the treatment is unsuccessful, they will try a different treatment. The disadvantage to this method is that it may take a long time to find a successful treatment. The purpose of the PREEMPT Study is to test whether using a mobile phone application (Trialist app) that allows patients and their health care providers to run personalized experiments comparing two pain treatments is more effective than usual care. Patients download the app, and working with their clinicians, set up a personalized trial that makes sense for them. Every day they answer questions to track levels of pain and side effects of treatment, such as fatigue and constipation. Once the personalized trial has ended, the responses to these daily questions on each treatment will be compared. During a regular clinic visit, the patient and the clinician will review visual displays of the results to facilitate treatment decision-making. Approximately 250 patients will be enrolled in the study. Half the patients will use the app and review results with the clinician, and half the patients will continue with their regular care (i.e., will not use the app). The two groups will be compared to see if using the app is successful in improving long term pain outcomes. The goal of the intervention using the Trialist app is to help patients engage actively and collaboratively with their clinicians and identify effective treatments more quickly.
Interventions
BEHAVIORALTrialist Intervention
Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.
DEVICEsmartphone
Sponsors
National Institute of Nursing Research (NINR)
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic musculoskeletal pain (e.g., neck, back, extremities) operationalized as pain present for 6 weeks or more and a pain score of 4 or higher (on a 0-to-10 scale) on at least one of three items from the PEG pain scale * Age 18-75 years * Own web-enabled Android or iOS phone with data plan * In judgment of treating clinician, pain potentially amenable to treatment with acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), low-dose opioids, a complementary/alternative treatment such as massage or meditation, or a simple combination of these treatments * Ability to speak and read English
Exclusion criteria
* Treated with surgery, radiation or chemotherapy for cancer in past 5 years * Other medical conditions that in clinician's judgment would limit life expectancy to less than 2 years or imperil patient safety * Pregnant or breastfeeding * Dementia, bipolar disorder, schizophrenia, active suicidality * Current alcohol or prescription drug abuse; history of disruptive behavior * Failed 5 or more analgesic medications because of lack of effectiveness or poor tolerability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | baseline, 26 weeks | Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | baseline, 13 weeks, 26 weeks, 52 weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | baseline, 13 weeks, 26 weeks, 52 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | baseline, 13 weeks, 26 weeks, 52 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Baseline, 13 weeks, 26 weeks, 52 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | baseline, 13 weeks, 26 weeks, 52 weeks | Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | baseline, 13 weeks, 26 weeks, 52 weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Baseline, 13 weeks, 26 weeks, 52 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Baseline, 13 weeks, 26 weeks, 52 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Baseline, 13 weeks, 26 weeks, 52 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. |
| Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | baseline, 13 weeks, 26 weeks, 52 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | Baseline, 13 weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks | Baseline, 13 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks | Baseline, 13 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. |
| Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | Baseline, 13 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. |
| Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | Baseline, 13 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. |
| Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks | Baseline, 13 weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks | Baseline, 13 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks | Baseline, 13 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks | Baseline, 13 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. |
| Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | Baseline, 52 weeks | Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. |
| Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | Baseline, 52 weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks | Baseline, 52 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks | Baseline, 52 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. |
| Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | Baseline, 52 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. |
| Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | Baseline, 52 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. |
| Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | Baseline, 26 weeks | Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks | Baseline, 52 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks | Baseline, 52 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks | Baseline, 52 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. |
| Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks | Baseline, 52 weeks | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. |
| Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks | Baseline, 52 weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks | Baseline, 26 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health. |
| Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks | Baseline, 26 weeks | Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health. |
| Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | Baseline, 26 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence. |
| Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | Baseline, 26 weeks | Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence. |
| Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks | Baseline, 26 weeks | Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks | Baseline, 26 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks | Baseline, 26 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction. |
| Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks | Baseline, 26 weeks | The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications. |
| Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks | 26 weeks | Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making. |
| Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | Baseline, 13 weeks | Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trialist Intervention Clinician and patient set up N-of-1 trial 4-12 weeks in length to compare two treatments for chronic pain. Patient uses Trialist smartphone app to monitor pain and associated side effects daily throughout length of N-of-1 trial. After trial ends, the patient reviews graphical displays of N-of-1 trial results with clinician.
Trialist Intervention: Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.
smartphone | 108 |
| Control-Usual Care Receive usual care from clinician for chronic pain, do not use Trialist smartphone app | 107 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | Withdrawal by Subject | 0 | 4 |
| Six Month Follow-up | Did not complete follow-up survey | 1 | 1 |
| Six Month Follow-up | Lost to Follow-up | 2 | 1 |
| Six Month Follow-up | Withdrawal by Subject | 1 | 1 |
| Three Month Follow-up | Death | 1 | 1 |
| Three Month Follow-up | Did not complete follow-up survey | 14 | 4 |
| Three Month Follow-up | Lost to Follow-up | 0 | 1 |
| Three Month Follow-up | Withdrawal by Subject | 4 | 1 |
| Twelve Month Follow-up | Did not complete follow-up survey | 1 | 3 |
| Twelve Month Follow-up | Enrolled within 12 months of study end | 14 | 8 |
| Twelve Month Follow-up | Lost to Follow-up | 0 | 1 |
| Twelve Month Follow-up | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Trialist Intervention | Control-Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 10.8 | 55.6 years STANDARD_DEVIATION 11.5 | 55.5 years STANDARD_DEVIATION 11.1 |
| Analgesic adherence (overuse) | 90.2 units on a scale STANDARD_DEVIATION 12.4 | 89.4 units on a scale STANDARD_DEVIATION 13.4 | 89.8 units on a scale STANDARD_DEVIATION 12.9 |
| Analgesic adherence (underuse) | 75.2 units on a scale STANDARD_DEVIATION 22.3 | 75.6 units on a scale STANDARD_DEVIATION 24.6 | 75.4 units on a scale STANDARD_DEVIATION 23.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 8 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 95 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Global mental health | 44.9 units on a scale STANDARD_DEVIATION 9.1 | 43.2 units on a scale STANDARD_DEVIATION 7.9 | 44.1 units on a scale STANDARD_DEVIATION 8.6 |
| Global physical health | 42.5 units on a scale STANDARD_DEVIATION 6.8 | 40.6 units on a scale STANDARD_DEVIATION 5.5 | 41.6 units on a scale STANDARD_DEVIATION 6.2 |
| Medication related shared decision making | 74.3 units on a scale STANDARD_DEVIATION 23.8 | 75.0 units on a scale STANDARD_DEVIATION 24.3 | 74.6 units on a scale STANDARD_DEVIATION 23.9 |
| Pain intensity | 53.5 units on a scale STANDARD_DEVIATION 5.4 | 53.8 units on a scale STANDARD_DEVIATION 5.1 | 53.7 units on a scale STANDARD_DEVIATION 5.2 |
| Pain interference | 64.0 units on a scale STANDARD_DEVIATION 5.9 | 64.7 units on a scale STANDARD_DEVIATION 5.8 | 64.3 units on a scale STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 15 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) White | 75 Participants | 80 Participants | 155 Participants |
| Region of Enrollment United States | 108 Participants | 107 Participants | 215 Participants |
| Satisfaction with medical care | 84.7 units on a scale STANDARD_DEVIATION 15.7 | 79.5 units on a scale STANDARD_DEVIATION 19.2 | 82.2 units on a scale STANDARD_DEVIATION 17.7 |
| Satisfaction with pain information | 50.5 units on a scale STANDARD_DEVIATION 38.8 | 50.7 units on a scale STANDARD_DEVIATION 37.8 | 50.6 units on a scale STANDARD_DEVIATION 38.2 |
| Satisfaction with pain medication | 65.2 units on a scale STANDARD_DEVIATION 22.1 | 63.4 units on a scale STANDARD_DEVIATION 23.6 | 64.4 units on a scale STANDARD_DEVIATION 22.8 |
| Sex: Female, Male Female | 50 Participants | 52 Participants | 102 Participants |
| Sex: Female, Male Male | 58 Participants | 55 Participants | 113 Participants |
| Trust in clinician | 76.8 units on a scale STANDARD_DEVIATION 15.8 | 75.3 units on a scale STANDARD_DEVIATION 17.1 | 76.1 units on a scale STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 108 | 1 / 107 |
| other Total, other adverse events | 0 / 108 | 0 / 107 |
| serious Total, serious adverse events | 0 / 108 | 0 / 107 |
Outcome results
Primary
Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time frame: baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | -3.22 units on a scale |
| Control-Usual Care | Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | -1.85 units on a scale |
95% CI: [-2.91, 0.19]
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 13 weeks | 1.40 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 26 weeks | 1.77 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 52 weeks | 1.61 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 13 weeks | 0.35 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 26 weeks | -0.13 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 52 weeks | 1.53 units on a scale |
p-value: 0.7Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time frame: baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 13 weeks | 2.53 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 26 weeks | 1.88 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 52 weeks | -3.53 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 13 weeks | -1.71 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 26 weeks | -2.76 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire | Change from baseline to 52 weeks | -1.62 units on a scale |
p-value: 0.2Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time frame: baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 13 weeks | -1.60 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 26 weeks | -2.86 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 52 weeks | -3.00 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 13 weeks | -1.92 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 26 weeks | -1.46 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 52 weeks | -1.76 units on a scale |
p-value: 0.06Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale
Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time frame: baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 13 weeks | -2.70 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 26 weeks | -3.22 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 52 weeks | -2.67 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 13 weeks | -1.91 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 26 weeks | -1.85 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale | Change from baseline to 52 weeks | -2.83 units on a scale |
p-value: 0.21Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time frame: baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Change from baseline to 13 weeks | -2.49 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Change from baseline to 26 weeks | -2.30 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Change from baseline to 52 weeks | -4.00 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Change from baseline to 13 weeks | -4.25 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Change from baseline to 26 weeks | -4.84 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale | Change from baseline to 52 weeks | -5.53 units on a scale |
p-value: 0.66Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Change from baseline to 13 weeks | -4.00 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Change from baseline to 26 weeks | -2.26 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Change from baseline to 52 weeks | -4.52 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Change from baseline to 13 weeks | -6.15 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Change from baseline to 26 weeks | -5.57 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care | Change from baseline to 52 weeks | -5.51 units on a scale |
p-value: 0.58Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Change from baseline to 13 weeks | 4.41 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Change from baseline to 26 weeks | 11.28 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Change from baseline to 52 weeks | 9.02 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Change from baseline to 13 weeks | -3.36 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Change from baseline to 26 weeks | 3.99 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information | Change from baseline to 52 weeks | 4.89 units on a scale |
p-value: 0.44Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time frame: Baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Change from baseline to 13 weeks | 1.46 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Change from baseline to 26 weeks | -0.18 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Change from baseline to 52 weeks | 0.77 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Change from baseline to 13 weeks | -0.34 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Change from baseline to 26 weeks | 1.39 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication | Change from baseline to 52 weeks | -0.34 units on a scale |
p-value: 0.73Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time frame: baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Change from baseline to 13 weeks | -0.35 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Change from baseline to 26 weeks | 0.21 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Change from baseline to 52 weeks | 0.36 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Change from baseline to 13 weeks | 0.30 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Change from baseline to 26 weeks | -0.72 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale | Change from baseline to 52 weeks | -0.39 units on a scale |
p-value: 0.35Mixed Models Analysis
Secondary
Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time frame: baseline, 13 weeks, 26 weeks, 52 weeks
Population: Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time\*treatment interaction as fixed effects and clinician and patient as random effects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Change from baseline to 13 weeks | 0.73 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Change from baseline to 26 weeks | 0.13 units on a scale |
| Trialist Intervention | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Change from baseline to 52 weeks | 0.16 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Change from baseline to 13 weeks | 0.44 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Change from baseline to 26 weeks | 0.30 units on a scale |
| Control-Usual Care | Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale | Change from baseline to 52 weeks | 0.42 units on a scale |
p-value: 0.86Mixed Models Analysis
Other Pre-specified
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | 1.40 units on a scale |
| Control-Usual Care | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | 0.35 units on a scale |
95% CI: [-2.54, 4.64]
Other Pre-specified
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | 1.77 units on a scale |
| Control-Usual Care | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | -0.13 units on a scale |
95% CI: [-1.66, 5.47]
Other Pre-specified
Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | 1.61 units on a scale |
| Control-Usual Care | Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | 1.53 units on a scale |
95% CI: [-3.61, 3.77]
Other Pre-specified
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | 2.53 units on a scale |
| Control-Usual Care | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks | -1.71 units on a scale |
95% CI: [-2.73, 11.2]
Other Pre-specified
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | 1.88 units on a scale |
| Control-Usual Care | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks | -2.76 units on a scale |
95% CI: [-2.25, 11.54]
Other Pre-specified
Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks
Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | -3.53 units on a scale |
| Control-Usual Care | Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks | -1.62 units on a scale |
95% CI: [-9.07, 5.26]
Other Pre-specified
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | -1.60 units on a scale |
| Control-Usual Care | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | -1.92 units on a scale |
95% CI: [-1.18, 1.81]
Other Pre-specified
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | -2.86 units on a scale |
| Control-Usual Care | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks | -1.46 units on a scale |
95% CI: [-2.87, 0.06]
Other Pre-specified
Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | -3.00 units on a scale |
| Control-Usual Care | Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | -1.76 units on a scale |
95% CI: [-2.77, 0.3]
Other Pre-specified
Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks
Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | -2.70 units on a scale |
| Control-Usual Care | Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks | -1.91 units on a scale |
95% CI: [-2.37, 0.8]
Other Pre-specified
Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks
Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | -2.67 units on a scale |
| Control-Usual Care | Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks | -2.83 units on a scale |
95% CI: [-1.47, 1.79]
Other Pre-specified
Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks
Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
Time frame: 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks | 79.6 units on a scale |
| Control-Usual Care | Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks | 67.7 units on a scale |
p-value: 0.0195% CI: [2.59, 21.24]Regression, Linear
Other Pre-specified
Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks
Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks | 74.8 units on a scale |
| Control-Usual Care | Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks | 65.4 units on a scale |
p-value: 0.05495% CI: [-0.15, 18.96]Regression, Linear
Other Pre-specified
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks | -2.49 units on a scale |
| Control-Usual Care | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks | -4.25 units on a scale |
95% CI: [-2.37, 5.89]
Other Pre-specified
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks | -2.30 units on a scale |
| Control-Usual Care | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks | -4.84 units on a scale |
95% CI: [-1.5, 6.6]
Other Pre-specified
Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks
Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks | -4.00 units on a scale |
| Control-Usual Care | Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks | -5.53 units on a scale |
95% CI: [-2.7, 5.77]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks | -4.00 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks | -6.15 units on a scale |
95% CI: [-2.84, 7.13]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks | -2.26 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks | -5.57 units on a scale |
95% CI: [-1.57, 8.19]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks | -4.52 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks | -5.51 units on a scale |
95% CI: [-4.11, 6.11]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks | 4.41 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks | -3.36 units on a scale |
95% CI: [-2.87, 18.42]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks | 11.28 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks | 3.99 units on a scale |
95% CI: [-3.16, 17.75]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks | 9.02 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks | 4.89 units on a scale |
95% CI: [-6.81, 15.07]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks | 1.46 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks | -0.34 units on a scale |
95% CI: [-4.41, 8.02]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks | -0.18 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks | 1.39 units on a scale |
95% CI: [-7.68, 4.54]
Other Pre-specified
Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks
The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks | 0.77 units on a scale |
| Control-Usual Care | Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks | -0.34 units on a scale |
95% CI: [-5.27, 7.48]
Other Pre-specified
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks | -0.35 units on a scale |
| Control-Usual Care | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks | 0.30 units on a scale |
95% CI: [-2.55, 1.24]
Other Pre-specified
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks | 0.21 units on a scale |
| Control-Usual Care | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks | -0.72 units on a scale |
95% CI: [-0.92, 2.79]
Other Pre-specified
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks | 0.36 units on a scale |
| Control-Usual Care | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks | -0.39 units on a scale |
95% CI: [-1.19, 2.7]
Other Pre-specified
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time frame: Baseline, 13 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks | 0.73 units on a scale |
| Control-Usual Care | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks | 0.44 units on a scale |
95% CI: [-1.01, 1.61]
Other Pre-specified
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time frame: Baseline, 26 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks | 0.13 units on a scale |
| Control-Usual Care | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks | 0.30 units on a scale |
95% CI: [-1.45, 1.12]
Other Pre-specified
Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks
Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.
Time frame: Baseline, 52 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Trialist Intervention | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks | 0.16 units on a scale |
| Control-Usual Care | Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks | 0.42 units on a scale |
95% CI: [-1.61, 1.09]