Chronic Pain
Conditions
Keywords
Clinical Decision Support, Patient Education Materials, Opioid Use, Chronic Noncancer Pain
Brief summary
Investigators will compare Clinical Decision Support (CDS) versus Patient Education and Activation Tools (PEATs) in patients prescribed long-term or multiple opioids to measure outcomes that are important to patients. Primary outcomes are pain interference, physical function, and satisfaction with patient-physician communication. Secondary outcomes are overall Health-Related Quality of Life and high-risk prescribing, including prescriptions over 90 morphine milligram equivalents per day and co-prescribing of benzodiazepines and opioids. Patients in the PEAT arm will receive patient materials during the intervention, developed to engage patients in chronic pain treatment, prior to Primary Care Physician office visits. In the provider-facing CDS arm, PCPs will receive computerized reminders about appropriate opioid use during office visits for enrolled patients. Patients in both groups will receive questionnaires about pain interference, quality of life, and physician-patient communication through the patient portal one month after each visit to their Primary Care Physician (PCP). Investigators will use multi-level regression models to compare the effectiveness of these two communication strategies.
Detailed description
Investigators will compare two strategies: (1) Engage PCPs with Clinical Decision Support at the point of care, raising active alerts through the Electronic Health Record (EHR) when there is risk of inappropriate opioid prescribing, thus leading to informed decision-making with the patient about alternative treatments; versus (2) Engage patients prior to their PCP visit using Patient Education and Activation Tools (PEATs) administered via REDCap, helping patients to prepare for their visit and encouraging discussion about treatment preferences, values and treatment goals at the time of the visit, thus leading to shared decision-making with the provider. Our CDS intervention will use Choosing Wisely and Centers for Disease Control and Prevention (CDC) guidelines, and our Patient Education and Activation Tool intervention will use widely disseminated material developed by Consumer Reports and the ACPA. Investigators will assess whether improved communication and patient activation through these strategies improve patient-reported outcomes related to pain interference and HRQOL. To assess these outcomes, investigators will use NIH Patient Reported Outcome Measurement Information System (PROMIS®) questionnaires to capture health domains identified by our patient partners as most important. Using PROs will also help capture whether the use of either of these strategies leads to unintended consequences for patients when opioids are reduced and other pain management strategies are not substituted. Recruitment procedures: The study team mails study materials including an introductory brochure, information sheet, and initial contact letter to eligible participants. Eligible participants are then called and asked if they would like to enroll in the study, at which point the study team obtains consent over the phone. Non-responders, eligible participants who the study team has not been able to reach by phone and for whom a voicemail was left, are automatically enrolled in an abbreviated arm of the study after two weeks of non-response. Those enrolled in both the full study PEATs group and abbreviated PEATs group will be sent the PEATs materials two days before an appointment with their primary care clinician. Participants may choose to opt out of any arm of the study. Data collection: Upon enrollment in the fully study, investigators will send patients an enrollment questionnaire, which includes questions on education, language proficiency, and health literacy. At this point, investigators will also send the two PROMIS questionnaires (pain interference and physical function) via REDCap. The study team has programmed the surveys to be sent via automatic email in REDCap. The email will contain a link where participants can access the questionnaire and redeem their Amazon gift card instantly. The total time to take this questionnaire is 2 minutes. All enrolled participants will receive monthly PROMIS questionnaires during the 12-month intervention period. Enrolled patients who have any follow-up visits during this intervention period in both full study arms will be sent the Communication Questionnaire (COMRADE) via REDCap one day after each office visit with their PCP. For participants enrolled in the abbreviated arm of the study, the study team will have access to medical records that will allow for a retrospective pull of relevant patient-reported outcome measures and PCP satisfaction data collected by the health system.
Interventions
OTHERClinical Decision Support
The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.
OTHERPatient Education and Activation Tools
The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication).
Sponsors
Patient-Centered Outcomes Research Institute
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The study team will randomize the study on the provider level and use a random number generator to assign providers to study arms. Patients within the physicians randomized to the Informed Decision Making (IDM) arm will not receive the PEAT materials; their physicians will receive the CDS alerts via the EHR when certain order criteria are triggered appropriately. Patients within the physicians randomized to the Shared Decision Making (SDM) arm will receive the PEAT materials via REDCap two days before their PCP office visit. They will receive these materials every time they have an office visit with their PCP.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Within a 90-day period prior to the patient recruitment date: * ≥30 days of prescriptions for opioid medications; or * 2 or more opioid prescriptions; or * a total amount of ≥700 Morphine Milligram Equivalents (MME) in a single opioid prescription; and * Patients who have had 1 or more Cedars-Sinai Medical Group primary care physician in the year prior to the study start date; and * At least 1 visit during the follow-up year (the follow-up year will start after they consent to be in the study). Prescriptions in the inpatient setting will not make a patient eligible for this study.
Exclusion criteria
* Individuals less than 18 years of age; or * Individuals with any cancer treatment (chemotherapy or radiotherapy) administered 180 days or less prior to patient recruitment; or * Individuals with a cancer diagnosis in the Problem List 180 days or less prior to patient recruitment (patients with cancer surveillance only will be included in the study); or * Individuals with palliative care treatment administered 180 days or less prior to patient recruitment; or * Individuals with any end-of-life treatment (comfort care) prior to patient recruitment; or * Patients currently taking prescription medications (e.g. Suboxone, subutex, Buprenex, Butrans, Probuphine, Belbuca, buprenorphine/naloxone, Zubsolv, and Bunavail) for Opioid Use or other Substance Use Disorder treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS - Pain Interference Short Form 8a | Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures). | PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. A t-score of 50 represents the mean pain interference reported by a representative US population. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period. |
| CG-CAHPS | 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures). | The Consumer Assessment of Healthcare Providers and System Clinician and Group Survey (CG-CAHPS) is a widely used PRO for collecting and reporting information from patients' about their experiences of care. We used the How well providers communicate with patients 6-item composite score. The response scale for these items was Yes, definitely, Yes, somewhat, and No. The composite score was represented as a binary value indicating whether a PCP received all top-box scores (represented by Yes, definitely responses) on the 6 items. We report the count of top box responses in the pre- and post-intervention periods by group. Analysis featured a mixed effects logistic regression model for repeated measures where the term of interest was an interaction term describing the change in the odds of a top box score in the PEAT group during the post-intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Physical Function 6b v1.2 | Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures). | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period. |
| Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians | 1-year pre-intervention vs. 1 year post-intervention | Physicians should avoid increasing dosage to ≥90 MME/day, and this measure compares odds of writing prescriptions over 90mme pre- vs. post-intervention |
| Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians | 1-year pre-intervention vs. 1-year post-intervention | Physicians should avoid co-prescribing of opioids and benzodiazepines. This binary outcome captures the presence (or lack) of a written prescriptions for opioids within a 24-hour window on either side of a prescription for benzodiazepines. |
| Patient Health Questionnaire-9 (PHQ-9) | 1-year pre-intervention vs. 1-year post-intervention at all appointments (i.e. repeated measures). | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The raw score was categorized by severity according to the scoring guide and analyzed as such. Raw scores were assigned the following categories: 0-4, None; 5-9, Mild; 10-14, Moderate; 15-19, Moderately severe; and 20 or greater, Severe. We report the count of categorized PHQ-9 responses in the pre- (baseline characteristics) and post-intervention periods by group. Analysis featured a mixed effects ordered logistic regression model for repeated measures where the term of interest was an interaction describing the change in the odds of a top box score in the PEAT group during the post-intervention period. Analysis did not require balanced data (i.e. any scores in any time period meant patient was included). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinical Decision Support Patients within the physicians randomized to the IDM arm will receive the Clinical Decision Support alerts via the EHR when certain order criteria are triggered appropriately.
Clinical Decision Support: The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication. | 445 |
| Patient Education and Activation Tools Patients within the physicians randomized to SDM will receive the PEAT materials via REDCap two days prior to their PCP office visit. They will receive these materials every time they have an office visit with their PCP.
Patient Education and Activation Tools: The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication). | 506 |
| Total | 951 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 11 | 13 |
Baseline characteristics
| Characteristic | Clinical Decision Support | Patient Education and Activation Tools | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 128 Participants | 126 Participants | 254 Participants |
| Age, Categorical Between 18 and 65 years | 317 Participants | 380 Participants | 697 Participants |
| Age, Continuous | 55.38 years STANDARD_DEVIATION 16.01 | 53.57 years STANDARD_DEVIATION 16.08 | 54.42 years STANDARD_DEVIATION 16.07 |
| CAHPS® Clinician & Group Survey (CG-CAHPS) Not Top Box | 14 Responses | 24 Responses | 38 Responses |
| CAHPS® Clinician & Group Survey (CG-CAHPS) Top Box | 108 Responses | 79 Responses | 188 Responses |
| Co-prescription of Opioids and Benzodiazepines Co-Prescriptions | 40 prescriptions | 30 prescriptions | 70 prescriptions |
| Co-prescription of Opioids and Benzodiazepines Not Co-Prescriptions | 20 prescriptions | 86 prescriptions | 106 prescriptions |
| Opioid Prescription Over 90 Morphine Milligram Equivalents (MME) (Dichotomous) Rx Not Over 90 | 737 prescriptions | 1212 prescriptions | 1949 prescriptions |
| Opioid Prescription Over 90 Morphine Milligram Equivalents (MME) (Dichotomous) Rx Over 90 | 68 prescriptions | 210 prescriptions | 278 prescriptions |
| Patient Health Questionnaire-9 (PHQ-9) Mild | 20 Responses | 21 Responses | 41 Responses |
| Patient Health Questionnaire-9 (PHQ-9) Moderate | 34 Responses | 28 Responses | 62 Responses |
| Patient Health Questionnaire-9 (PHQ-9) Moderately Severe | 32 Responses | 31 Responses | 63 Responses |
| Patient Health Questionnaire-9 (PHQ-9) None | 633 Responses | 678 Responses | 1311 Responses |
| Patient Health Questionnaire-9 (PHQ-9) Severe | 23 Responses | 26 Responses | 49 Responses |
| PROMIS - Pain Interference Short Form 8a | 62.18 t-score STANDARD_DEVIATION 8.54 | 62.79 t-score STANDARD_DEVIATION 6.85 | 62.46 t-score STANDARD_DEVIATION 7.78 |
| PROMIS Physical Function 6b v1.2 | 38.82 t-score STANDARD_DEVIATION 9.24 | 38.32 t-score STANDARD_DEVIATION 7.39 | 38.59 t-score STANDARD_DEVIATION 8.41 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 29 Participants | 55 Participants |
| Race (NIH/OMB) Black or African American | 93 Participants | 120 Participants | 213 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 | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 41 Participants | 39 Participants | 80 Participants |
| Race (NIH/OMB) White | 283 Participants | 313 Participants | 596 Participants |
| Region of Enrollment United States | 445 participants | 506 participants | 951 participants |
| Sex: Female, Male Female | 262 Participants | 290 Participants | 552 Participants |
| Sex: Female, Male Male | 183 Participants | 216 Participants | 399 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 445 | 3 / 506 |
| other Total, other adverse events | 0 / 445 | 0 / 506 |
| serious Total, serious adverse events | 1 / 445 | 3 / 506 |
Outcome results
Primary
CG-CAHPS
The Consumer Assessment of Healthcare Providers and System Clinician and Group Survey (CG-CAHPS) is a widely used PRO for collecting and reporting information from patients' about their experiences of care. We used the How well providers communicate with patients 6-item composite score. The response scale for these items was Yes, definitely, Yes, somewhat, and No. The composite score was represented as a binary value indicating whether a PCP received all top-box scores (represented by Yes, definitely responses) on the 6 items. We report the count of top box responses in the pre- and post-intervention periods by group. Analysis featured a mixed effects logistic regression model for repeated measures where the term of interest was an interaction term describing the change in the odds of a top box score in the PEAT group during the post-intervention period.
Time frame: 1-year pre-intervention vs. 1-year post-intervention (i.e. repeated measures).
Population: Sample is limited to patients who returned a CG-CAHPS survey following a visit to their PCP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Decision Support | CG-CAHPS | Post-intervention : Top Box | 188 Responses |
| Clinical Decision Support | CG-CAHPS | Post-intervention : Not Top Box | 34 Responses |
| Patient Education and Activation Tools | CG-CAHPS | Post-intervention : Top Box | 194 Responses |
| Patient Education and Activation Tools | CG-CAHPS | Post-intervention : Not Top Box | 27 Responses |
Comparison: Question: Which communication strategy used during the clinical encounter is more effective in improving how satisfied patients feel over time after communicating with their physician about chronic pain treatment risks and benefits?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level.p-value: 0.01995% CI: [1.2, 7.31]Regression, Logistic
Primary
PROMIS - Pain Interference Short Form 8a
PROMIS - Pain Interference instruments assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Pain Interference, a T-score of 60 is one SD higher pain than average. A t-score of 50 represents the mean pain interference reported by a representative US population. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period.
Time frame: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).
Population: Consists of all participants who contributed at least one response to the PROMIS-PI survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Decision Support | PROMIS - Pain Interference Short Form 8a | 61.68 score on a scale | Standard Deviation 9.22 |
| Patient Education and Activation Tools | PROMIS - Pain Interference Short Form 8a | 60.26 score on a scale | Standard Deviation 9.51 |
Comparison: Question: Which communication strategy used during the clinical encounter is more effective in reducing pain interference over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level.p-value: 0.54195% CI: [-2.9, 1.52]Mixed Models Analysis
Secondary
Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians
Physicians should avoid co-prescribing of opioids and benzodiazepines. This binary outcome captures the presence (or lack) of a written prescriptions for opioids within a 24-hour window on either side of a prescription for benzodiazepines.
Time frame: 1-year pre-intervention vs. 1-year post-intervention
Population: These are patients who had at least one prescription for benzodiazepines as written by their PCP, and where PCP was included in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Decision Support | Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians | Co-Prescription | 196 prescriptions |
| Clinical Decision Support | Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians | Not Co-Prescription | 139 prescriptions |
| Patient Education and Activation Tools | Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians | Co-Prescription | 264 prescriptions |
| Patient Education and Activation Tools | Number of Opioid Co-prescription of Opioids and Benzodiazepines Written by Physicians | Not Co-Prescription | 168 prescriptions |
Comparison: Question: Which communication strategy used during the clinical encounter is more effective in reducing co-prescription of opioids and benzodiazepines over time for patients with chronic pain who were taking opioids at baseline?p-value: 0.5195% CI: [0.34, 1.71]Mixed Models Analysis
Secondary
Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians
Physicians should avoid increasing dosage to ≥90 MME/day, and this measure compares odds of writing prescriptions over 90mme pre- vs. post-intervention
Time frame: 1-year pre-intervention vs. 1 year post-intervention
Population: Includes patients with at least one Rx for opioids written by PCPs randomized in the study (i.e. does not include patients who had opioids written by physicians not included in the study).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Decision Support | Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians | Post-intervention Rx Over 90 | 208 prescriptions |
| Clinical Decision Support | Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians | Post-intervention Rx Not Over 90 | 3278 prescriptions |
| Patient Education and Activation Tools | Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians | Post-intervention Rx Over 90 | 679 prescriptions |
| Patient Education and Activation Tools | Number of Opioid Prescriptions Over 90 MME/Day Written by Physicians | Post-intervention Rx Not Over 90 | 3625 prescriptions |
Comparison: Question: Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 morphine milligrams equivalent (MME) over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level.p-value: 0.0195% CI: [1.13, 2.36]Mixed Models Analysis
Secondary
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The raw score was categorized by severity according to the scoring guide and analyzed as such. Raw scores were assigned the following categories: 0-4, None; 5-9, Mild; 10-14, Moderate; 15-19, Moderately severe; and 20 or greater, Severe. We report the count of categorized PHQ-9 responses in the pre- (baseline characteristics) and post-intervention periods by group. Analysis featured a mixed effects ordered logistic regression model for repeated measures where the term of interest was an interaction describing the change in the odds of a top box score in the PEAT group during the post-intervention period. Analysis did not require balanced data (i.e. any scores in any time period meant patient was included).
Time frame: 1-year pre-intervention vs. 1-year post-intervention at all appointments (i.e. repeated measures).
Population: Includes all subjects who had at least one PHQ-9 score in the medical record during the study period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinical Decision Support | Patient Health Questionnaire-9 (PHQ-9) | Mild | 9 participants |
| Clinical Decision Support | Patient Health Questionnaire-9 (PHQ-9) | Moderate | 17 participants |
| Clinical Decision Support | Patient Health Questionnaire-9 (PHQ-9) | Moderately Severe | 14 participants |
| Clinical Decision Support | Patient Health Questionnaire-9 (PHQ-9) | Severe | 4 participants |
| Clinical Decision Support | Patient Health Questionnaire-9 (PHQ-9) | None | 220 participants |
| Patient Education and Activation Tools | Patient Health Questionnaire-9 (PHQ-9) | None | 270 participants |
| Patient Education and Activation Tools | Patient Health Questionnaire-9 (PHQ-9) | Severe | 11 participants |
| Patient Education and Activation Tools | Patient Health Questionnaire-9 (PHQ-9) | Moderate | 23 participants |
| Patient Education and Activation Tools | Patient Health Questionnaire-9 (PHQ-9) | Mild | 16 participants |
| Patient Education and Activation Tools | Patient Health Questionnaire-9 (PHQ-9) | Moderately Severe | 15 participants |
Comparison: PHQ-9 was categorized by assigning scores of 0, 1, 2, and 3 to the response categories (not at all: several days, more than half the days, nearly every day, respectively) and then summing. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The analysis was conducted as a multilevel ordered logistic regression.p-value: 0.2695% CI: [0.76, 2.34]Regression, Logistic
Secondary
PROMIS Physical Function 6b v1.2
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. We report pre- and post-intervention means. Analysis featured a linear mixed model for repeated measures where the term of interest was an interaction term describing the change in the PEAT group during the post-intervention period.
Time frame: Assessed at baseline at randomization, monthly up to 20 months after start of intervention (i.e. repeated measures).
Population: Consists of all participants who contributed at least one response to the PROMIS-Physical Function survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinical Decision Support | PROMIS Physical Function 6b v1.2 | 38.26 score on a scale | Standard Deviation 9.38 |
| Patient Education and Activation Tools | PROMIS Physical Function 6b v1.2 | 39.35 score on a scale | Standard Deviation 9.29 |
Comparison: Question: Which communication strategy used during the clinical encounter is more effective in improving physical function over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level.p-value: 0.71995% CI: [-2.73, 1.88]Mixed Models Analysis