Chronic Pain
Conditions
Keywords
Pragmatic Clinical Trial, Comparative Effectiveness Research, Analgesics, Opioid, Decision Making, Shared, Motivational Interviewing, Cognitive Therapy, Patient Reported Outcome Measures, Chronic Pain, Pain, Neurologic Manifestations
Brief summary
Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life. This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States. The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient. The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later. The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.
Detailed description
Objective: To compare the effectiveness of individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) versus patient-clinician shared decision making (SDM) on change in daily dosage of prescribed opioids, physical functioning, and pain interference for individuals with chronic non-cancer pain (CNCP). Rationale: About 24% of Americans suffer from CNCP and clinicians often prescribe opioids to treat it. Once on chronic opioid therapy (COT), individuals often continue with this class of medication for years. Evidence for the effectiveness of COT to treat CNCP is limited, exposing individuals to known risks. Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction. Study Design and Approach: This was a large-scale, pragmatic randomized controlled trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings. A key eligibility criterion was individuals who were prescribed ≥ 20 milligrams of morphine equivalents for more than three months. Interventions: Researchers examined the comparative effectiveness of MI+CBT versus SDM for who are on COT. Neither approach is directive, and both support patient choice. Although MI+CBT and SDM are both behavioral intervention strategies, they differ in content covered and training of those delivering the intervention (behavioral vs. medical). Participants in both study arms received guideline-concordant pharmacotherapy treatment, based on clinical guidelines for opioid therapy for CNCP. Outcomes: * Primary: The change from baseline in average daily prescribed opioid dosage, measured in milligrams of morphine equivalents, at 12 months, with secondary time points at 6 months and 18 months * Secondary: The change from baseline to 6 and 12 months (primary timepoint) in the PROMIS Short Form v1.0 Pain Interference and PROMIS Short Form v1.0 Physical Function scales. Timeline: The project commenced in February 2018. Participant recruitment occurred from June 2019 to March 2022. Delivery of the intervention occurred on a rolling basis through March 2023. Recruitment, Screening, Enrollment, and Randomization: The study randomized 525 participants from primary care and pain clinics at three medical centers in North Carolina and Tennessee. The researchers identified individuals who were potentially eligible through electronic health records and invited them to participate. A Research Coordinator contacted individuals to complete screening, enrollment, and randomization. Data Collection: The researchers collected validated patient-reported outcomes through Web-based and phone-based surveys and leveraged existing harmonized electronic health record (EHR) data for clinical outcomes. Data Analysis: Outcomes were analyzed for all randomized participants in an intent-to-treat fashion, irrespective of the amount of intervention received. Because some individuals did not attend an intervention session, sensitivity analyses were based on a modified intent-to-treat population limited to participants receiving at least 1 intervention session and a per-protocol population limited to participants receiving at least four CBT or SDM sessions. Changes from baseline were analyzed with a repeated measures linear model accounting for correlation of measurements over time, with effects for intervention arm, time interval as a categorical predictor, intervention-by-time interaction, and adjustment for baseline value and study site. Differential treatment effects for two preplanned subgroups based on sex and prior mental health diagnosis, as defined by IDC-10 codes recorded in the EHR, were assessed at 12 months via a subgroup-by-intervention interaction within the repeated measures model. Qualitative research methods were used to obtain participant input on their experiences.
Interventions
BEHAVIORALShared Decision Making
The Shared Decision Making (SDM) intervention is a patient-provider communication intervention to explore and compare treatment options, assess a patient's values and preferences, and reach a shared decision about chronic pain treatment. Participants in the SDM arm received their regular pain care visits with a designated SDM-trained clinician over a 12-month period. SDM intervention participants scheduled pain visits as often as needed for pain management (typically quarterly). SDM participants also received an electronic and physical packet of educational materials after randomization.
BEHAVIORALMotivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain
The Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) intervention is an empirically based behavioral pain management behavioral therapy intervention, including MI to enhance motivation for active participation in the CBT-CP, and the use of CBT-CP to enhance pain coping skills. MI + CBT-CP participants received one MI session plus up to eight weekly CBT-CP group sessions.
Sponsors
Patient-Centered Outcomes Research Institute
University of North Carolina Health Care System
Duke Health
Vanderbilt University Medical Center
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned to one of two intervention arms for the duration of the study. The study used real-time 1:1 ratio randomization to limit participant loss prior to treatment. Eligible patients were randomized using a stratified, permuted-block design, as this constrained randomization approach ensured balance between treatment groups within each of the 3 clinical institutions (the only stratification factor) at the completion of each block. Consequently, throughout the trial, the intervention arms were expected to have approximately equal sample sizes both within an institution and across the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 85 years * History of chronic non-cancer pain (CNCP) * Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents * Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.
Exclusion criteria
* Not meeting the above inclusion criteria * Opioid use is for pain directly related to an active cancer diagnosis * Opioid use is for maintenance treatment of an opioid use disorder * Suicide attempt within the past 3 years * Active suicidal ideation * Currently receiving Cognitive-Behavioral Therapy (CBT) * Non-English speaking * Other reason at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12 | Month 12 (PRIMARY TIMEPOINT) | The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 12 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period. |
| Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18 | Month 18 | Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline. |
| Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15 | Month 15 | Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline. |
| Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9 | Month 9 | Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline. |
| Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6 | Month 6 | Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline. |
| Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3 | Month 3 | Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline. |
| Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12 | Month 12 | Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline. |
| Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18 | Month 18 | The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 18 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period. |
| Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15 | Month 15 | The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 15 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period. |
| Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9 | Month 9 | The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 9 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period. |
| Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6 | Month 6 | The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 6 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period. |
| Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3 | Month 3 | The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 3 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6 | Month 6 | The Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher T-scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score. |
| Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12 | Month 12 | The Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher T-scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score. |
| Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6 | Month 6 | The Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living. Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher T-scores indicate higher physical functioning and better health. Change = Month 6 Score - Baseline Score. |
| Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12 | Month 12 | The Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living. Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher T-scores indicate higher physical functioning and better health. Change = Month 12 Score - Baseline Score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 12 | Month 12 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety is a validated, self-reported instrument assessing anxiety over the past 7 days. Anxiety measures self-reported fear, anxiety, hyperarousal, and somatic symptoms related to arousal. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher anxiety and worse health. Change = Month 12 Score - Baseline Score. |
| Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 6 | Month 6 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety is a validated, self-reported instrument assessing anxiety over the past 7 days. Anxiety measures self-reported fear, anxiety, hyperarousal, and somatic symptoms related to arousal. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher anxiety and worse health. Change = Month 6 Score - Baseline Score. |
| Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 12 | Month 12 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity is a validated, self-reported instrument assessing pain intensity over the past 7 days. Possible scores on each item range in value from 1 (no pain) to 5 (very severe). Higher T-scores indicate higher pain intensity and worse health. Change = Month 12 Score - Baseline Score. |
| Intent to Taper at Month 12 | Month 12 | Intent to Taper was assessed with a self-reported item, newly developed for this study, that assessed intent to reduce the amount of opioids taken: Please say how much you agree with this statement: 'Reducing the amount of opioid medicines I take is a goal of mine.' Possible response options included Strongly Agree, Agree, Uncertain, Disagree, and Strongly Disagree. Responses of Strongly Agree or Agree were categorized as an intent to taper, and responses of Uncertain, Disagree, Strongly Disagree, or Don't Know were categorized as no intent to taper. |
| Intent to Taper at Month 6 | Month 6 | Intent to Taper was assessed with a self-reported item, newly developed for this study, that assessed intent to reduce the amount of opioids taken: Please say how much you agree with this statement: 'Reducing the amount of opioid medicines I take is a goal of mine.' Possible response options included Strongly Agree, Agree, Uncertain, Disagree, and Strongly Disagree. Responses of Strongly Agree or Agree were categorized as an intent to taper, and responses of Uncertain, Disagree, Strongly Disagree, or Don't Know were categorized as no intent to taper. |
| Discontinuation of Opioid Medications at Month 12 | Month 12 | Discontinuation of opioid medications at Month 12 was assessed with a self-reported item newly developed for this study and electronic health record (EHR) data. Discontinuation was defined as a response of No to a question on the Month 12 participant survey that asked: Are you currently taking an opioid medicine now? Commonly prescribed opioids include hydrocodone, oxycodone, codeine, morphine, and fentanyl AND no opioid prescriptions in the EHR within 15 days prior to Month 12 through Month 18. |
| Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 12 | Month 12 | The Brief Pain Inventory (BPI) Pain Interference is a validated, self-reported instrument assessing pain interference over the past 7 days in 7 categories: general activity, walking, work, mood, enjoyment of life, relation with others, and sleep. Possible scores on each item range from 0 (does not interfere) to 10 (completely interferes). Higher scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score. |
| Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 6 | Month 6 | The Brief Pain Inventory (BPI) Pain Interference is a validated, self-reported instrument assessing pain interference over the past 7 days in 7 categories: general activity, walking, work, mood, enjoyment of life, relation with others, and sleep. Possible scores on each item range from 0 (does not interfere) to 10 (completely interferes). Higher scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score. |
| Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 12 | Month 12 | The Brief Pain Inventory (BPI) Pain Severity is a validated, self-reported instrument assessing pain severity at its worst and least in the past 7 days, on average, and right now. Possible scores on each item range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate higher pain severity and worse health. Change = Month 12 Score - Baseline Score. |
| Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 6 | Month 6 | The Brief Pain Inventory (BPI) Pain Severity is a validated, self-reported instrument assessing pain severity at its worst and least in the past 7 days, on average, and right now. Possible scores on each item range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate higher pain severity and worse health. Change = Month 6 Score - Baseline Score. |
| Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 12 | Month 12 | The Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Depression is a validated, self-reported instrument assessing depression over the past 7 days. Depression measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher depression and worse health. Change = Month 12 Score - Baseline Score. |
| Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 6 | Month 6 | The Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Depression is a validated, self-reported instrument assessing depression over the past 7 days. Depression measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher depression and worse health. Change = Month 6 Score - Baseline Score. |
| Relative Opioid Use Self-report at Month 6 | Month 6 | Opioid use relative to baseline was assessed with a self-reported item, newly developed for this study: Since you started taking part in this study, would you say that your overall use of opioids has increased, stayed about the same, or decreased? In thinking about your overall use we ask you consider how often you take the opioid medicine, the different types of opioid medicines, and their amounts. Possible response options included: My overall use of opioids has increased; My overall use of opioids has stayed about the same; and My overall use of opioids has decreased. |
| Relative Opioid Use Self-report at Month 12 | Month 12 | Opioid use relative to baseline was assessed with a self-reported item, newly developed for this study: Since you started taking part in this study, would you say that your overall use of opioids has increased, stayed about the same, or decreased? In thinking about your overall use we ask you consider how often you take the opioid medicine, the different types of opioid medicines, and their amounts. Possible response options included: My overall use of opioids has increased; My overall use of opioids has stayed about the same; and My overall use of opioids has decreased. |
| Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 6 | Month 6 | The Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity is a validated, self-reported instrument assessing pain intensity over the past 7 days. Possible scores on each item range in value from 1 (no pain) to 5 (very severe). Higher T-scores indicate higher pain intensity and worse health. Change = Month 6 Score - Baseline Score. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 3 academic health systems between June 26, 2019 and March 31, 2022.
Pre-assignment details
Of 543 consented participants, 525 were randomized to treatment. Of those not randomized, 7 were lost to follow-up, 6 were determined ineligible after consent, 1 withdrew consent, 2 were withdrawn by an investigator, and 2 were not randomized for reasons unknown.
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) participants received the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the MI+CBT-CP intervention. MI + CBT-CP participants received one MI session plus up to eight weekly CBT-CP group sessions. | 263 |
| Shared Decision Making (SDM) Shared Decision Making (SDM) participants received guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the SDM intervention during their opioid management visits. Participants in the SDM arm received their regular pain care visits with a designated SDM-trained clinician over a 12-month period. SDM intervention participants scheduled pain visits as often as needed for pain management (typically quarterly). SDM participants also received an electronic and physical packet of educational materials after randomization. | 262 |
| Total | 525 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 6 |
| Overall Study | Ineligible | 1 | 5 |
| Overall Study | Lost to Follow-up | 31 | 12 |
| Overall Study | Physician Decision | 2 | 6 |
| Overall Study | Withdrawal by Subject | 34 | 5 |
Baseline characteristics
| Characteristic | Shared Decision Making (SDM) | Total | Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) |
|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 11.6 | 58.0 years STANDARD_DEVIATION 11.5 | 57.4 years STANDARD_DEVIATION 11.3 |
| Average Daily Opioid Dose Categories High (90+ MME) | 65 Participants | 151 Participants | 86 Participants |
| Average Daily Opioid Dose Categories Low (20 - <50 MME) | 104 Participants | 197 Participants | 93 Participants |
| Average Daily Opioid Dose Categories Moderate (50 - <90 MME) | 64 Participants | 116 Participants | 52 Participants |
| Average Daily Opioid Dose Categories None | 5 Participants | 11 Participants | 6 Participants |
| Average Daily Opioid Dose Categories Very Low (<20 MME) | 24 Participants | 50 Participants | 26 Participants |
| Average Daily Opioid Dose (in Morphine Milligram Equivalents [MME]) | 50 Morphine Milligram Equivalents | 53 Morphine Milligram Equivalents | 59 Morphine Milligram Equivalents |
| Body Mass Index Not Obese (BMI < 30) | 120 Participants | 225 Participants | 105 Participants |
| Body Mass Index Obese (BMI >=30) | 142 Participants | 300 Participants | 158 Participants |
| Brief Pain Index (BPI) Pain Severity Mild | 10 Participants | 13 Participants | 3 Participants |
| Brief Pain Index (BPI) Pain Severity Missing | 0 Participants | 2 Participants | 2 Participants |
| Brief Pain Index (BPI) Pain Severity Moderate | 176 Participants | 365 Participants | 189 Participants |
| Brief Pain Index (BPI) Pain Severity Severe | 76 Participants | 145 Participants | 69 Participants |
| Charlson Comorbidity Index (CCI) categories based on diagnosis codes 1 or more CGI Index Categories | 127 Participants | 262 Participants | 135 Participants |
| Charlson Comorbidity Index (CCI) categories based on diagnosis codes None | 135 Participants | 263 Participants | 128 Participants |
| Education Bachelor's degree or more | 79 Participants | 168 Participants | 89 Participants |
| Education High school degree (or General Education Diploma [GED]) or less | 86 Participants | 158 Participants | 72 Participants |
| Education Missing | 0 Participants | 2 Participants | 2 Participants |
| Education Some college or a 2-year degree | 97 Participants | 197 Participants | 100 Participants |
| Employment Status Missing | 0 Participants | 2 Participants | 2 Participants |
| Employment Status Not employed for health reasons or disabled | 140 Participants | 283 Participants | 143 Participants |
| Employment Status Not employed, retired | 64 Participants | 121 Participants | 57 Participants |
| Employment Status Other (looking for work, in school, homemaker) | 16 Participants | 22 Participants | 6 Participants |
| Employment Status Working part- or full-time | 42 Participants | 97 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 254 Participants | 506 Participants | 252 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 6 Participants |
| Health Literacy Level Average | 114 Participants | 228 Participants | 114 Participants |
| Health Literacy Level High | 89 Participants | 186 Participants | 97 Participants |
| Health Literacy Level Low | 59 Participants | 109 Participants | 50 Participants |
| Health Literacy Level Missing | 0 Participants | 2 Participants | 2 Participants |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-Score | 65.9 units on a scale (T-Score) STANDARD_DEVIATION 6 | 65.8 units on a scale (T-Score) STANDARD_DEVIATION 5.9 | 65.8 units on a scale (T-Score) STANDARD_DEVIATION 5.9 |
| Presence of 1+ Comorbid Mental Health Diagnoses No | 154 Participants | 298 Participants | 144 Participants |
| Presence of 1+ Comorbid Mental Health Diagnoses Yes | 108 Participants | 227 Participants | 119 Participants |
| Presence of Substance Use Disorder Diagnosis Code No | 193 Participants | 390 Participants | 197 Participants |
| Presence of Substance Use Disorder Diagnosis Code Yes | 69 Participants | 135 Participants | 66 Participants |
| PROMIS Physical Functioning T-Score | 35.1 units on a scale (T-Score) STANDARD_DEVIATION 6.3 | 34.7 units on a scale (T-Score) STANDARD_DEVIATION 6.2 | 34.4 units on a scale (T-Score) STANDARD_DEVIATION 6 |
| Race/Ethnicity, Customized Race Black or African American | 57 Participants | 124 Participants | 67 Participants |
| Race/Ethnicity, Customized Race Missing | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Multiracial | 9 Participants | 20 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Other | 12 Participants | 23 Participants | 11 Participants |
| Race/Ethnicity, Customized Race White | 182 Participants | 352 Participants | 170 Participants |
| Sex/Gender, Customized Sex at Birth Female | 163 Participants | 330 Participants | 167 Participants |
| Sex/Gender, Customized Sex at Birth Male | 99 Participants | 192 Participants | 93 Participants |
| Sex/Gender, Customized Sex at Birth Missing | 0 Participants | 3 Participants | 3 Participants |
| Study Site Duke University | 90 Participants | 181 Participants | 91 Participants |
| Study Site University of North Carolina at Chapel Hill (UNC) | 86 Participants | 173 Participants | 87 Participants |
| Study Site Vanderbilt University Medical Center (VUMC) | 86 Participants | 171 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 262 | 6 / 263 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 21 / 262 | 17 / 263 |
Outcome results
Primary
Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 6 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Time frame: Month 6
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6 | -5.9 Morphine Milligram Equivalents (MME) |
| Shared Decision Making (SDM) | Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6 | 0.3 Morphine Milligram Equivalents (MME) |
p-value: 0.25395% CI: [-16.8, 4.4]Mixed Models Analysis
Primary
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 12 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Time frame: Month 12 (PRIMARY TIMEPOINT)
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12 | -11.6 Morphine Milligram Equivalents (MME) |
| Shared Decision Making (SDM) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12 | -6.0 Morphine Milligram Equivalents (MME) |
p-value: 0.3195% CI: [-16.6, 5.3]Mixed Models Analysis
Primary
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 15 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Time frame: Month 15
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15 | -9.4 Morphine Milligram Equivalents (MME) |
| Shared Decision Making (SDM) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15 | -6.8 Morphine Milligram Equivalents (MME) |
p-value: 0.6595% CI: [-13.7, 8.6]Mixed Models Analysis
Primary
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 18 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Time frame: Month 18
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18 | -3.1 Morphine Milligram Equivalents (MME) |
| Shared Decision Making (SDM) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18 | -12.5 Morphine Milligram Equivalents (MME) |
p-value: 0.10295% CI: [-1.9, 20.8]Mixed Models Analysis
Primary
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 3 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Time frame: Month 3
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3 | 0.0 Morphine Milligram Equivalents (MME) |
| Shared Decision Making (SDM) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3 | -0.3 Morphine Milligram Equivalents (MME) |
p-value: 0.96395% CI: [-10.3, 10.7]Mixed Models Analysis
Primary
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9
The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was then multiplied by conversion factors to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 9 months post-randomization. Change in daily opioid dose was computed as the difference between the dose calculated during that period and the dose from the baseline period.
Time frame: Month 9
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9 | -6.6 Morphine Milligram Equivalents (MME) |
| Shared Decision Making (SDM) | Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9 | -7.3 Morphine Milligram Equivalents (MME) |
p-value: 0.995% CI: [-10.1, 11.5]Mixed Models Analysis
Primary
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Time frame: Month 12
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12 | 0.29 Estimated proportion |
| Shared Decision Making (SDM) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12 | 0.30 Estimated proportion |
p-value: 0.8395% CI: [0.5, 1.75]Mixed Models Analysis
Primary
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Time frame: Month 15
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15 | 0.30 Estimated proportion |
| Shared Decision Making (SDM) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15 | 0.32 Estimated proportion |
p-value: 0.7595% CI: [0.47, 1.71]Mixed Models Analysis
Primary
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Time frame: Month 18
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18 | 0.26 Estimated proportion |
| Shared Decision Making (SDM) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18 | 0.35 Estimated proportion |
p-value: 0.2595% CI: [0.35, 1.31]Mixed Models Analysis
Primary
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Time frame: Month 3
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3 | 0.13 Estimated proportion |
| Shared Decision Making (SDM) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3 | 0.16 Estimated proportion |
p-value: 0.4795% CI: [0.42, 1.5]Mixed Models Analysis
Primary
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Time frame: Month 6
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6 | 0.21 Estimated proportion |
| Shared Decision Making (SDM) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6 | 0.21 Estimated proportion |
p-value: 0.9695% CI: [0.54, 1.9]Mixed Models Analysis
Primary
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9
Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.
Time frame: Month 9
Population: Intent-to-treat population; those missing EHR prescription data at a certain timepoint did not contribute data for that timepoint in the mixed repeated measures model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9 | 0.22 Estimated proportion |
| Shared Decision Making (SDM) | Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9 | 0.28 Estimated proportion |
p-value: 0.2895% CI: [0.38, 1.33]Mixed Models Analysis
Secondary
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12
The Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher T-scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 1 participant in the CBT arm and 5 in the SDM arm did not complete the entire 12-month survey, but did complete the PROMIS Pain Interference section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12 | 0.1 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12 | 0.0 units on a scale (T-score) |
p-value: 0.9295% CI: [-1.1, 1.2]Mixed Models Analysis
Secondary
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6
The Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher T-scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey. 1 participant in the SDM arm did not complete the entire 6-month survey, but did complete the PROMIS Pain Interference section of the survey and was included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6 | 0.5 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6 | 0.3 units on a scale (T-score) |
p-value: 0.795% CI: [-0.9, 1.4]Mixed Models Analysis
Secondary
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12
The Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living. Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher T-scores indicate higher physical functioning and better health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 1 participant in the CBT arm and 5 in the SDM arm did not complete the entire 12-month survey, but did complete the PROMIS Physical Functioning section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12 | -0.3 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12 | -0.5 units on a scale (T-score) |
p-value: 0.7595% CI: [-0.8, 1.1]Mixed Models Analysis
Secondary
Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6
The Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living. Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher T-scores indicate higher physical functioning and better health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6 | -0.4 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6 | -0.6 units on a scale (T-score) |
p-value: 0.6495% CI: [-0.7, 1.2]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 12
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety is a validated, self-reported instrument assessing anxiety over the past 7 days. Anxiety measures self-reported fear, anxiety, hyperarousal, and somatic symptoms related to arousal. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher anxiety and worse health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 3 participants in the SDM arm did not complete the entire 12-month survey, but did complete the PROMIS Anxiety section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 12 | 1.9 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 12 | 1.7 units on a scale (T-score) |
p-value: 0.7695% CI: [-1.4, 1.9]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 6
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety is a validated, self-reported instrument assessing anxiety over the past 7 days. Anxiety measures self-reported fear, anxiety, hyperarousal, and somatic symptoms related to arousal. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher anxiety and worse health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey. 1 participant in the SDM arm did not complete the entire 6-month survey, but did complete the PROMIS Anxiety section of the survey and was included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 6 | 1.7 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 6 | 1.8 units on a scale (T-score) |
p-value: 0.8695% CI: [-1.8, 1.5]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 12
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Depression is a validated, self-reported instrument assessing depression over the past 7 days. Depression measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher depression and worse health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 3 participants in the SDM arm did not complete the entire 12-month survey, but did complete the PROMIS Depression section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 12 | 1.5 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 12 | 2.0 units on a scale (T-score) |
p-value: 0.5295% CI: [-2.1, 1.1]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 6
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Depression is a validated, self-reported instrument assessing depression over the past 7 days. Depression measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher depression and worse health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 6 | 1.3 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 6 | 1.7 units on a scale (T-score) |
p-value: 0.5595% CI: [-2, 1.1]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 12
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity is a validated, self-reported instrument assessing pain intensity over the past 7 days. Possible scores on each item range in value from 1 (no pain) to 5 (very severe). Higher T-scores indicate higher pain intensity and worse health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 1 participant in the CBT arm and 3 in the SDM arm did not complete the entire 12-month survey, but did complete the PROMIS Pain Intensity section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 12 | -0.9 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 12 | -1.5 units on a scale (T-score) |
p-value: 0.3395% CI: [-0.6, 1.8]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 6
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity is a validated, self-reported instrument assessing pain intensity over the past 7 days. Possible scores on each item range in value from 1 (no pain) to 5 (very severe). Higher T-scores indicate higher pain intensity and worse health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey. 1 participant in the SDM arm did not complete the entire 6-month survey, but did complete the PROMIS Pain Intensity section of the survey and was included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 6 | -0.8 units on a scale (T-score) |
| Shared Decision Making (SDM) | Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 6 | -1.0 units on a scale (T-score) |
p-value: 0.6995% CI: [-0.9, 1.4]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 12
The Brief Pain Inventory (BPI) Pain Interference is a validated, self-reported instrument assessing pain interference over the past 7 days in 7 categories: general activity, walking, work, mood, enjoyment of life, relation with others, and sleep. Possible scores on each item range from 0 (does not interfere) to 10 (completely interferes). Higher scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 3 participants in the SDM arm did not complete the entire 12-month survey, but did complete the BPI Pain Interference section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 12 | 0.1 units on a scale |
| Shared Decision Making (SDM) | Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 12 | -0.1 units on a scale |
p-value: 0.4695% CI: [-0.3, 0.6]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 6
The Brief Pain Inventory (BPI) Pain Interference is a validated, self-reported instrument assessing pain interference over the past 7 days in 7 categories: general activity, walking, work, mood, enjoyment of life, relation with others, and sleep. Possible scores on each item range from 0 (does not interfere) to 10 (completely interferes). Higher scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 6 | 0.0 units on a scale |
| Shared Decision Making (SDM) | Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 6 | -0.2 units on a scale |
p-value: 0.3395% CI: [-0.2, 0.6]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 12
The Brief Pain Inventory (BPI) Pain Severity is a validated, self-reported instrument assessing pain severity at its worst and least in the past 7 days, on average, and right now. Possible scores on each item range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate higher pain severity and worse health. Change = Month 12 Score - Baseline Score.
Time frame: Month 12
Population: Intent-to-treat population among those that completed a 12-month survey. 3 participants in the SDM arm did not complete the entire 12-month survey, but did complete the BPI Pain Severity section of the survey and were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 12 | -0.2 units on a scale |
| Shared Decision Making (SDM) | Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 12 | -0.2 units on a scale |
p-value: 0.9195% CI: [-0.3, 0.3]Mixed Models Analysis
Other Pre-specified
Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 6
The Brief Pain Inventory (BPI) Pain Severity is a validated, self-reported instrument assessing pain severity at its worst and least in the past 7 days, on average, and right now. Possible scores on each item range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate higher pain severity and worse health. Change = Month 6 Score - Baseline Score.
Time frame: Month 6
Population: Intent-to-treat population among those that completed a 6-month survey.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 6 | -0.1 units on a scale |
| Shared Decision Making (SDM) | Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 6 | -0.2 units on a scale |
p-value: 0.3795% CI: [-0.2, 0.4]Mixed Models Analysis
Other Pre-specified
Discontinuation of Opioid Medications at Month 12
Discontinuation of opioid medications at Month 12 was assessed with a self-reported item newly developed for this study and electronic health record (EHR) data. Discontinuation was defined as a response of No to a question on the Month 12 participant survey that asked: Are you currently taking an opioid medicine now? Commonly prescribed opioids include hydrocodone, oxycodone, codeine, morphine, and fentanyl AND no opioid prescriptions in the EHR within 15 days prior to Month 12 through Month 18.
Time frame: Month 12
Population: Intent-to-treat population and those that completed the 12-month survey; 2 participants in the SDM arm did not complete the entire 12-month survey but did complete the self-report use of opioid medication section and were included in the analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Discontinuation of Opioid Medications at Month 12 | Taking an opioid prescription at 12 months | 119 Participants |
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Discontinuation of Opioid Medications at Month 12 | Discontinued opioid prescription at 12 months | 10 Participants |
| Shared Decision Making (SDM) | Discontinuation of Opioid Medications at Month 12 | Taking an opioid prescription at 12 months | 145 Participants |
| Shared Decision Making (SDM) | Discontinuation of Opioid Medications at Month 12 | Discontinued opioid prescription at 12 months | 9 Participants |
p-value: 0.5295% CI: [-0.08, 0.04]Chi-squared
Other Pre-specified
Intent to Taper at Month 12
Intent to Taper was assessed with a self-reported item, newly developed for this study, that assessed intent to reduce the amount of opioids taken: Please say how much you agree with this statement: 'Reducing the amount of opioid medicines I take is a goal of mine.' Possible response options included Strongly Agree, Agree, Uncertain, Disagree, and Strongly Disagree. Responses of Strongly Agree or Agree were categorized as an intent to taper, and responses of Uncertain, Disagree, Strongly Disagree, or Don't Know were categorized as no intent to taper.
Time frame: Month 12
Population: Intent-to-treat population among those that completed this specific question on the 12-month survey. If participant reported not currently taking an opioid at the 12-month survey, this question was skipped.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Intent to Taper at Month 12 | 0.62 Estimated proportion |
| Shared Decision Making (SDM) | Intent to Taper at Month 12 | 0.57 Estimated proportion |
p-value: 0.4195% CI: [0.71, 2.31]Mixed Models Analysis
Other Pre-specified
Intent to Taper at Month 6
Intent to Taper was assessed with a self-reported item, newly developed for this study, that assessed intent to reduce the amount of opioids taken: Please say how much you agree with this statement: 'Reducing the amount of opioid medicines I take is a goal of mine.' Possible response options included Strongly Agree, Agree, Uncertain, Disagree, and Strongly Disagree. Responses of Strongly Agree or Agree were categorized as an intent to taper, and responses of Uncertain, Disagree, Strongly Disagree, or Don't Know were categorized as no intent to taper.
Time frame: Month 6
Population: Intent-to-treat population among those that completed this specific question on the 6-month survey. If participant reported not currently taking an opioid at the 6-month survey, this question was skipped.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Intent to Taper at Month 6 | 0.66 Estimated proportion |
| Shared Decision Making (SDM) | Intent to Taper at Month 6 | 0.56 Estimated proportion |
p-value: 0.1795% CI: [0.85, 2.59]Mixed Models Analysis
Other Pre-specified
Relative Opioid Use Self-report at Month 12
Opioid use relative to baseline was assessed with a self-reported item, newly developed for this study: Since you started taking part in this study, would you say that your overall use of opioids has increased, stayed about the same, or decreased? In thinking about your overall use we ask you consider how often you take the opioid medicine, the different types of opioid medicines, and their amounts. Possible response options included: My overall use of opioids has increased; My overall use of opioids has stayed about the same; and My overall use of opioids has decreased.
Time frame: Month 12
Population: Intent-to-treat population among those that completed this specific question on the 12-month survey. If participant reported not currently taking an opioid at the 12-month survey, this question was skipped.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Relative Opioid Use Self-report at Month 12 | Opioid Use has Increased since Study Start | 8 Participants |
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Relative Opioid Use Self-report at Month 12 | Opioid Use has Stayed about the Same since Study Start | 71 Participants |
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Relative Opioid Use Self-report at Month 12 | Opioid Use has Decreased since Study Start | 29 Participants |
| Shared Decision Making (SDM) | Relative Opioid Use Self-report at Month 12 | Opioid Use has Increased since Study Start | 10 Participants |
| Shared Decision Making (SDM) | Relative Opioid Use Self-report at Month 12 | Opioid Use has Stayed about the Same since Study Start | 92 Participants |
| Shared Decision Making (SDM) | Relative Opioid Use Self-report at Month 12 | Opioid Use has Decreased since Study Start | 28 Participants |
p-value: 0.67Chi-squared
Other Pre-specified
Relative Opioid Use Self-report at Month 6
Opioid use relative to baseline was assessed with a self-reported item, newly developed for this study: Since you started taking part in this study, would you say that your overall use of opioids has increased, stayed about the same, or decreased? In thinking about your overall use we ask you consider how often you take the opioid medicine, the different types of opioid medicines, and their amounts. Possible response options included: My overall use of opioids has increased; My overall use of opioids has stayed about the same; and My overall use of opioids has decreased.
Time frame: Month 6
Population: Intent-to-treat population among those that completed this specific question on the 6-month survey. If participant reported not currently taking an opioid at the 6-month survey, this question was skipped.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Relative Opioid Use Self-report at Month 6 | Opioid Use Increased since Study Start | 13 Participants |
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Relative Opioid Use Self-report at Month 6 | Opioid Use Stayed About the Same since Study Start | 83 Participants |
| Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) | Relative Opioid Use Self-report at Month 6 | Opioid Use Decreased since Study Start | 26 Participants |
| Shared Decision Making (SDM) | Relative Opioid Use Self-report at Month 6 | Opioid Use Increased since Study Start | 13 Participants |
| Shared Decision Making (SDM) | Relative Opioid Use Self-report at Month 6 | Opioid Use Stayed About the Same since Study Start | 89 Participants |
| Shared Decision Making (SDM) | Relative Opioid Use Self-report at Month 6 | Opioid Use Decreased since Study Start | 33 Participants |
p-value: 0.79Chi-squared