Trial Outcomes & Findings for Integrated Services for Pain: Interventions to Reduce Pain Effectively (NCT NCT03454555)
NCT ID: NCT03454555
Last Updated: 2025-08-12
Results Overview
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.
COMPLETED
NA
543 participants
Month 12 (PRIMARY TIMEPOINT)
2025-08-12
Participant Flow
Participants were recruited at 3 academic health systems between June 26, 2019 and March 31, 2022.
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those not randomized, 7 were lost to follow-up, 6 were determined ineligible after consent, 1 withdrew consent, 2 were withdrawn by an investigator, and 2 were not randomized for reasons unknown.
Participant milestones
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
Motivational Interviewing (MI) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) \[MI+CBT-CP\] 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
263
|
262
|
|
Overall Study
COMPLETED
|
189
|
228
|
|
Overall Study
NOT COMPLETED
|
74
|
34
|
Reasons for withdrawal
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
Motivational Interviewing (MI) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) \[MI+CBT-CP\] 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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
31
|
12
|
|
Overall Study
Physician Decision
|
2
|
6
|
|
Overall Study
Withdrawal by Subject
|
34
|
5
|
|
Overall Study
Ineligible
|
1
|
5
|
Baseline Characteristics
Age was unknown or not reported for 8 participants.
Baseline characteristics by cohort
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=263 Participants
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.
|
Shared Decision Making (SDM)
n=262 Participants
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.
|
Total
n=525 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 11.3 • n=259 Participants • Age was unknown or not reported for 8 participants.
|
58.6 years
STANDARD_DEVIATION 11.6 • n=258 Participants • Age was unknown or not reported for 8 participants.
|
58.0 years
STANDARD_DEVIATION 11.5 • n=517 Participants • Age was unknown or not reported for 8 participants.
|
|
Sex/Gender, Customized
Sex at Birth · Female
|
167 Participants
n=263 Participants
|
163 Participants
n=262 Participants
|
330 Participants
n=525 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Male
|
93 Participants
n=263 Participants
|
99 Participants
n=262 Participants
|
192 Participants
n=525 Participants
|
|
Sex/Gender, Customized
Sex at Birth · Missing
|
3 Participants
n=263 Participants
|
0 Participants
n=262 Participants
|
3 Participants
n=525 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=263 Participants
|
6 Participants
n=262 Participants
|
11 Participants
n=525 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
252 Participants
n=263 Participants
|
254 Participants
n=262 Participants
|
506 Participants
n=525 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=263 Participants
|
2 Participants
n=262 Participants
|
8 Participants
n=525 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
67 Participants
n=263 Participants
|
57 Participants
n=262 Participants
|
124 Participants
n=525 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
170 Participants
n=263 Participants
|
182 Participants
n=262 Participants
|
352 Participants
n=525 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
11 Participants
n=263 Participants
|
12 Participants
n=262 Participants
|
23 Participants
n=525 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
11 Participants
n=263 Participants
|
9 Participants
n=262 Participants
|
20 Participants
n=525 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
4 Participants
n=263 Participants
|
2 Participants
n=262 Participants
|
6 Participants
n=525 Participants
|
|
Study Site
University of North Carolina at Chapel Hill (UNC)
|
87 Participants
n=263 Participants
|
86 Participants
n=262 Participants
|
173 Participants
n=525 Participants
|
|
Study Site
Duke University
|
91 Participants
n=263 Participants
|
90 Participants
n=262 Participants
|
181 Participants
n=525 Participants
|
|
Study Site
Vanderbilt University Medical Center (VUMC)
|
85 Participants
n=263 Participants
|
86 Participants
n=262 Participants
|
171 Participants
n=525 Participants
|
|
Education
High school degree (or General Education Diploma [GED]) or less
|
72 Participants
n=263 Participants
|
86 Participants
n=262 Participants
|
158 Participants
n=525 Participants
|
|
Education
Some college or a 2-year degree
|
100 Participants
n=263 Participants
|
97 Participants
n=262 Participants
|
197 Participants
n=525 Participants
|
|
Education
Bachelor's degree or more
|
89 Participants
n=263 Participants
|
79 Participants
n=262 Participants
|
168 Participants
n=525 Participants
|
|
Education
Missing
|
2 Participants
n=263 Participants
|
0 Participants
n=262 Participants
|
2 Participants
n=525 Participants
|
|
Health Literacy Level
High
|
97 Participants
n=263 Participants
|
89 Participants
n=262 Participants
|
186 Participants
n=525 Participants
|
|
Health Literacy Level
Average
|
114 Participants
n=263 Participants
|
114 Participants
n=262 Participants
|
228 Participants
n=525 Participants
|
|
Health Literacy Level
Low
|
50 Participants
n=263 Participants
|
59 Participants
n=262 Participants
|
109 Participants
n=525 Participants
|
|
Health Literacy Level
Missing
|
2 Participants
n=263 Participants
|
0 Participants
n=262 Participants
|
2 Participants
n=525 Participants
|
|
Employment Status
Working part- or full-time
|
55 Participants
n=263 Participants
|
42 Participants
n=262 Participants
|
97 Participants
n=525 Participants
|
|
Employment Status
Not employed, retired
|
57 Participants
n=263 Participants
|
64 Participants
n=262 Participants
|
121 Participants
n=525 Participants
|
|
Employment Status
Not employed for health reasons or disabled
|
143 Participants
n=263 Participants
|
140 Participants
n=262 Participants
|
283 Participants
n=525 Participants
|
|
Employment Status
Other (looking for work, in school, homemaker)
|
6 Participants
n=263 Participants
|
16 Participants
n=262 Participants
|
22 Participants
n=525 Participants
|
|
Employment Status
Missing
|
2 Participants
n=263 Participants
|
0 Participants
n=262 Participants
|
2 Participants
n=525 Participants
|
|
Body Mass Index
Obese (BMI >=30)
|
158 Participants
n=263 Participants
|
142 Participants
n=262 Participants
|
300 Participants
n=525 Participants
|
|
Body Mass Index
Not Obese (BMI < 30)
|
105 Participants
n=263 Participants
|
120 Participants
n=262 Participants
|
225 Participants
n=525 Participants
|
|
Average Daily Opioid Dose (in Morphine Milligram Equivalents [MME])
|
59 Morphine Milligram Equivalents
n=257 Participants • Eleven participants did not have an opioid prescription during the baseline period (defined as 3 months before enrollment): 5 had an opioid prescribed at an outside clinic and later transferred to the study clinic, 4 received an opioid just before the baseline period, and 2 received a type of opioid (e.g., injectable) that was not included in the study.
|
50 Morphine Milligram Equivalents
n=257 Participants • Eleven participants did not have an opioid prescription during the baseline period (defined as 3 months before enrollment): 5 had an opioid prescribed at an outside clinic and later transferred to the study clinic, 4 received an opioid just before the baseline period, and 2 received a type of opioid (e.g., injectable) that was not included in the study.
|
53 Morphine Milligram Equivalents
n=514 Participants • Eleven participants did not have an opioid prescription during the baseline period (defined as 3 months before enrollment): 5 had an opioid prescribed at an outside clinic and later transferred to the study clinic, 4 received an opioid just before the baseline period, and 2 received a type of opioid (e.g., injectable) that was not included in the study.
|
|
Average Daily Opioid Dose Categories
None
|
6 Participants
n=263 Participants
|
5 Participants
n=262 Participants
|
11 Participants
n=525 Participants
|
|
Average Daily Opioid Dose Categories
Very Low (<20 MME)
|
26 Participants
n=263 Participants
|
24 Participants
n=262 Participants
|
50 Participants
n=525 Participants
|
|
Average Daily Opioid Dose Categories
Low (20 - <50 MME)
|
93 Participants
n=263 Participants
|
104 Participants
n=262 Participants
|
197 Participants
n=525 Participants
|
|
Average Daily Opioid Dose Categories
Moderate (50 - <90 MME)
|
52 Participants
n=263 Participants
|
64 Participants
n=262 Participants
|
116 Participants
n=525 Participants
|
|
Average Daily Opioid Dose Categories
High (90+ MME)
|
86 Participants
n=263 Participants
|
65 Participants
n=262 Participants
|
151 Participants
n=525 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference T-Score
|
65.8 units on a scale (T-Score)
STANDARD_DEVIATION 5.9 • n=263 Participants
|
65.9 units on a scale (T-Score)
STANDARD_DEVIATION 6.0 • n=262 Participants
|
65.8 units on a scale (T-Score)
STANDARD_DEVIATION 5.9 • n=525 Participants
|
|
PROMIS Physical Functioning T-Score
|
34.4 units on a scale (T-Score)
STANDARD_DEVIATION 6.0 • n=263 Participants
|
35.1 units on a scale (T-Score)
STANDARD_DEVIATION 6.3 • n=262 Participants
|
34.7 units on a scale (T-Score)
STANDARD_DEVIATION 6.2 • n=525 Participants
|
|
Brief Pain Index (BPI) Pain Severity
Missing
|
2 Participants
n=263 Participants
|
0 Participants
n=262 Participants
|
2 Participants
n=525 Participants
|
|
Brief Pain Index (BPI) Pain Severity
Mild
|
3 Participants
n=263 Participants
|
10 Participants
n=262 Participants
|
13 Participants
n=525 Participants
|
|
Brief Pain Index (BPI) Pain Severity
Moderate
|
189 Participants
n=263 Participants
|
176 Participants
n=262 Participants
|
365 Participants
n=525 Participants
|
|
Brief Pain Index (BPI) Pain Severity
Severe
|
69 Participants
n=263 Participants
|
76 Participants
n=262 Participants
|
145 Participants
n=525 Participants
|
|
Presence of 1+ Comorbid Mental Health Diagnoses
Yes
|
119 Participants
n=263 Participants
|
108 Participants
n=262 Participants
|
227 Participants
n=525 Participants
|
|
Presence of 1+ Comorbid Mental Health Diagnoses
No
|
144 Participants
n=263 Participants
|
154 Participants
n=262 Participants
|
298 Participants
n=525 Participants
|
|
Charlson Comorbidity Index (CCI) categories based on diagnosis codes
None
|
128 Participants
n=263 Participants
|
135 Participants
n=262 Participants
|
263 Participants
n=525 Participants
|
|
Charlson Comorbidity Index (CCI) categories based on diagnosis codes
1 or more CGI Index Categories
|
135 Participants
n=263 Participants
|
127 Participants
n=262 Participants
|
262 Participants
n=525 Participants
|
|
Presence of Substance Use Disorder Diagnosis Code
Yes
|
66 Participants
n=263 Participants
|
69 Participants
n=262 Participants
|
135 Participants
n=525 Participants
|
|
Presence of Substance Use Disorder Diagnosis Code
No
|
197 Participants
n=263 Participants
|
193 Participants
n=262 Participants
|
390 Participants
n=525 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=220 Participants
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.
|
Shared Decision Making (SDM)
n=223 Participants
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.
|
|---|---|---|
|
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12
|
-11.6 Morphine Milligram Equivalents (MME)
Interval -19.1 to -4.1
|
-6.0 Morphine Milligram Equivalents (MME)
Interval -14.0 to 2.0
|
PRIMARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=254 Participants
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.
|
Shared Decision Making (SDM)
n=253 Participants
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.
|
|---|---|---|
|
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3
|
0.0 Morphine Milligram Equivalents (MME)
Interval -7.2 to 7.1
|
-0.3 Morphine Milligram Equivalents (MME)
Interval -8.0 to 7.4
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=238 Participants
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.
|
Shared Decision Making (SDM)
n=247 Participants
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.
|
|---|---|---|
|
Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6
|
-5.9 Morphine Milligram Equivalents (MME)
Interval -13.2 to 1.4
|
0.3 Morphine Milligram Equivalents (MME)
Interval -7.4 to 8.1
|
PRIMARY outcome
Timeframe: Month 9Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=228 Participants
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.
|
Shared Decision Making (SDM)
n=236 Participants
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.
|
|---|---|---|
|
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9
|
-6.6 Morphine Milligram Equivalents (MME)
Interval -14.0 to 0.8
|
-7.3 Morphine Milligram Equivalents (MME)
Interval -15.1 to 0.6
|
PRIMARY outcome
Timeframe: Month 15Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=206 Participants
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.
|
Shared Decision Making (SDM)
n=216 Participants
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.
|
|---|---|---|
|
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15
|
-9.4 Morphine Milligram Equivalents (MME)
Interval -17.1 to -1.7
|
-6.8 Morphine Milligram Equivalents (MME)
Interval -14.9 to 1.2
|
PRIMARY outcome
Timeframe: Month 18Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=197 Participants
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.
|
Shared Decision Making (SDM)
n=197 Participants
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.
|
|---|---|---|
|
Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18
|
-3.1 Morphine Milligram Equivalents (MME)
Interval -10.9 to 4.8
|
-12.5 Morphine Milligram Equivalents (MME)
Interval -20.7 to -4.4
|
PRIMARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=220 Participants
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.
|
Shared Decision Making (SDM)
n=223 Participants
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.
|
|---|---|---|
|
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12
|
0.29 Estimated proportion
Interval 0.2 to 0.38
|
0.30 Estimated proportion
Interval 0.22 to 0.4
|
PRIMARY outcome
Timeframe: Month 3Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=254 Participants
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.
|
Shared Decision Making (SDM)
n=253 Participants
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.
|
|---|---|---|
|
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3
|
0.13 Estimated proportion
Interval 0.09 to 0.2
|
0.16 Estimated proportion
Interval 0.11 to 0.23
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=238 Participants
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.
|
Shared Decision Making (SDM)
n=247 Participants
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.
|
|---|---|---|
|
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6
|
0.21 Estimated proportion
Interval 0.14 to 0.29
|
0.21 Estimated proportion
Interval 0.14 to 0.29
|
PRIMARY outcome
Timeframe: Month 9Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=228 Participants
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.
|
Shared Decision Making (SDM)
n=236 Participants
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.
|
|---|---|---|
|
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9
|
0.22 Estimated proportion
Interval 0.15 to 0.31
|
0.28 Estimated proportion
Interval 0.2 to 0.38
|
PRIMARY outcome
Timeframe: Month 15Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=206 Participants
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.
|
Shared Decision Making (SDM)
n=216 Participants
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.
|
|---|---|---|
|
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15
|
0.30 Estimated proportion
Interval 0.21 to 0.41
|
0.32 Estimated proportion
Interval 0.23 to 0.42
|
PRIMARY outcome
Timeframe: Month 18Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=197 Participants
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.
|
Shared Decision Making (SDM)
n=197 Participants
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.
|
|---|---|---|
|
Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18
|
0.26 Estimated proportion
Interval 0.18 to 0.37
|
0.35 Estimated proportion
Interval 0.25 to 0.46
|
SECONDARY outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=142 Participants
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.
|
Shared Decision Making (SDM)
n=159 Participants
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.
|
|---|---|---|
|
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)
Interval -0.4 to 1.4
|
0.3 units on a scale (T-score)
Interval -0.4 to 1.0
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=130 Participants
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.
|
Shared Decision Making (SDM)
n=157 Participants
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.
|
|---|---|---|
|
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)
Interval -0.8 to 1.0
|
0.0 units on a scale (T-score)
Interval -0.7 to 0.7
|
SECONDARY outcome
Timeframe: Month 6Population: Intent-to-treat population among those that completed a 6-month survey.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=142 Participants
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.
|
Shared Decision Making (SDM)
n=158 Participants
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.
|
|---|---|---|
|
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)
Interval -1.1 to 0.3
|
-0.6 units on a scale (T-score)
Interval -1.3 to 0.1
|
SECONDARY outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=130 Participants
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.
|
Shared Decision Making (SDM)
n=157 Participants
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.
|
|---|---|---|
|
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)
Interval -1.0 to 0.4
|
-0.5 units on a scale (T-score)
Interval -1.1 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=141 Participants
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.
|
Shared Decision Making (SDM)
n=159 Participants
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.
|
|---|---|---|
|
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)
Interval -1.6 to 0.1
|
-1.0 units on a scale (T-score)
Interval -1.8 to -0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=130 Participants
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.
|
Shared Decision Making (SDM)
n=155 Participants
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.
|
|---|---|---|
|
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)
Interval -1.8 to 0.0
|
-1.5 units on a scale (T-score)
Interval -2.3 to -0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=142 Participants
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.
|
Shared Decision Making (SDM)
n=159 Participants
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.
|
|---|---|---|
|
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)
Interval 0.6 to 2.8
|
1.8 units on a scale (T-score)
Interval 0.7 to 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=128 Participants
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.
|
Shared Decision Making (SDM)
n=155 Participants
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.
|
|---|---|---|
|
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)
Interval 0.8 to 3.1
|
1.7 units on a scale (T-score)
Interval 0.5 to 2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: Intent-to-treat population among those that completed a 6-month survey.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=142 Participants
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.
|
Shared Decision Making (SDM)
n=158 Participants
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.
|
|---|---|---|
|
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)
Interval 0.2 to 2.3
|
1.7 units on a scale (T-score)
Interval 0.6 to 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=129 Participants
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.
|
Shared Decision Making (SDM)
n=155 Participants
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.
|
|---|---|---|
|
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)
Interval 0.4 to 2.6
|
2.0 units on a scale (T-score)
Interval 0.9 to 3.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: Intent-to-treat population among those that completed a 6-month survey.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=142 Participants
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.
|
Shared Decision Making (SDM)
n=158 Participants
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.
|
|---|---|---|
|
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
Interval -0.3 to 0.1
|
-0.2 units on a scale
Interval -0.4 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=129 Participants
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.
|
Shared Decision Making (SDM)
n=155 Participants
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.
|
|---|---|---|
|
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
Interval -0.4 to 0.0
|
-0.2 units on a scale
Interval -0.4 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: Intent-to-treat population among those that completed a 6-month survey.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=142 Participants
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.
|
Shared Decision Making (SDM)
n=158 Participants
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.
|
|---|---|---|
|
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
Interval -0.3 to 0.3
|
-0.2 units on a scale
Interval -0.5 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=129 Participants
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.
|
Shared Decision Making (SDM)
n=155 Participants
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.
|
|---|---|---|
|
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
Interval -0.2 to 0.4
|
-0.1 units on a scale
Interval -0.2 to 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=129 Participants
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.
|
Shared Decision Making (SDM)
n=154 Participants
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.
|
|---|---|---|
|
Discontinuation of Opioid Medications at Month 12
Taking an opioid prescription at 12 months
|
119 Participants
|
145 Participants
|
|
Discontinuation of Opioid Medications at Month 12
Discontinued opioid prescription at 12 months
|
10 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=123 Participants
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.
|
Shared Decision Making (SDM)
n=135 Participants
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.
|
|---|---|---|
|
Intent to Taper at Month 6
|
0.66 Estimated proportion
Interval 0.56 to 0.74
|
0.56 Estimated proportion
Interval 0.47 to 0.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=108 Participants
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.
|
Shared Decision Making (SDM)
n=130 Participants
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.
|
|---|---|---|
|
Intent to Taper at Month 12
|
0.62 Estimated proportion
Interval 0.52 to 0.72
|
0.57 Estimated proportion
Interval 0.47 to 0.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=122 Participants
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.
|
Shared Decision Making (SDM)
n=135 Participants
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.
|
|---|---|---|
|
Relative Opioid Use Self-report at Month 6
Opioid Use Increased since Study Start
|
13 Participants
|
13 Participants
|
|
Relative Opioid Use Self-report at Month 6
Opioid Use Stayed About the Same since Study Start
|
83 Participants
|
89 Participants
|
|
Relative Opioid Use Self-report at Month 6
Opioid Use Decreased since Study Start
|
26 Participants
|
33 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12Population: 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.
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.
Outcome measures
| Measure |
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=108 Participants
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.
|
Shared Decision Making (SDM)
n=130 Participants
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.
|
|---|---|---|
|
Relative Opioid Use Self-report at Month 12
Opioid Use has Increased since Study Start
|
8 Participants
|
10 Participants
|
|
Relative Opioid Use Self-report at Month 12
Opioid Use has Stayed about the Same since Study Start
|
71 Participants
|
92 Participants
|
|
Relative Opioid Use Self-report at Month 12
Opioid Use has Decreased since Study Start
|
29 Participants
|
28 Participants
|
Adverse Events
Shared Decision Making (SDM)
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
Serious adverse events
| Measure |
Shared Decision Making (SDM)
n=262 participants at risk
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.
|
Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)
n=263 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
2.3%
6/262 • Number of events 6 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
2.3%
6/263 • Number of events 6 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Psychiatric disorders
Opioid Overdose
|
1.5%
4/262 • Number of events 4 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
0.76%
2/263 • Number of events 2 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Psychiatric disorders
Suicidal ideation
|
0.76%
2/262 • Number of events 2 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
0.76%
2/263 • Number of events 2 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
|
Psychiatric disorders
Opioid Withdrawal
|
3.4%
9/262 • Number of events 12 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
3.0%
8/263 • Number of events 9 • Adverse Events were reported from baseline through the 12-month intervention phase of the study.
Study adverse event (AE) reporting was limited to 4 types of events: suicide ideation (active suicidal ideation or attempted suicide), opioid withdrawal, opioid overdose, and death. AEs were collected by study coordinators, self-reported on surveys at 6 and 12 months, and by electronic health record International Classification of Diseases, Tenth Revision (ICD-10) codes. Other (Not Including Serious) Adverse Events were not monitored/assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place