Trial Outcomes & Findings for Strategies to Improve Pain and Enjoy Life (NCT NCT03743402)

NCT ID: NCT03743402

Last Updated: 2023-04-07

Results Overview

Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: 12 months after randomization
• Results posted on: 2023-04-07

Participant Flow

Using electronic health records and claims data, 1381 individuals fulfilled a subset of study inclusion criteria and were contacted to assess further inclusion criteria. 170 of these individuals fulfilled all inclusion criteria, as determined using two phone screenings and were contacted to participate in the study. 153 of these individuals returned a baseline questionnaire and were randomized.

Participant milestones

Measure	Pain Self-Management This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Overall Study STARTED	79	74
Overall Study Availability of at Least One Primary Outcome Measure at 6 Months Post-baseline	79	74
Overall Study COMPLETED	78	73
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Strategies to Improve Pain and Enjoy Life

Baseline characteristics by cohort

Measure	Pain Self-Management n=79 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=74 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.	Total n=153 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 10.7 • n=5 Participants	60.7 years STANDARD_DEVIATION 10.6 • n=7 Participants	60.7 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	45 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	62 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	79 participants n=5 Participants	74 participants n=7 Participants	153 participants n=5 Participants
Daily Opioid Morphine Milligram Equivalents (MME)	77.1 MME/day STANDARD_DEVIATION 67.9 • n=5 Participants	72.8 MME/day STANDARD_DEVIATION 30.3 • n=7 Participants	75.0 MME/day STANDARD_DEVIATION 53.0 • n=5 Participants
Pain, Enjoyment of Life, and General Activity (PEG) Score	6.5 score on a scale STANDARD_DEVIATION 1.8 • n=5 Participants	6.6 score on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	6.6 score on a scale STANDARD_DEVIATION 1.8 • n=5 Participants
Pain Self-Efficacy Questionnaire (PSEQ) Score	29.9 score on a scale STANDARD_DEVIATION 10.4 • n=5 Participants	27.7 score on a scale STANDARD_DEVIATION 13.0 • n=7 Participants	28.8 score on a scale STANDARD_DEVIATION 11.8 • n=5 Participants
Patient Health Questionnaire-8 (PHQ-8) Score	8.1 score on a scale STANDARD_DEVIATION 5.1 • n=5 Participants	8.8 score on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	8.5 score on a scale STANDARD_DEVIATION 4.9 • n=5 Participants
Generalized Anxiety Disorder-7 (GAD-7) Score	4.7 score on a scale STANDARD_DEVIATION 4.8 • n=5 Participants	5.3 score on a scale STANDARD_DEVIATION 4.5 • n=7 Participants	5.0 score on a scale STANDARD_DEVIATION 4.6 • n=5 Participants
Prescription Opioid Misuse Index (POMI) Score	0.7 score on a scale STANDARD_DEVIATION 0.9 • n=5 Participants	0.8 score on a scale STANDARD_DEVIATION 0.9 • n=7 Participants	0.7 score on a scale STANDARD_DEVIATION 0.9 • n=5 Participants
Prescribed Opioids Difficulties Scale (PODS) Score	9.3 score on a scale STANDARD_DEVIATION 7.5 • n=5 Participants	10.5 score on a scale STANDARD_DEVIATION 8.1 • n=7 Participants	9.9 score on a scale STANDARD_DEVIATION 7.8 • n=5 Participants
Opioid Craving Score	1.0 score on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	1.5 score on a scale STANDARD_DEVIATION 2.8 • n=7 Participants	1.3 score on a scale STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with complete electronic prescription records available during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.

Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).

Outcome measures

Measure	Pain Self-Management n=75 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=72 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Daily Opioid Morphine Milligram Equivalents (MME)	65.17 MME/day Interval 58.86 to 71.49	67.51 MME/day Interval 62.49 to 72.54

PRIMARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals who completed the 6-month and/or 12-month PEG questionnaire and with complete baseline data used for adjustment in regression models.

A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Pain, Enjoyment of Life, and General Activity (PEG) Score	6.14 score on a scale Interval 5.79 to 6.49	6.14 score on a scale Interval 5.76 to 6.51

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with complete electronic prescription records available during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.

Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).

Outcome measures

Measure	Pain Self-Management n=75 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=72 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Daily Opioid Morphine Milligram Equivalents (MME)	73.03 MME/day Interval 67.65 to 78.42	71.74 MME/day Interval 67.37 to 76.11

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals who completed the 6-month and/or 12-month PEG questionnaire and with complete baseline data used for adjustment in regression models.

A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Pain, Enjoyment of Life, and General Activity (PEG) Score	6.06 score on a scale Interval 5.63 to 6.49	6.59 score on a scale Interval 6.22 to 6.95

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain.

Outcome measures

Measure	Pain Self-Management n=62 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=69 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Pain Self-Efficacy Questionnaire (PSEQ) Score	32.31 score on a scale Interval 8.61 to 56.01	30.21 score on a scale Interval 22.06 to 38.35

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain.

Outcome measures

Measure	Pain Self-Management n=62 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=69 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Pain Self-Efficacy Questionnaire (PSEQ) Score	31.97 score on a scale Interval 19.47 to 44.47	27.65 score on a scale Interval 15.56 to 39.74

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed PHQ-8 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity.

Outcome measures

Measure	Pain Self-Management n=61 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=68 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Patient Health Questionnaire-8 (PHQ-8) Score	8.25 score on a scale Interval 5.24 to 11.26	8.60 score on a scale Interval 7.19 to 10.01

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed PSEQ questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity.

Outcome measures

Measure	Pain Self-Management n=61 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=68 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Patient Health Questionnaire-8 (PHQ-8) Score	7.54 score on a scale Interval 5.89 to 9.19	8.04 score on a scale Interval 6.33 to 9.75

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed GAD-7 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Generalized Anxiety Disorders-7 (GAD-7) Score	4.89 score on a scale Interval 2.79 to 7.0	5.14 score on a scale Interval 3.57 to 6.72

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed GAD-7 questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Generalized Anxiety Disorders-7 (GAD-7) Score	5.20 score on a scale Interval 4.07 to 6.33	4.91 score on a scale Interval 4.03 to 5.8

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed PGIC questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Patient Global Impression of Change (PGIC) Score	3.12 score on a scale Interval 2.76 to 3.47	2.51 score on a scale Interval 2.16 to 2.86

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed PGIC questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Patient Global Impression of Change (PGIC) Score	3.71 score on a scale Interval 3.27 to 4.15	2.38 score on a scale Interval 2.04 to 2.73

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed POMI questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=69 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Prescription Opioid Misuse Index (POMI) Score	0.56 score on a scale Interval 0.38 to 0.74	0.47 score on a scale Interval 0.33 to 0.61

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed POMI questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=69 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Prescription Opioid Misuse Index (POMI) Score	0.39 score on a scale Interval 0.23 to 0.55	0.26 score on a scale Interval 0.11 to 0.41

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed PODS questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns.

Outcome measures

Measure	Pain Self-Management n=61 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=67 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Prescription Opioid Difficulties Scale (PODS) Score	9.03 score on a scale Interval 1.71 to 16.36	7.43 score on a scale Interval 4.87 to 10.0

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed PODS questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns.

Outcome measures

Measure	Pain Self-Management n=61 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=67 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Prescription Opioid Difficulties Scale (PODS) Score	8.15 score on a scale Interval 5.63 to 10.67	7.68 score on a scale Interval 5.08 to 10.27

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with completed opioid craving questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Opioid Craving Score	1.36 score on a scale Interval 0.79 to 1.93	1.40 score on a scale Interval 0.86 to 1.94

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with completed opioid craving questionnaires at 6- and/or 12-months post-randomization with non-missing baseline data used for adjustment in regression models.

A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving.

Outcome measures

Measure	Pain Self-Management n=64 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=71 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Opioid Craving Score	0.97 score on a scale Interval 0.5 to 1.44	1.33 score on a scale Interval 0.74 to 1.91

SECONDARY outcome

Timeframe: 6 months after randomization

Population: Randomized individuals with complete electronic pharmacy records during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.

Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).

Outcome measures

Measure	Pain Self-Management n=72 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=76 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
At Least 30% Reduction in Daily Opioid Dose	9 participants	4 participants

SECONDARY outcome

Timeframe: 12 months after randomization

Population: Randomized individuals with complete electronic pharmacy records during the 6- and/or 12-month post-randomization assessment period with non-missing baseline data used for adjustment in regression models.

Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).

Outcome measures

Measure	Pain Self-Management n=72 Participants This arm includes patients randomized to Pain Self-Management Training. This intervention has 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper, and 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=76 Participants Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
At Least 30% Reduction in Daily Opioid Dose	10 participants	7 participants

Adverse Events

Pain Self-Management

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pain Self-Management n=79 participants at risk This arm includes patients Patients randomized to Pain self-management training; This intervention will have 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper 4. opioid and non-opioid prescribing guidance for the patient's primary care provider.	Usual Care n=74 participants at risk Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
Musculoskeletal and connective tissue disorders Musculoskeletal pain after PMR	5.1% 4/79 • Number of events 4 • Data were collected for 12 months, ending at participants' final follow up time point.	0.00% 0/74 • Data were collected for 12 months, ending at participants' final follow up time point.
Nervous system disorders Headache after PMR	2.5% 2/79 • Number of events 2 • Data were collected for 12 months, ending at participants' final follow up time point.	0.00% 0/74 • Data were collected for 12 months, ending at participants' final follow up time point.
General disorders Stopped taking prescribed opioids	1.3% 1/79 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.	0.00% 0/74 • Data were collected for 12 months, ending at participants' final follow up time point.
Psychiatric disorders Increased anxiety / anger when reminded of appointment with study staff	1.3% 1/79 • Number of events 1 • Data were collected for 12 months, ending at participants' final follow up time point.	0.00% 0/74 • Data were collected for 12 months, ending at participants' final follow up time point.

Additional Information

Dr. Mark Sullivan

University of Washington

Phone: 2066853184

Email: sullimar@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place