Strategies to Improve Pain and Enjoy Life

Study Overview
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Brief Summary
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In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.

Detailed Description
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In a National Institute on Drug Abuse-funded R34 pilot study of pain self-management training for prescription opioid taper support, it was demonstrated that 22 weeks of opioid taper support promotes opioid dose reduction more effectively than usual care (43% vs 19% dose reduction from baseline) with no increase in pain intensity and significantly reduced activity interference. This intervention will now be adapted and tested in a large integrated primary care system. To address patients' fears of opioid taper that limited recruitment into this pilot study, subjects will be randomized to pain self-management training and then offered the option of self-paced opioid taper. Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on moderate-high dose (≥ 40mg morphine equivalent dose) long-term opioid therapy (LtOT) in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider. Specific Aim 1: To adapt a previously developed prescription opioid taper support intervention into a telephone-delivered pain self-management training that provides the option for supported opioid taper. This will be delivered in multiple primary care clinics by a nurse interventionist trained and supervised by a pain psychologist and will include guidance in opioid and non-opioid medication prescribing. Specific Aim 2: To test in a randomized trial the effects of this intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (questionnaire and electronic health record text indicators), and patient-reported opioid difficulties; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and anxiety and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower opioid doses, greater percent reduction of opioid dose, lower proportions with problem opioid use, lower opioid craving, and lower levels of patient-reported opioid-related difficulties at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, higher global impression of change, and lower levels of anxiety and depressive symptoms at 6 and 12 months after randomization. The proposed trial will determine whether pain self-management training can promote prescription opioid taper in moderate-higher-dose long-term opioid therapy patients without increasing pain level or activity and enjoyment interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.

Official Title
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Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Pain self-management training
* Behavioral: video education, motivational interviewing
* Behavioral: voluntary self-paced opioid taper
* Behavioral: prescribing guidance for primary care provider
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years receiving care at a Kaiser Washington primary care clinic; Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months; currently on higher-dose long-term opioid therapy, defined as >90 days' supply in the past 180 days with a mean daily dose of 40 mg MED or greater in the past 90 days, as first identified via Kaiser's pharmacy dispensing data and subsequently validated by patient self-report during screening for the trial consent to participate in the study arm to which they are randomly assigned able to read, speak, and write English adequate for outcome measures enrollment in Kaiser for at least 6 months prior and no plans to disenroll over the next year. Exclusion Criteria: receiving treatment for cancer enrollment in palliative or hospice care use in past year of parenteral, transdermal, or transmucosal opioids residing in nursing home or assisted living using any implanted device for pain control psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year current suicidal ideation with plan or intent dementia diagnosis in Electronic Health Record Patients on buprenorphine for any reason, or methadone or naltrexone for treatment of Opioid Use Disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are individually randomized to pain self-management training for opioid taper or usual care. Those randomized to pain self-management training will be offered assistance with opioid taper during approximately the fourth session of pain self-management training.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain self-management<br>This intervention will have 4 components: telephone-delivered evidence-based pain self-management training, web-based video of successfully tapered patients with motivational interviewing debriefing, a voluntary, self-paced opioid taper opioid and non-opioid prescribing guidance for the patient's primary care provider. | Behavioral: Pain self-management training<br>* This intervention will have 4 components: telephone-delivered evidence-based pain self-management training, web-based video of successfully tapered patients with motivational interviewing debriefing, a voluntary, self-paced opioid taper opioid and non-opioid prescribing guidance for the patient's primary care provider.<br>* Other names: phone cognitive-behavioral pain self-management training;Behavioral: video education, motivational interviewing<br>* web-based video of successfully tapered patients with motivational interviewing debriefing<br>* Other names: exposure to successfully tapered patients with debriefing;Behavioral: voluntary self-paced opioid taper<br>* Voluntary self-paced opioid taper where patient chooses whether, when and how much to taper opioids. Taper schedule and strategy will be proposed to patients, but they will negotiate details with their primary care provider.<br>* Other names: opioid daily dose reduction;Behavioral: prescribing guidance for primary care provider<br>* Based upon review of medications and diagnoses in the electronic medical record, the principal investigator will offer guidance on opioid taper rate and strategy. He will also offer suggestions to adjust or initiate other psychotropic medications to treat pain or psychiatric comorbid illness that may be unmasked through opioid taper. All prescriptions will be written by the primary care provider.<br>* Other names: medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidity;|
| Active Comparator: usual care<br>Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. | Other: usual care<br>* Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses<br>* Other names: standard opioid therapy for chronic pain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Opioid Morphine Milligram Equivalents (MME) | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). | 12 months after randomization | 
| Pain, Enjoyment of Life, and General Activity (PEG) Score | 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. | 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Opioid Morphine Milligram Equivalents (MME) | Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME). | 6 months after randomization | 
| Pain, Enjoyment of Life, and General Activity (PEG) Score | 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. | 6 months after randomization | 
| Pain Self-Efficacy Questionnaire (PSEQ) Score | 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. | 6 months after randomization | 
| Pain Self-Efficacy Questionnaire (PSEQ) Score | 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. | 12 months after randomization | 
| Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | 6 months after randomization | 
| Patient Health Questionnaire-8 (PHQ-8) Score | An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity. | 12 months after randomization | 
| Generalized Anxiety Disorders-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | 6 months after randomization | 
| Generalized Anxiety Disorders-7 (GAD-7) Score | A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity. | 12 months after randomization | 
| Patient Global Impression of Change (PGIC) Score | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) | 6 months after randomization | 
| Patient Global Impression of Change (PGIC) Score | Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good) | 12 months after randomization | 
| Prescription Opioid Misuse Index (POMI) Score | 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. | 6 months after randomization | 
| Prescription Opioid Misuse Index (POMI) Score | 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. | 12 months after randomization | 
| Prescription Opioid Difficulties Scale (PODS) Score | 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. | 6 months after randomization | 
| Prescription Opioid Difficulties Scale (PODS) Score | 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. | 12 months after randomization | 
| Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | 6 months after randomization | 
| Opioid Craving Score | A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving. | 12 months after randomization | 
| At Least 30% Reduction in Daily Opioid Dose | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). | 6 months after randomization | 
| At Least 30% Reduction in Daily Opioid Dose | Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME). | 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-term opioid therapy, chronic pain self-management, primary care prescribing guidance