STRIPE: Strategies to Improve Pain and Enjoy Life
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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 (PSMOT). 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pain self-management 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
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.
Other Names:
Behavioral: video education, motivational interviewing
web-based video of successfully tapered patients with motivational interviewing debriefing
Other Names:
Drug: voluntary self-paced opioid taper
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 may modify it as wished.
Other Names:
Drug: prescribing guidance for primary care provider
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
Other Names:
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| Active Comparator: usual care Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. |
Other: usual care
Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses
Other Names:
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Outcome Measures
Primary Outcome Measures
- mean daily opioid dose [over following 30 days, assessed at 6 and 12 (primary) months after randomization]
mean daily opioid dose in mg morphine equivalent dose (MED)
- PEG score (Pain, Enjoyment interference, General activity interference) [past week, assessed at 6 and 12 (primary) months after randomization]
mean of 0-10 ratings of Pain severity, General activity interference, Enjoyment of life interference.
Secondary Outcome Measures
- Prescription Opioid Misuse Index (POMI) [lifetime, assessed at 6 and 12 months after randomization]
6-item self-report of aberrant opioid use behaviors, Y vs N, range 0 (better) -6 (worse)
- Prescription Opioid Difficulties Scale (PODS) [past 2 weeks, assessed at 6 and 12 months after randomization]
Self-report measure with two 8-item subscales assessing psychosocial problems attributed to opioids and opioid control concerns, items scored 0 (good)-4 (bad), range 0-32 for each scale, subscales not summed
- Patient Health Questionnaire-8 (PHQ-8) [past 2 weeks, assessed at 6 and 12 months after randomization]
eight item self report measure assessing depressive symptom severity, range 0 (good) -24 (bad)
- Generalized Anxiety Disorders-7 (GAD-7) [past 2 weeks, assessed at 6 and 12 months after randomization]
seven item self-report measure assessing anxiety symptom severity, range 0 (good) -21 (bad)
- Pain Self-Efficacy Questionnaire (PSEQ) [current, assessed at 6 and 12 months after randomization]
10 item self-report measure assessing confidence in ability to do activities despite pain, scored 0-6, range 0 (bad) to 60 (good)
- Opioid craving [past week, assessed at 6 and 12 months after randomization]
0-10 numerical scale for self-report of opioid craving, single item, range 0 (good) -10 (bad)
- Patient Global Impression of Change Scale (PGIC) [during time in trial, assessed at 6 and 12 months after randomization]
single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 18-80 years
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receiving care at a Kaiser Washington primary care clinic;
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Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months;
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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
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consent to participate in the study arm to which they are randomly assigned
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able to read, speak, and write English adequate for outcome measures
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enrollment in Kaiser for at least 6 months prior and no plans to disenroll over the next year.
Exclusion Criteria:
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receiving treatment for cancer
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enrollment in palliative or hospice care
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use in past year of parenteral, transdermal, or transmucosal opioids
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residing in nursing home or assisted living
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using any implanted device for pain control
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American Psychiatric Association Diagnostic and Statistical Manual 5th edition (DSM-5) Opioid Use Disorder (OUD) according to International Classification Diseases OUD diagnoses in the Electronic Health Record
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psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year
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current suicidal ideation with plan or intent
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dementia diagnosis in Electronic Health Record
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Patients on buprenorphine for any reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Washington | Seattle | Washington | United States | 98112 |
Sponsors and Collaborators
- University of Washington
- Kaiser Permanente
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Mark D Sullivan, MD, PhD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SITE00000193
- R01DA044970-01