N/A
N=153
Strategies to Improve Pain and Enjoy Life
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03743402 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Daily Opioid Morphine Milligram Equivalents (MME) — 65.17; 67.51 MME/day — p=0.58
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pain self-management training (Behavioral); video education, motivational interviewing (Behavioral); voluntary self-paced opioid taper (Behavioral); prescribing guidance for primary care provider (Behavioral); usual care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Opioid Morphine Milligram Equivalents (MME) |
73.03; 71.74 | 0.72 |
| PRIMARY Pain, Enjoyment of Life, and General Activity (PEG) Score |
6.06; 6.59 | 0.07 |
| SECONDARY Daily Opioid Morphine Milligram Equivalents (MME) |
73.03; 71.74 | 0.72 |
| SECONDARY Pain, Enjoyment of Life, and General Activity (PEG) Score |
6.06; 6.59 | 0.07 |
| SECONDARY Pain Self-Efficacy Questionnaire (PSEQ) Score |
31.97; 27.65 | 0.02 sig |
| SECONDARY Pain Self-Efficacy Questionnaire (PSEQ) Score |
31.97; 27.65 | 0.02 sig |
| SECONDARY Patient Health Questionnaire-8 (PHQ-8) Score |
7.54; 8.04 | 0.48 |
| SECONDARY Patient Health Questionnaire-8 (PHQ-8) Score |
7.54; 8.04 | 0.48 |
| SECONDARY Generalized Anxiety Disorders-7 (GAD-7) Score |
5.20; 4.91 | 0.65 |
| SECONDARY Generalized Anxiety Disorders-7 (GAD-7) Score |
5.20; 4.91 | 0.65 |
| SECONDARY Patient Global Impression of Change (PGIC) Score |
3.71; 2.38 | <0.01 sig |
| SECONDARY Patient Global Impression of Change (PGIC) Score |
3.71; 2.38 | <0.01 sig |
| SECONDARY Prescription Opioid Misuse Index (POMI) Score |
0.39; 0.26 | 0.26 |
| SECONDARY Prescription Opioid Misuse Index (POMI) Score |
0.39; 0.26 | 0.26 |
| SECONDARY Prescription Opioid Difficulties Scale (PODS) Score |
8.15; 7.68 | 0.59 |
| SECONDARY Prescription Opioid Difficulties Scale (PODS) Score |
8.15; 7.68 | 0.59 |
| SECONDARY Opioid Craving Score |
0.97; 1.33 | 0.30 |
| SECONDARY Opioid Craving Score |
0.97; 1.33 | 0.30 |
| SECONDARY At Least 30% Reduction in Daily Opioid Dose |
10; 7 | 0.53 |
| SECONDARY At Least 30% Reduction in Daily Opioid Dose |
10; 7 | 0.53 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03743402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.