Strategies to Improve Pain and Enjoy Life

NCT03743402 | Completed Results DMC

• 2 other identifiers: SITE00000193R01DA044970-01
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

long-term opioid therapy; chronic pain self-management; primary care prescribing guidance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Daily Opioid Morphine Milligram Equivalents (MME)

  6 months after randomization

• Pain, Enjoyment of Life, and General Activity (PEG) Score

  6 months after randomization

• Pain Self-Efficacy Questionnaire (PSEQ) Score

  6 months after randomization

• Pain Self-Efficacy Questionnaire (PSEQ) Score

  12 months after randomization

• Patient Health Questionnaire-8 (PHQ-8) Score

  6 months after randomization

Study Arms (2)

Pain self-management

EXPERIMENTAL

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.

Behavioral: Pain self-management training; Behavioral: video education, motivational interviewing; Behavioral: voluntary self-paced opioid taper; Behavioral: prescribing guidance for primary care provider

usual care

ACTIVE COMPARATOR

Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.

Other: usual care

Interventions

Pain self-management training BEHAVIORAL

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.

Also known as: phone cognitive-behavioral pain self-management training

Pain self-management

video education, motivational interviewing BEHAVIORAL

web-based video of successfully tapered patients with motivational interviewing debriefing

Also known as: exposure to successfully tapered patients with debriefing

Pain self-management

voluntary self-paced opioid taper BEHAVIORAL

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.

Also known as: opioid daily dose reduction

Pain self-management

prescribing guidance for primary care provider BEHAVIORAL

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.

Also known as: medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidity

Pain self-management

usual care OTHER

Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses

Also known as: standard opioid therapy for chronic pain

usual care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Kaiser Permanente: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

Location

Related Publications (3)

• Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28.

  PMID: 27908840 BACKGROUND

• Wartko PD, Krakauer C, Turner JA, Cook AJ, Boudreau DM, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Pain. 2023 Dec 1;164(12):2852-2864. doi: 10.1097/j.pain.0000000000002982. Epub 2023 Aug 25.

  PMID: 37624901 DERIVED

• Wartko PD, Boudreau DM, Turner JA, Cook AJ, Wellman RD, Fujii MM, Garcia RC, Moser KA, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 2021 Jul 2.

  PMID: 34217889 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Motivational Interviewing; Physicians, Primary Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Physicians; Health Personnel

Results Point of Contact

• Title: Dr. Mark Sullivan
• Organization: University of Washington

sullimar@uw.edu

2066853184

Study Officials

• Mark D Sullivan, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessment will be conducted by Kaiser survey team which will be blind to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: November 16, 2018
• Study Start: April 4, 2019
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after January 30, 2023 until January 30, 2028
• Access Criteria: Availability of data and materials: The datasets generated and analyzed during the current study are not publicly available to protect participant privacy. Deidentified analysis datasets may be made available upon email request to the corresponding author. Any data shared may require an application with description of the planned research purpose and an execution of a data use agreement with approval from the KPWA IRB overseeing this trial. Further, if the researcher would also like the R analysis code used for this manuscript, they can request this at the time of requesting the deidentified analysis dataset.

Locations

US (1)