- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743402
Strategies to Improve Pain and Enjoy Life (STRIPE)
April 5, 2023 updated by: Mark Sullivan, University of Washington
Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering
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.
Study Overview
Status
Completed
Conditions
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.
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 Type
Interventional
Enrollment (Actual)
153
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98112
- Kaiser Permanente Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain self-management
This intervention will have 4 components:
|
This intervention will have 4 components:
Other Names:
web-based video of successfully tapered patients with motivational interviewing debriefing
Other Names:
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.
Other Names:
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.
Other Names:
|
Active Comparator: usual care
Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Opioid Morphine Milligram Equivalents (MME)
Time Frame: 12 months after randomization
|
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
Time Frame: 12 months after randomization
|
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)
Time Frame: 6 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)
|
12 months after randomization
|
Prescription Opioid Misuse Index (POMI) Score
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
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
Time Frame: 6 months after randomization
|
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
Time Frame: 12 months after randomization
|
Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).
|
12 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark D Sullivan, MD, PhD, University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2019
Primary Completion (Actual)
January 27, 2022
Study Completion (Actual)
January 27, 2022
Study Registration Dates
First Submitted
October 9, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SITE00000193
- R01DA044970-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Data will be available after January 30, 2023 until January 30, 2028
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Istanbul UniversityCompletedLow Back Pain, Mechanical, Biofeedback, Pain, Chronic
Clinical Trials on Pain self-management training
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedMultiple Sclerosis | Low Back Pain | Chronic Pain | Muscular Dystrophies | Spinal Cord Injury | Other and Unspecified Amputation Stump ComplicationsUnited States
-
Luzerner KantonsspitalRecruiting
-
University of MichiganNational Institute on Aging (NIA); Weill Medical College of Cornell University and other collaboratorsNot yet recruitingChronic PainUnited States
-
Seattle Children's HospitalThe Hospital for Sick Children; Northwestern University; Emory University; University... and other collaboratorsCompleted
-
CHU de Quebec-Universite LavalCompleted
-
University of the Sciences in PhiladelphiaUnknownObesity | Chronic PainUnited States
-
VA Office of Research and DevelopmentCompleted
-
University of MichiganNational Institute on Aging (NIA)Not yet recruitingChronic Pain | Cognitive Impairment
-
US Department of Veterans AffairsCompleted
-
University of California, San FranciscoNational Cancer Institute (NCI)Completed