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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pain self-management

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

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.
Other Names:
  • phone cognitive-behavioral pain self-management training
Behavioral: video education, motivational interviewing
web-based video of successfully tapered patients with motivational interviewing debriefing
Other Names:
  • exposure to successfully tapered patients with debriefing
Behavioral: 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 will negotiate details with their primary care provider.
Other Names:
  • opioid daily dose reduction
Behavioral: 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. All prescriptions will be written by the primary care provider.
Other Names:
  • medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidity
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:
  • standard opioid therapy for chronic pain

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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