Development/Testing of SUMMIT: a Tool to Help Patients Manage Pain While Tapering Opioids

NCT04746833 | Completed Results

• 1 other identifier: IIR 17-228
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

There are nearly one million veterans being treated with long-term opioid therapy (LTOT) for chronic pain. Numerous short and long-term harms associated with LTOT and mounting evidence suggest they have modest or no benefit. Yet, currently available resources to support veterans to taper are inadequate. Primary care, where most LTOT in VHA is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. A scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from LTOT. As such, the goal of this study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain.

Conditions

Chronic Pain

Keywords

m-health

Outcome Measures

Primary Outcomes (2)

• Daily Morphine Milligram Equivalents (MME)

  Morphine milligram equivalents per day based on participant self report.

  9-months

• Minutes of Summit App Use

  Total number of minutes of use of the Summit app over the 6 month intervention

  6 months

Secondary Outcomes (1)

• Behavior Intervention Rating Scale (BIRS)

  six months

Study Arms (2)

SUMMIT

EXPERIMENTAL

Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.

Behavioral: SUMMIT

control

PLACEBO COMPARATOR

Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys

Behavioral: control

Interventions

SUMMIT BEHAVIORAL

multicomponent web-based application focused on pain self-management skills

SUMMIT

control BEHAVIORAL

My Pain Diary app

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

Related Publications (1)

• Becker WC. "Clues" That Patients May Be Willing to Consider Opioid Reductions. J Gen Intern Med. 2020 Jun;35(6):1629-1630. doi: 10.1007/s11606-020-05712-6. No abstract available.

  PMID: 32221855 RESULT

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brent A. Moore
• Organization: VA Connecticut Healthcare System

brent.moore@yale.edu

2034352243

Study Officials

• William C Becker, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: We will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial. Eligible participants will be randomized to LIMIT versus a pain monitoring app. Outcome measures will be collected over 9 months. To ensure rigor and successful future implementation, we will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: March 24, 2021
• Primary Completion: March 23, 2023
• Study Completion: November 30, 2023
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)