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

• ClinicalTrials.gov Identifier: NCT04746833
• Recruitment Status: Recruiting
• First Posted: February 10, 2021
• Last Update Posted: May 21, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Behavioral: SUMMIT; Behavioral: control	Phase 2; Phase 3

Detailed Description:

The investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called SUMMIT. Eligible participants will be randomized to SUMMIT versus a pain monitoring app. Outcome measures will be collected over 9 months.

To ensure rigor and successful future implementation, the investigators 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment

Intervention Model Description

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.

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development and Pilot Testing of LIMIT: a Multicomponent Tool to Support Opioid Tapering
• Actual Study Start Date: March 24, 2021
• Estimated Primary Completion Date: March 23, 2022
• Estimated Study Completion Date: September 22, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: SUMMIT; 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; multicomponent web-based application focused on pain self-management skills
Placebo Comparator: control; 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; My Pain Diary app

Outcome Measures

Primary Outcome Measures :

1. opioid dose [ Time Frame: 9-months ]
   Daily dose of opioid analgesics taken, by participant self report.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Inclusion criteria for Veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month.

Exclusion Criteria:

Exclusion criteria will be Veterans on liquid methadone or buprenorphine for opioid use disorder (OUD) and those who have transitioned to buprenorphine (transdermal or sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing aids or glasses), psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related research study.

Contacts and Locations

Contacts

Contact: Sara Edmond, PhD; (203) 932-5711 ext 3288; sara.edmond@va.gov

Contact: William C Becker, MD; (203) 932-5711 ext 2427; William.Becker4@va.gov

Locations

United States, Connecticut

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; Not yet recruiting

West Haven, Connecticut, United States, 06516

Contact: Sara Edmond, PhD 203-932-5711 ext 3288 sara.edmond@va.gov

Sub-Investigator: Liana Fraenkel, MD MPH FRCPC

Principal Investigator: William C Becker, MD

United States, Massachusetts

VA Central Western Massachusetts Healthcare System, Leeds, MA; Active, not recruiting

Leeds, Massachusetts, United States, 01053-9764

United States, Pennsylvania

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

Philadelphia, Pennsylvania, United States, 19104

Contact: Manik Chhabra, MD manik.chhabra@va.gov

United States, Utah

VA Salt Lake City Health Care System, Salt Lake City, UT; Active, not recruiting

Salt Lake City, Utah, United States, 84148

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: William C Becker, MD; VA Connecticut Healthcare System West Haven Campus, West Haven, CT

More Information

Publications of Results:

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04746833
• Other Study ID Numbers: IIR 17-228
• First Posted: February 10, 2021
• Last Update Posted: May 21, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

m-health

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations