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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04746833

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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

Anticipated 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.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 :

Mar 24, 2021

Anticipated Primary Completion Date :

Sep 23, 2022

Anticipated Study Completion Date :

Sep 22, 2023

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut	United States	06516
2	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts	United States	01053-9764
3	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania	United States	19104
4	VA Salt Lake City Health Care System, Salt Lake City, UT	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT04746833

Other Study ID Numbers:

IIR 17-228

First Posted:

Feb 10, 2021

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

m-health

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Apr 27, 2022