Viewing Study NCT05681520



Ignite Creation Date: 2024-05-06 @ 6:30 PM
Last Modification Date: 2024-10-26 @ 2:49 PM
Study NCT ID: NCT05681520
Status: RECRUITING
Last Update Posted: 2024-04-04
First Post: 2022-12-16

Brief Title: Pilot of Peers Enhancing Engagement for Pain Services
Sponsor: VA Office of Research and Development
Organization: VA Office of Research and Development

Study Overview

Official Title: Pilot of Peers Enhancing Engagement for Pain Services
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PEEPS
Brief Summary: Chronic non-cancer pain is common among Veterans and more work is needed to understand how best to support Veterans with chronic pain to improve pain-related function and quality of life Peer specialists may be valuable resource to support Veterans in pain management Peer specialists individuals with lived experience who are hired and trained to work with Veterans are increasingly being used outside traditional mental health settings More research is needed to understand how best to train peer specialists to work in new settings and with new presenting problems such as chronic pain Peer support to help Veterans improve pain-related function increase physical activity and engage in recommended pain care is especially needed In this study the investigators will finalize a peer-led intervention and then pilot it with 24 Veterans with chronic pain in order to establish feasibility and acceptability results will be used to develop a larger proposal testing the intervention in a randomized trial
Detailed Description: Background Chronic pain and particularly high-impact chronic pain that is pain last three months or longer that impacts daily functioning in one or more domains is a leading cause of disability often associated with declining functioning lost days of work and worsened quality of life The Veterans Health Administration VHA identified both improved pain management and reduced opioid-related harms as national priorities with an emphasis on improving function and pain-related disability Peer specialists may be an untapped and valuable resource to support Veterans with chronic pain and enhance the effectiveness of pain treatment Peer specialists are individuals with lived experience who work with Veterans to encourage patient activation and help patients manage chronic conditions Peer specialists work in a variety of clinical settings most commonly mental health clinics and are well-suited to help patients who are harder to engage in services or those needing more support to promote self-management strategies Peer support is particularly effective for patients with more severe illnesses or higher levels of distress and thus may be helpful for Veterans with high-impact chronic pain

Significance Chronic pain is one of the most common and costly problems among Veterans using VHA healthcare VHA guidelines for pain management and opioid therapy encourage non-pharmacological pain management strategies NPMs and non-opioid medications for chronic pain management However NPMs that emphasize improved pain-related function are often underutilized Addressing pain management and opioid misuse are VHA priorities and this research directly aligns with VHA Rehabilitation Research Development RRD priorities including promotion of non-pharmacological activity-based interventions for chronic pain impacting outcomes such as pain it also aligns with RRDs broader goal of maximizing Veterans function and quality of life

Innovation Impact The role of peer specialists in VHA is rapidly expanding beyond traditional mental health settings leading to an urgent need for additional research to understand how best to use peer specialists unique skills to enhance care for Veterans in a wider range of settings No studies to date have evaluated the use of peer specialists to support improvements in pain-related function among Veterans with chronic pain The current proposal is innovative because it proposes for the first time using peer specialists to focus on pain management If proven effective this project could pave the way for widespread implementation of peer specialists into new settings where they can support pain management

Specific Aims The specific aims of this project are to 1 Use intervention mapping IM to refine the intervention Peers Enhancing Engagement for Pain Services PEEPS and 2 Pilot test the feasibility and acceptability of PEEPS and collect function-focused outcome measures for use in a rigorous prospective study

Methodology After refining the intervention protocol using intervention mapping the investigators propose a single arm pilot trial where the investigators will enroll 24 Veterans with high-impact chronic pain to participate in PEEPS collecting data at baseline and three-months post baseline The primary focus will be feasibility and acceptability the investigators will also collect data on pain-related function activity steps walked using pedometers and well-beingquality of life

Next StepsImplementation These data will inform the development of a larger proposal testing PEEPS in a multicenter randomized controlled trial

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
I21RX004381-01A1 NIH None httpsreporternihgovquickSearchI21RX004381-01A1