PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial
- Conditions
- Chronic Pain
- Interventions
- Behavioral: PREVAIL Interdisciplinary Team
- Registration Number
- NCT06427356
- Lead Sponsor
- Salem Veterans Affairs Medical Center
- Brief Summary
The goal of this clinical trial is to \[primary purpose learn if a team that involves five types of pain specialists (interventional pain, psychology, pharmacy, nutrition, physical therapy) can treat chronic pain in Veterans. The main questions it aims to answer are:
* Do patients report less pain after six months in the program?
* Do patients report that pain gets in the way of their life less after six months in the program? The researchers will compare participants who participate in the program to those that wait for six months before participating in the program.
Participants will
* Meet with the team of pain specialists to develop a plan to treat their pain
* Receive calls from a coach once per month
* Return to meet with the team of pain specialists for a six-month follow-up appointment
* Fill out surveys
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Veteran receiving care at the Salem VA Health Care System (Salem VAHCS) per electronic medical record (EMR)
- Patient participating in PREVAIL Interdisciplinary Team Track per EMR
- Chronic Pain Diagnosis: Defined as pain lasting more than three months per EMR
- Diagnosis of Mild Neurocognitive Disorder or Major Neurocognitive Disorder based on Diagnostic Statistical Manual of Mental Disorders, 5th edition, Text Revision (DSM-5-TR) per EMR
- Veteran has a current acute physical injury that would artificially elevate pain scores during study period per EMR
- Veteran intends to have a pain-related surgery during the study period per EMR
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interdisciplinary Team PREVAIL Interdisciplinary Team Participants complete surveys, meet with five pain specialists to develop individualized treatment plans based on whole health, receive monthly coaching calls for five months, then meet with the pain specialists once more for a 6-month follow-up appointment and complete surveys.
- Primary Outcome Measures
Name Time Method Brief Pain Inventory (BPI) Baseline, 6-months A 9-item scale used to quantify an individual's pain experience (0-10) with higher scores suggesting worse pain severity and pain interference.
- Secondary Outcome Measures
Name Time Method Short Form-36 Item (SF-36) Baseline, 6-months A 36-item scale to assess quality of life, including any impact of health problems on completing activities, as well as energy and emotions, with lower scores indicating a higher impact of health problems.
Insomnia Severity Index Baseline, 6-months A 7-item scale that assesses sleep disturbances, with higher scores reflecting more sleep difficulty.
Pain Self-Efficacy Questionnaire Baseline, 6-months A 10-item scale used to determine how confident an individual is in accomplishing tasks despite the pain (0=not at all confident and 6= completely confident) with higher scores denoting higher levels of pain self-efficacy.
University of Washington- Concerns about Pain Scale 24-item Baseline, 6-months A 24-item scale used to assess one's perception of their pain experience (1= never, 5= always), with higher scores indicating higher levels of pain catastrophizing.