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Clinical Trials/NCT06427356
NCT06427356
Recruiting
N/A

PREVAIL: Efficacy of a Veterans Healthcare Administration (VHA) Whole Health Interdisciplinary Pain Clinic

Salem Veterans Affairs Medical Center1 site in 1 country150 target enrollmentJuly 1, 2024

Overview

Phase
N/A
Intervention
PREVAIL Interdisciplinary Team
Conditions
Chronic Pain
Sponsor
Salem Veterans Affairs Medical Center
Enrollment
150
Locations
1
Primary Endpoint
Brief Pain Inventory (BPI)
Status
Recruiting
Last Updated
2 months ago

Overview

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
Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
April 1, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Salem Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Rena E. Courtney

Program Director/Psychologist

Salem Veterans Affairs Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: PREVAIL Interdisciplinary Team

Waitlist Control

Participants complete surveys but do not engage with the pain specialists for 6 months.

Outcomes

Primary Outcomes

Brief Pain Inventory (BPI)

Time Frame: 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 Outcomes

  • Short Form-36 Item (SF-36)(Baseline, 6-months)
  • Pain Self-Efficacy Questionnaire(Baseline, 6-months)
  • Insomnia Severity Index(Baseline, 6-months)
  • University of Washington- Concerns about Pain Scale 24-item(Baseline, 6-months)

Study Sites (1)

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