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NCT Number: NCT06427356

PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salem VA Health Care System

Salem, Virginia, 24153, United States

Location status: Recruiting

Location contact

Rena E Courtney, PhD

CONTACT

[email protected]

5409822463 ext. 4478

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PREVAIL Interdisciplinary Team

Behavioral

Patient meets simultaneously with an interdisciplinary team (IDT) five pain specialists and develops an individualized treatment plan based on Whole Health. Participants receive five months of coaching calls then return six months later for a follow-up visit with the IDT.

Primary outcomes

  1. 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

  1. Short Form-36 Item (SF-36)

    Time frame: 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.

  2. Insomnia Severity Index

    Time frame: Baseline, 6-months

    A 7-item scale that assesses sleep disturbances, with higher scores reflecting more sleep difficulty.

  3. Pain Self-Efficacy Questionnaire

    Time frame: 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.

  4. University of Washington- Concerns about Pain Scale 24-item

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kris Ann Oursler, MD

CONTACT

[email protected]

540-982-2463

Rena E Courtney, PhD

CONTACT

[email protected]

540-982-2463 ext. 4478

Sponsors and collaborators

Lead sponsor

Salem Veterans Affairs Medical Center

Fed

Collaborators

  • Bedford VA Health Care System
  • Durham VA Health Care System
  • Stanford University
  • VISN 6 MIRECC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 23, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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