PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial

NCT06427356 | Recruiting

• 1 other identifier: REC 0004
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain

Keywords

Whole health; rural health; Interdisciplinary team

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI)

  A 9-item scale used to quantify an individual's pain experience (0-10) with higher scores suggesting worse pain severity and pain interference.

  Baseline, 6-months

Secondary Outcomes (4)

• Short Form-36 Item (SF-36)

  Baseline, 6-months

• Insomnia Severity Index

  Baseline, 6-months

• Pain Self-Efficacy Questionnaire

  Baseline, 6-months

• University of Washington- Concerns about Pain Scale 24-item

  Baseline, 6-months

Study Arms (2)

Interdisciplinary Team

EXPERIMENTAL

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.

Behavioral: PREVAIL Interdisciplinary Team

Waitlist Control

NO INTERVENTION

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

Interventions

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.

Interdisciplinary Team

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salem Veterans Affairs Medical Center: lead
• Durham VA Health Care System: collaborator
• VISN 6 MIRECC: collaborator
• Bedford VA Health Care System: collaborator
• Stanford University: collaborator

Study Sites (1)

Salem VA Health Care System

Salem, Virginia, 24153, United States

RECRUITING

Related Publications (3)

• Courtney RE, Schadegg MJ. Chronic, Noncancer Pain Care in the Veterans Administration: Current Trends and Future Directions. Anesthesiol Clin. 2023 Jun;41(2):519-529. doi: 10.1016/j.anclin.2023.02.004. Epub 2023 Mar 15.

  PMID: 37245954 BACKGROUND

• Darnall BD, Edwards KA, Courtney RE, Ziadni MS, Simons LE, Harrison LE. Innovative treatment formats, technologies, and clinician trainings that improve access to behavioral pain treatment for youth and adults. Front Pain Res (Lausanne). 2023 Jul 20;4:1223172. doi: 10.3389/fpain.2023.1223172. eCollection 2023.

  PMID: 37547824 BACKGROUND

• Courtney RE, Schadegg MJ, Bolton R, Smith S, Harden SM. Using a Whole Health Approach to Build Biopsychosocial-Spiritual Personal Health Plans for Veterans with Chronic Pain. Pain Manag Nurs. 2024 Feb;25(1):69-74. doi: 10.1016/j.pmn.2023.09.010. Epub 2023 Oct 13.

  PMID: 37839983 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Rena E Courtney, PhD

  Salem VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rena E Courtney, PhD

CONTACT

540-982-2463; rena.courtney2@va.gov

Kris Ann Oursler, MD

CONTACT

540-982-2463; krisann.oursler@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director/Psychologist

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: July 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)