- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06427356
PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial
February 13, 2026 updated by: Rena E. Courtney, Salem Veterans Affairs Medical Center
PREVAIL: Efficacy of a Veterans Healthcare Administration (VHA) Whole Health Interdisciplinary Pain Clinic
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rena E Courtney, PhD
- Phone Number: 4478 540-982-2463
- Email: rena.courtney2@va.gov
Study Contact Backup
- Name: Kris Ann Oursler, MD
- Phone Number: 540-982-2463
- Email: krisann.oursler@va.gov
Study Locations
-
-
Virginia
-
Salem, Virginia, United States, 24153
- Recruiting
- Salem VA Health Care System
-
Contact:
- Rena E Courtney, PhD
- Phone Number: 4478 5409822463
- Email: rena.courtney2@va.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: Waitlist Control
Participants complete surveys but do not engage with the pain specialists for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 6-months
|
|
Insomnia Severity Index
Time Frame: Baseline, 6-months
|
A 7-item scale that assesses sleep disturbances, with higher scores reflecting more sleep difficulty.
|
Baseline, 6-months
|
|
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.
|
Baseline, 6-months
|
|
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.
|
Baseline, 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rena E Courtney, PhD, Salem VA Health Care System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
May 17, 2024
First Submitted That Met QC Criteria
May 17, 2024
First Posted (Actual)
May 23, 2024
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC 0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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