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Recruiting NCT06427356

PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PREVAIL Interdisciplinary Team.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Behavioral PREVAIL Interdisciplinary Team
    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 outcome measures

  • Brief Pain Inventory (BPI) [Time frame: Baseline, 6-months]
Secondary outcome measures (4)
  • Short Form-36 Item (SF-36) [Time frame: Baseline, 6-months]
  • Insomnia Severity Index [Time frame: Baseline, 6-months]
  • Pain Self-Efficacy Questionnaire [Time frame: Baseline, 6-months]
  • University of Washington- Concerns about Pain Scale 24-item [Time frame: Baseline, 6-months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Salem VA Health Care System — Salem

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. PMID 37245954
  • 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
  • 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

Identifiers

NCT: NCT06427356 · REC 0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗