Clinical trial NCT06427356: PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial
Official title: PREVAIL: Efficacy of a Veterans Healthcare Administration (VHA) Whole Health Interdisciplinary Pain Clinic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Whole health
rural health
Interdisciplinary team
Lead sponsor: Salem Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Durham VA Health Care System
name: VISN 6 MIRECC
name: Bedford VA Health Care System
name: Stanford University
First posted: 2024-05-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline, 6-months
Secondary outcomes:
measure: Short Form-36 Item (SF-36)
timeFrame: Baseline, 6-months
measure: Insomnia Severity Index
timeFrame: Baseline, 6-months
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline, 6-months
measure: University of Washington- Concerns about Pain Scale 24-item
timeFrame: Baseline, 6-months
Other outcomes:
Locations:
Study officials:
affiliation: Salem VA Health Care System
name: Rena E Courtney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.