PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial

NCT ID: NCT06427356

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PREVAIL Interdisciplinary Team

Intervention Type 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.

Waitlist Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Durham VA Health Care System

FED

Sponsor Role collaborator

VISN 6 MIRECC

UNKNOWN

Sponsor Role collaborator

Bedford VA Health Care System

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Salem Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rena E Courtney, PhD

Role: PRINCIPAL_INVESTIGATOR

Salem VA Health Care System

Central Contacts

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Rena E Courtney, PhD

Role: CONTACT

540-982-2463 ext. 4478

Kris Ann Oursler, MD

Role: CONTACT

540-982-2463

References

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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.

Reference Type BACKGROUND
PMID: 37245954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37547824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37839983 (View on PubMed)

Other Identifiers

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REC 0004

Identifier Type: -

Identifier Source: org_study_id

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