## Protocol Section
### Identification Module
**NCT ID:** NCT06427356

**Brief Title:** PREVAIL Interdisciplinary Track: A Pragmatic Randomized Clinical Trial

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

#### Organization Study ID Info
**ID:** REC 0004
#### Organization
**Class:** FED
**Full Name:** Salem Veterans Affairs Medical Center
### Status Module
#### Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** Durham VA Health Care System

**Class:** UNKNOWN

**Name:** VISN 6 MIRECC

**Class:** UNKNOWN

**Name:** Bedford VA Health Care System

**Class:** OTHER

**Name:** Stanford University

#### Lead Sponsor

**Class:** FED

**Name:** Salem Veterans Affairs Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Chronic Pain

**Keywords:**

- Whole health

- rural health

- Interdisciplinary team

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: PREVAIL Interdisciplinary Team

**Label:** Interdisciplinary Team

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Waitlist Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interdisciplinary Team

**Description:** 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.

**Name:** PREVAIL Interdisciplinary Team

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Brief Pain Inventory (BPI)

**Time Frame:** Baseline, 6-months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Short Form-36 Item (SF-36)

**Time Frame:** Baseline, 6-months

**Description:** A 7-item scale that assesses sleep disturbances, with higher scores reflecting more sleep difficulty.

**Measure:** Insomnia Severity Index

**Time Frame:** Baseline, 6-months

**Description:** 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.

**Measure:** Pain Self-Efficacy Questionnaire

**Time Frame:** Baseline, 6-months

**Description:** 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.

**Measure:** University of Washington- Concerns about Pain Scale 24-item

**Time Frame:** Baseline, 6-months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rena.courtney2@va.gov

**Name:** Rena E Courtney, PhD

**Phone:** 540-982-2463

**Phone Ext:** 4478

**Role:** CONTACT

**Contact 2:**

**Email:** krisann.oursler@va.gov

**Name:** Kris Ann Oursler, MD

**Phone:** 540-982-2463

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Salem VA Health Care System

**Name:** Rena E Courtney, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 37245954

**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.

**PMID:** 37547824

**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.

**PMID:** 37839983

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-31
