PREVAIL: Efficacy of a Veterans Healthcare Administration (VHA) Whole Health Interdisciplinary Pain Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PREVAIL Interdisciplinary Team (Behavioral)
Waitlist Control
Participants complete surveys but do not engage with the pain specialists for 6 months.
结局指标
主要结局
Brief Pain Inventory (BPI)
时间窗: 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.
次要结局
- Short Form-36 Item (SF-36)(Baseline, 6-months)
- Pain Self-Efficacy Questionnaire(Baseline, 6-months)
- Insomnia Severity Index(Baseline, 6-months)
- University of Washington- Concerns about Pain Scale 24-item(Baseline, 6-months)
研究者
Rena E. Courtney
Program Director/Psychologist
Salem Veterans Affairs Medical Center