跳至主要内容
临床试验/NCT05681520
NCT05681520已完成不适用

Pilot of Peers Enhancing Engagement for Pain Services

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Acceptability

研究概览

简要总结

Chronic non-cancer pain is common among Veterans, and more work is needed to understand how best to support Veterans with chronic pain to improve pain-related function and quality of life. Peer specialists may be valuable resource to support Veterans in pain management. Peer specialists, individuals with lived experience who are hired and trained to work with Veterans, are increasingly being used outside traditional mental health settings. More research is needed to understand how best to train peer specialists to work in new settings and with new presenting problems, such as chronic pain. Peer support to help Veterans improve pain-related function, increase physical activity, and engage in recommended pain care, is especially needed. In this study, the investigators will finalize a peer-led intervention and then pilot it with 24 Veterans with chronic pain in order to establish feasibility and acceptability; results will be used to develop a larger proposal testing the intervention in a randomized trial.

详细描述

Background: Chronic pain, and particularly high-impact chronic pain (that is, pain last three months or longer that impacts daily functioning in one or more domains) is a leading cause of disability, often associated with declining functioning, lost days of work, and worsened quality of life. The Veterans Health Administration (VHA) identified both improved pain management and reduced opioid-related harms as national priorities, with an emphasis on improving function and pain-related disability. Peer specialists may be an untapped and valuable resource to support Veterans with chronic pain and enhance the effectiveness of pain treatment. Peer specialists are individuals with lived experience who work with Veterans to encourage patient activation and help patients manage chronic conditions. Peer specialists work in a variety of clinical settings, most commonly mental health clinics, and are well-suited to help patients who are harder to engage in services or those needing more support to promote self-management strategies. Peer support is particularly effective for patients with more severe illnesses or higher levels of distress, and thus may be helpful for Veterans with high-impact chronic pain.

Significance: Chronic pain is one of the most common and costly problems among Veterans using VHA healthcare. VHA guidelines for pain management and opioid therapy encourage non-pharmacological pain management strategies (NPMs) and non-opioid medications for chronic pain management. However, NPMs that emphasize improved pain-related function are often underutilized. Addressing pain management and opioid misuse are VHA priorities and this research directly aligns with VHA Rehabilitation Research & Development (RR&D) priorities, including promotion of non-pharmacological activity-based interventions for chronic pain, impacting outcomes such as pain; it also aligns with RR&D's broader goal of maximizing Veteran's function and quality of life.

Innovation & Impact: The role of peer specialists in VHA is rapidly expanding beyond traditional mental health settings, leading to an urgent need for additional research to understand how best to use peer specialists' unique skills to enhance care for Veterans in a wider range of settings. No studies to date have evaluated the use of peer specialists to support improvements in pain-related function among Veterans with chronic pain. The current proposal is innovative because it proposes, for the first time, using peer specialists to focus on pain management. If proven effective, this project could pave the way for widespread implementation of peer specialists into new settings where they can support pain management.

Specific Aims: The specific aims of this project are to (1) Use intervention mapping (IM) to refine the intervention, Peers Enhancing Engagement for Pain Services (PEEPS) and (2) Pilot test the feasibility and acceptability of PEEPS and collect function-focused outcome measures for use in a rigorous prospective study.

Methodology: After refining the intervention protocol using intervention mapping, the investigators propose a single arm pilot trial where the investigators will enroll 24 Veterans with high-impact chronic pain to participate in PEEPS, collecting data at baseline and three-months post baseline. The primary focus will be feasibility and acceptability; the investigators will also collect data on pain-related function, activity (steps walked, using pedometers), and well-being/quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veteran receiving care from VA Connecticut Healthcare System
  • referred to a VA Connecticut Pain Management Team
  • has high-impact chronic pain as defined by the Graded Chronic Pain Scale - Revised
  • willing/able to participate in sessions either in person or via video

排除标准

  • moderate to severe cognitive impairment or apparent difficulty communicating with the research staff
  • inability to read or understand English
  • severely impaired hearing or speech that would preclude them from participating in telephone interviews

结局指标

主要结局

Acceptability

时间窗: 3 months

Intervention acceptability as indicated by results of qualitative interviews

Feasibility - Number of completers

时间窗: through study completion, approximately 18 months

Number of Veterans who completed at least 3 sessions with the peer specialist

次要结局

  • Feasibility - Recruiting 24 participants(through study completion, approximately 18 months)
  • Feasibility - Enrollment of >15% of those invited(through study completion, approximately 18 months)
  • Feasibility - Retention >60%(through study completion, approximately 18 months)
  • Acceptability - Quantitative(3 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Pilot of Peers Enhancing Engagement for Pain Services | 临床试验