跳至主要内容
临床试验/NCT05492903
NCT05492903进行中(未招募)不适用

Translating an Intervention to Address Chronic Pain Among Home Care Workers

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
140
试验地点
2
主要终点
Between Groups Difference in Changes in Ratings of Pain Interference with Work

研究概览

简要总结

Home care workers (HCWs) are at-risk for chronic pain and associated problems, including emotional distress, opioid use and misuse, and work-related disability. To address these issues, the proposed study will adapt an established peer-led and supportive group program to address the needs of HCWs with chronic pain. The new program, named COMPASS for Navigating Pain (COMPASS-NP), will integrate work-based injury protections with pain education and cognitive-behavioral therapy strategies for pain self-management in order to reduce pain interference with HCWs' work and life, and advance their safety, health, and well-being.

详细描述

Organizational intervention research can be all breakthrough with no follow-through. Few effective interventions developed by scientists are widely adopted in practice. To address this research-to-practice gap and address a socially important problem, the investigators will translate their established and disseminated COMPASS (COMmunity of Practice And Safety Support) intervention to address the needs of home care workers (HCWs) with chronic pain. The burden of injuries and pain is great among HCWs, which places them at-risk for emotional distress, opioid use/misuse, and work-related disability. Moreover, HCWs are predominantly low income, middle aged women. Between 1999 and 2015 middle-aged women experienced a 471% increase in prescription opioid-related overdoses. COMPASS is a peer-led and scripted group curriculum that produced many significant impacts on meaningful outcomes for HCWs in a randomized controlled trial (Cohen's d range = .45 to .84), including increased safety communication with clients and hazard correction in homes. COMPASS was subsequently adopted by the Oregon Home Care Commission, and is currently offered statewide as a paid training course to publicly funded HCWs. While these are exceptional research-to-practice impacts, the original curriculum did not directly address chronic pain, and resulted in only small non-significant reductions in pain severity. The investigators also found that HCWs with pain-related limitations at baseline made significant safety changes, but experienced less benefit from the intervention than workers without limitations. An added barrier is that protective low-tech ergonomic tools (e.g., slide boards, transfer belts) are typically not funded by insurance. The investigators' qualitative research revealed that low-wage HCWs are often forced to improvise or do without such tools. In the translation plan, existing COMPASS lessons will be adapted for HCWs with chronic pain, and new lessons from the Pain Survival Guide (co-authored by Dr. Turk, Co-I) will integrate pain education and proven cognitive-behavioral therapy pain self-management strategies. The investigators will also strengthen injury protections by including an online ergonomic assessment and voucher for HCWs to purchase tools. The translated COMPASS for Navigating Pain (COMPASS-NP) intervention will be evaluated with a cluster randomized waitlist control design. The primary hypothesis is that COMPASS-NP will reduce pain interference with work and life. Secondary outcomes include pain/injury prevention behaviors (e.g., ergonomic tool use), injuries, pain severity, risk for opioid misuse, and worker well-being. Regional implementation and evaluation with partners in Oregon (government), Washington (labor), and Idaho (private sector) will maximize dissemination knowledge and impact. The 5-year project will accomplish 4 aims: 1) Adapt and pilot COMPASS-NP in Oregon; 2) Determine effects of COMPASS-NP across Oregon, Washington, and Idaho; 3) Describe the translation and implementation of COMPASS-NP across partners and systems; and 4) Disseminate COMPASS-NP knowledge, tools, and toolkits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

  • 18 years (adults)
  • Employed as a home care worker
  • Has chronic pain (pain lasting 3+ months and > 4 average intensity)
  • The presence of pain interference with work (response of 'agree' or 'strongly agree' on single-item)
  • Currently working 4 hours or more per week
  • Access to the internet with a video capable device (e.g., smart phone, tablet, or computer)

排除标准

  • Prior exposure to the original COMPASS program
  • Experiencing a surgery in the prior 6 months
  • Current pregnancy or intention to become pregnant during the study period.

结局指标

主要结局

Between Groups Difference in Changes in Ratings of Pain Interference with Work

时间窗: Changes between 0 weeks and 10 weeks

Work Limitations Questionnaire (1-5; 5=worst \[limited all the time\]). Assesses limitations related to time, physical, mental-interpersonal, and outputs.

Between Groups Difference in Changes in Ratings of Pain Interference with Life

时间窗: Changes between 0 weeks and 10 weeks

Brief Pain Inventory Subscale on pain interference (0-10; 10=worst \[completely interferes\]). Interference related to general activity, walking, work, relations with other people, sleep, and enjoyment of life.

次要结局

  • Between Groups Difference in Changes in Average Nightly Sleep Duration(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Pain Medication Use(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Reported Number of Pain/Injury Prevention Actions(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in the Rating of Average Pain Severity(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Ratings of Well-being(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Daily Minutes of Physical Activity(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Average Nightly Sleep Efficiency(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Reported Number of Minor Injuries(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Reported Number of Lost Work Time Injuries(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Risk of Future Opioid Misuse(Changes between 0 weeks and 10 weeks)
  • Between Groups Difference in Changes in Current Opioid Misuse(Changes between 0 weeks and 10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Olson

Principal Investigator

Oregon Health and Science University

研究点 (2)

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