Precision Multi-Axis Pain Assessment of Injured Workers to Improve Treatment and Work Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Work status
研究概览
简要总结
The percentage of loss time claims receiving Loss of Earnings benefits at 3 months has continued to rise amongst injured workers in Ontario despite the Workplace Safety and Insurance Board (WSIB) approach of "Better at Work". The primary health services to address loss time claims associated with musculoskeletal injuries include the evidenced-based programs of care, occupational health assessment program and musculoskeletal specialty programs, however, these are set to be revised and relaunched in Q1 2023. Across treatment protocols there are challenges that, at least in part, appear to contribute to the increasing percentage of workers on full loss of earnings at 3 months include (1) inconsistent early identification of workers who should be triaged to various health services and (2) reliable determination of the optimal timing of referral to the most targeted care to enable a safe and sustainable return to work. The investigators aim to develop and evaluate a predictive assessment model to triage workers to the best service within the first 8 weeks of their claim to increase the rate of early return to work, with the long-term goal that the triage protocol becomes part of a person-centric protocol that reduces the duration of work-related disability.
The investigators will develop and evaluate an assessment protocol for injured workers that enter any of the musculoskeletal-specific WSIB programs of care, which have been consolidated into a single program as of 2023. This study will be a prospective inception cohort design using data collected from injured workers receiving WSIB musculoskeletal programs of care services at CBI Health clinics in Ontario Canada. Worker data will be collected at intake to the program of care service and again approximately four and eight weeks after intake (or earlier if a worker completes the program of care). The investigators will complete data analysis in three steps including descriptive and bivariate associations, Maximum Likelihood-based Latent Profile Analysis, and evaluation of results against successful work outcomes and secondary outcomes. Qualitative data will be mined for alternative indicators of recovery / non-recovery. The study recruitment goal is 300 - 350 workers with complete follow-up within a 2-year period.
详细描述
Background and Rationale It has long been known that early and targeted acute-stage intervention is the best way to prevent chronic pain. For 15 years the Principal Investigator has been developing novel tools, strategies, and frameworks for predicting and preventing the acute-to-chronic transition in other populations. These include self-report tools that have individually demonstrated >75% accuracy in predicting 12-month outcomes when administered in the first weeks from injury, new interpretations of common pain assessment and evaluation tools, and new frameworks for understanding pain and its management at both the acute and chronic stages. The investigators have used advanced analytic techniques to identify and describe the recovery trajectories present in a sample of people with mixed musculoskeletal injuries using data collected within days to weeks, predicting outcomes up to 12 months post-injury. In a recently-completed project, some of these innovations were integrated into a single online questionnaire targeting Canadian military veterans with chronic pain. The results of that analysis revealed a 5-cluster solution based on responses to self-report measures of 7 domains (or axes) of drivers of the pain experience. The investigators believe this strategy will also have value when translated and implemented in more acutely injured workers in Canada as a single risk stratification and management protocol. The longer-term goal is to use this type of simple self-assessment protocol to empower injured workers and claims managers to triage into the right care pathway, reduce time off work, and improve the likelihood of successful outcomes.
Based on our team's extensive work in the prognosis of post-traumatic musculoskeletal injuries, the investigators propose that it is possible to identify those who can be expected to achieve a full return to work within only the programs of care and differentiate them from those who will experience some form of delayed or non-return to work and can do so within the first 3 weeks (21 days) from injury with >80% accuracy.
Objective Development and validation of a multi-axis 'risk/prognosis' worker-reported screening tool comprising tools that can be administered within the first 8 weeks of work-related injury and provide >80% accuracy in predicting work recovery trajectories over the subsequent 2 months.
Recruitment Recruitment will occur through CBIH programs of care provider clinics for injured workers, using both emailed and posted invitations. In both cases explicit opt-in consent will be obtained for this study following the protocol for digital online consent procedures from Western's Research Ethics Board (REB).
Members of the research team at Western will monitor the portal for new participants daily. New participants will be entered into a Master List that includes only name, contact email address, and a study-specific randomly-generated 4-digit ID number. The Master List is necessary to permit the linking of responses across data collection periods and will be stored separately from the raw data file that will include only ID number. The research team member will subsequently create a unique survey link tied to the participant's email addresses and send that to the participant within two working days. That survey will start with the screening questions for inclusion. Those who pass the screen will proceed with the full set of survey questions, while those who are screen-failed will be presented with a thank participant screen and their study involvement will end. Upon entry into the Master List, follow-up dates at 1 and 2 months post-inception will be automatically calculated, and the research team members will use those to ensure follow-up survey forms are sent on time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants are those aged ≥18 years, able to read 6th grade English, presenting to a program of care for rehabilitation of a workplace injury with a primary musculoskeletal or Low Back Pain component.
排除标准
- •Participants with significant cognitive impairment or learning disability (self-reported) that interfere with following multi-step instructions will be excluded from this study. The exclusive focus on those entering program of care-based rehab will naturally exclude workers with catastrophic injuries (e.g., loss of limb, multiple fractures, burns) or those for whom a mental health disorder (e.g., PTSD, depression) is the primary diagnosis, thereby homogenizing the types of injuries included.
结局指标
主要结局
Work status
时间窗: 8 weeks
Full Return-to-Work, Return-to-Work with temporary restrictions, or redirected to other treatment options. With the Full RTW category serving as the reference against which the other outcomes will be considered.
次要结局
- Body diagram(8 weeks)
- Pain severity(8 weeks)
- EuroQoL-5D (EQ5D-5L)(8 weeks)
研究者
Dave Walton
Associate Professor, School of Physical Therapy (cross-appt. Dept. of Psychiatry)
Western University, Canada
