The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial.
The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial.
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DOI：
10.2196/51474
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发表时间：
2023-10-30
影响因子：
1.7
通讯作者：
Walker-Bone, Karen
中科院分区：
文献类型：
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作者：
Blake, Holly;Chaplin, Wendy J;Wainwright, Elaine;Taylor, Gordon;McNamee, Paul;McWilliams, Daniel;Abbott-Fleming, Victoria;Holmes, Jain;Fecowycz, Aaron;Walsh, David Andrew;Walker-Bone, Karen
慢性或持续性疼痛影响一个人的工作能力或在工作中的生产力，产生很高的社会和经济负担。然而，为慢性疼痛患者提供的与工作有关的建议和支持是可变的或缺乏的。工作疼痛（PAW）工具包是与疼痛患者、医疗保健专业人员和雇主共同创建的。它旨在增加有关员工权利的知识，以及如何获得管理工作场所疼痛慢性病的支持，并提供有关促进慢性疼痛管理的生活方式行为的建议。我们的目的是建立一个明确的集群随机对照试验的可行性比较访问PAW工具包和电话支持电话从职业治疗师（PAW）与治疗照常（即，标准的支持，从他们的雇主）。我们的主要成果是建立这种数字工作场所健康干预的可行性，可接受性，可用性和安全性参数。我们将评估候选的主要和次要结果的可行性，并测试确定性试验的研究过程。这是一项开放标签、平行2组实用可行性群集随机对照试验，具有探索性卫生经济学分析和嵌套定性访谈研究。我们的目标是从英国至少8个工作场所集群（任何类型，>10名员工）招募120名参与者。工作场所的招聘是通过个人方式进行的，个人参与者的招聘是基于网络的。合格的参与者是年龄≥18岁的职业活跃的成年人，他们可以上网，并且自我报告慢性疼痛干扰了他们从事或享受生产性工作的能力。使用受限的1：1群集水平随机化将就业环境分配至PAW或常规治疗;受试者对组分配不设盲。在站点和个人层面的同意后，参与者完成基于网络的基线调查（时间0），包括工作能力，健康和福祉以及医疗保健资源使用的措施。在3个月（时间1）和6个月（时间2）时进行随访。可行性结果涉及招募;干预保真度（例如，交付，覆盖，吸收和参与）;保留;和随访。定性评价（时间2）映射到能力、机会、动机-行为模型，并将探讨员工和雇主对干预措施的接受程度，沿着影响干预措施实施和接受的个人和背景因素。于二零二三年三月获得伦理批准。2023年6月开始试招募。PAW工具包是第一个基于证据的数字健康干预措施，旨在支持工作中慢性或持续性疼痛的自我管理。这项研究将为确定性试验的设计提供信息，包括样本量估计、聚类位点识别方法、主要和次要结局的选择以及最终的卫生经济学模型。调查结果将为未来提供这种数字健康干预的方法提供信息。ClinicalTrials.gov NCT 05838677; https://clinicaltrials.gov/study/NCT05838677 DERR 1 -10.2196/51474
Chronic or persistent pain affects one’s ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain. We aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes’ feasibility and test research processes for a definitive trial. This is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation–Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention. Ethics approval was obtained in March 2023. Trial recruitment began in June 2023. The PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes’ selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention. ClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677 DERR1-10.2196/51474