Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial
Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial
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DOI：
10.2196/17939
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发表时间：
2020-07-01
影响因子：
1.7
通讯作者：
Foster, Nadine E.
中科院分区：
文献类型：
--
作者：
Hill, Jonathan;Garvin, Stefannie;Foster, Nadine E.
背景：肌肉骨骼 (MSK) 疼痛是疼痛和残疾的主要原因。我们之前开发了一种预后工具（Start Back Tool），该工具通过支持使用匹配治疗的决策来指导初级保健腰痛管理，已被证明是有效的。合乎逻辑的下一步是确定预后分层护理是否对更广泛的常见 MSK 疼痛表现有益处。 目的：本研究旨在确定，对于患有 5 种最常见 MSK 表现（背部、颈部、膝盖、肩部和多部位疼痛）中的 1 种的患者，分层护理是否涉及使用 Keele Start MSK 工具将个体分配为低、中和高风险亚组，并将这些亚组与推荐的匹配临床管理方案相匹配，与通常的非分层初级保健相比，具有临床意义和成本效益。方法：这是一项务实的双臂平行（分层与非分层护理）整群随机对照试验，采用健康经济分析和混合方法过程评估。背景是英国初级保健，涉及 24 个平均规模的全科诊所，按 1:1 的比例（每组 12 个）随机分配（按诊所规模分层），试验统计学家和结果数据收集者采用盲法。随机分组是一般做法，观察单位是没有严重病理、紧急医疗需求或脆弱性迹象的 MSK 斯隆成年顾问。使用全科医生 (GP) 咨询点电子病历 (EMR) 模板对潜在参与者记录进行标记并邀请个人。该干预由包含 Keele Start MSK 工具（用于分层为预后亚组）和推荐的匹配治疗方案的 EMR 模板（基于计算机）提供支持。使用意向治疗分析的主要结果是疼痛强度，在 6 个月内每月测量一次。次要结果包括身体功能和生活质量，以及用于捕捉临床医生决策的匿名 EMR 审核。经济评估的重点是估计增量质量调整生命年和 MSK 斯隆疼痛相关医疗保健成本。过程评估正在探索一系列影响干预的潜在因素，并了解患者和临床医生如何看待干预，重点是先验假设的干预目标和使用焦点小组和访谈的定性方法进行定量分析。目标样本量是来自 24 个全科诊所的 1200 名患者，超过 5000 名 MSK 咨询可用于匿名病历数据比较。结果：试验招募于 2018 年 5 月 18 日开始，在 24 个全科医生诊所进行了 14 个月的招募期后，于 2019 年 7 月 15 日结束。随访和访谈数据收集于 2020 年 2 月完成。结论：据我们所知，该试验是首次尝试测试针对 MSK 疼痛初级保健患者的预后分层护理方法。该试验的结果将于 2020 年夏季公布。
Background: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations.Objective: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care.Methods: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons.Results: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020.Conclusions: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020.