Smith Toby, Clark Lucy, Khoury Reema, Man Mei-See, Hanson Sarah, Welsh Allie, Clark Allan, Hopewell Sally, Pfeiffer Klaus, Logan Pip, Crotty Maria, Costa Matthew, Lamb Sarah E
Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Bone Jt Open. 2021 Nov;2(11):909-920. doi: 10.1302/2633-1462.211.BJO-2021-0136.
This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.
This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a 'good' recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals.
A multicentre recruitment approach will provide greater external validity across population characteristics in England. The mixed-methods approach will permit in-depth examination of the intervention and trial design parameters. The findings will inform whether and how a definitive trial may be undertaken to test the effectiveness of this caregiver intervention for patients after hip fracture surgery. Cite this article: 2021;2(11):909-920.
本研究旨在评估开展一项实用的多中心随机对照试验（RCT）的可行性，以检验一项非正式照护者培训计划对髋部骨折手术后患者康复的临床效果和成本效益。
这将是一项混合方法的可行性随机对照试验，招募60例髋部骨折手术后的患者及其非正式照护者。患者将被随机分为接受常规国民保健服务（NHS）护理，与接受常规NHS护理加照护者 - 患者二元培训计划（HIP HELPER）。该计划将包括由护士、物理治疗师或职业治疗师为患者和照护者提供的三次、每次一小时的一对一培训课程。培训将在患者出院前在医院环境中进行。内容将包括康复的实用技能，如：转移和行走；康复目标设定和期望；节奏和压力管理技巧；以及介绍《HIP HELPER照护者工作手册》，该手册提供有关康复、锻炼、工作表和目标设定计划的信息，以促进“良好”康复。出院后，将通过三次电话指导课程支持患者和照护者进行康复。在基线和随机分组后四个月收集的数据将包括：筛查记录、干预记录、保真度检查表、质量保证监测访问数据，以及评估生活质量、身体、情绪、不良事件和资源使用结果的临床结局。将通过对20名参与者（患者和非正式照护者）和12名卫生专业人员进行定性方法来探讨研究干预措施和随机对照试验设计的可接受性。
多中心招募方法将在英格兰不同人群特征中提供更高的外部效度。混合方法将允许对干预措施和试验设计参数进行深入研究。研究结果将为是否以及如何进行确定性试验以检验这种照护者干预对髋部骨折手术后患者的有效性提供信息。引用本文：2021；2(11):909 - 920。
