Centre for Research, Development and Technology Transfer, Rosenheim Technical University of Applied Sciences, Hochschulstraße 1, 83024, Rosenheim, Germany.
Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-Universität München, Marchioninistraße 17, 81377, Munich, Germany.
BMC Fam Pract. 2021 Apr 2;22(1):62. doi: 10.1186/s12875-021-01410-2.
Community-dwelling older people are frequently affected by vertigo, dizziness and balance disorders (VDB). We previously developed a care pathway (CPW) to improve their mobility and participation by offering standardized approaches for general practitioners (GPs) and physical therapists (PTs). We aimed to assess the feasibility of the intervention, its implementation strategy and the study procedures in preparation for the subsequent main trial.
This 12-week prospective cohort feasibility study was accompanied by a process evaluation designed according to the UK Medical Research Council's Guidance for developing and evaluating complex interventions. Patients with VDB (≥65 years), GPs and PTs in primary care were included. The intervention consisted of a diagnostic screening checklist for GPs and a guide for PTs. The implementation strategy included specific educational trainings and a telephone helpline. Data for mixed-method process evaluation were collected via standardized questionnaires, field notes and qualitative interviews. Quantitative data were analysed using descriptive statistics, qualitative data using content analysis.
A total of five GP practices (seven single GPs), 10 PT practices and 22 patients were included in the study. The recruitment of GPs and patients was challenging (response rates: GP practices: 28%, PT practices: 39%). Ninety-one percent of the patients and all health professionals completed the study. The health professionals responded well to the educational trainings; the utilization of the telephone helpline was low (one call each from GPs and PTs). Familiarisation with the routine of application of the intervention and positive attitudes were emphasized as facilitators of the implementation of the intervention, whereas a lack of time was mentioned as a barrier. Despite difficulties in the GPs' adherence to the intervention protocol, the GPs, PTs and patients saw benefit in the intervention. The patients' treatment adherence to physical therapy was good. There were minor issues in data collection, but no unintended consequences.
Although the process evaluation provided good support for the feasibility of study procedures, the intervention and its implementation strategy, we identified a need for improvement in recruitment of participants, the GP intervention part and the data collection procedures. The findings will inform the main trial to test the interventions effectiveness in a cluster RCT.
Projektdatenbank Versorgungsforschung Deutschland (German registry Health Services Research) VfD_MobilE-PHY_17_003910, date of registration: 30.11.2017; Deutsches Register Klinischer Studien (German Clinical Trials Register) DRKS00022918, date of registration: 03.09.2020 (retrospectively registered).
社区居住的老年人经常受到眩晕、头晕和平衡障碍（VDB）的影响。我们之前开发了一种护理途径（CPW），通过为全科医生（GP）和物理治疗师（PT）提供标准化方法来提高他们的活动能力和参与度。我们旨在评估干预措施的可行性、实施策略和研究程序，为随后的主要试验做准备。
这项为期 12 周的前瞻性队列可行性研究伴随着一个根据英国医学研究理事会（MRC）为开发和评估复杂干预措施而制定的指导方针进行的过程评估。纳入了患有 VDB（≥65 岁）的患者、初级保健中的全科医生和物理治疗师。干预措施包括 GP 的诊断筛查检查表和 PT 的指南。实施策略包括特定的教育培训和电话热线。通过标准化问卷、现场记录和定性访谈收集混合方法过程评估数据。使用描述性统计分析定量数据，使用内容分析分析定性数据。
共有 5 家全科医生诊所（7 名单 GP）、10 家物理治疗师诊所和 22 名患者参与了这项研究。全科医生和患者的招募工作具有挑战性（GP 诊所的回应率：28%，PT 诊所：39%）。91%的患者和所有卫生专业人员完成了研究。卫生专业人员对教育培训反应良好；电话热线的利用率很低（每位 GP 和 PT 各打一个电话）。熟悉应用干预措施的常规和积极的态度被强调为实施干预措施的促进因素，而缺乏时间被认为是一个障碍。尽管 GP 难以遵守干预方案，但 GP、PT 和患者都认为干预措施有好处。患者对物理治疗的治疗依从性良好。数据收集方面存在一些小问题，但没有出现意外后果。
尽管过程评估为研究程序、干预措施及其实施策略的可行性提供了很好的支持，但我们发现参与者招募、GP 干预部分和数据收集程序需要改进。研究结果将为一项集群 RCT 提供干预措施有效性的信息。
德国医疗保健研究项目数据库（German registry Health Services Research）VfD_MobilE-PHY_17_003910，注册日期：2017 年 11 月 30 日；德国临床试验注册处（German Clinical Trials Register）DRKS00022918，注册日期：2020 年 9 月 3 日（回溯注册）。
