Centre for Health Services Research, The University of Queensland, Woolloongabba, Queensland, Australia
Internal Medicine Services, The Prince Charles Hospital, Chermside, Queensland, Australia.
BMJ Open. 2024 Aug 3;14(8):e076328. doi: 10.1136/bmjopen-2023-076328.
The GOAL Cluster Randomised Controlled Trial (NCT04538157) is now underway, investigating the impact of comprehensive geriatric assessment (CGA) for frail older people with chronic kidney disease (CKD). The primary outcome is the attainment of patient-identified goals at 3 months, assessed using the goal attainment scaling process. The protocol requires a dedicated process evaluation that will occur alongside the main trial, to investigate issues of implementation, mechanisms of impact and contextual factors that may influence intervention success. This process evaluation will offer novel insights into how and why CGA might be beneficial for frail older adults with CKD and provide guidance when considering how to implement this complex intervention into clinical practice.
This process evaluation protocol follows guidance from the Medical Research Council and published guidance specific for the evaluation of cluster-randomised trials. A mixed methodological approach will be taken using data collected as part of the main trial and data collected specifically for the process evaluation. Recruitment and process data will include site feasibility surveys, screening logs and site issues registers from all sites, and minutes of meetings with intervention and control sites. Redacted CGA letters will be analysed both descriptively and qualitatively. Approximately 60 semistructured interviews will be analysed with a qualitative approach using a reflexive thematic analysis, with both inductive and deductive approaches underpinned by an interpretivist perspective. Qualitative analyses will be reported according to the Consolidated criteria for Reporting Qualitative research guidelines. The Standards for Quality Improvement Reporting Excellence guidelines will also be followed.
Ethics approval has been granted through Metro South Human Research Ethics Committee (HREC/2020/QMS/62883). Dissemination will occur through peer-reviewed journals and feedback to trial participants will be facilitated through the central coordinating centre.
NCT04538157.
GOAL 集群随机对照试验（NCT04538157）目前正在进行中，旨在研究综合老年评估（CGA）对患有慢性肾脏病（CKD）的虚弱老年人的影响。主要结果是在 3 个月时通过目标实现评分过程评估患者确定的目标的实现情况。该方案需要进行专门的过程评估，该评估将与主要试验同时进行，以调查实施问题、影响机制以及可能影响干预成功的背景因素。该过程评估将为 CGA 如何以及为何可能有益于患有 CKD 的虚弱老年成年人提供新的见解，并为考虑如何将这种复杂的干预措施实施到临床实践中提供指导。
本过程评估方案遵循医学研究委员会的指导和专门针对集群随机试验评估的指南。将采用混合方法学方法，使用作为主要试验一部分收集的数据和专门为过程评估收集的数据。招募和过程数据将包括所有站点的站点可行性调查、筛选日志和站点问题登记册，以及干预和对照站点的会议记录。经过编辑的 CGA 信件将进行描述性和定性分析。大约 60 次半结构化访谈将使用定性方法进行分析，采用反思性主题分析，采用归纳和演绎方法，并以解释主义观点为基础。定性分析将根据《定性研究报告统一标准指南》进行报告。还将遵循《质量改进报告卓越标准指南》。
伦理批准已通过 Metro South 人类研究伦理委员会（HREC/2020/QMS/62883）获得。传播将通过同行评议的期刊进行，将通过中央协调中心为试验参与者提供反馈。
NCT04538157。
