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Abstract
Introduction 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.
Methods and analysis 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 and dissemination 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.
Trial registration number NCT04538157.
- Clinical Trial
- Health Services for the Aged
- Chronic renal failure
- Patient Reported Outcome Measures
- QUALITATIVE RESEARCH
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Footnotes
Contributors STF developed this process evaluation protocol and was involved in planning and design of the work. RH is the lead investigator of the GOAL trial and formed the original idea and design for the trial. She was involved in planning and design of the process evaluation design. MM, AV and EK were involved in trial coordination, including planning of the work. EMA was involved in planning of data management. AV is an investigator on the GOAL trial and contributed to design and planning of this work. DJ is an investigator on the GOAL trial and contributed to design and planning of this work. MJ is an investigator on the GOAL trial. She was involved in planning and design of the process evaluation work. All authors contributed to creation of this manuscript, including reviewing and approval of the final manuscript. All authors agreed to be accountable for all aspects of the work herein. RH is the guarantor.
Funding This research is funded by a National Health and Medical Research Council grant. Specifically, a Targeted Call for Research into Frailty in Hospital Care, awarded in 2019 (APP1178519). AV receives grant support from a Queensland Advancing Clinical Research Fellowship (Grant Number: NA) and an NHMRC Emerging Leader Grant (1196033). DJ is a current recipient of an NHMRC Leadership Investigator Grant (1194485).
Disclaimer The funder will have no role in study design, data collection, analysis or publications decisions.
Competing interests DJ has received consultancy fees, research grants, speaker’s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care, consultancy fees from Astra Zeneca, Bayer and AWAK, speaker’s honoraria from ONO and Boehringer Ingelheim & Lilly, and travel sponsorships from Ono and Amgen.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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