Protocol for a process evaluation of a stepped wedge randomised controlled trial to reduce unnecessary hospitalisations of older people from residential aged care: the EDDIE+ study

Abstract

IntroductionThe Early Detection of Deterioration in Elderly residents (EDDIE+) programme is a theory-informed, multi-component intervention aimed at upskilling and empowering nursing and personal care staff to identify and manage early signs of deterioration in residents of aged care facilities. The intervention aims to reduce unnecessary hospital admissions from residential aged care (RAC) homes. Alongside a stepped wedge randomised controlled trial, an embedded process evaluation will be conducted to assess the fidelity, acceptability, mechanisms of action and contextual barriers and enablers of the EDDIE+ intervention.Methods and analysisTwelve RAC homes in Queensland, Australia are participating in the study. A comprehensive mixed-methods process evaluation, informed by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework, will assess intervention fidelity, contextual barriers and enablers, mechanisms of action, and the acceptability of the programme from various stakeholder perspectives. Quantitative data will be collected prospectively from project documentation, including baseline context mapping of participating sites, activity tracking and regular check-in communication sheets. Qualitative data will be collected postintervention via semi-structured interviews with a range of stakeholder groups. The i-PARIHS constructs of innovation, recipients, context and facilitation will be applied to frame the analysis of quantitative and qualitative data.Ethics and disseminationEthical approval for this study has been granted by the Bolton Clarke Human Research Ethics Committee (approval number: 170031) with administrative ethical approval granted by the Queensland University of Technology University Human Research Ethics Committee (2000000618). Full ethical approval includes a waiver of consent for access to residents’ demographic, clinical and health services de-identified data. A separate health services data linkage based on RAC home addresses will be sought through a Public Health Act application. Study findings will be disseminated through multiple channels, including journal publications, conference presentations and interactive webinars with a stakeholder network.Trial registration numberAustralia New Zealand Clinical Trial Registry (ACTRN12620000507987).

From pilot to a multi-site trial: Refining the Early Detection of Deterioration in Elderly Residents (EDDIE+) intervention

“…New evidence and policy changes in the aged care sector meant review and re nement were necessary. Further, the intervention was to be implemented in a stepped-wedge cluster randomised trial, across multiple sites, so a clear structured process for planning and evaluating the implementation was essential for the required rigour of this study design, and to inform the proposed process evaluation (10). In addition, Australia's Royal Commission into Aged Care Quality and Safety had just released its ndings (1 March 2021), highlighting the numerous challenges faced by the sector (11).…”