The holistic assessment and care planning in partnership intervention study (HAPPI): A protocol for a feasibility, cluster randomized controlled trial

Abstract

During an initial phase of this research, an e-Delphi survey was conducted to gain consensus among stakeholders on the components of a nurse-led assessment and care planning intervention for older people who live with frailty in primary care. This feasibility randomized controlled trial (fRCT) will test the proposed intervention and its implementation and determine methods for the design of a conclusive randomized controlled trial. The fRCT, with embedded qualitative study, aims to recruit 60 participants. Moderately and severely frail older people will be identified using the electronic frailty index (eFI) and the intervention will be delivered by senior community nurses. The control participants will receive usual primary care for frailty. The study is funded by the National Institute of Health Research (NIHR; funding granted in May 2016, ref: ICA-CDRF-2016-02-018) and received NHS and University Research Ethics Committee approval in 2018. There is evidence that the delivery of complex interventions for community-dwelling older people can reduce care home and hospital admissions and falls, there is less evidence for the benefit of any specific type or intensity of intervention or the additional benefits of targeting the frail population. This trial will determine feasibility of the intervention, define recruitment and retention parameters and trial logistics, and decide outcome measures. This study aims to address the limitations of current research by using a systematic method of frailty diagnosis and participant identification, trialling implementation of a person-centred intervention, and testing of feasibility parameters. ISRCTN: 74345449.