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

J Adv Nurs. 2019 Nov;75(11):3078-3087. doi: 10.1111/jan.14106. Epub 2019 Jul 30.

Abstract

Aim: 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.

Methods: 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.

Discussion: 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.

Impact: 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.

Trial registration number: ISRCTN: 74345449.

目的: 在这项研究的初始阶段,开展线上德尔菲法调查,以便在利益相关者之间就护士主导的评估和护理计划干预措施的组成部分达成共识,这些干预措施针对衰弱老人的初级护理。这项可行性随机对照试验(fRCT)将检验所提出的干预措施及其实施情况,并确定结论性随机对照试验的设计方法。 方法: 可行性随机对照试验采用定性研究的方法,预计招募60名参与者。使用电子衰老指数(eFI)识别中度衰老和重度衰老老年人,并由社区高级护士进行干预。对照组受试者将接受普通衰老的初级护理。该研究由美国国立卫生研究院资助(NIHR;2016年5月批准的资金,编号:ICA-CDRF-2016-02-018),并于2018年获得NHS和伦理委员会的批准。 讨论有证据表明,为社区老年人提供多种干预措施可以减少疗养院和医院的入院率和跌倒率,没有多少证据表明任何特定类型或具有强度的干预措施有益处,或有衰老人口的额外益处。该试验将确定干预的可行性,决定招募人数、保留参数和试验后勤,并明确结果评估标准。: 影响: 本研究旨在通过使用系统的衰弱性诊断、参与者识别方法,以人为本的干预试行措施和可行性参数测试来解决当前研究的局限性。 试验注册号: ISRCTN:74345449。.

Keywords: assessment; frailty; holistic intervention; nursing; older people; primary care.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Feasibility Studies
  • Female
  • Frail Elderly / statistics & numerical data*
  • Geriatric Nursing / standards*
  • Holistic Nursing / standards*
  • Humans
  • Intersectoral Collaboration
  • Male
  • Patient Care Planning / standards*
  • Practice Guidelines as Topic*
  • Primary Health Care / standards*
  • Qualitative Research
  • Surveys and Questionnaires