Frailty in older people: Rehabilitation Treatment Research Examining Separate Settings (FORTRESS): protocol for a hybrid type II stepped wedge, cluster, randomised trial

Abstract

Background Frailty in older people is associated with increased risk of falls, longer length of stay in hospital, increased risk of institutionalisation and death. Frailty can be measured using validated tools. Multi-component frailty interventions are recommended in clinical practice guidelines but are not routinely implemented in clinical practice. Methods The Frailty in Older people: Rehabilitation, Treatment, Research Examining Separate Settings (FORTRESS) trial is a multisite, hybrid type II, stepped wedge, cluster, randomised trial with blinded assessment and intention-to-treat analysis being conducted in Australia. The study aims to determine the effectiveness and cost-effectiveness of an embedded individualised multicomponent frailty intervention (commencing in hospital and continuing in the community) on readmissions, frailty and quality of life when compared with usual care. Frail older people admitted to study wards with no significant cognitive impairment, who are expected to return home after discharge, will be eligible to participate. Participants will receive extra sessions of physiotherapy, pharmacy, and dietetics during their admission. A Community Implementation Facilitator will coordinate implementation of the frailty management strategies and primary network liaison. The primary outcome is number of days of non-elective hospital readmissions during 12 month follow-up period. Secondary outcomes include frailty status measured using the FRAIL scale; quality of life measured using the EQ-5D-5L; and time-to-event for readmission and readmission rates. The total cost of delivering the intervention will be assessed, and cost-effectiveness analyses will be conducted. Economic evaluation will include analyses for health outcomes measured in terms of the main clinical outcomes. Implementation outcomes will be collected as part of a process evaluation. Recruitment commenced in 2020 and we are aiming to recruit 732 participants over the three-year duration of the study. Discussion This study will reveal whether intervening with frail older people to address factors contributing to frailty can reduce hospital readmissions and improve frailty status and quality of life. If the FORTRESS intervention provides a clinically significant and cost-effective result, it will demonstrate an improved approach to treating frail patients, both in hospital and when they return home. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000760976p. ANZCTR registered 24 July 2020.

Frailty evidence‐practice gaps in acute care hospitals

“…A retrospective audit of electronic medical records (EMR) was undertaken to identify current practice in acute care and quantify evidence-practice gaps relating to frailty guideline recommendations. Medical records were audited of frail older patients admitted to two acute care hospitals at Southern Adelaide Local Health Network in Adelaide and Northern Sydney Local Health District, Sydney, who were a subset of recruited control group participants in the Frailty in Older People, Rehabilitation, Treatment, Research Examining Separate Settings (FORTRESS) trial 13 from December 2020 to February 2022. Details of the FORTRESS study and methodology are published elsewhere.…”

“…Details of the FORTRESS study and methodology are published elsewhere. 13 This study received ethics approval from the Northern Sydney Local Health District Human Research Ethics Committee, reference number: 2020/ETH01057.…”

“…Medical records were audited of frail older patients admitted to two acute care hospitals at Southern Adelaide Local Health Network in Adelaide and Northern Sydney Local Health District, Sydney, who were a subset of recruited control group participants in the Frailty in Older People, Rehabilitation, Treatment, Research Examining Separate Settings (FORTRESS) trial 13 from December 2020 to February 2022. Details of the FORTRESS study and methodology are published elsewhere 13 . This study received ethics approval from the Northern Sydney Local Health District Human Research Ethics Committee, reference number: 2020/ETH01057.…”

Implementation of a frailty intervention in the transition from hospital to home: a realist process evaluation protocol for the FORTRESS trial

“…Details of the trial are presented elsewhere. 9 This protocol describes the methodology of the process evaluation which will occur concurrently.…”

“…The aim of the FORTRESS (Frailty in Older people: Rehabilitation, Treatment, Research Examining Separate Settings) trial is to implement and evaluate an evidence-based frailty intervention in hospital and community settings for ‘frail’ older people by examining the effectiveness and uptake of frailty interventions. Details of the trial are presented elsewhere 9. This protocol describes the methodology of the process evaluation which will occur concurrently.…”