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

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.