Frailty in older people: rehabilitation treatment research examining separate settings PLUS (FORTRESS PLUS): protocol for a single arm intervention trial with comparison to historical controls.

backgroundFew older frail adults hospitalised with medical conditions other than stroke or post-surgery receive acute inpatient rehabilitation and most of these services are of short duration and low intensity. This study hopes to deliver an intensive frailty intervention to inform clinical practice guidelines and health policy for frail older adults who have been acutely hospitalised and are at risk of functional decline upon hospital discharge.

methodsThe FORTRESS PLUS trial is a single arm intervention study which will employ comparison to historical controls from the intervention arm of the 2020 FORTRESS Study. FORTRESS Plus expands on the 2020 FORTRESS study with broader eligibility, a longer follow-up period, and strengthened post-discharge support. The study aims to determine whether an intensive intervention addressing malnutrition, polypharmacy and sedentary activity in frail older adults will improve health-related quality of life outcomes, mood, physical function, social isolation, frailty, and hospital readmissions. Frail older people aged 75 or older who are admitted to 3 different study wards located within Hornsby Ku-ring-gai Hospital with no significant cognitive impairment measured by an MMSE (Mini Mental State Examination) score of 22 and above, who are expected to return home after discharge, will be eligible to participate. Participants will receive dietetic review, pharmacy review and a comprehensive geriatric assessment during their acute admission if indicated. All participants receive the pharmacy review to identify possible polypharmacy and those who have been identified will receive further intervention for the pharmacist to deprescribe potentially inappropriate medications. Only those who have been identified at the time of screening as having unintentionally lost 5 kg or 5% of their body weight over the past year receive the dietary intervention. They will receive nutritional education, informing them what their optimal oral intake is. Upon discretion from the dietician this may warrant possible referral for protein supplementation for continuation at home post discharge or requesting diet order during their admission to meet these requirements i.e. a high protein high energy diet. The dietician may also create short term goals with the patient such as "finish all meals" and refer onto a speech pathologist if there are concerns with swallowing or feeding at mealtimes. All participants receive a comprehensive geriatric assessment. Upon discharge home, participants will receive 7 weekly sessions of supervised home exercise delivered by an Exercise Physiologist, with additional unsupervised sessions encouraged throughout the week. The primary outcome is the improvement in quality of life measured using the EQ-5D-5 L and the secondary outcomes include number hospital readmissions within 12 months, frailty status measured using the 5 item FRAIL scale; physical function measured using the Short Physical Performance Battery test (SPPB) and mood will be measured using the short form Geriatric Depression Scale (GDS-15). Implementation outcomes will be collected as part of a process evaluation. Recruitment commenced in October 2023, and 141 participants have been recruited from three acute wards in Hornsby Ku-ring-gai Hospital. These wards are 2D (general medicine/cardiology), 3D (rehabilitation) and 4D (general medicine/stroke). The recruitment phase of the project concluded in July 2024. DISCUSSION: This study will reveal whether addressing factors contributing to frailty can improve quality of life, physical function, mood, and frailty status. If the FORTRESS Plus intervention provides a clinically significant result, it will demonstrate that an intensive intervention over a number of weeks is required for frail older people following discharge from hospital.

trial registrationThis study is registered under the ANZCTR Australian New Zealand Clinical Trials Registry with the trial ID of ACTRN12623001103651 registered 20 October 2023.