Examining the feasibility of implementing of an evidence-based Frailty Response Program in hospital settings for frail adults with aortic stenosis undergoing heart valve replacement procedures (FRAIL-AS Response Trial)

The Frailty Response Clinical Protocol This will be delivered by structural heart team clinicians and is comprised of five evidence-based components tailored to patients frailty classification (mild, moderate or severe), it involves: i) nutritional assessment: each hospital may use an existing a validated questionnaire such as the commonly used Malnutrition Screening Tool - MST (estimated 10 minutes to complete), conducted with the patient (either via telephone or in-person) by the hospital clinicians prior to TAVI ii) patient frailty information; provision of written information to patients describing what frailty is and how patients can recognise it and how to manage it, either before or post TAVI. Using existing hospital resources or publicly available resources such as the British Geriatric Society ‘What is Frailty’ information sheet. iii) general practitioner notification of patient frailty; correspondence sent from the clinicians to the patients GP notifying them that the patient has been identified as being frail v) referral for cardiac rehabilitation; after undergoing a TAVI procedure, aligned with routine care, patients will be referred by hospital clinicians to a cardiac rehabilitation program iv) referral for geriatric assessment (moderate and severe frailty only), prior or within 3 months after the TAVI procedure, a referral from the hospital clinicians to a geriatrician requesting the patient undergo a comprehensive geriatric assessment The Frailty Response Program Implementation Strategy The following evidence-based approaches and strategies for changing clinician behaviours will be used to implement the intervention, they will be commenced post randomisation and expected to be conducted for up to 3 months prior to prospective data collection: i) Use of local clinical champions (hospital clinical champions) identified at the start of the trial at each site. Nursing and medical clinical champions will be identified from each transcatheter aortic valve implantation (TAVI) clinical team to support conduct of the trial and implementation of the intervention. Activities may include active engagement with the research team, raising awareness of the trial and implementation of the intervention at site amongst broader clinical colleagues, working with the research teams to identify local solutions to embed the intervention and assisting with trial data collection alongside the research team. ii) Frailty Response Clinical Protocol education. To enable compliance with implementation of the Frailty Response Clinical Protocol training will be provided by the research team and relevant clinical experts. The education session is anticipated to run for 1 hour, with an overview of the trial and question and answer session. iii) Barriers and enablers meeting. A meeting on barriers and enablers will be conducted at each intervention hospital, involving the local TAVI clinical teams and other relevant personnel. The meeting aims to identify local barriers, enablers, and potential solutions to facilitate the implementation of the Frailty Response Program intervention in TAVI clinical programs. The barriers and enablers meeting is anticipated to run for 1 hour, and will be facilitated by a member of the research team. Following the meeting, action plans will be devised with the local clinical champion and the researchers, and any required local adjustments for the effective implementation of the Frailty Response Clinical Protocol will be discussed and included. iv) Frailty education session. The session is expected to run for 1hr and will be delivered by the research team and relevant clinical experts for TAVI clinical teams. The aim is to enhance awareness and understanding of frailty, emphasising measurement using the validated Clinical Frailty Scale. v) External Remote Facilitation. The researchers will provide external remote facilitation to intervention hospitals. Their role will involve providing information about the Frailty Response Program intervention to participating hospitals and granting intervention hospitals access to the frailty education session (recorded, emailed upon request to clinical champion). vi) Clinical processes of care audit and feedback report. Clinical champions in intervention hospitals will receive a baseline report of their pre-implementation clinical processes of care audit data highlighting compliance with the Frailty Response Clinical Protocol prior to the intervention. Process evaluation Clinicians from selected intervention hospitals, stratified by (1) hospital type (private or public) and (2) performance status (high and low performing, determined by final trial results on Frailty Response Clinical Protocol compliance), will be invited to participate in focus groups and semi-structured interviews. Clinical champions from the respective hospitals will facilitate engagement. The process evaluation aims to explore organisational, contextual, and structural factors influencing the successful or unsuccessful adoption of the intervention.