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Trial registered on ANZCTR


Registration number
ACTRN12624000318583
Ethics application status
Approved
Date submitted
7/02/2024
Date registered
25/03/2024
Date last updated
21/04/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
Frailty response in patients with aortic stenosis undergoing transcatheter aortic valve implantation: a pilot, cluster randomised controlled trial (FRAIL-AS Response Trial)
Secondary ID [1] 311492 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FRAIL-AS Response Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 332821 0
Frailty 332822 0
Transcatheter aortic valve implantation 332823 0
Valvular heart disease 332824 0
Condition category
Condition code
Cardiovascular 329542 329542 0 0
Other cardiovascular diseases
Surgery 329543 329543 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).

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.
Intervention code [1] 327942 0
Behaviour
Intervention code [2] 328164 0
Treatment: Other
Comparator / control treatment
Standard care in response to frailty identification in patients with aortic stenosis undergoing TAVI. This may include reviews by geriatricians, additional clinical assessments and rehabilitation, as deemed appropriate by treating clinicians based on an individual’s needs.
Control group
Active

Outcomes
Primary outcome [1] 337335 0
Number of hospitals that achieve a minimum 10% increase in the number of patients receiving a nutritional assessment upon frailty identification.
Timepoint [1] 337335 0
Post frailty identification at an individual patient level e.g. within two weeks of identifying frailty at an individual patient level.
Secondary outcome [1] 431496 0
Any change in quality of life (EQ-5D-5L) for patients treated at intervention hospitals compared to control hospitals.
Timepoint [1] 431496 0
1, 6- and 12-months post TAVI
Secondary outcome [2] 431497 0
Any change in frailty classification for patients treated at intervention hospitals compared to control hospitals
Timepoint [2] 431497 0
1, 6- and 12-months post TAVI
Secondary outcome [3] 431498 0
Any change in all-cause mortality for patients treated at intervention hospitals compared to control hospitals.
Timepoint [3] 431498 0
6- and 12-months post TAVI
Secondary outcome [4] 431499 0
Any change in number of hospital admissions for patients treated at intervention hospitals compared to control hospitals
Timepoint [4] 431499 0
6- and 12-months post TAVI
Secondary outcome [5] 431502 0
Any change in proportion of frail patients with aortic stenosis provided with information on frailty at intervention hospitals compared to control hospitals
Timepoint [5] 431502 0
At discharge post TAVI
Secondary outcome [6] 431504 0
At intervention hospitals only. Factors promoting and sustaining uptake of the intervention through a qualitative exploration of organisational, contextual, and structural influences impacting delivery of the Frailty Response Clinical Protocol.
Timepoint [6] 431504 0
At the conclusion of the trial
Secondary outcome [7] 432598 0
Any change in clinical complications (composite including neurological, bleeding, vascular, new conduction disturbances and arrythmias, acute kidney injury and myocardial infarction) for patients treated at intervention hospitals compared to control hospitals
Timepoint [7] 432598 0
6- and 12-months post TAVI
Secondary outcome [8] 432601 0
Any change in proportion of general practitioners (GPs) of frail patients with aortic stenosis notified of their frailty at intervention hospitals compared to control hospitals
Timepoint [8] 432601 0
At discharge post TAVI
Secondary outcome [9] 432604 0
Any change in proportion of frail patients with aortic stenosis referred for cardiac rehabilitation at intervention hospitals compared to control hospitals
Timepoint [9] 432604 0
At discharge post TAVI
Secondary outcome [10] 432605 0
Any change in the proportion of frail patients with aortic stenosis referred to a geriatrician for a comprehensive geriatric assessment (for mod-severe frail patients only)
Timepoint [10] 432605 0
Up to 3 months post TAVI
Secondary outcome [11] 433208 0
Any change in quality of life (KCCQ) for patients treated at intervention hospitals compared to control hospitals.
Timepoint [11] 433208 0
1, 6- and 12-months post TAVI

Eligibility
Key inclusion criteria
Hospitals
To be eligible to participate in the trial, hospitals must:
• have a TAVI clinical program (or equivalent) performing equal to or greater than 50 TAVI procedures per year
• be currently collecting routine patient data for the Australasian Cardiac Outcomes Registry (ACOR) - TAVI Registry.

Patients within eligible hospitals will be included if:
• they are aged 18 years or older.
• have a diagnosis of aortic stenosis and have been scheduled to undergoing a TAVI procedure.
• have been routinely identified as being frail (a score of mild-5, moderate-6, severe-7 on the scale) using the Clinical Frailty Scale (CFS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hosptials who do not have a TAVI clinical program (or equivalent) performing more than 50 TAVI procedures per year.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospitals and wards will be randomly allocated a unique code by a member of the study team. At the beginning of the trial an independent statistician not involved with the trial will randomly allocate hospitals, using computer software to one of two allocations (intervention or control), using the unique codes provided. Allocation will be based on clusters and allocation concealment will be at an individual participant level.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation, stratified by by payer (public or private) hospital status.
A pilot, cluster randomised controlled trial (cRCT).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features


The unit of randomisation will be hospitals. Hospitals (with their respective TAVI clinical programs) will be randomised 1:1 to intervention (Frailty Response Program) or control (standard care) groups using a computer-generated sequence.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Blinded outcome assessment will be undertaken for all analyses of primary and secondary outcome measures.

Intention-to-treat principle will be followed with patients analysed according to their randomisation group. Individual patient level data analysis will be conducted, focusing on descriptive analyses due to the pilot trial design. The primary (patients screened for malnutrition) and secondary outcomes will be assessed using proportions and distribution. Within-group and between-group changes (adjusting for clustering) will be compared using t-tests, Mann-Whitney U, chi-squared test and ANOVA tests. Analysis will include comparison of outcomes between private and public hospitals examining difference in proportions of change and treatment for frailty management hospitals.

For the process evaluation, deductive content analysis will be guided by the Normalisation Process Theory. Analysis will occur in two separate stages, the first to determine major emerging themes and the second, reviewed inductively to identify additional themes to be included in the analysis.

No interim analyses are planned for outcomes. As noted earlier, an interim analysis of the sample size is planned.

An economic evaluation in the form of a costing analysis will be undertaken to understand the scalability and sustainability of the Frailty Response Program intervention in other hospitals. The costing analysis will inform a business case alongside the assessment of the benefits to health care organisations for investing in the uptake of Frailty Response Program intervention.

The costs of implementing the Frailty Response Program intervention will be estimated using the time capture tool and the salaries of the personnel involved. The patient-level healthcare resource utilisation, including length of stay and hospital admissions will be examined, as well as any additional quality of life data collected at the follow-up time points. This detailed costing analysis will inform a future comprehensive cost-effective analysis in Phase III trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315779 0
Government body
Name [1] 315779 0
New South Wales Health: Early-Mid Career Cardiovascular Research Capacity Program Grant
Country [1] 315779 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Country
Australia
Secondary sponsor category [1] 317905 0
None
Name [1] 317905 0
None
Address [1] 317905 0
Country [1] 317905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314639 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 314639 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 314639 0
Australia
Date submitted for ethics approval [1] 314639 0
24/01/2024
Approval date [1] 314639 0
22/02/2024
Ethics approval number [1] 314639 0

Summary
Brief summary
Frailty is present in 3 out of 10 people who undergo TAVI. However, there's limited evidence for managing frailty, which worsens outcomes in patients post TAVI.

This trial aims to assess the feasibility of implementing a tailored Frailty Response Program for frail aortic stenosis patients undergoing TAVI. Using a cluster randomised controlled trial design, it will compare this program to standard care in hospitals. The multicomponent program (nutrition, patient information, GP notification, geriatric assessment and rehabilitation) adjusted to the patient's frailty status, will commence pre-TAVI and patients will be followed up for 12-months post procedures. This project aims to determine the impact of evidence-based frailty management on aortic stenosis patient outcomes post TAVI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132246 0
Dr Nicola Straiton
Address 132246 0
Nursing Research Institute - Australian Catholic University, St Vincent's Health Network Sydney and StVincent's Hospital, Melbourne. Level 5, deLacy building St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010
Country 132246 0
Australia
Phone 132246 0
+61 2 8382 4024
Fax 132246 0
Email 132246 0
nicola.straiton@acu.edu.au
Contact person for public queries
Name 132247 0
Nicola Straiton
Address 132247 0
Nursing Research Institute - Australian Catholic University, St Vincent's Health Network Sydney and StVincent's Hospital, Melbourne. Level 5, deLacy building St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010
Country 132247 0
Australia
Phone 132247 0
+61 2 8382 4024
Fax 132247 0
Email 132247 0
nicola.straiton@acu.edu.au
Contact person for scientific queries
Name 132248 0
Nicola Straiton
Address 132248 0
Nursing Research Institute - Australian Catholic University, St Vincent's Health Network Sydney and StVincent's Hospital, Melbourne. Level 5, deLacy building St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010
Country 132248 0
Australia
Phone 132248 0
+61 2 8382 4024
Fax 132248 0
Email 132248 0
nicola.straiton@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In keeping with the requirements of ethics approval, only summary data not individual data will be presented or published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.