Introduction
The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research question
What is the clinical and cost-effectiveness of proactive comprehensive geriatric assessment (CGA) embedded into cardiac services for frail older heart failure patients with preserved ejection fraction (HFpEF)?
- Intervention: A comprehensive geriatric assessment (CGA) clinic review using a structured CGA-tool for generalisability. Applicants to specify the likely impact of the CGA assessment on practice and changes in outcomes for patients.
- Patient group: Adults with objective evidence of frailty (to be defined and justified by the applicants), under review by or referred into cardiac services, with symptoms consistent with heart failure and preserved ejection fraction (HFpEF) on cardiac imaging.
Exclusion criteria: Patients already under regular review from geriatric medicine services, or those with significant alternative valvular/structural cardiac disease (e.g., advanced aortic stenosis) to explain their symptoms.
Applicants may consider working with the United Kingdom Heart Failure with Preserved Ejection Fraction Registry (UK HFpEF) to facilitate recruitment.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Setting: Secondary and tertiary hospitals with cardiac centres accepting referrals for echocardiography and/or outpatient assessment of heart failure; and/or any other settings where CGA can be delivered (Applicants to specify and justify).
- Comparator: Usual care.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
- Important outcomes: Functional dependency measure to capture disability and loss of independence using validated tools; hospitalisation with heart failure; unscheduled hospitalisation for any other reason.
Other outcomes to consider: Mortality; quality of life using a patient self-reported measure; ‘Home Time’ – a composite measure of days spent alive and out of hospital; completion of a documented anticipatory care plan; prescribed medication burden; n-terminal pro-brain natriuretic peptide (NTproBNP) status and trajectory; referral to geriatric medicine services (i.e. capturing treatment arm overlap within those on a usual care pathway); cost-effectiveness.
a. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant). - Minimum duration of follow-up: Two years.
Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
Rationale
Heart failure is a major cause of morbidity amongst older adults, particularly in those who are frail, and the incidence is rising in line with an ageing population. Approximately 10% of adults aged over 70 years old have heart failure, with half of these patients experiencing heart failure with preserved ejection fraction (HFpEF). Ejection fraction refers to the percentage of the blood in the left ventricle which is pumped out with each heartbeat. An ejection fraction below 40% is defined as reduced ejection fraction (HFrEF), and an ejection fraction that is 40% and above (with evidence of diastolic dysfunction) is defined as HFpEF. Evidence-based treatments and care pathways exist for HFrEF but do not currently exist for HFpEF (the first trial of an apparently effective therapy for HFpEF has only been published in October 2021). The workforce currently managing HFpEF (primarily cardiologists and heart failure specialist nurses) struggle to meet the needs of this population, as cardiology pathways have been designed around non-frail, single organ pathology. They are less well equipped to deal with medical complexity and uncertainty (e.g. frailness and multimorbidity) that is highly prevalent in the HFpEF patient group. There is already an acceptance in cardiology services of the need for a multi-dimensional and multidisciplinary approach.
Geriatricians are well-placed to improve coordinated care for these patients and the comprehensive geriatric assessment (CGA) provides an opportunity for early interventions to optimise current treatments and management of multimorbidity. Evidence in general suggests that it is those individuals with early-moderate disability that benefit most from the proactive CGA approach at scale. However, in current practice, ongoing management for HFpEF is often in primary care, with geriatricians not involved in patient care until there has already been deterioration in their condition and hospitalisation with decompensated heart failure.
CGA involves a multidimensional holistic assessment of physical, functional (including mobility and balance), social, environmental, and psychological factors as well as a medication review. Following this assessment, a personalised care plan is developed to address any issues, including any relevant interventions and planned reviews. The CGA is the foundation of geriatric medicine and is a well-established intervention, associated with an improvement in maintenance of independent living following acute hospitalisation. However, its impact for cardiac patients is currently unknown.
CGA is not currently deployed for people with HFpEF (especially as outpatients). Evidence of effectiveness for this specific group of patients is lacking, but experts suggest that people with HFpEF may be particularly suited to benefit from CGA. Without evidence of effectiveness, there is no incentive to implement CGA in this vulnerable underserved patient group. Further research is therefore needed to establish the clinical and cost-effectiveness of using CGA in HFpEF patients to help guide UK clinical practice. The HTA Programme therefore wishes to commission the trial outlined above.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted online no later than 1pm on the 30 November 2022. Applications will be considered by the HTA Funding Committee at its meeting in January 2023.
Guidance notes and supporting information for HTA Programme applications are available.
Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2023.
Applications received electronically after 1300 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact us at htacommissioning@nihr.ac.uk.