Title: In older people with suspected heart failure, does adding a focused ultrasound scan to the current community pathway improve health care quality? (HF-FOCUS)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background: Breathlessness affects 1 in 4 people aged over 65. It is a complex, multifactorial condition affected by physical deconditioning, lung, and heart disease; it reduces quality of life, leads to increased use of hospital services and risk of death. Effective treatment relies on accurate diagnosis, but current community pathways are not designed for the complexities of diagnosis in older people with multiple conditions. Individuals may need several hospital tests and appointments which are difficult for those who are frail or living in care homes. The ability to improve decision-making at the point-of-care is desirable as low diagnostic confidence contributes to treatment delays, unscheduled and inappropriate care. Hand-held ultrasound equipment is widely available and used in hospitals as to extend bedside examination, improving diagnostic confidence. However, there is little evidence about the cost-effectiveness and clinical impact of changing service models and no evidence about the use of focused scans (FOCUS) in the context of community care for older people. Hypothesis: Adding FOCUS to the diagnostic pathway for older people with breathlessness (suspected heart failure) will improve the quality of care. Potential benefits include faster and more accurate decisions at the point-of-care, earlier initiation of treatment, and reduced unscheduled care. Aim: To build on pre-clinical development and pilot work by undertaking a feasibility and initial evaluation study of this complex intervention in a community setting. There is a need to build evidence and refine programme theory before progressing to a multi-centre RCT. Research plan: There are 4 key elements of work informed by the NIHR Framework for Developing and Evaluating Complex Interventions (2021). A mixed-methods approach will allow us to understand the interplay between context, mechanisms and outcomes. The setting for the work is an Acute Clinical Team (ACT) providing medical care in residential settings for Swansea Bay University Health Board. The target population is individuals over 65y referred to the team with new or worsening breathlessness. 1.Formal mapping of the current context. Retrospective cohort study of older patients referred to the ACT in 2015-2018 (c.3000 patients). The cohort will be acquired and anonymised for individual linkage with routinely collected electronic health record and administrative data sources (SAIL Databank). We will describe the real-world patient pathway, outcomes, diagnoses, and resource use for elderly patients with breathlessness receiving community medical care. 2. Small-scale study (c.30 patients) of feasibility and acceptability of delivering FOCUS in a home visit. This will allow us to refine programme theory and test methods prior to evaluation. 3. Effectiveness and process evaluation of adding FOCUS to the current pathway (c.225 patients). Trained nurses will add FOCUS to the current model of care during a home visit. Images will be analysed by nurses and remotely reviewed by a specialist (blind to nurse results). We will determine the feasibility of the methods and intervention, acceptability, comparative diagnostic accuracy, and implementation challenges. 4. Data linkage of participants in 3 with SAIL Databank to assess whether participants are typical of the broader population, to identify potential control subjects and randomization methods for a future RCT.

Lay abstract: We want to improve community healthcare for older people with breathlessness, particularly those who struggle to attend hospitals for tests. We have trained nurses to do a basic ultrasound heart scan (FOCUS) and want to test whether adding this to standard care during a home visit improves a nurse’s ability to decide what is causing breathlessness, whether hospital tests are needed, and what medicine is best. This is important - 1 in 4 older people live with breathlessness and it is linked with reduced quality of life and more frequent use of health services. Finding the cause of breathlessness can be difficult and may involve several tests, often done in hospital. This is particularly difficult for older people who are frail or who live in care homes. It is sensible to improve out -of-hospital testing, particularly given the pandemic, but there is a risk that non-specialists might overuse tests or make an inaccurate diagnosis. Hand-held ultrasound scanners may improve out-of-hospital testing. They are already used by hospital specialists to provide useful information at the bedside. However, there is no evidence that nurses can accurately use the equipment during home visits or whether this improves the care quality. Our project is designed to address these knowledge gaps. Research will be conducted with older people who receive care at home from an Acute Clinical Team (ACT) team in the Neath Port Talbot area. Many of those referred to the team are older and frail, a significant proportion report breathlessness. Initially, we will describe the current healthcare system for older people with breathlessness. We will look back at anonymous health record data from approximately 3000 patients who were referred to the ACT (using the SAIL Databank). This will help us to understand how the real-world care compares with published guidelines. We can check whether there are inequalities in care and whether the service is effective. Next, we will ask nurses to add FOCUS to their normal clinical assessment of patients with breathlessness. This will be done on a small scale (30 patients) so that we can check the test is acceptable to patients and whether nurses can do it in the way we planned. We will then move to an evaluation phase (225 patients). Nurses will record their diagnosis before and after the scan so we can determine whether it improves their ability to understand whether heart pumping problems are a possible cause of breathlessness. A specialist will check every heart scan result so that we can measure the nurse’s accuracy and understand how the scan might have changed the pathway. Throughout the project we will ask the patients and nurses to share their experiences. We will use this information to understand how it might be best to implement FOCUS in future. We have actively involved patients and the public in the design of this study. Patient care will not be affected by FOCUS in this trial because public advisers did not want nurses to act on the results until there is greater evidence about accuracy of interpretation. Our findings will be useful to community nurses and acute clinical teams across the UK. Our goal is to change practice so that older people receive better quality and more timely care, avoiding unnecessary trips to hospital. A larger study across more locations is needed before that change is warranted, but our data will help us to decide whether to do a larger trial and how it should be designed.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: RESPIRATORY;CARDIOVASCULAR