None listed
Conditions
Brief summary
When left undiagnosed and untreated, Heart Failure (HF) is a complex, chronic condition associated with poor quality of life, recurrent hospital admissions and premature mortality. Consistent with a recent Strengthening Medicare Taskforce Report, this project is applying the latest point-of-care technology (including an Artificial-Intelligence guided cardiac imaging) to enhance the pivotal role of Primary Health Care Nurses (PHCNs) to cost-effectively detect and then care for people with HF in primary care. In a two-phased approach, a target of 750 (revised downwards after an initial assessment of the screening protocol results) at risk people across 3 urban, regional and rural communities, will be screened for previously undetected HF. Those found to have HF, will then be invited to participate in a trial of standard GP care versus a Practice Nurse-coordinated, multidisciplinary, primary care surveillance and intervention program. We hypothesize that those people assigned to the Practice Nurse coordinated care program will experience better health outcomes than those assigned to receive standard GP care. During minimum two-years follow-up we will compare the health outcomes (including need for hospital care, quality of life, and change in heart failure status and treatment at 12 months) of those exposed to standard care versus the Practice Nurse-led care program.
Interventions
Trial participants will be randomized (1:1 stratified for biological sex and study site) to:
1. An enhanced form of standard primary care, whereby the participant's usual GP will receive a report detailing the results of an artificial intelligence-guided portable echo, 12-lead ECG and clinical profiling, along with a 2-page summary of the current (European Society of Cardiology/Cardiac Society of Australia & New Zealand) recommendations for the treatment/management of adults with evidence of le
Trial participants will be randomized (1:1 stratified for biological sex and study site) to: 1. An enhanced form of standard primary care, whereby the participant's usual GP will receive a report detailing the results of an artificial intelligence-guided portable echo, 12-lead ECG and clinical profiling, along with a 2-page summary of the current (European Society of Cardiology/Cardiac Society of Australia & New Zealand) recommendations for the treatment/management of adults with evidence of left ventricular dysfunction/clinical heart failure. Where appropriate, GPs will have access to a Cardiologist to seek advice on specific treatment goals. 2. In addition to the above, participants will be case-managed by primary health care nurse (PHCN) who will perform a home visit (taking 60-90 minutes to complete), assess their ongoing health care/personal needs using an established tool (the Green Amber Red Delineation of Need and Risk in HF - GARDIAN-HF) and provide individualized support for the 12 months following initial screening/group randomization. This will include specific plans to up-titrate any prescribed pharmacological therapy and application of non-pharmacological strategies to enhance health literacy (liaising with local pharmacists), self-care and overall heart health (e.g. exercise and dietary plans). Adherence to pharmacological treatment will be monitored via clinical response (e.g. lowered BP and lipid levels) along with documentation of all routine (e.g. attendance to scheduled GP visits) and additional (e.g. phone calls and home visits) health care contacts. To deliver the intervention all PHCN will receive educational materials pertaining to cardiac imaging, cardiac anatomy and heart failure management in the 3 months prior to formal commencement of the project. In the month prior to this timepoint, they will also under a 2-day, face-to-face educational program on heart failure care (from a primary care perspective) by an expert in the field. All training/educational activities will be overseen by the Australian Primary Health Care Nurses Association.
The trial component of the PANACEA-HF Study is nested within a prospective, multicenter heart failure surveillance project whereby a target of 750 men and women (additional target ration of 1:1) with the eligible age and clinical profile are screened for trial eligibility (evidence of any form of HF applying a primary care-adapted algorithm) via a combination of symptomatic profiling, 12-lead ECG, point-of-care NT-proBNP and AI-PoCUS performed by specifically trained primary health care nurses a
The trial component of the PANACEA-HF Study is nested within a prospective, multicenter heart failure surveillance project whereby a target of 750 men and women (additional target ration of 1:1) with the eligible age and clinical profile are screened for trial eligibility (evidence of any form of HF applying a primary care-adapted algorithm) via a combination of symptomatic profiling, 12-lead ECG, point-of-care NT-proBNP and AI-PoCUS performed by specifically trained primary health care nurses at each participating clinic. Once identified as eligible, trial participants will be randomized (1:1 stratified for biological sex and study site) to: 1. An enhanced form of standard primary care, whereby the participant's usual GP will receive a report detailing the results of an artificial intelligence-guided portable echo, 12-lead ECG and clinical profiling, along with a 2-page summary of the current (European Society of Cardiology/Cardiac Society of Australia & New Zealand) recommendations for the treatment/management of adults with evidence of left ventricular dysfunction/clinical heart failure. Where appropriate, GPs will have access to a Cardiologist to seek advice on specific treatment goals. 2. In addition to the above, participants will be case-managed by primary health care nurse (PHCN) who will perform a home visit (taking 60-90 minutes to complete), assess their ongoing health care/personal needs using an established tool (the Green Amber Red Delineation of Need and Risk in HF - GARDIAN-HF) and provide individualized support for the 12 months following initial screening/group randomization. This will include specific plans to up-titrate any prescribed pharmacological therapy and application of non-pharmacological strategies to enhance health literacy (liaising with local pharmacists), self-care and overall heart health (e.g. exercise and dietary plans). Adherence to pharmacological treatment will be monitored via clinical response (e.g. lowered BP and lipid levels) along with documentation of all routine (e.g. attendance to scheduled GP visits) and additional (e.g. phone calls and home visits) health care contacts. To deliver the intervention all PHCN will receive educational materials pertaining to cardiac imaging, cardiac anatomy and heart failure management in the 3 months prior to formal commencement of the project. In the month prior to this timepoint, they will also under a 2-day, face-to-face educational program on heart failure care (from a primary care perspective) by an expert in the field. All training/educational activities will be overseen by the Australian Primary Health Care Nurses Association.
Sponsors
University of Notre Dame Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible individuals being actively treated at participating GP clinics who: 1. Are aged 60 years. 2. Have the common antecedents of heart failure (any combination hypertension, diabetes and any form of cardiovascular disease) documented in their GP records. 3. On targeted echocardiographic screening have evidence of left ventricular dysfunction (systolic or diastolic) combined with an bio-marker evidence of elevated filling pressures (NT-proBNP) and/or symptoms indicative of cardiac congestion. 4. Live independently
Exclusion criteria
1. Unable to provide informed consent 2. Terminal illness likely to result in death (as considered by the treating GP) within the next 12-24 months. 3. Pre-existing diagnosis (according to the GP records) of heart failure.
Outcome results
None listed