None listed
Conditions
Brief summary
Chronic heart failure is one of the leading causes of death and disability within our ageing population. Chronic heart failure management programs now form part of the gold-standard care for patients hospitalised with the syndrome to prevent costly recurrent readmissions and prolong survival. However, there is still a need to apply these cost-effectively - particularly in respect to meeting the needs of high risk individuals and those living remotely to a heart failure service. Following on from the original WHICH? Trial we are now testing two different ways of applying chronic heart failure management to determine which is most cost-effective in reducing recurrent hospital stay. Specifically, we are testing a more intensive program of care, based on each person’s needs and where they live, with a standard program of care and support. We will compare the impact of standard care in the community (Group 1) with more intensive care in the community (Group 2). Health outcomes will be compared at 12 months with plans for more prolonged follow-up to 5 years post index hospital discharge.
Interventions
Initial profiling of subjects to determine incremental risk of rehospitalisation or death using the Green Amber Red Delineation of Individual risk And Need in Heart Failure (GARDIAN-HF) tool.
Based on subject location (metropolitan or remote dwelling) and GARDIAN-HF profiling, subjects will be exposed to a more intensive, nurse-led management program (including incremental face-to-face visits and structured telephone support), and monitoring of BNP levels using a point of care machine (for thos
Initial profiling of subjects to determine incremental risk of rehospitalisation or death using the Green Amber Red Delineation of Individual risk And Need in Heart Failure (GARDIAN-HF) tool. Based on subject location (metropolitan or remote dwelling) and GARDIAN-HF profiling, subjects will be exposed to a more intensive, nurse-led management program (including incremental face-to-face visits and structured telephone support), and monitoring of BNP levels using a point of care machine (for those aged younger than 75 years at the date of index hospitalisation) for a minimum of 12 months post index discharge. Active surveillance and management will continue for a minimum of 12 months for major endpoint analyses and then up to 5 years to determine the longer-term effects of the study intervention. The incremental face-to-face visits include a full physical assessment (i.e. lying and standing blood pressure, pulse, heart sounds, oedema, etc), symptom assessment (i.e. NYHA class, dyspnoea and appetite/evidence of cachexia or malnutrition), and compliance with clinical monitoring and self-management (i.e. daily weighs, fluid intake assessment, and medication adherence), ongoing HF self-management education, assessment of self-care behaviours (i.e. attendance to GP/ Cardiologist, emotional levels, immunisation status and health-related quality of life) and a plan of future care including medication titration and ordering of further tests (i.e. pathology, x-ray), in consultation with the individuals health care team, communication with GP, and/or referral to community services or allied health professionals. The structured telephone support includes a range of pre-determined questions including presence of symptoms (shortness of breath, or weight increase), length of symptoms, and maintenance of low sodium diet and fluid restriction. The individuals who are randomly allocated into the intensive management arm of the study will receive at least two home visits throughout the initial 12 month follow-up period. All intensive management patients will also receive weekly to monthly structured telephone support by the National Heart Foundation of Australia (NHFA). Those participants who are designated into standard care and live remotely from the hospital (i.e. greater than 30km’s from the recruitment site) will receive monthly structured telephone support from the NHFA. Each home visit will take a minimum of 60 minutes. The initial structured telephone support call will take approximately 20 minutes for the initial call and approximately 8 minutes for each call thereafter. Detailed reports of initial profiling and management will be sent to the subject's heath care team (i.e. GP) utilising the GARDIAN-HF tool.
Sponsors
Professor Simon Stewart
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Individuals discharged to home following an admission to a participating hospital will be eligible for study randomisation if they: 1) have a diagnosis of chronic heart failure and 2) a history of 1 or more admissions to hospital with acute HF (including the index hospitalisation).
Exclusion criteria
Patients will be excluded if they have a terminal condition, are non-English speaking and unable to give fully informed consent (in the absence of an interpreter) and/or unable to give fully informed consent for another reason.
Outcome results
None listed