The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.
Heart failure (HF) is a leading cause of death, hospitalization, and healthcare system expenditure in Canada. While care in HF clinics - multidisciplinary clinics that focus on optimal management of HF - improves health outcomes in HF, there are disparities in access to such care across our province. To respond to the needs of patients and the health care system, the investigators propose to develop and implement a virtual model of care that will enable Canadians with HF to receive outpatient HF care and medical optimization remotely. The investigators hypothesize that relative to routine care alone, virtual HF clinics will improve a composite of implementation and clinical outcomes. A pilot phase was conducted to assess the acceptability and feasibility of the intervention, assess change in health status, refine the virtual delivery process and healthcare processes, and use these to finalize protocols and guide the larger clinical trial. Data collection during the pilot phase focused on the process outcomes approved by HiREB (ID 5441).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
891
Patients will receive virtual visits for 3 months following hospitalization / emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.
Care as determined by the treating physician
St. Joseph's Healthcare Hamilton
Hamilton, Onatrio, Canada
RECRUITINGHamilton General Hospital
Hamilton, Ontario, Canada
RECRUITINGJuravinski Hospital Cancer Centre
Hamilton, Ontario, Canada
Primary "Hierarchical" Composite Outcome of:
1. Target dose of BB, ARNI or ACEi/ARB, MRA, and SGLT2i at 90 days 2. GDMT intensification at 30 days, defined as (a) initiation or up-titration of beta-blocker; (b) switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol; (c) initiation or up-titration of ACEi/ARB or ARNI; (d) switch from ACEi/ARB to ARNI; (e) initiation or up-titration of MRA; or (f) initiation of SGLT2i 3. Change in health status, as measured by the KCCQ-12 summary score at 90 days PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES"
Time frame: 30 and 90 days
Co-primary "Hierarchical" Composite Outcome of:
1. All cause death at 180 days 2. HF hospitalization at 180 days 3. All-cause ED visit at 180 days 4. Change in KCCQ-12 summary score at 90 days PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES"
Time frame: 90 and 180 days
GDMT use
Achievement of at least 50% of the target doses of BB, ACEi/ARB or ARNI, MRA, SGLT2i at 90 days.
Time frame: 90 days
Clinical Outcomes
i) Time to composite all-cause death, HF hospitalization, or all-cause ED visit at 180 days ii) Components of composite endpoint * Time to all-cause death * Time to HF hospitalization * Time to all-cause ED visit iii) Change in health status (KCCQ-12 summary score) at 90 days
Time frame: 90 days and 180 days
Healthcare utilization
i) direct healthcare cost at 90 and 180 days
Time frame: 90 days and 180 days
Healthcare utilization
ii) number of virtual and in-person clinic visits per patient in 90 days.
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Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
NOT_YET_RECRUITINGUnity Health Toronto
Toronto, Ontario, Canada
NOT_YET_RECRUITINGFattouma Bourguiba Hospital
Monastir, Tunisia
RECRUITINGHedi Chaker Hospital
Sfax, Tunisia
RECRUITINGSahloul Hospital
Sousse, Tunisia
RECRUITINGMilitary Hospital
Tunis, Tunisia
RECRUITINGTime frame: 90 days and 180 days