Virtual Care for Heart Failure - Randomized Clinical Trial (RCT) (Pilot Phase)

Study Overview
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Brief Summary
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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 will assess the feasibility of this model of care in a pilot randomized controlled trial, and collect feedback from patients and providers. The investigators hypothesize that virtual clinics will be feasible. The investigators will also measure healthcare processes, and use these to guide a larger clinical trial that will measure clinical outcomes in patients receiving virtual versus usual care.

Official Title
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VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT (Pilot Phase)

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Virtual HF Care
* Other: Routine HF Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥ 18 years old who: are being discharged after hospitalization or urgent visit (emergency department) for HF OR have been referred for an initial consult at a cardiology clinic within 30 days of hospitalization or urgent visit for HF have left ventricular ejection fraction (LVEF) < 55% within the preceding 3 months Have NT-proBNP of > 900 pg/ml have a mailing address for the patient or caregiver are competent (either independently or with caregiver) in using the virtual care platform during a brief demonstration provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual HF care<br>Patients will receive virtual HF care to optimize medical therapies | Other: Virtual HF Care<br>* 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.<br>|
| Other: Routine HF care<br>Participants will receive routine HF care | Other: Routine HF Care<br>* Care as determined by the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heath status |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients randomized |  | 90 days | 
| Proportion of patients allocated to the virtual HF clinic who require crossover to the routine HF clinic |  | 90 days | 
| Proportion of patients that are seen in clinic within 7 days post discharge |  | date of discharge to 7 days | 
| Proportion of patients on all classes of guideline-directed medical therapy (GDMT) at baseline, 30 days and 90 days |  | 90 days | 
| Proportion of patients who have heath status data collected at baseline, 30 days and 90 days |  | 90 days | 
| Qualitative feedback on patient satisfaction and usability of technology |  | 90 days | 
| Number of visits per patient during 90 days |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Randomized Controlled Trial, Digital Health, Knowledge Translation