VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF)

Population Health Research Institute (PHRI)

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Virtual HF Care; Other: Routine HF Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05724433

VICTORY-HF RCT

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 891 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adult patients ≥ 18 years old who:

1. Are being discharged after hospitalization or urgent visit for HF as

   1. a primary diagnosis or
   2. significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.

2. Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.

3. Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED

4. Have a mailing address for patient or caregiver

5. Provide verbal consent

Exclusion criteria

1. Died or left hospital before medically advised hospital discharge
2. Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)
3. Unable to engage with digital health technology or follow up
4. Severe valve disease
5. Recipient of or on waiting list for LVAD or cardiac transplant
6. Complex congenital heart disease, hypertrophic obstructive cardiomyopathy, or amyloid cardiomyopathy
7. Severe lung disease with symptoms on minimal exertion, forced expiratory volume during 1 second (FEV1) < 1 litre, severe pulmonary hypertension with RVSP > 60 mm Hg, or on home oxygen
8. Severe kidney disease (persistent eGFR < 30 mL/min/1.73m2)
9. Active malignancy
10. Receiving palliative care or expected life expectancy < 6 months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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891 participants in 2 patient groups

Virtual HF care

Experimental group

Description:

Patients will receive virtual HF care to optimize medical therapies

Treatment:

Other: Virtual HF Care

Routine HF care

Other group

Description:

Participants will receive routine HF care

Treatment:

Other: Routine HF Care