Clinical trial NCT05724433: VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization
Official title: VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization (VICTORY-HF) RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Randomized Controlled Trial
Digital Health
Knowledge Translation
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: McMaster University
First posted: 2023-02-13
Enrollment: 891
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an unblinded parallel multi-center Randomized Controlled Trial (RCT) of virtual HF clinics + routine care versus routine care alone in patients discharged after a hospitalization or urgent/emergency visit for HF. Randomization will be at the level of the patients and stratified by hospital site.

Patients and clinicians will be unblinded, but those analyzing data will be blinded. We will adopt a pragmatic approach to this study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Primary "Hierarchical" Composite Outcome of:
timeFrame: 30 and 90 days
measure: Co-primary "Hierarchical" Composite Outcome of:
timeFrame: 90 and 180 days
Secondary outcomes:
measure: GDMT use
timeFrame: 90 days
measure: Clinical Outcomes
timeFrame: 90 days and 180 days
measure: Healthcare utilization
timeFrame: 90 days and 180 days
measure: Healthcare utilization
timeFrame: 90 days and 180 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Onatrio
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba Hospital
city: Sfax
country: Tunisia
facility: Hedi Chaker Hospital
city: Sousse
country: Tunisia
facility: Sahloul Hospital
city: Tunis
country: Tunisia
facility: Military Hospital
Study officials:
affiliation: McMaster University
name: Harriette Van Spall, MD
role: PRINCIPAL_INVESTIGATOR
References: