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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
| McMaster University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual HF care | Experimental | Patients will receive virtual HF care to optimize medical therapies |
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| Routine HF care | Other | Participants will receive routine HF care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual HF Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary "Hierarchical" Composite Outcome of: |
PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES" | 30 and 90 days |
| Co-primary "Hierarchical" Composite Outcome of: |
PLEASE NOTE: THESE ARE "HIERACHIAL OUTCOMES" | 90 and 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| GDMT use | Achievement of at least 50% of the target doses of BB, ACEi/ARB or ARNI, MRA, SGLT2i at 90 days. | 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
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Inclusion Criteria:
Adult patients ≥ 18 years old who:
Are being discharged after hospitalization or urgent visit for HF as
Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.
Have NT-proBNP of > 900 pg/ml during hospital admission or within 7 days after discharge from the ED
Have a mailing address for patient or caregiver
Provide verbal consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harriette GC Van Spall, MD MPH | Contact | (905) 521-2100 | 40601 | Harriette.VanSpall@phri.ca |
| VICTORY-HF Project office | Contact | victory-hf@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Harriette Van Spall, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare Hamilton | Recruiting | Hamilton | Onatrio | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Routine HF Care | Other | Care as determined by the treating physician |
|
| 90 days and 180 days |
| Healthcare utilization | i) direct healthcare cost at 90 and 180 days | 90 days and 180 days |
| Healthcare utilization | ii) number of virtual and in-person clinic visits per patient in 90 days. | 90 days and 180 days |
| Hamilton General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| Juravinski Hospital Cancer Centre | Recruiting | Hamilton | Ontario | L8V 5C2 | Canada |
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| Thunder Bay Regional Health Sciences Centre | Not yet recruiting | Thunder Bay | Ontario | Canada |
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| Unity Health Toronto | Not yet recruiting | Toronto | Ontario | Canada |
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| Fattouma Bourguiba Hospital | Recruiting | Monastir | Tunisia |
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| Hedi Chaker Hospital | Recruiting | Sfax | Tunisia |
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| Sahloul Hospital | Recruiting | Sousse | Tunisia |
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| Military Hospital | Recruiting | Tunis | Tunisia |
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