Evaluation of a Primary Care Based Heart Failure Management Program
Study Details
Study Description
Brief Summary
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
Study Design
Outcome Measures
Primary Outcome Measures
- Process-of-care composite score assessed at baseline, at 6 months for effectiveness of the intervention, and at 12 months for sustainability of the effect. The score includes assessment of: []
- ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated. []
- Each component of the score will be given one point. []
Secondary Outcome Measures
- Disease specific quality of life (QOL)with Minnessota Living with Heart Failure. []
- NYHA functional class. []
- Other outcomes []
- All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room. []
- Hospitalizations for HF: > 24-hour hospital stay including the time spent in the emergency room with clinical evidence of HF including at least one of the following: increased dyspnea on exertion, orthopnea, nocturnal dyspnea, elevated jugular venous []
- Emergency room visits for deterioration of HF requiring IV or additional PO diuretics: <24-hour stay in hospital/emergency room with clinical evidence of HF. []
- Referral to Hamilton Health Sciences HF clinic or other institution. []
- Quality adjusted survival []
- Overall costs []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women, age more or equal to 65 years AND
-
Diagnosis of HF confirmed with the following criteria:
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Previous hospital admission for HF OR
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Definite HF confirmed with the Boston HF criteria OR
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Possible HF confirmed with the Boston HF criteria AND evidence of left ventricular systolic dysfunction (left ventricular ejection function <40%) on echocardiography, radionuclide angiography, or left ventricular angiogram documented in the patient's family physicians clinic chart.
Exclusion Criteria:
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Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year.
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Patients in a long-term-care facility with nursing care.
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Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period.
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Patients expected to be away from the country during the intervention period for a duration of >3 months.
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Patients unable or refusing to sign consent.
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Patients currently followed in the Hamilton Health Sciences HF clinic. These patients are excluded as they are currently enrolled in a HF disease management strategy.
-
Patients currently enrolled in another clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McMaster University | Hamilton | Ontario | Canada | L8N3Z5 |
Sponsors and Collaborators
- Hamilton Health Sciences Corporation
- Heart and Stroke Foundation of Canada
Investigators
- Principal Investigator: Catherine Demers, MD, MSc, FRCPC, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSF2004h00511