Heart Failure
Conditions
Keywords
Heart Failure, Family physicians, academic detailing, process of care
Brief summary
Evaluation of a primary care based (family physicians) HF management strategy in patients with heart failure in the community
Detailed description
Cluster randomized clinical trial (family physician is cluster) evaluating a primary care based heart failure management strategy
Interventions
BEHAVIORALPrimary care based disease management strategy
Sponsors
Heart and Stroke Foundation of Canada
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women, age more or equal to 65 years AND 2. Diagnosis of HF confirmed with the following criteria: 1. Previous hospital admission for HF OR 2. Definite HF confirmed with the Boston HF criteria OR 3. 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
1. Patients with terminal illness (e.g. cancer) with a life expectancy of less than one year. 2. Patients in a long-term-care facility with nursing care. 3. Patients awaiting cardiac surgery for correctable causes of HF (e.g., severe valvular disease or extensive ischemia) during the study period. 4. Patients expected to be away from the country during the intervention period for a duration of \>3 months. 5. Patients unable or refusing to sign consent. 6. 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. 7. Patients currently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
| Disease specific quality of life (QOL)with Minnessota Living with Heart Failure. | — |
| Quality adjusted survival | — |
| Overall costs | — |
| Referral to Hamilton Health Sciences HF clinic or other institution. | — |
| NYHA functional class. | — |
| Other outcomes | — |
Countries
Canada
Outcome results
None listed