Clinical trial NCT00182182: Evaluation of a Primary Care Based Heart Failure Management Program
Official title: Congestive Heart Failure Assessment and Management in Primary Care: CHAMP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: Heart Failure
Family physicians
academic detailing
process of care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2005-09-16
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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:
measure: ACE-inhibitor use unless contraindicated,ACE-inhibitor dosage is at >50% of clinical trial target dose,Beta-blocker use unless contraindicated.
measure: Each component of the score will be given one point.
Secondary outcomes:
measure: Disease specific quality of life (QOL)with Minnessota Living with Heart Failure.
measure: NYHA functional class.
measure: Other outcomes
measure: All-cause hospitalization defined as > 24-hour hospital stay including the time spent in the emergency room.
measure: 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
measure: 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.
measure: Referral to Hamilton Health Sciences HF clinic or other institution.
measure: Quality adjusted survival
measure: Overall costs
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Catherine Demers, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: