Evaluation of a Nurse Case Management Model for Chronic Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 969
- Locations
- 4
- Primary Endpoint
- The following outcomes will be measured at one and two years following each participant's enrollment in the study: mortality, health related quality of life, patient satisfaction with care, resource utilization (outpatient visits, admissions.
Study Overview
Brief Summary
Despite established clinical practice guidelines, wide variations exist in the care of chronic heart failure (CHF) patients in Veterans Health Administration. Previous randomized, controlled studies have suggested that a nurse case management model may improve the outcomes of care for patients with CHF. However, these studies involved selected groups of patients (i.e., those who agreed to participate in randomized trials) in selected settings (i.e., tertiary care facilities); so, the findings are not likely to be indicative of the true effectiveness of case management in a large population of CHF patients.
Detailed Description
BACKGROUND / RATIONALE:
Despite established clinical practice guidelines, wide variations exist in the care of chronic heart failure (CHF) patients in Veterans Health Administration. Previous randomized, controlled studies have suggested that a nurse case management model may improve the outcomes of care for patients with CHF. However, these studies involved selected groups of patients (i.e., those who agreed to participate in randomized trials) in selected settings (i.e., tertiary care facilities); so, the findings are not likely to be indicative of the true effectiveness of case management in a large population of CHF patients.
OBJECTIVE(S):
This study will evaluate the impact of a nurse practitioner case management model compared with usual care in patients with congestive heart failure (CHF). Outcomes include health-related quality of life, patient satisfaction, compliance with medication guidelines, mortality, readmissions, bed days of care, outpatient visits, emergency room visits, and pharmacy costs.
METHODS:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient receives all cardiology care at a VISN 11 VAMC.
- •Must have chronic heart failure (CHF) secondary to systolic or diastolic dysfunction, as defined by meeting (1) or (2) below:
- •Systolic Dysfunction, defined by a history or documentation of LVEF = 40% (or fractional shortening = 20%-if LVEF not documented)
- •AND at least ONE of the following:
- •Current diagnosis or history of CHF and/or
- •Physical findings and/or symptoms of CHF within two months of enrollment and/or
- •Hospitalization for CHF within 12 months OR
- •Diastolic Dysfunction, defined by a history of documentation of LVEF > 40% (or fractional shortening > 20% if LVEF not documented) AND Physical findings and/or symptoms of CHF within two months of enrollment.
Exclusion Criteria
- •Based on medical record data, patient does not have any co-morbidity other than CHF which, in the opinion of the investigator, limits life expectancy to less than six months (e.g., metastatic CA, hospice care, renal failure with a creatinine above 5.0 mg/dL or on dialysis, HIV).
Arms & Interventions
Arm 1
Intervention: Case management using advanced nurse practitioners (Behavioral)
Outcomes
Primary Outcomes
The following outcomes will be measured at one and two years following each participant's enrollment in the study: mortality, health related quality of life, patient satisfaction with care, resource utilization (outpatient visits, admissions.
Secondary Outcomes
- Feedback regarding the intervention from the directors, chiefs of staff, cardiologists, nurse practitioners, and primary care providers at the participating sites.