Heart Failure Management Program Versus Usual Care

Study Overview
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Brief Summary
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Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home. HF disease management programs have been shown to reduce rehospitalizations in community settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF). This study will investigate the the effect of a heart failure-disease management program on the outcome of all-cause hospital readmissions, emergency room admissions and mortality for 30 days post-SNF admission using 7 component heart failure disease management program.

Official Title
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Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care

Conditions
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Cardiac Failure, Congestive Heart Failure

Intervention / Treatment
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* Other: Heart Failure Disease Management Program
* Other: Heart Failure Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart Failure is listed as the hospital discharge primary diagnosis Heart Failure is listed as the hospital discharge secondary diagnosis Exclusion Criteria: Any life threatening condition which predicts mortality in 6 months or less
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heart Failure Disease Management Program<br>Patients will receive personalized care to include medication titration, daily weights, symptom and activity assessment, documentation of ejection fraction, patient and caregiver education,dietary surveillance, discharge instructions and follow up visit within 7 days of SNF discharge | Other: Heart Failure Disease Management Program<br>* Subjects will be assessed 3 times a week while in SNF.<br>|
| Placebo Comparator: Heart Failure Usual Care<br>SNF patients with HF will receive usual care | Other: Heart Failure Usual Care<br>* Subjects will receive standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 60 day post SNF admission outcomes | To determine the difference in the composite endpoint of 60-day all-cause hospitalization, all-cause emergency department visits and all-cause mortality between HF patients in Skilled Nursing Facilities cared for by a heart failure-disease management program vs usual care. | Up to 60 days post SNF admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in health status and self-care 60 days post SNF admission | To compare the difference in health status and self-care for patients with HF cared for by a SNF heart failure-disease management program vs usual care 60 days post SNF admission. Health Status will be measured by the KCCQ (Kansas City Cardiomyopathy Questionnaire) which is a 23 item questionnaire specific for patients with HF. It includes aspects of physical function, symptoms (frequency, severity and stability), social function, self-efficacy, knowledge, and quality of life. HF Self Management will be measured using the SCHFI (Self-Care HF Index) which consists of 15 item scale with 3 domains of self care including self care maintenance (behaviors to maintain clinical stability), self-care management (decision making process with regard to symptom changes), and confidence to manage symptoms. | 60 days post SNF admission | 
| Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF) | To determine if a SNF HF disease management program vs. usual care results in a greater proportion of HF patients who were previously living at home return home vs. admission to long term care post SNF discharge. | 60 days post SNF admission | 
| Difference in Cost-effectiveness | To assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF | Up to 60 days post SNF admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skilled Nursing Facility, Heart Failure, Transitional Care