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Heart Failure Management Program Versus Usual Care

Not Applicable
Completed
Conditions
Congestive Heart Failure
Cardiac Failure
Interventions
Other: Heart Failure Usual Care
Other: Heart Failure Disease Management Program
Registration Number
NCT01822912
Lead Sponsor
University of Colorado, Denver
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
713
Inclusion Criteria
  • Heart Failure is listed as the hospital discharge primary diagnosis
  • Heart Failure is listed as the hospital discharge secondary diagnosis
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Exclusion Criteria
  • Any life threatening condition which predicts mortality in 6 months or less
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Heart Failure Usual CareHeart Failure Usual CareSNF patients with HF will receive usual care
Heart Failure Disease Management ProgramHeart Failure Disease Management ProgramPatients 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
Primary Outcome Measures
NameTimeMethod
Change in 60 day post SNF admission outcomesUp to 60 days post SNF admission

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.

Secondary Outcome Measures
NameTimeMethod
Difference in health status and self-care 60 days post SNF admission60 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.

Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)60 days post SNF admission

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.

Difference in Cost-effectivenessUp to 60 days post SNF admission

To assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF

Trial Locations

Locations (1)

University of Colorado

🇺🇸

Aurora, Colorado, United States

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