Heart Failure Management Program Versus Usual Care

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822912
• Other study ID #: 14-0006
• Secondary ID: R01HL113387
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: March 2019

Study information

• Verified date: August 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 713
• Est. completion date: March 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Failure
• Congestive Heart Failure
• Heart Failure

Intervention

Other:
• Heart Failure Disease Management Program
Subjects will be assessed 3 times a week while in SNF.
• Heart Failure Usual Care
Subjects will receive standard of care.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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