Heart Failure Management Program Versus Usual Care

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

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.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure; Cardiac Failure
• Intervention / Treatment: Other: Heart Failure Disease Management Program; Other: Heart Failure Usual Care

• Study Type: Interventional
• Enrollment (Actual): 713
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heart Failure Disease Management Program; 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; Subjects will be assessed 3 times a week while in SNF.
Placebo Comparator: Heart Failure Usual Care; SNF patients with HF will receive usual care	Other: Heart Failure Usual Care; Subjects will receive standard of care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Rebecca Boxer, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Lum H, Obafemi O, Dukes J, Nowels M, Samon K, Boxer RS. Use of Medical Orders for Scope of Treatment for Heart Failure Patients During Postacute Care in Skilled Nursing Facilities. J Am Med Dir Assoc. 2017 Oct 1;18(10):885-890. doi: 10.1016/j.jamda.2017.05.021. Epub 2017 Jul 6.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; Skilled Nursing Facility; Transitional Care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 14-0006; R01HL113387 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO