Heart Failure Management Program Versus Usual Care

NCT01822912 | Completed

• 2 other identifiers: 14-0006R01HL113387
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Failure; Congestive Heart Failure

Keywords

Skilled Nursing Facility; Heart Failure; Transitional Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in health status and self-care 60 days post SNF admission

  60 days post SNF admission

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

  60 days post SNF admission

• Difference in Cost-effectiveness

  Up to 60 days post SNF admission

Study Arms (2)

Heart Failure Disease Management Program

ACTIVE COMPARATOR

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

Heart Failure Usual Care

PLACEBO COMPARATOR

SNF patients with HF will receive usual care

Other: Heart Failure Usual Care

Interventions

Heart Failure Disease Management Program OTHER

Subjects will be assessed 3 times a week while in SNF.

Heart Failure Disease Management Program

Heart Failure Usual Care OTHER

Subjects will receive standard of care.

Heart Failure Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart Failure is listed as the hospital discharge primary diagnosis
• Heart Failure is listed as the hospital discharge secondary diagnosis

You may not qualify if:

• Any life threatening condition which predicts mortality in 6 months or less

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 28688730 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rebecca Boxer, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 4, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)