Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Heart Failure Management Program Versus Usual Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Case Western Reserve University
Sponsor:
Information provided by (Responsible Party):
Rebecca Boxer, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01822912
First received: March 26, 2013
Last updated: April 2, 2013
Last verified: March 2013
  Purpose

Heart Failure patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home.

Heart Failure 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.


Condition Intervention
Cardiac Failure
Congestive Heart Failure
Other: Heart Failure Disease Management Program
Other: Heart Failure Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • 30 day post SNF admission outcomes [ Time Frame: Up to 60 days post SNF admission ] [ Designated as safety issue: No ]
    To determine the difference in the composite endpoint of 30-day all-cause hospitalization, all-cause emergency department visits and all-cause mortality between heart failure patients in Skilled Nursing Facilities cared for by a heart failure-disease management program vs usual care.


Secondary Outcome Measures:
  • Health status and self care 60 days post SNF admission [ Time Frame: 60 days post SNF admission ] [ Designated as safety issue: No ]
    To compare the difference in health status and self-care for patients with heart failure 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.

  • Patients living at home 60 days post-SNF admission with Heart Failure (HF) [ Time Frame: 60 days post SNF admission ] [ Designated as safety issue: No ]
    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.

  • Cost-effectiveness [ Time Frame: Up to 60 days post SNF admission ] [ Designated as safety issue: No ]
    To assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF


Estimated Enrollment: 1400
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Patients in the Disease Management Program will be assessed 3 times a week while in SNF.
Placebo Comparator: Heart Failure Usual Care
SNF patients with Heart Failure will receive usual care
Other: Heart Failure Usual Care

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822912

Contacts
Contact: Jill Bradisse, MA 216-285-4119 jill.bradisse@uhhospitals.org
Contact: Christine Bodnar, BSN 216-285-4120 christine.bodnar@uhhospitals.org

Locations
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 41111
Principal Investigator: Rebecca Boxer, MD, MS         
Sponsors and Collaborators
Case Western Reserve University
  More Information

No publications provided

Responsible Party: Rebecca Boxer, Medical Doctor, Assistant Professor of Medicine, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01822912     History of Changes
Other Study ID Numbers: SNF Connect, RO1HL113387
Study First Received: March 26, 2013
Last Updated: April 2, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Skilled Nursing Facility
Heart Failure
Transitional Care

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014