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Heart Failure Management Program Versus Usual Care

Primary Purpose

Cardiac Failure, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Failure Disease Management Program
Heart Failure Usual Care
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Failure focused on measuring Skilled Nursing Facility, Heart Failure, Transitional Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Heart Failure Disease Management Program

Heart Failure Usual Care

Arm Description

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

SNF patients with HF will receive usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2013
Last Updated
August 5, 2019
Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01822912
Brief Title
Heart Failure Management Program Versus Usual Care
Official Title
Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Failure, Congestive Heart Failure
Keywords
Skilled Nursing Facility, Heart Failure, Transitional Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
713 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Disease Management Program
Arm Type
Active Comparator
Arm Description
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
Arm Title
Heart Failure Usual Care
Arm Type
Placebo Comparator
Arm Description
SNF patients with HF will receive usual care
Intervention Type
Other
Intervention Name(s)
Heart Failure Disease Management Program
Intervention Description
Subjects will be assessed 3 times a week while in SNF.
Intervention Type
Other
Intervention Name(s)
Heart Failure Usual Care
Intervention Description
Subjects will receive standard of care.
Primary Outcome Measure Information:
Title
Change in 60 day post SNF admission outcomes
Description
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.
Time Frame
Up to 60 days post SNF admission
Secondary Outcome Measure Information:
Title
Difference in health status and self-care 60 days post SNF admission
Description
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.
Time Frame
60 days post SNF admission
Title
Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)
Description
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.
Time Frame
60 days post SNF admission
Title
Difference in Cost-effectiveness
Description
To assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF
Time Frame
Up to 60 days post SNF admission

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Boxer, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28688730
Citation
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.
Results Reference
derived

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Heart Failure Management Program Versus Usual Care

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