Effect of Post Discharge Follow-up on Readmission Rates for Congestive Heart Failure Patients

Heart failure, a disease that affects a large proportion of the aging population, continues
to be associated with poor outcomes especially in patients who require hospitalization. Each
year, nearly 1 million Americans are newly diagnosed with congestive heart failure and
currently, there are at least 5 million Americans living with this chronic disease. The
number of patients with heart failure is expected to reach 10 million by the year 2037.This
population consumes a large proportion of health care resources with the main cost being
hospitalization. The heart failure 30-day readmission rates hover around 25% nationally,
with an approximate cost of $7,000 per hospitalization.

In an effort to improve care and reduce costs, heart failure disease management programs are
becoming more prevalent. Recent data suggests that multi-disciplinary disease management
programs may reduce mortality and hospitalizations as well as improve costs, patients'
ability to self-care, and quality of life. It provides a means to increase the use of
evidence-based therapies, improve patient education, and decrease resource usage. Heart
failure management programs involve early assessment, optimized treatment, easy access to
care, and education and psychosocial support.

Patients hospitalized for decompensated congestive heart failure are among the highest risk
group for morbidity and mortality among people with chronic heart failure and a large
proportion of this risk occurs early after discharge. Thus, the goals of these programs
should include managing the gap between the inpatient and outpatient settings and should
ideally involve a multidisciplinary team in order to serve these patients in a comprehensive
manner. We propose to determine the relative efficacy of a post-discharge disease management
system.

PRIMARY OBJECTIVE:

The primary objective of this study is to determine if the time to first hospital
readmission can be lengthened using a disease management model.

STUDY DESIGN:

This is a prospective, one year pilot study that will enroll patients admitted to Saint
Francis Hospital and Medical Center (SFHMC) with the admitting diagnosis of acute
decompensated heart failure that have been referred to the Congestive Heart Failure Disease
Management Program by the attending physician. The patients will be enrolled in the study
and followed for a maximum of 90 days post-discharge. A case control group of 60-100
subjects will also be established for primary endpoint analysis.

METHODS:

Patients who meet study criteria, informed consent will be obtained before hospital
discharge or at the first Disease Management visit. Patients will be followed for 90 days
post-discharge. Clinic visits, homecare agency and visits, heart failure education class
attendance, and dates of hospital readmission will be tracked. Descriptive characteristics
of patients will be recorded at the time of enrollment. Descriptive characteristics include
demographics, etiology of heart failure, symptoms, physical assessment, current medications,
lab results, and diagnostic test results.

In everyday practice, the Congestive Heart Failure Disease Management Program administers
clinical questionnaires to patients to assess quality of life and heart failure management
knowledge. The clinical questionnaires that constitute standard of care for these patients
include:

- Atlanta Heart Failure Knowledge Test: given to each patient at the first Disease
Management visit and after attending the Congestive Heart Failure educational series to
determine level of understanding of self-management of heart failure.

- Kansas City Living with Cardiomyopathy Questionnaire: This is a validated quality of
life survey. The questionnaire is a 23-item, self-administered instrument that
quantifies physical function, symptoms (frequency, severity and recent change), social
function, self-efficacy and knowledge, and quality. This survey is administered to each
patient upon enrollment into the Disease Management Program and prior to discharge from
the Disease Management Program.

Results from these questionnaires will be collected and enrollment and discharge scores will
be compared for improvement in level of understanding of self-management of heart failure
and overall quality of life.

One hundred consecutive patients discharged from SFHMC with a primary diagnosis of acute
decompensated heart failure that have not been referred to the Congestive heart Failure
Disease Management Program will undergo retrospective chart review to establish a case
control group. The study team will perform a retrospective chart review to abstract the
following data: hospital admission date, hospital discharge date, attending physician, age,
and ejection fraction.

RISKS AND SAFETY:

There are no physical or psychological risks associated with this study. The study does not
involve any experimental treatments or invasive therapies. There is a less than minimal risk
of disclosure of clinical information maintained in the file linking the patient's medical
record to the data. This file will be kept to allow follow up tracking for heart failure
re-admission. The file will be password protected and available solely to the site Principal
Investigator and Institutional Review Board-approved study staff. At the end of the study,
following data analysis and publication of an abstract and paper in appropriate peer
reviewed journal(s), the file linking the patient names to the case report forms will be
destroyed.

POTENTIAL BENEFITS:

There are no potential benefits to patients whose records are entered into the database. The
potential benefit is to society and future patients diagnosed with heart failure.
Implementation of a disease management model may improve functional and clinical outcomes
through more productive interactions between patients and providers. A disease management
model may decrease hospital re-admission rates and the associated cost. If this disease
management model proves effective, the results will provide a framework for expanding care
opportunities and for establishing a new model for heart failure patients in this health
care system as well as in other systems.

DATA ANALYSIS:

The primary endpoint will be assessed as a continuous variable using Kaplan Meier survival
analysis. The time to all-cause readmission and readmission for heart failure will be
assessed using this methodology. The time to all-cause readmission and readmission for heart
failure in the CHF Disease Management Group will be compared to aggregate hospital
readmission data.

The QOL questionnaire will be analyzed using a t-test comparing enrollment and 2 month KCCQ
scores. The validity of each individual domain of this questionnaire has been independently
established and all components of the summary score are considered valid representations of
their intended domains.

Inclusion Criteria:

- Age =/or >18

- Admitted to the Heart Failure Unit with acute decompensated heart failure

- Referred to the Congestive Heart Failure Disease Management Program

Exclusion Criteria:

- Age<18

- Mentally incapacitated

- Discharge to a skilled nursing facility