Veterans Affairs Lowering Readmission in Heart Failure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:October 2010
End Date:September 2013

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VALOR (Veterans Affairs Lowering Readmissions) in Heart Failure Study

Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the
most common indication for readmission in older adults and the most frequent reason for
30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy
to lower HF recurrence. However, adherence to medications and dietary recommendations is low
in HF patients. Nonadherence is often due to an interaction among the environment, the
patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality
improvement program (QIP) to improve HF care using a pretest-posttest design. This
interdisciplinary theory-based prospective experimental study will target improving HF
treatment using patient-based behavioral and checklist intervention, as well as provider and
system-targeted checklists and treatment defaults (posttest or intervention phase); this
will be compared to current best practice (CBP) evaluated in the pretest (pretest or
pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient,
provider and system levels, will improve QOL and lower HF recurrence compared to CBP.

Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the
most common indication for readmission in older adults and the most frequent reason for
30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy
to lower HF recurrence. However, adherence to medications and dietary recommendations is low
in HF patients. Nonadherence is often due to an interaction among the environment, the
patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality
improvement program (QIP) to improve HF care using a pretest-posttest design. This
interdisciplinary theory-based prospective experimental study will target improving HF
treatment using patient-based behavioral and checklist intervention, as well as provider and
system-targeted checklists and treatment defaults (posttest or intervention phase); this
will be compared to current best practice (CBP) evaluated in the pretest (pretest or
pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient,
provider and system levels, will improve QOL and lower HF recurrence compared to CBP.

The primary specific aims are 1) To test the effect of QIP on HF-specific quality of life
compared to the CBP group, and 2) To evaluate the impact of QIP group on general quality of
life compared to the CBP group.

Secondary specific aims are to:

1) assess the effect of QIP on medication adherence at 3 months, 2) examine the effect of
QIP on diet adherence at 3 months, and 3) evaluate the effect of QIP on satisfaction, and 4)
assess the effect of QIP on intervention acceptability. We will also examine the impact of
QIP at 3 months on keeping routine outpatient visits, health-care utilization, exercise
capacity, weight, perceived stress, depression, cardiovascular events and deaths.

Exploratory aim is to examine the effect of the QIP on 30 day post-discharge HF readmission
rates compared to CBP.

We have enrolled 136 veterans being discharged from the hospital with a diagnosis of HF.
Patients enrolled in the pretest phase will receive the HF management based on current best
practice (CBP). Patients enrolled in the posttest phase receive the comprehensive quality
improvement program (QIP) that intervenes on patient, provider and system levels. The QIP
will consist of 3 monthly phone calls to promote diet and medication adherence using the
transtheoretical model as a behavioral framework and checklists to facilitate patients'
self-monitoring of their diet, physical activity, weight and medication taking. Further,
providers during the posttest phase will use checklists for inpatient and outpatient care of
HF patients. Data, including quality of life (QOL), medication adherence, and dietary
adherence, will be collected from patients at baseline (prior to hospital discharge) and 3
months. Hospital readmissions, emergency room visits, and healthcare utilization will be
tracked for 6 months. If, as expected, there are no differences in demographic or other
confounders (EF, comorbidities, etc), the pretest and posttest groups will be compared by
the Fisher's Exact test for discrete outcomes (30-day readmissions or ER visits). We will
use the Student's ttest (two-tailed) for normally distributed outcomes and the Wilcoxon
rank-sum test for categorical variables and continuous variables not normally distributed.

This study will inform and enhance quality improvement efforts in heart failure care in VA
New York Harbor and elsewhere. It will also provide data for a rigorous effectiveness trial
to test this promising intervention that could reduce HF recurrence and improve QOL in HF.
If this promising theory-driven approach can work in a clinical setting where improvements
in HF care are so urgent, it will be an important scientific contribution.

Inclusion Criteria:

- All patients admitted with either systolic or diastolic HF will be identified through
ongoing daily prospective manual search of admission records in VA NYHHS

- Men and women ( 21 years) being discharged after a HF admission will be eligible

- They must have an available phone

Exclusion Criteria:

- Patients with poor short-term survival (< 3 months)

- recent major surgery (< 1 month)

- planned discharge to a long-term-care facility

- severe dementia or other serious psychiatric illness

- temporarily in the area

- those unable to provide consent, refusal to participate

- logistic or discretionary reasons (including participation in another study) will be
excluded
We found this trial at
1
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New York, New York 10010
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New York, NY
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