Clinical trial NCT01144182: Veterans Affairs Lowering Readmission in Heart Failure
Official title: VALOR (Veterans Affairs Lowering Readmissions) in Heart Failure Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
quality of life
readmissions
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-06-15
Enrollment: 136
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: General Quality of Life From the Standardized Physical Component Score
timeFrame: 3 months after discharge
measure: Heart Failure Specific Quality of Life
timeFrame: 3 months after discharge
Secondary outcomes:
measure: Standardized Mental Component Score
timeFrame: 3 months after discharge
measure: Physical Functioning
timeFrame: 3 months after discharge
measure: Role Physical
timeFrame: 3 months after discharge
measure: Pain Index
timeFrame: 3 months after discharge
measure: General Health
timeFrame: 3 months after discharge
measure: Vitality
timeFrame: 3 months after discharge
measure: Social Functioning
timeFrame: 3 months after discharge
measure: Role Emotional
timeFrame: 3 months after discharge
measure: Mental Health
timeFrame: 3 months after discharge
measure: Physical Subscale of Heart Failure Specific Quality of Life
timeFrame: 3 months after discharge
measure: Emotional Subscale of Heart Failure Specific Quality of Life
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Health Care System
state: New York
Study officials:
affiliation: VA New York Harbor Health Care System
name: Sundar Natarajan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: