VA New York Harbor Health Care System
New York, 10010, United States
NCT Number: NCT01144182
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
New York, 10010, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months after discharge
Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.
Time frame: 3 months after discharge
Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life
Time frame: 3 months after discharge
Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL.
Time frame: 3 months after discharge
Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL.
VA Office of Research and Development
Fed
VALOR (Veterans Affairs Lowering Readmissions) in Heart Failure Study
Acronym: VALOR in HF
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