Veterans Affairs Lowering Readmission in Heart Failure

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Behavioral: Comprehensive quality improvement program (QIP)

Registration Number: NCT01144182

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 136

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quality improvement program (QIP)	Comprehensive quality improvement program (QIP)	Comprehensive quality improvement program (QIP) 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.

Primary Outcome Measures

Name	Time	Method
Heart Failure Specific Quality of Life	3 months after discharge	Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.
General Quality of Life From the Standardized Physical Component Score	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

Secondary Outcome Measures

Name	Time	Method
Role Physical	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
General Health	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
Emotional Subscale of Heart Failure Specific Quality of Life	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.
Physical Functioning	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
Standardized Mental Component Score	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
Role Emotional	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
Mental Health	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
Vitality	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
Physical Subscale of Heart Failure Specific Quality of Life	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.
Pain Index	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
Social Functioning	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