Veterans Affairs Lowering Readmission in Heart Failure (VALOR in HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Comprehensive quality improvement program (QIP)

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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • VA New York Harbor Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Current Best Practice (CBP); CBP received no intervention and only current best practices for inpatient HF care.
Active Comparator: 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.	Behavioral: Comprehensive quality improvement program (QIP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Quality of Life From the Standardized Physical Component Score	Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Heart Failure Specific Quality of Life	Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.	3 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Mental Component Score	Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Physical Functioning	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Role Physical	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Pain Index	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
General Health	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Vitality	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Social Functioning	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Role Emotional	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Mental Health	Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life	3 months after discharge
Physical Subscale of Heart Failure Specific Quality of Life	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.	3 months after discharge
Emotional Subscale of Heart Failure Specific Quality of Life	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.	3 months after discharge

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Sundar Natarajan, MD MSc, VA New York Harbor Health Care System

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 10, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: quality of life; readmissions; heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RRP 09-412