Veterans Affairs Lowering Readmission in Heart Failure
VALOR in HF
VALOR (Veterans Affairs Lowering Readmissions) in Heart Failure Study
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Oct 2010
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
October 16, 2015
CompletedOctober 16, 2015
August 1, 2015
2.8 years
June 10, 2010
February 9, 2015
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (11)
Standardized Mental Component Score
3 months after discharge
Physical Functioning
3 months after discharge
Role Physical
3 months after discharge
Pain Index
3 months after discharge
General Health
3 months after discharge
- +6 more secondary outcomes
Study Arms (2)
Current Best Practice (CBP)
NO INTERVENTIONCBP received no intervention and only current best practices for inpatient HF care.
Quality improvement program (QIP)
ACTIVE COMPARATORComprehensive 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA New York Harbor Health Care System
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sundar Natarajan, MD, M.Sc.
- Organization
- VA New York Harbor Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Sundar Natarajan, MD MSc
VA New York Harbor Health Care System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 15, 2010
Study Start
October 1, 2010
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
October 16, 2015
Results First Posted
October 16, 2015
Record last verified: 2015-08