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Using Simulation and Implementation Science to Improve Self-care Skills for Patients with Ventricular Assist Device and their Caregivers: The SimVAD Trial

Award Number: R01HL183194
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Using Simulation and Implementation Science to Improve Self-care Skills for Patients with Ventricular Assist Device and their Caregivers: The SimVAD Trial - Modified Project Summary/Abstract Section Ventricular assist devices (VADs) are surgically implanted into the failing heart to provide circulatory support and have dramatically improved survival in these patients. Following VAD implantation, a driveline passes from the device through the skin, connecting to a system controller and power source. Risks after VAD implantation include driveline exit-site (DLES) infections, re-hospitalizations, and death. After VAD implantation, patients and caregivers are required to engage in daily VAD selfcare and recognize VAD-specific signs and symptoms requiring immediate medical attention. With improper VAD self-care, patients can die from preventable complications. Yet, no rigorous standardized training exists for patients and caregivers to ensure adequate attainment of VAD self-care skills. We have shown that VAD self-care training strategies vary widely across the US without requiring patients and caregivers to demonstrate competency prior to the end of training. This process leads to variable skill acquisition and retention, which increases patient harm. Simulation-based mastery learning (SBML) can be used to prevent such uneven skills. SBML is an intense form of competency-based education in which learners are required to achieve a high level of skill on a simulator. SBML eliminates subjectivity in training. We performed a pilot study that showed VAD selfcare SBML (SimVAD) for patients and caregivers resulted in superior skills and lower patient DLES infections compared to traditional training. SimVAD has yet to be disseminated to other VAD centers. We propose to conduct a study to evaluate the effectiveness and implementation of SimVAD across 8 VAD implant centers. Our specific aims are to: Aim 1. Evaluate the effectiveness of SimVAD by comparing patient and caregiver self-care skills at hospital discharge and 3, 6 and 12 months after discharge between the pre-implementation control and post SimVAD implementation. Aim 2. Conduct a process evaluation of SimVAD implementation determinants (facilitators and barriers) per the Consolidated Framework for Implementation Research (CFIR 2.0), and outcomes (acceptability, appropriateness, feasibility, fidelity, and sustainment) per the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Aim 3. Evaluate the effect of SimVAD on patient and caregiver health-related quality of life (HRQOL), selfefficacy, and caregiver perceived burden at 3, 6, and 12 months post implantation by comparing these outcomes between the pre-implementation control and post SimVAD implementation. Aim 4. (Exploratory) Examine the effect of SimVAD on DLES infections and readmissions at 3 and 12 months post VAD implantation by comparing these outcomes between the pre-implementation control and post SimVAD implementation.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $914,694 )
2026	2026	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	1	7/10/2026	NEW	$914,694
														Subtotal = $914,694

Grand Total All Awards = $914,694

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Using Simulation and Implementation Science to Improve Self-care Skills for Patients with Ventricular Assist Device and their Caregivers: The SimVAD Trial

Award Number: R01HL183194

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/15/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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