Ventricular Assist Device (VAD) Infection Prevention Survey

Understanding and Addressing Variation in Healthcare-Associated Infections After Durable Ventricular Assist Device Therapy: Organizational: Aim 1 Survey

Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. The investigators long term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation.

This will be done by addressing the following aims:

Aim 1. Identify determinants of center-level variability in HAI rates. Aim 2. Develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates.

Aim 3. Develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

The investigators will use a focused survey of U.S. VAD centers to identify determinants of center variation in 90-day HAI rates:

• Process Factors (e.g., intranasal mupirocin),
• Provider Factors (e.g., surgeon technique),
• Device Factors (e.g., centrifugal vs. axial),
• Center Factors (e.g., provider communication).

Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Healthcare Associated Infection; Ventricular Assist Device
• Intervention / Treatment: Other: VAD Infection Prevention Survey

Detailed Description

Annually, more than 250,000 patients in the U.S. with end-stage heart failure stand to benefit from ventricular assist device (VAD) therapy. Despite VADs providing long-term "durable" support, this therapy is associated with substantial risk (50% mortality at 4 years) and expense ($179,000 for inpatient services). Additionally, 60% of patients develop a healthcare-associated infection (HAI) within 90-days of implantation. Broad adoption of durable VAD therapy is hindered in part by HAIs, given associated sequelae (6-fold increased risk of 1-year mortality) and costs ($264,000 - $869,000 per patient). It is critical to determine how best to prevent HAIs in order to maximize the benefit of VAD therapy. While several studies have reported variation in HAI rates across centers after complex cardiac surgery, less is known in the setting of durable VADs. The average 90-day HAI rate after VAD implantation is as high as 19 events per 100 patient-months and varies (25th - 75th percentile, 9-23) across centers. While some argue that centers with lower HAI rates select healthier patients, others counter that improved practices (e.g., standardizing empirical and targeted antimicrobial therapy) or enhanced provider teamwork are more predictive of improved outcomes.

While evidence-based HAI prevention guidelines and implementation tools (e.g., checklists) exist, these approaches are not comprehensive (e.g., neglecting device-specific determinants) or customizable to local context, thus limiting usability, adoption, and likelihood of significant effectiveness for preventing HAIs. Understanding the barriers and facilitators within individual centers for maximizing adoption of prevention measures would serve as the foundation for targeted improvement strategies. Without this knowledge, evidence-based, action-oriented recommendations will have limited local adoption and ultimately effectiveness in preventing HAIs after VAD implantation.

The investigators long-term goal is to develop and subsequently promote wide-scale adoption of evidence-based HAI prevention practices following durable VAD implantation. The objective of this proposal is to identify prevention recommendations for the most significant HAIs after VAD implantation. To achieve this objective, the investigators will undertake a mixed methods study of adult patients receiving VADs in the U.S. from 2009 - 2017 and develop a modular toolkit of evidence-based recommendations. To determine best practices for preventing HAIs, the investigators will examine center-level differences in HAI rates to identify strategies used by centers with low rates, and potential barriers among centers with high rates.

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthcare providers involved in the medical management of a Ventricular Assist Device (VAD) recipient during the peri-operative period, specifically surgeons, cardiologist, VAD coordinators.

Description

Inclusion Criteria:

Healthcare providers involved in the medical management of a Ventricular Assist Device (VAD) recipient during the peri-operative period, including those with the following roles: surgeons, cardiologists and VAD coordinators

Exclusion Criteria:

Healthcare providers not caring for VAD recipient patients.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VAD Healthcare Providers; Adult healthcare providers of VAD therapy recipients.	Other: VAD Infection Prevention Survey; Healthcare providers caring for VAD Therapy recipients will answer questions regarding processes of care at their institutions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
An organization's use of practices associated with center HAI rates.	We will use a survey to identify a center's use of practices that may explain their center's HAI rate	March 2019 - March 2020

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Donald S Likosky, Ph.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: HUM00157335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not be sharing individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No