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CompletedNCT03843021Updated Jul 14, 2023

Ventricular Assist Device (VAD) Infection Prevention Survey

An observational study in Heart Failure, Healthcare Associated Infection and Ventricular Assist Device, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-14.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
208
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Healthcare Associated Infection
  • Ventricular Assist Device
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 208 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

Healthcare providers not caring for VAD recipient patients.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
208 participants (actual)
Patient registry
No

Groups and cohorts

  • VAD Healthcare Providers

    Adult healthcare providers of VAD therapy recipients.

    Other: VAD Infection Prevention Survey

Interventions

  • OtherVAD Infection Prevention Survey

    Healthcare providers caring for VAD Therapy recipients will answer questions regarding processes of care at their institutions.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: March 2019 - March 2020

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

References and documents

Individual participant data

Plan to share: No — We will not be sharing individual participant data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03843021
Lead sponsor
University of Michigan
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Dr. Donald Likosky (Principal Investigator, University of Michigan) — Principal investigator
First posted
Feb 15, 2019
Start date
May 29, 2019
Primary completion
Dec 23, 2022
Completion
Dec 23, 2022
Last update
Jul 14, 2023

Study contacts

Donald S Likosky, Ph.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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