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Ventricular Assist Device (VAD) Infection Prevention Survey

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ClinicalTrials.gov Identifier: NCT03843021
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Dr. Donald Likosky, University of Michigan

Brief 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.


Condition or disease Intervention/treatment
Heart Failure Healthcare Associated Infection Ventricular Assist Device 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.


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Other
Official Title: Understanding and Addressing Variation in Healthcare-Associated Infections After Durable Ventricular Assist Device Therapy: Organizational: Aim 1 Survey
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2023

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.




Primary Outcome Measures :
  1. An organization's use of practices associated with center HAI rates. [ Time Frame: March 2019 - March 2020 ]
    We will use a survey to identify a center's use of practices that may explain their center's HAI rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843021


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Donald S Likosky, Ph.D. University of Michigan

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Responsible Party: Dr. Donald Likosky, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT03843021     History of Changes
Other Study ID Numbers: HUM00157335
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes