Understanding and Addressing Variations in HAIs After Durable Ventricular Assist Device Therapy

Understanding and Addressing Variations in Healthcare-associated Infections (HAIs) After Durable Ventricular Assist Device Therapy

Substantial center variability exists in healthcare-associated infection (HAI) rates following durable ventricular assist device (VAD) implantation for patients with advanced heart failure. Preliminary evidence suggests that this variability may be related to process (e.g., pre-operative intranasal mupirocin), provider (e.g., surgeon technique, physician teamwork), device, (e.g., centrifugal vs. axial flow), and center specific (e.g., infection prevention strategies and resources) factors. The investigators will undertake a mixed methods study to: (1) identify determinants of center-level variability in HAI rates, (2) develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates, and (3) develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

Study Overview

• Status: Completed
• Conditions: Healthcare-Associated Infections

Detailed Description

Durable ventricular assist devices (VADs) provide long-term mechanical circulatory support as a bridge to cardiac transplantation or as permanent therapy, and have the potential to benefit more than 250K patients with advanced heart failure (HF) refractory to guideline-directed medical therapy. Upwards of six out of every 10 VAD patients develop a healthcare-associated infection (HAI) following implant. Broader adoption of durable VAD therapy is hindered by HAIs given their association with mortality (5.6-fold increased risk of 1-year mortality) and healthcare expenditures ($264K - $869K per patient).

Most studies evaluating HAIs in the setting of VAD therapy have been limited to post-hoc analyses of small trials, or single center experiences. 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 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 barriers to lowering HAI rates among centers with high rates. The investigators will use a novel dataset including administrative claims and detailed clinical data, along with in-depth center surveys, to address the following aims: (i) identify determinants of center-level variability in HAI rates, (ii) develop a comprehensive understanding of barriers and facilitators for achieving low center HAI rates, and (iii) develop, iteratively enhance, and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

These studies will have a positive impact on clinical practice by identifying targets for an interventional study. Moreover, the mixed methods approach will serve as a model for evaluating and improving clinical care more broadly - especially in the setting of complex surgical procedures.

• Study Type: Observational
• Enrollment (Actual): 34958

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: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have received a FDA-approved, durable ventricular assist device implant.

Description

Inclusion Criteria:

• Female and Male adult patients 18 and over who have received a FDA-approved, durable ventricular assist device implant from 2008 onwards

Exclusion Criteria:

• Children

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults with HAIs after VAD therapy; Adult patients who have received a ventricular assist device implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who have developed a healthcare-associated infection within 90 days following a ventricular assist device (VAD) implant	Any healthcare-associated infection within 90 days following a VAD implant	90 days following a VAD implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of healthcare-associated infection	Healthcare-associated infection subtype	90 days following a VAD implant

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Infections; Durable Left Ventricular Assist Device Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Cross Infection
• Other Study ID Numbers: HUM00155687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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