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

NCT03749434 | Completed

• 1 other identifier: HUM00155687
• Study Type: observational
• Target: 34,958
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthcare-Associated Infections

Keywords

Infections; Durable Left Ventricular Assist Device Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Type of healthcare-associated infection

  90 days following a VAD implant

Study Arms (1)

Adults with HAIs after VAD therapy

Adult patients who have received a ventricular assist device implant.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Children

Sponsors & Collaborators

• University of Michigan: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cross Infection; Infections

Condition Hierarchy (Ancestors)

Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald Likosky, PhD.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Richard and Norma Sarns Research Professor of Cardiac Surgery

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: February 4, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)