Ventricular Assist Device (VAD) Infection Prevention Survey

NCT03843021 | Completed

• 1 other identifier: HUM00157335
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Healthcare Associated Infection; Ventricular Assist Device

Outcome Measures

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

  March 2019 - March 2020

Study Arms (1)

VAD Healthcare Providers

Adult healthcare providers of VAD therapy recipients.

Other: VAD Infection Prevention Survey

Interventions

VAD Infection Prevention Survey OTHER

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

VAD Healthcare Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Healthcare providers not caring for VAD recipient patients.

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

Heart Failure; Cross Infection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald S Likosky, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: May 29, 2019
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)