Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03749434 |
| Other study ID # |
HUM00155687 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 4, 2019 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
