Understanding and addressing variation in health care-associated infections after durable ventricular assist device therapy: Protocol for a mixed methods study

P. Paul Chandanabhumma, Michael D. Fetters, Francis D. Pagani, Preeti N. Malani, John M. Hollingsworth, Russell J. Funk, Keith D. Aaronson, Min Zhang, Robert L. Kormos, Carol E. Chenoweth, Supriya Shore, Tessa M.F. Watt, Lourdes Cabrera, Donald Likosky

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4 Scopus citations


BACKGROUND: Durable ventricular assist device (VAD) therapy is reserved for patients with advanced heart failure who have a poor estimated 1-year survival. However, despite highly protocolized management processes, patients are at a unique risk for developing a health care-associated infection (HAI). Few studies have examined optimal strategies for HAI prevention after durable VAD implantation, despite variability in rates across centers and their impact on short- and long-term outcomes.

OBJECTIVE: The objective of this study is to develop recommendations for preventing the most significant HAIs after durable VAD implantation. The study has 3 specific aims: (1) identify determinants of center-level variability in HAI rates, (2) develop comprehensive understanding of barriers and facilitators for achieving low center-level HAI rates, and (3) develop and disseminate a best practices toolkit for preventing HAIs that accommodates various center contexts.

METHODS: This is a sequential mixed methods study starting with a cross-sectional assessment of current practices. To address aim 1, we will conduct (1) a systematic review of HAI prevention studies and (2) in-depth quantitative analyses using administrative claims, in-depth clinical data, and organizational surveys of VAD centers. For aim 2, we will apply a mixed methods patient tracer assessment framework to conduct semistructured interviews, field observations, and document analysis informed by findings from aim 1 at 5 high-performing (ie, low HAIs) and 5 low-performing (ie, high HAI) centers, which will be examined using a mixed methods case series analysis. For aim 3, we will build upon the findings from the previous aims to develop and field test an HAI preventive toolkit, acquire stakeholder input at an annual cardiac surgical conference, disseminate the final version to VAD centers nationwide, and conduct follow-up surveys to assess the toolkit's adoption.

RESULTS: The project was funded by the Agency for Healthcare Research and Quality in 2018 and enrollment for the overall project is ongoing. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019.

CONCLUSIONS: This mixed methods study seeks to quantitatively assess the determinants of HAIs across clinical centers and qualitatively identify the context-specific facilitators and barriers for attaining low HAI rates. The mixed data findings will be used to develop and disseminate a stakeholder-acceptable toolkit of evidence-based HAI prevention recommendations that will accommodate the specific contexts and needs of VAD centers.


Original languageEnglish (US)
Article numbere14701
JournalJMIR Research Protocols
Issue number1
StatePublished - Jan 7 2020

Bibliographical note

Funding Information:
The INTERMACS dataset was provided by Dr. Marissa Miller, National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Data in INTERMACS used for this study were previously collected under contract with the NIH (contract number HHSN268201100025C). This project was supported by grant number R01HS026003 from the AHRQ, US Department of Health and Human Services. Additional funding was provided by the National Institutes of Health (grant number T32-HL-007853). Opinions expressed in this manuscript do not represent those of INTERMACS, NHLBI, CMS, US FDA or AHRQ.

Publisher Copyright:
© 2020 Journal of Medical Internet Research. All rights reserved.


  • Cardiac surgical procedures
  • Heart failure
  • Infection
  • Mixed methods
  • Ventricular assist device


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