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      Understanding and Addressing Variation in Health Care–Associated Infections After Durable Ventricular Assist Device Therapy: Protocol for a Mixed Methods Study


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          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.


          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.


          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.


          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.


          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.

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          Most cited references47

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          Integrating Quantitative and Qualitative Results in Health Science Mixed Methods Research Through Joint Displays.

          Mixed methods research is becoming an important methodology to investigate complex health-related topics, yet the meaningful integration of qualitative and quantitative data remains elusive and needs further development. A promising innovation to facilitate integration is the use of visual joint displays that bring data together visually to draw out new insights. The purpose of this study was to identify exemplar joint displays by analyzing the various types of joint displays being used in published articles.
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            A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

            In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.
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              Seventh INTERMACS annual report: 15,000 patients and counting.

              The seventh annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 9 years of patient enrollment. The Registry includes >15,000 patients from 158 participating hospitals. Trends in device strategy, patient profile at implant and survival are presented. Risk factors for mortality with continuous-flow pumps are updated, and the major causes/modes of death are presented. The adverse event burden is compared between eras, and health-related quality of life is reviewed. A detailed analysis of outcomes after mechanical circulatory support for ambulatory heart failure is presented. Recent summary data from PediMACS and MedaMACS is included. With the current continuous-flow devices, survival at 1 and 2 years is 80% and 70%, respectively.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                January 2020
                7 January 2020
                : 9
                : 1
                : e14701
                [1 ] Mixed Methods Program Department of Family Medicine University of Michigan Ann Arbor, MI United States
                [2 ] Department of Cardiac Surgery University of Michigan Ann Arbor, MI United States
                [3 ] Division of Infectious Diseases Department of Internal Medicine University of Michigan Ann Arbor, MI United States
                [4 ] Department of Urology University of Michigan Ann Arbor, MI United States
                [5 ] Department of Strategic Management and Entrepreneurship Carlson School of Management University of Minnesota Minneapolis, MN United States
                [6 ] Division of Cardiovascular Medicine Department of Internal Medicine University of Michigan Ann Arbor, MI United States
                [7 ] Department of Biostatistics School of Public Health University of Michigan Ann Arbor, MI United States
                [8 ] Department of Cardiothoracic Surgery University of Pittsburgh Medical Center Pittsburgh, PA United States
                Author notes
                Corresponding Author: Donald Likosky likosky@ 123456umich.edu
                Author information
                ©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. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.01.2020.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 20 May 2019
                : 18 August 2019
                : 26 September 2019
                : 29 October 2019

                heart failure,ventricular assist device,infection,cardiac surgical procedures,mixed methods


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