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      <Title language="en">Bridging Technology and Organizational Change: A Context-Sensitive Strategy for Mandatory HIS Implementation in a University Hospital</Title>
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          <Lastname>Gaul</Lastname>
          <LastnameHeading>Gaul</LastnameHeading>
          <Firstname>Carolina</Firstname>
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          <Affiliation>Charit&#233; &#8211; Universit&#228;tsmedizin Berlin, Berlin, Germany</Affiliation>
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          <Affiliation>Charit&#233; &#8211; Universit&#228;tsmedizin Berlin, Berlin, Germany</Affiliation>
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          <Lastname>Balzer</Lastname>
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          <Firstname>Felix</Firstname>
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          <Affiliation>Charit&#233; &#8211; Universit&#228;tsmedizin Berlin, Berlin, Germany</Affiliation>
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          <Lastname>Compton</Lastname>
          <LastnameHeading>Compton</LastnameHeading>
          <Firstname>Friederike</Firstname>
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          <Affiliation>Charit&#233; &#8211; Universit&#228;tsmedizin Berlin, Berlin, Germany</Affiliation>
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          <Corporatename>German Medical Science GMS Publishing House</Corporatename>
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        <Address>D&#252;sseldorf</Address>
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      <SubjectheadingDDB>610</SubjectheadingDDB>
      <Keyword language="en">hospital information systems</Keyword>
      <Keyword language="en">implementation science</Keyword>
      <Keyword language="en">context sensitivity</Keyword>
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      <DatePublished>20251103</DatePublished>
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    <Language>engl</Language>
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      <AltText language="en">This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License.</AltText>
      <AltText language="de">Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung).</AltText>
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      <Meeting>
        <MeetingId>M0631</MeetingId>
        <MeetingSequence>145</MeetingSequence>
        <MeetingCorporation>Deutsche Gesellschaft f&#252;r Medizinische Informatik, Biometrie und Epidemiologie</MeetingCorporation>
        <MeetingName>70. Jahrestagung der Deutschen Gesellschaft f&#252;r Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)</MeetingName>
        <MeetingTitle></MeetingTitle>
        <MeetingSession>PS 7: IT-Infrastruktur 2</MeetingSession>
        <MeetingCity>Jena</MeetingCity>
        <MeetingDate>
          <DateFrom>20250907</DateFrom>
          <DateTo>20250911</DateTo>
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      <MainHeadline>Text</MainHeadline><Pgraph><Mark1>Introduction:</Mark1> The implementation of hospital information system (HIS) is often framed as a technological upgrade, yet it fundamentally alters clinical workflows and organizational culture &#8211; particularly in mandatory settings. At a large German university hospital, a vendor based HIS will be introduced by 2028, affecting more than 23,000 staff across 100&#43; specialist departments. Evidence shows that mandatory implementations may provoke resistance and tensions if contextual factors are not adequately addressed <TextLink reference="1"></TextLink>, <TextLink reference="2"></TextLink>. This study protocol adapts the Basel Approach for Contextual Analysis in Implementation Science (BANANA) <TextLink reference="3"></TextLink> to systematically identify and address these factors during the pre-implementation phase. </Pgraph><Pgraph><Mark1>Methods:</Mark1> The study follows a multi-method design based on BANANA&#8217;s six-step framework <TextLink reference="3"></TextLink>.</Pgraph><Pgraph><UnorderedList><ListItem level="1">A theoretical framework will be selected through expert consensus among implementation researchers. </ListItem><ListItem level="1">A hermeneutic literature review will be conducted alongside insights from internal project documents. </ListItem><ListItem level="1">Stakeholders &#8211; including clinicians, project staff, and implementation experts &#8211; will be recruited through internal communication channels and professional networks. </ListItem><ListItem level="1">Semi-structured interviews will explore perceived contextual barriers and facilitators. </ListItem><ListItem level="1">Based on the interview findings, tailored implementation strategies will be selected using the Expert Recommendations for Implementing Change (ERIC) <TextLink reference="4"></TextLink>. </ListItem><ListItem level="1">The contextual analysis process and its findings will be reported transparently in line with implementation science standards. </ListItem></UnorderedList></Pgraph><Pgraph>Figure 1 <ImgLink imgNo="1" imgType="figure" /></Pgraph><Pgraph><Mark1>Results:</Mark1> The study is expected to classify key contextual barriers and produce stakeholder-informed strategies tailored to the hospital&#8217;s environment. These outcomes will form the basis of an implementation guide that addresses the complexities of a mandatory HIS rollout in a university hospital. </Pgraph><Pgraph><Mark1>Discussion:</Mark1> This research is situated at the intersection of medical informatics and implementation science, addressing a highly complex, mandatory digital transformation at a German university hospital. Such transformations require not only interoperability and standardization of data flows across departments but also deep integration into clinical routines. These technical challenges &#8211; ranging from infrastructure compatibility to interface usability and system reliability &#8211; can significantly disrupt clinical processes if not managed thoughtfully. Despite the technological sophistication of the HIS, resistance, low adoption, and workflow misalignment remain persistent risks, particularly in mandatory implementation settings <TextLink reference="1"></TextLink>, <TextLink reference="2"></TextLink>. This is precisely where implementation science adds value: by providing structured methodologies to understand context, engage stakeholders, and tailor implementation strategies to real-world conditions. Using the BANANA approach for contextual analysis and drawing upon prominent implementation frameworks and tools, this project contributes a context-sensitive, user-informed guide for implementation within a complex environment <TextLink reference="5"></TextLink>, <TextLink reference="3"></TextLink>, <TextLink reference="4"></TextLink>. Ultimately, the integration of implementation science into medical informatics is not just beneficial &#8211; it is essential. Only through interdisciplinary collaboration can we ensure that complex digital health technologies are not only technically sound but also usable, accepted, and effective in practice. </Pgraph><Pgraph> </Pgraph><Pgraph><Mark1>Conclusion:</Mark1> Operationalizing BANANA <TextLink reference="3"></TextLink> in a large clinical setting offers a structured approach to early-stage contextual analysis. By identifying barriers and co-designing solutions with stakeholders, this study aims to reduce resistance and support successful HIS adoption. The results may inform other large-scale digital health implementations.</Pgraph><Pgraph>The authors declare that they have no competing interests.</Pgraph><Pgraph>The authors declare that a positive ethics committee vote has been obtained.</Pgraph></TextBlock>
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