People and organizational issues are critical in both
implementing medical informatics systems and in dealing with the altered
organizations that new systems often create. The people and organizational
issues area—like medical informatics itself—is a blend of many
disciplines. The academic disciplines of psychology, sociology, social
psychology, social anthropology, organizational behavior and organizational
development, management, and cognitive sciences are rich with research with
significant potential to ease the introduction and on-going use of information
technology in today's complex health systems. These academic areas contribute
research data and core information for better understanding of such issues as
the importance of and processes for creating future direction; managing a
complex change process; effective strategies for involving individuals and
groups in the informatics effort; and effectively managing the altered
organization. This article reviews the behavioral and business referent
disciplines that can potentially contribute to improved implementations and
on-going management of change in the medical informatics arena.
New system design and evaluation methodologies are being
developed to address social, organizational, political, and other
non-technological issues in medical informatics. This paper describes a social
interactionist framework for researching these kinds of organizational issues,
based on research within medical informatics and other disciplines over the
past 20 years. It discusses how effective evaluation strategies may be
undertaken to address organizational issues concerning computer information
systems in medicine and health care. The paper begins with a theoretical
framework for evaluation. It then describes the 4Cs of evaluation:
communication, care, control, and context. Five methodological guidelines are
given for conducting comprehensive evaluations that address these 4Cs. An
example of an evaluation research design that fits the guidelines and was used
in an evaluation of an on-line clinical imaging system is discussed. Results
of the evaluation study illustrate how this approach addresses organizational
concerns and the 4Cs.
Everyone attending the AMIA conference has likely either heard about or had firsthand experience of a failed health information technology implementation. The line dividing failed implementations from successful ones frequently seems perilously thin, dependent on people and organizational factors as much as on technology design. What implementation lessons have informatics researchers and practitioners learned from prior failures and successes? Can the research domain of Implementation Science assist practitioners to improve implementation planning and execution? Implementation Science draws on multiple disciplines and perspectives (e.g., clinical, organizational, engineering, behavioral, social science) to understand technology adoption, explore patterns of technology use, and define organizational strategies for sustainable deployment. Through two case study presentations and a series of questions, our presentation will actively engage the audience in a discussion of what an evidence-based approach to implementation might mean at different institutions and explore practical implications of Implementation Science for decision-makers and technology implementers. The presentation will translate research on implementation into implementation lessons and practical strategies for practitioners.
Multi-disciplinary and multi-site biomedical research programs frequently require infrastructures capable of enabling the collection, management, analysis, and dissemination of heterogeneous, multi-dimensional, and distributed data and knowledge collections spanning organizational boundaries. We report on the design and initial deployment of an extensible biomedical informatics platform that is intended to address such requirements.
A common approach to distributed data, information, and knowledge management needs in the healthcare and life science settings is the deployment and use of a service-oriented architecture (SOA). Such SOA technologies provide for strongly-typed, semantically annotated, and stateful data and analytical services that can be combined into data and knowledge integration and analysis “pipelines.” Using this overall design pattern, we have implemented and evaluated an extensible SOA platform for clinical and translational science applications known as the Translational Research Informatics and Data-management grid (TRIAD). TRIAD is a derivative and extension of the caGrid middleware and has an emphasis on supporting agile “working interoperability” between data, information, and knowledge resources.
Based upon initial verification and validation studies conducted in the context of a collection of driving clinical and translational research problems, we have been able to demonstrate that TRIAD achieves agile “working interoperability” between distributed data and knowledge sources.
Informed by our initial verification and validation studies, we believe TRIAD provides an example instance of a lightweight and readily adoptable approach to the use of SOA technologies in the clinical and translational research setting. Furthermore, our initial use cases illustrate the importance and efficacy of enabling “working interoperability” in heterogeneous biomedical environments.
Clinical research informatics; data access; data integration; data analysis; standards; workflow; socio-organizational issues
Information technology can support the implementation of clinical research findings in practice settings. Technology can address the quality gap in health care by providing automated decision support to clinicians that integrates guideline knowledge with electronic patient data to present real-time, patient-specific recommendations. However, technical success in implementing decision support systems may not translate directly into system use by clinicians. Successful technology integration into clinical work settings requires explicit attention to the organizational context. We describe the application of a “sociotechnical” approach to integration of ATHENA DSS, a decision support system for the treatment of hypertension, into geographically dispersed primary care clinics. We applied an iterative technical design in response to organizational input and obtained ongoing endorsements of the project by the organization's administrative and clinical leadership. Conscious attention to organizational context at the time of development, deployment, and maintenance of the system was associated with extensive clinician use of the system.
The 20th anniversary of the groundbreaking report of the Commission on Health Research for Development inspired a Symposium to assess progress made in strengthening essential national health research capacity in developing countries and in global research partnerships. Significant aspects of the health gains achieved in the 20th century can be attributed to the advancement and translation of knowledge, and knowledge continues to occupy center stage amidst growing complexity that characterizes the global health field. The way forward will entail a reinvigoration of research-generated knowledge as a crucial ingredient for global cooperation and global health advances. To do this we will need to overcome daunting gaps, including the divides between domestic and global health, among the disciplines of research (biomedical, clinical, epidemiological, health systems), between clinical and public health approaches, public and private investments, and between knowledge gained and action implemented. Overcoming systematically these obstacles can accelerate progress towards research for equity in health and development.
Clinical research informatics is the rapidly evolving sub-discipline within biomedical informatics that focuses on developing new informatics theories, tools, and solutions to accelerate the full translational continuum: basic research to clinical trials (T1), clinical trials to academic health center practice (T2), diffusion and implementation to community practice (T3), and ‘real world’ outcomes (T4). We present a conceptual model based on an informatics-enabled clinical research workflow, integration across heterogeneous data sources, and core informatics tools and platforms. We use this conceptual model to highlight 18 new articles in the JAMIA special issue on clinical research informatics.
Clinical research informatics; clinical and translational research; visualization of data and knowledge; knowledge representations; methods for integration of information from disparate sources; data models; data exchange; knowledge bases; knowledge acquisition; knowledge acquisition and knowledge management
Climate has a long history in organizational studies, but few theoretical models integrate the complex effects of climate during innovation implementation. In 1996, a theoretical model was proposed that organizations could develop a positive climate for implementation by making use of various policies and practices that promote organizational members' means, motives, and opportunities for innovation use. The model proposes that implementation climate--or the extent to which organizational members perceive that innovation use is expected, supported, and rewarded--is positively associated with implementation effectiveness. The implementation climate construct holds significant promise for advancing scientific knowledge about the organizational determinants of innovation implementation. However, the construct has not received sufficient scholarly attention, despite numerous citations in the scientific literature. In this article, we clarify the meaning of implementation climate, discuss several measurement issues, and propose guidelines for empirical study.
Implementation climate differs from constructs such as organizational climate, culture, or context in two important respects: first, it has a strategic focus (implementation), and second, it is innovation-specific. Measuring implementation climate is challenging because the construct operates at the organizational level, but requires the collection of multi-dimensional perceptual data from many expected innovation users within an organization. In order to avoid problems with construct validity, assessments of within-group agreement of implementation climate measures must be carefully considered. Implementation climate implies a high degree of within-group agreement in climate perceptions. However, researchers might find it useful to distinguish implementation climate level (the average of implementation climate perceptions) from implementation climate strength (the variability of implementation climate perceptions). It is important to recognize that the implementation climate construct applies most readily to innovations that require collective, coordinated behavior change by many organizational members both for successful implementation and for realization of anticipated benefits. For innovations that do not possess these attributes, individual-level theories of behavior change could be more useful in explaining implementation effectiveness.
This construct has considerable value in implementation science, however, further debate and development is necessary to refine and distinguish the construct for empirical use.
There is a critical gap in our nation's ability to accurately measure and manage the quality of medical care. A robust healthcare quality information system (HQIS) has the potential to address this deficiency through the capture, codification, and analysis of information about patient treatments and related outcomes. Because non-technical issues often present the greatest challenges, this paper provides an overview of these socio-technical issues in building a successful HQIS, including the human, organizational, and knowledge management (KM) perspectives. Through an extensive literature review and direct experience in building a practical HQIS (the National Comprehensive Cancer Network Outcomes Research Database system), we have formulated an “informatics blueprint” to guide the development of such systems. While the blueprint was developed to facilitate healthcare quality information collection, management, analysis, and reporting, the concepts and advice provided may be extensible to the development of other types of clinical research information systems.
Clinical Research Informatics (CRI) is a rapidly developing sub-domain of Biomedical Informatics that has seen considerable growth in recent years. While there are numerous activities and initiatives ongoing in this domain, systematic consideration and analysis of the challenges and opportunities that exist in this area are lacking. To begin to address this gap in knowledge and inform next steps in advancing this developing domain, we conducted a facilitated discussion among a diverse group of interested participants attending a meeting of the Clinical Research Informatics Working Group at the AMIA 2006 annual symposium. Findings from our analysis of these data are presented here and indicate a broad array of challenges and opportunities facing this developing area. These findings add new information to the limited literature regarding CRI and should provide direction for those working to set the CRI research and development agenda.
Managed care is now the dominant form of healthcare in the United States. The need for clinical research about the organization, delivery, and outcomes of primary care services in managed care models is high, yet access to managed care organizations as sites for clinical research may be problematic. The purpose of this article is to describe issues involved in obtaining access to managed care settings for clinical research and practical strategies for successful collaboration using literature review and case description. Three steps for developing collaborative relationships with managed care organizations (MCOs) are presented: 1) assessment of organizational structure, history, and culture; 2) finding common ground; and 3) project implementation. These steps are discussed within the context of MCO systems issues and a relationship-centered approach to communication between researchers and individuals from the MCO. Successful relationships with MCOs for clinical research are possible when careful attention is paid to inclusion of MCOs as collaborators in the development of the research questions and design, and as partners in the research implementation process.
This Viewpoint paper has grown out of a presentation at the American College of Medical Informatics 2007 Winter Symposium, the resulting discussion, and several activities that have coalesced around an issue that most informaticians accept as true but is not commonly considered during the implementation of Electronic Health Records (EHR) outside of academia or research institutions. Successful EHR implementation is facilitated and sometimes determined by formative evaluation, usually focusing on process rather than outcomes. With greater federal funding for the implementation of electronic health record systems in health care organizations unfamiliar with research protocols, the need for formative evaluation assistance is growing. Such assistance, in the form of tools and protocols necessary to do formative evaluation and resulting in successful EHR implementations, should be provided by practicing medical informaticians.
The effective and timely integration of the best available research evidence into healthcare practice has considerable potential to improve the quality of provided care. Knowledge translation (KT) approaches aim to develop, implement, and evaluate strategies to address the research-practice gap. However, most KT research has been directed toward implementation strategies that apply cognitive, behavioral, and, to a lesser extent, organizational theories. In this paper, we discuss the potential of institutional theory to inform KT-related research.
Despite significant research, there is still much to learn about how to achieve KT within healthcare systems and practices. Institutional theory, focusing on the processes by which new ideas and concepts become accepted within their institutional environments, holds promise for advancing KT efforts and research. To propose new directions for future KT research, we present some of the main concepts of institutional theory and discuss their application to KT research by outlining how institutionalization of new practices can lead to their ongoing use in organizations. In addition, we discuss the circumstances under which institutionalized practices dissipate and give way to new insights and ideas that can lead to new, more effective practices.
KT research informed by institutional theory can provide important insights into how knowledge becomes implemented, routinized, and accepted as institutionalized practices. Future KT research should employ both quantitative and qualitative research designs to examine the specifics of sustainability, institutionalization, and deinstitutionalization of practices to enhance our understanding of these complex constructs.
As we have advanced in medical informatics and created many impressive innovations, we also have learned that technologic developments are not sufficient to bring the value of computer and information technologies to health care systems. This paper proposes a model for improving how we develop and deploy information technology. The authors focus on trends in people, organizational, and social issues (POI/OSI), which are becoming more complex as both health care institutions and information technologies are changing rapidly. They outline key issues and suggest high-priority research areas. One dimension of the model concerns different organizational levels at which informatics applications are used. The other dimension draws on social science disciplines for their approaches to studying implications of POI/OSI in informatics. By drawing on a wide variety of research approaches and asking questions based in social science disciplines, the authors propose a research agenda for high-priority issues, so that the challenges they see ahead for informatics may be met better.
OBJECTIVE: To interpret the results of a cross-site study of physician order entry (POE) in hospitals using a diffusion of innovations theory framework. METHODS: Qualitative study using observation, focus groups, and interviews. Data were analyzed by an interdisciplinary team of researchers using a grounded approach to identify themes. Themes were then interpreted using classical Diffusion of Innovations (DOI) theory as described by Rogers . RESULTS: Four high level themes were identified: organizational issues; clinical and professional issues; technology implementation issues; and issues related to the organization of information and knowledge. Further analysis using the DOI framework indicated that POE is an especially complex information technology innovation when one considers communication, time, and social system issues in addition to attributes of the innovation itself. CONCLUSION: Implementation strategies for POE should be designed to account for its complex nature. The ideal would be a system that is both customizable and integrated with other parts of the information system, is implemented with maximum involvement of users and high levels of support, and is surrounded by an atmosphere of trust and collaboration.
Implementation of evidence-based practices in real-world settings is a complex process impacted by many factors, including intervention, dissemination, service provider, and organizational characteristics. Efforts to improve knowledge translation have resulted in greater attention to these factors. Researcher attention to the applicability of findings to applied settings also has increased. Much less attention, however, has been paid to intervention feasibility, an issue important to applied settings.
In a systematic review of 121documents regarding integrated treatment programs for women with substance abuse issues and their children, we examined the presence of feasibility-related information. Specifically, we analysed study descriptions for information regarding feasibility factors in six domains (intervention, practitioner, client, service delivery, organizational, and service system).
On average, fewer than half of the 25 feasibility details assessed were included in the documents. Most documents included some information describing the participating clients, the services offered as part of the intervention, the location of services, and the expected length of stay or number of sessions. Only approximately half of the documents included specific information about the treatment model. Few documents indicated whether the intervention was manualized or whether the intervention was preceded by a standardized screening or assessment process. Very few provided information about the core intervention features versus the features open to local adaptation, or the staff experience or training required to deliver the intervention.
As has been found in reviews of intervention studies in other fields, our findings revealed that most documents provide some client and intervention information, but few documents provided sufficient information to fully evaluate feasibility. We consider possible explanations for the paucity of feasibility information and provide suggestions for better reporting to promote diffusion of evidence-based practices.
Knowledge translation; Feasibility; Substance abuse; Women; Treatment; Review
Health care leaders emphasize the need to include information technology and informatics concepts in formal education programs, yet integration of informatics into health educational programs has progressed slowly. The AMIA 1999 Spring Congress was held to address informatics educational issues across health professions, including the educational needs in the various health professions, goals for health informatics education, and implementation strategies to achieve these goals. This paper presents the results from AMIA work groups focused on informatics education for non-informatics health professionals. In the categories of informatics needs, goals, and strategies, conference attendees suggested elements in these areas: educational responsibilities for faculty and students, organizational responsibilities, core computer skills and informatics knowledge, how to learn informatics skills, and resources required to implement educational strategies.
Accelerating the translation of new scientific discoveries to improve human health and disease management is the overall goal of a series of initiatives integrated in the National Institutes of Health (NIH) “Roadmap for Medical Research.” The Clinical and Translational Research Award (CTSA) program is, arguably, the most visible component of the NIH Roadmap providing resources to institutions to transform their clinical and translational research enterprises along the goals of the Roadmap. The CTSA program emphasizes biomedical informatics as a critical component for the accomplishment of the NIH’s translational objectives. To be optimally effective, emerging biomedical informatics programs must link with the information technology (IT) platforms of the enterprise clinical operations within academic health centers.
This report details one academic health center’s transdisciplinary initiative to create an integrated academic discipline of biomedical informatics through the development of its infrastructure for clinical and translational science infrastructure and response to the CTSA mechanism. This approach required a detailed informatics strategy to accomplish these goals. This transdisciplinary initiative was the impetus for creation of a specialized biomedical informatics core, the Center for Biomedical Informatics (CBI). Development of the CBI codified the need to incorporate medical informatics including quality and safety informatics and enterprise clinical information systems within the CBI. This paper describes the steps taken to develop the biomedical informatics infrastructure, its integration with clinical systems at one academic health center, successes achieved, and barriers encountered during these efforts.
CTSA; information technology clinical and translational research; biomedical informatics
Recently there has been a remarkable upsurge in activity surrounding the adoption of personal health record (PHR) systems for patients and consumers. The biomedical literature does not yet adequately describe the potential capabilities and utility of PHR systems. In addition, the lack of a proven business case for widespread deployment hinders PHR adoption. In a 2005 working symposium, the American Medical Informatics Association's College of Medical Informatics discussed the issues surrounding personal health record systems and developed recommendations for PHR-promoting activities. Personal health record systems are more than just static repositories for patient data; they combine data, knowledge, and software tools, which help patients to become active participants in their own care. When PHRs are integrated with electronic health record systems, they provide greater benefits than would stand-alone systems for consumers. This paper summarizes the College Symposium discussions on PHR systems and provides definitions, system characteristics, technical architectures, benefits, barriers to adoption, and strategies for increasing adoption.
The 2001 U.S. Army Medical Research and Materiel Command (USAMRMC) Biomedical Informatics Roadmap Meeting was devoted to developing a strategic plan in four focus areas: Hospital and Clinical Informatics, E-Health, Combat Health Informatics, and Bioinformatics and Biomedical Computation. The driving force of this Roadmap Meeting was the recent accelerated pace of change in biomedical informatics in which emerging technologies have the potential to affect significantly the Army research portfolio and investment strategy in these focus areas. The meeting was structured so that the first two days were devoted to presentations from experts in the field, including representatives from the three services, other government agencies, academia, and the private sector, and the morning of the last day was devoted to capturing specific biomedical informatics research needs in the four focus areas. This white paper summarizes the key findings and recommendations and should be a powerful tool for the crafting of future requests for proposals to help align USAMRMC new strategic research investments with new developments and emerging technologies.
Knowledge translation (KT) is an imperative in order to implement research-based and contextualized practices that can answer the numerous challenges of complex health problems. The Chronic Care Model (CCM) provides a conceptual framework to guide the implementation process in chronic care. Yet, organizations aiming to improve chronic care require an adequate level of organizational readiness (OR) for KT. Available instruments on organizational readiness for change (ORC) have shown limited validity, and are not tailored or adapted to specific phases of the knowledge-to-action (KTA) process. We aim to develop an evidence-based, comprehensive, and valid instrument to measure OR for KT in healthcare. The OR for KT instrument will be based on core concepts retrieved from existing literature and validated by a Delphi study. We will specifically test the instrument in chronic care that is of an increasing importance for the health system.
Phase one: We will conduct a systematic review of the theories and instruments assessing ORC in healthcare. The retained theoretical information will be synthesized in a conceptual map. A bibliography and database of ORC instruments will be prepared after appraisal of their psychometric properties according to the standards for educational and psychological testing. An online Delphi study will be carried out among decision makers and knowledge users across Canada to assess the importance of these concepts and measures at different steps in the KTA process in chronic care.
Phase two: A final OR for KT instrument will be developed and validated both in French and in English and tested in chronic disease management to measure OR for KT regarding the adoption of comprehensive, patient-centered, and system-based CCMs.
This study provides a comprehensive synthesis of current knowledge on explanatory models and instruments assessing OR for KT. Moreover, this project aims to create more consensus on the theoretical underpinnings and the instrumentation of OR for KT in chronic care. The final product--a comprehensive and valid OR for KT instrument--will provide the chronic care settings with an instrument to assess their readiness to implement evidence-based chronic care.
This paper provides a “viewpoint discussion”
based on a presentation made to the 2000 Symposium of the American College of
Medical Informatics. It discusses potential opportunities for researchers in
health informatics to become involved in the rapidly growing field of
bioinformatics, using the activities of the Yale Center for Medical
Informatics as a case study. One set of opportunities occurs where
bioinformatics research itself intersects with the clinical world. Examples
include the correlations between individual genetic variation with clinical
risk factors, disease presentation, and differential response to treatment;
and the implications of including genetic test results in the patient record,
which raises clinical decision support issues as well as legal and ethical
issues. A second set of opportunities occurs where bioinformatics research can
benefit from the technologic expertise and approaches that informaticians have
used extensively in the clinical arena. Examples include database organization
and knowledge representation, data mining, and modeling and simulation.
Microarray technology is discussed as a specific potential area for
collaboration. Related questions concern how best to establish collaborations
with bioscientists so that the interests and needs of both sets of researchers
can be met in a synergistic fashion, and the most appropriate home for
bioinformatics in an academic medical center.
Since 2003, the United States National Institutes of Health (NIH) has sought to restructure the clinical research enterprise in the United States by promoting collaborative research partnerships between academically-based investigators and community-based physicians. By increasing community-based provider participation in research (CBPPR), the NIH seeks to advance the science of discovery by conducting research in clinical settings where most people get their care, and accelerate the translation of research results into everyday clinical practice. Although CBPPR is seen as a promising strategy for promoting the use of evidence-based clinical services in community practice settings, few empirical studies have examined the organizational factors that facilitate or hinder the implementation of CBPPR. The purpose of this study is to explore the organizational start-up and early implementation of CBPPR in community-based practice.
We used longitudinal, case study research methods and an organizational model of innovation implementation to theoretically guide our study. Our sample consisted of three community practice settings that recently joined the National Cancer Institute’s (NCI) Community Clinical Oncology Program (CCOP) in the United States. Data were gathered through site visits, telephone interviews, and archival documents from January 2008 to May 2011.
The organizational model for innovation implementation was useful in identifying and investigating the organizational factors influencing start-up and early implementation of CBPPR in CCOP organizations. In general, the three CCOP organizations varied in the extent to which they achieved consistency in CBPPR over time and across physicians. All three CCOP organizations demonstrated mixed levels of organizational readiness for change. Hospital management support and resource availability were limited across CCOP organizations early on, although they improved in one CCOP organization. As a result of weak IPPs, all three CCOPs created a weak implementation climate. Patient accrual became concentrated over time among those groups of physicians for whom CBPPR exhibited a strong innovation-values fit. Several external factors influenced innovation use, complicating and enriching our intra-organizational model of innovation implementation.
Our results contribute to the limited body of research on the implementation of CBPPR. They inform policy discussions about increasing and sustaining community clinician involvement in clinical research and expand on theory about organizational determinants of implementation effectiveness.
Implementation; Academic-community research partnerships; Cancer clinical trials
Clinical informatics intervention research suffers from a lack of attention to external validity in study design, implementation, evaluation, and reporting. This hampers the ability of others to assess the fit of a clinical informatics intervention with demonstrated efficacy in one setting for implementation in their setting. The objective of this model formulation paper is to demonstrate the applicability of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework with proposed extensions to clinical informatics intervention research and describe the framework's role in facilitating the translation of evidence into practice and generation of evidence from practice. Both aspects are essential to reap the clinical and public health benefits of clinical informatics research.
We expanded RE-AIM through the addition of assessment questions relevant to clinical informatics intervention research including those related to predisposing, enabling, and reinforcing factors and validated it with two case studies.
The first case study supported the applicability of RE-AIM to inform real world implementation of a clinical informatics intervention with demonstrated efficacy in randomized controlled trials (RCTs) - the Choice (Creating better Health Outcomes by Improving Communication about Patients' Experiences) intervention. The second, an RCT of a personal digital assistant–based decision support system for guideline-based care, illustrated how RE-AIM can be used to inform the design of an efficacy RCT that captures essential contextual details typically lacking in RCT design and reporting.
The case studies validate, through example, the applicability of RE-AIM to inform the design, implementation, evaluation, and reporting of clinical informatics intervention studies.
The desideratum of semantic interoperability has been intensively discussed in medical informatics circles in recent years. Originally, experts assumed that this issue could be sufficiently addressed by insisting simply on the application of shared clinical terminologies or clinical information models. However, the use of the term ‘ontology’ has been steadily increasing more recently. We discuss criteria for distinguishing clinical ontologies from clinical terminologies and information models. Then, we briefly present the role clinical ontologies play in two multicentric research projects. Finally, we discuss the interactions between these different kinds of knowledge representation artifacts and the stakeholders involved in developing interoperational real-world clinical applications. We provide ontology engineering examples from two EU-funded projects.
Clinical Ontologies; Formal Ontologies; Knowledge Representation