Anticipating and addressing the unintended consequences of health IT and policy: a report from the AMIA 2009 Health Policy Meeting

Federal legislation (Health Information Technology for Economic and Clinical Health (HITECH) Act) has provided funds to support an unprecedented increase in health information technology (HIT) adoption for healthcare provider organizations and professionals throughout the U.S. While recognizing the promise that widespread HIT adoption and meaningful use can bring to efforts to improve the quality, safety, and efficiency of healthcare, the American Medical Informatics Association devoted its 2009 Annual Health Policy Meeting to consideration of unanticipated consequences that could result with the increased implementation of HIT. Conference participants focused on possible unintended and unanticipated, as well as undesirable, consequences of HIT implementation. They employed an input–output model to guide discussion on occurrence of these consequences in four domains: technical, human/cognitive, organizational, and fiscal/policy and regulation. The authors outline the conference''s recommendations: (1) an enhanced research agenda to guide study into the causes, manifestations, and mitigation of unintended consequences resulting from HIT implementations; (2) creation of a framework to promote sharing of HIT implementation experiences and the development of best practices that minimize unintended consequences; and (3) recognition of the key role of the Federal Government in providing leadership and oversight in analyzing the effects of HIT-related implementations and policies.     

Health information technology: fallacies and sober realities

Current research suggests that the rate of adoption of health information technology (HIT) is low, and that HIT may not have the touted beneficial effects on quality of care or costs. The twin issues of the failure of HIT adoption and of HIT efficacy stem primarily from a series of fallacies about HIT. We discuss 12 HIT fallacies and their implications for design and implementation. These fallacies must be understood and addressed for HIT to yield better results. Foundational cognitive and human factors engineering research and development are essential to better inform HIT development, deployment, and use.     

Clinical decision support: progress and opportunities

In 2005, the American Medical Informatics Association undertook a set of activities relating to clinical decision support (CDS), with support from the office of the national coordinator and the Agency for Healthcare Research and Quality. They culminated in the release of the roadmap for national action on CDS in 2006. This article assesses progress toward the short-term goals within the roadmap, and recommends activities to continue to improve CDS adoption throughout the United States. The report finds that considerable progress has been made in the past four years, although significant work remains. Healthcare quality organizations are increasingly recognizing the role of health information technology in improving care, multi-site CDS demonstration projects are under way, and there are growing incentives for adoption. Specific recommendations include: (1) designating a national entity to coordinate CDS work and collaboration; (2) developing approaches to monitor and track CDS adoption and use; (3) defining and funding a CDS research agenda; and (4) updating the CDS ‘critical path’.The quality and safety of medical care in the United States have drawn increased attention in the past decade. Studies suggest many errors could be avoided with the use of health information and communications technology (HIT).^{i 1–4} Such improvements have been facilitated by the adoption of computerized provider order entry systems, electronic medical records that improve accessibility to clinical data, and a variety of approaches loosely grouped together and referred to as clinical decision support (CDS) systems. To foster better health processes, better individual patient care, and better population health, CDS systems intelligently provide, at appropriate times, knowledge or information (person-specific or population-specific). Clinicians, patients and individuals thus benefit from CDS.⁵ Clinical decision support interventions may include alerting and reminder systems, dosing calculators, and order sets and tools that provide access to medical knowledge at the point of care. Evidence suggests that computerization of medical record systems and even implementation of provider order entry systems may not be sufficient to ensure high quality care.⁶ Rather, CDS represents the effecter arm for clinical process improvement,^2–4 provided that it is effectively utilized and implemented with careful consideration of clinical workflow.In the summer of 2005, the Office of the National Coordinator for Health Information Technology (ONC), along with the Agency for Healthcare Research and Quality (AHRQ) asked the American Medical Informatics Association (AMIA) to develop a plan to guide federal and private sector activities to advance CDS. In response, AMIA established the CDS roadmap development steering committee to lead this effort. A set of meetings and consensus panels led to the production of the roadmap for national action on CDS (the ‘CDS roadmap’) in 2006.⁵ This report recommended activities to facilitate CDS development, implementation and use throughout the United States to improve the quality, safety and efficiency of healthcare. The roadmap included a critical path that recommended activities in the three-year timeframe following the report''s publication.Since then, significant effort by numerous stakeholders, including federal agencies, quality organizations, informatics groups, healthcare systems and individual researchers have devoted effort to CDS. To assess national progress in CDS, we conducted an environmental scan, reviewing published literature, white papers, reports by multiple stakeholders and recent legislation. Using the critical path activities as a framework, our report presents a synthesis of progress to date. We discuss future directions and recommend specific next steps, taking into consideration trends in clinical computing and increased availability of funds to support HIT as part of the recent US federal stimulus package.     

Understanding the acceptability of a computer decision support system in pediatric primary care

Objective

Individual users’ attitudes and opinions help predict successful adoption of health information technology (HIT) into practice; however, little is known about pediatric users’ acceptance of HIT for medical decision-making at the point of care.

Materials and methods

We wished to examine the attitudes and opinions of pediatric users’ toward the Child Health Improvement through Computer Automation (CHICA) system, a computer decision support system linked to an electronic health record in four community pediatric clinics. Surveys were administered in 2011 and 2012 to all users to measure CHICA''s acceptability and users’ satisfaction with it. Free text comments were analyzed for themes to understand areas of potential technical refinement.

Results

70 participants completed the survey in 2011 (100% response rate) and 64 of 66 (97% response rate) in 2012. Initially, satisfaction with CHICA was mixed. In general, users felt the system held promise; however various critiques reflected difficulties understanding integrated technical aspects of how CHICA worked, as well as concern with the format and wording on generated forms for families and users. In the subsequent year, users’ ratings reflected improved satisfaction and acceptance. Comments also reflected a deeper understanding of the system''s logic, often accompanied by suggestions on potential refinements to make CHICA more useful at the point of care.

Conclusions

Pediatric users appreciate the system''s automation and enhancements that allow relevant and meaningful clinical data to be accessible at point of care. Understanding users’ acceptability and satisfaction is critical for ongoing refinement of HIT to ensure successful adoption into practice.     

HIT Implementation in Critical Access Hospitals: Extent of Implementation and Business Strategies Supporting IT Use

Small rural hospitals face considerable financial and personnel resource shortages which hinder their efforts to implement complex health information technology (HIT) systems. A survey on the use of HIT was completed by 85% of Iowa’s 82 Critical Access Hospitals (CAH). Analyses indicate that low IT staffing in CAHs is a barrier to implementing HIT solutions. CAHs with fewer staff tend to employ alternative business strategies. There is a clear relationship between having IT staff at a CAH and the types of technologies used. Many CAHs report having difficulty expanding upon HIT functionalities due to the challenges of finding IT staff with healthcare expertise. Most CAHs are in the transition point of planning for or beginning implementation of complex clinical information systems. Strategies for addressing these challenges will need to evolve as the HIT investments by rural hospitals race to keep pace with the goals for the nation.     

Experience in implementing inpatient clinical note capture via a provider order entry system

Care providers' adoption of computer-based health-related documentation (“note capture”) tools has been limited, even though such tools have the potential to facilitate information gathering and to promote efficiency of clinical charting. The authors have developed and deployed a computerized note-capture tool that has been made available to end users through a care provider order entry (CPOE) system already in wide use at Vanderbilt. Overall note-capture tool usage between January 1, 1999, and December 31, 2001, increased substantially, both in the number of users and in their frequency of use. This case report is provided as an example of how an existing care provider order entry environment can facilitate clinical end-user adoption of a computer-assisted documentation tool—a concept that may seem counterintuitive to some.     

Crossing the Evidence Chasm: Building Evidence Bridges from Process Changes to Clinical Outcomes

Objective

Although demand for information about the effectiveness and efficiency of health care information technology grows, large-scale resource-intensive randomized controlled trials of health care information technology remain impractical. New methods are needed to translate more commonly available clinical process measures into potential impact on clinical outcomes.

Design

The authors propose a method for building mathematical models based on published evidence that provides an evidence bridge between process changes and resulting clinical outcomes. This method combines tools from systematic review, influence diagramming, and health care simulations.

Measurements

The authors apply this method to create an evidence bridge between retinopathy screening rates and incidence of blindness in diabetic patients.

Results

The resulting model uses changes in eye examination rates and other evidence-based population parameters to generate clinical outcomes and costs in a Markov model.

Conclusion

This method may serve as an alternative to more expensive study designs and provide useful estimates of the impact of health care information technology on clinical outcomes through changes in clinical process measures.The announcement ¹ and reaffirmation ² of the federal commitment to advancing health care information technology (HIT) has been further bolstered by events in the Gulf South after the recent hurricane seasons. ³ This commitment creates both opportunities and challenges for health services and clinical informatics researchers. Clinicians, policy makers, lobbyists, economists, and the media demand evidence-based recommendations for HIT. To make decisions that will affect millions of lives and billions of dollars, decision makers require more than efficacy studies—they require results that indicate both the effectiveness and the efficiency of HIT solutions. The ability of the informatics research community to respond to this need with useful and credible evidence will determine our relevance to the debate.Many evaluations of health services focus primarily on process measures. ⁴ For example, there are numerous studies in the disease management literature that report the impact of technology on the rate of annual eye or foot examinations for diabetic patients. ^5–14 However, there are few published studies that evaluate HIT’s impact on the rate of blindness or amputations. Despite the increasing demand for credible clinical outcomes evidence, many studies in HIT lack the power to detect changes in clinical outcomes, a product of limited time and resources. ¹⁵ In addition, the rapid evolution of new technologies makes the study subject itself, HIT, a moving target. By the time a large-scale trial is completed, the state of the art will have moved on. ¹⁶ Evaluations in HIT therefore tend to be relatively brief studies comparing convenient measures, more often made in a laboratory environment, or potentially idiosyncratic academic environments, than in real-world clinical settings, thus limiting generalizability. These studies would be classified by Fuchs and Garber ¹⁷ as stage 1 and 2 technology assessments—evaluating the performance of the technology itself and perhaps the impact of the technology on processes of care. However, the demand for outcomes evidence mandates that future HIT research be at the level of stage 3 technology assessments, in which comprehensive clinical, economic, and social outcomes are evaluated to determine both the effectiveness and efficiency of the intervention. The importance of linking process measures to clinical outcomes has been previously described, but progress has been limited. ¹⁸ We propose an approach to maximize the ability of HIT evaluation research to report clinical and financial outcomes.     

HITECH to 21st century cures: clinician burden and evolving health IT policy

Adoption and use of health information technology (IT) was identified as 1 solution to quality and safety issues that permeate the United States health care system. Implementation of health IT has accelerated across the US over the past decade, in part, as a result of legislative and regulatory requirements and incentives. However, adoption of these systems has burdened clinician users due to design, configuration, and implementation issues, resulting in poor usability, challenges to workflow integration, and cumbersome documentation requirements. The path to alleviating these clinician burdens requires a clear understanding of the intent and evolution of pertinent regulations and the context in which they exist. This article reviews the Office of the National Coordinator of Health Information Technology’s efforts, documents current regulatory actions, and discusses additional policy opportunities that can further improve clinician satisfaction and effectiveness in providing health care with health IT that is an asset, not an obstacle.     

Informatics,evidence-based care,and research; implications for national policy: a report of an American Medical Informatics Association health policy conference

There is an increased level of activity in the biomedical and health informatics world (e-prescribing, electronic health records, personal health records) that, in the near future, will yield a wealth of available data that we can exploit meaningfully to strengthen knowledge building and evidence creation, and ultimately improve clinical and preventive care. The American Medical Informatics Association (AMIA) 2008 Health Policy Conference was convened to focus and propel discussions about informatics-enabled evidence-based care, clinical research, and knowledge management. Conference participants explored the potential of informatics tools and technologies to improve the evidence base on which providers and patients can draw to diagnose and treat health problems. The paper presents a model of an evidence continuum that is dynamic, collaborative, and powered by health informatics technologies. The conference''s findings are described, and recommendations on terminology harmonization, facilitation of the evidence continuum in a “wired” world, development and dissemination of clinical practice guidelines and other knowledge support strategies, and the role of diverse stakeholders in the generation and adoption of evidence are presented.     

Leveraging health information technology to achieve the “triple aim” of healthcare reform

Objective To investigate experiences with leveraging health information technology (HIT) to improve patient care and population health, and reduce healthcare expenditures.Materials and methods In-depth qualitative interviews with federal government employees, health policy, HIT and medico-legal experts, health providers, physicians, purchasers, payers, patient advocates, and vendors from across the United States.Results The authors undertook 47 interviews. There was a widely shared belief that Health Information Technology for Economic and Clinical Health (HITECH) had catalyzed the creation of a digital infrastructure, which was being used in innovative ways to improve quality of care and curtail costs. There were however major concerns about the poor usability of electronic health records (EHRs), their limited ability to support multi-disciplinary care, and major difficulties with health information exchange, which undermined efforts to deliver integrated patient-centered care. Proposed strategies for enhancing the benefits of HIT included federal stimulation of competition by mandating vendors to open-up their application program interfaces, incenting development of low-cost consumer informatics tools, and promoting Congressional review of the The Health Insurance Portability and Accountability Act (HIPPA) to optimize the balance between data privacy and reuse. Many underscored the need to “kick the legs from underneath the fee-for-service model” and replace it with a data-driven reimbursement system that rewards high quality care.Conclusions The HITECH Act has stimulated unprecedented, multi-stakeholder interest in HIT. Early experiences indicate that the resulting digital infrastructure is being used to improve quality of care and curtail costs. Reform efforts are however severely limited by problems with usability, limited interoperability and the persistence of the fee-for-service paradigm—addressing these issues therefore needs to be the federal government’s main policy target.     

Mediation of adoption and use: a key strategy for mitigating unintended consequences of health IT implementation

Objective

Without careful attention to the work of users, implementation of health IT can produce new risks and inefficiencies in care. This paper uses the technology use mediation framework to examine the work of a group of nurses who serve as mediators of the adoption and use of a barcode medication administration (BCMA) system in an inpatient setting.

Materials and methods

The study uses ethnographic methods to explore the mediators'' work. Data included field notes from observations, documents, and email communications. This variety of sources enabled triangulation of findings between activities observed, discussed in meetings, and reported in emails.

Results

Mediation work integrated the BCMA tool with nursing practice, anticipating and solving implementation problems. Three themes of mediation work include: resolving challenges related to coordination, integrating the physical aspects of BCMA into everyday practice, and advocacy work.

Discussion

Previous work suggests the following factors impact mediation effectiveness: proximity to the context of use, understanding of users'' practices and norms, credibility with users, and knowledge of the technology and users'' technical abilities. We describe three additional factors observed in this case: ‘influence on system developers,’ ‘influence on institutional authorities,’ and ‘understanding the network of organizational relationships that shape the users'' work.’

Conclusion

Institutionally supported clinicians who facilitate adoption and use of health IT systems can improve the safety and effectiveness of implementation through the management of unintended consequences. Additional research on technology use mediation can advance the science of implementation by providing decision-makers with theoretically durable, empirically grounded evidence for designing implementations.     

The Effects of Creating Psychological Ownership on Physicians' Acceptance of Clinical Information Systems

ObjectiveMotivated by the need to push further our understanding of physicians' acceptance of clinical information systems, we propose a relatively new construct, namely, psychological ownership. We situated the construct within a nomological net using a prevailing and dominant information technology adoption behavior model as a logical starting point.DesignA mail survey was sent to the population of users of a regional physician order entry (POE) system aimed at speeding up the transmission of clinical data, mainly laboratory tests and radiology examinations, within a community health network.MeasurementsAll scales, but one, were measured using previously validated instruments. For its part, the psychological ownership scale was developed using a multistage iterative procedure.ResultsNinety-one questionnaires were returned to the researchers, for a response rate of 72.8%. Our findings reveal that, in order to foster physicians' adoption of a clinical information system, it is important to encourage and cultivate a positive attitude toward using the new system. In this connection, positive perception of the technology's usefulness is crucial. Second, results demonstrate that psychological ownership of a POE system is positively associated with physicians' perceptions of system utility and system user friendliness. Last, through their active involvement and participation, physicians feel they have greater influence on the development process, thereby developing feelings of ownership toward the clinical system.ConclusionPsychological ownership's highly significant associations with user participation and crucial beliefs driving technology acceptance behaviors among physicians affirm the value of this construct in extending our understanding of POE adoption.     

Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force

The current commercial health information technology (HIT) arena encompasses a number of competing firms that provide electronic health applications to hospitals, clinical practices, and other healthcare-related entities. Such applications collect, store, and analyze patient information. Some vendors incorporate contract language whereby purchasers of HIT systems, such as hospitals and clinics, must indemnify vendors for malpractice or personal injury claims, even if those events are not caused or fostered by the purchasers. Some vendors require contract clauses that force HIT system purchasers to adopt vendor-defined policies that prevent the disclosure of errors, bugs, design flaws, and other HIT-software-related hazards. To address this issue, the AMIA Board of Directors appointed a Task Force to provide an analysis and insights. Task Force findings and recommendations include: patient safety should trump all other values; corporate concerns about liability and intellectual property ownership may be valid but should not over-ride all other considerations; transparency and a commitment to patient safety should govern vendor contracts; institutions are duty-bound to provide ethics education to purchasers and users, and should commit publicly to standards of corporate conduct; and vendors, system purchasers, and users should encourage and assist in each others'' efforts to adopt best practices. Finally, the HIT community should re-examine whether and how regulation of electronic health applications could foster improved care, public health, and patient safety.     

The impact of the heparin-induced thrombocytopenia (HIT) computerized alert on provider behaviors and patient outcomes

Objective

The aim of this study was to measure the effect of an electronic heparin-induced thrombocytopenia (HIT) alert on provider ordering behaviors and on patient outcomes.

Materials and Methods

A pop-up alert was created for providers when an individual''s platelet values had decreased by 50% or to <100 000/mm³ in the setting of recent heparin exposure. The authors retrospectively compared inpatients admitted between January 24, 2008 and August 24, 2008 to a control group admitted 1 year prior to the HIT alert. The primary outcome was a change in HIT antibody testing. Secondary outcomes included an assessment of incidence of HIT antibody positivity, percentage of patients started on a direct thrombin inhibitor (DTI), length of stay and overall mortality.

Results

There were 1006 and 1081 patients in the control and intervention groups, respectively. There was a 33% relative increase in HIT antibody test orders (p=0.01), and 33% more of these tests were ordered the first day after the criteria were met when a pop-up alert was given (p=0.03). Heparin was discontinued in 25% more patients in the alerted group (p=0.01), and more direct thrombin inhibitors were ordered for them (p=0.03). The number who tested HIT antibody-positive did not differ, however, between the two groups (p=0.99). The length of stay and mortality were similar in both groups.

Conclusions

The HIT alert significantly impacted provider behaviors. However, the alert did not result in more cases of HIT being detected or an improvement in overall mortality. Our findings do not support implementation of a computerized HIT alert.     

Risk prediction for chronic kidney disease progression using heterogeneous electronic health record data and time series analysis

Background As adoption of electronic health records continues to increase, there is an opportunity to incorporate clinical documentation as well as laboratory values and demographics into risk prediction modeling.Objective The authors develop a risk prediction model for chronic kidney disease (CKD) progression from stage III to stage IV that includes longitudinal data and features drawn from clinical documentation.Methods The study cohort consisted of 2908 primary-care clinic patients who had at least three visits prior to January 1, 2013 and developed CKD stage III during their documented history. Development and validation cohorts were randomly selected from this cohort and the study datasets included longitudinal inpatient and outpatient data from these populations. Time series analysis (Kalman filter) and survival analysis (Cox proportional hazards) were combined to produce a range of risk models. These models were evaluated using concordance, a discriminatory statistic.Results A risk model incorporating longitudinal data on clinical documentation and laboratory test results (concordance 0.849) predicts progression from state III CKD to stage IV CKD more accurately when compared to a similar model without laboratory test results (concordance 0.733, P<.001), a model that only considers the most recent laboratory test results (concordance 0.819, P < .031) and a model based on estimated glomerular filtration rate (concordance 0.779, P < .001).Conclusions A risk prediction model that takes longitudinal laboratory test results and clinical documentation into consideration can predict CKD progression from stage III to stage IV more accurately than three models that do not take all of these variables into consideration.     

Implementation of a Patient Charting System: Challenges Encountered and Tactics Adopted in a Burn Center

The rapid movement of information technologies into health care organizations has raised managerial concern regarding the capability of today's institutions to satisfactorily manage their introduction. Indeed, several health care institutions have consumed huge amounts of money and frustrated countless people in wasted information systems implementation efforts. Unfortunately, there are no easy answers as to why so many health informatics projects are not more successful. In this light, the aim of this study is to provide a deeper understanding of how clinical information systems are being implemented by emphasizing research efforts on the dynamic nature of the process, that is, the “how” and “why” of what happened. Using a case study methodology, we examined the implementation of a patient charting system in the Burn Center of a large, not-for-profit, teaching hospital. Based on an in-depth examination of this implementation, several insights are offered to those who have responsibility for managing complex and risky clinical information system implementation projects.     

A network collaboration implementing technology to improve medication dispensing and administration in critical access hospitals

We report how seven independent critical access hospitals collaborated with a rural referral hospital to standardize workflow policies and procedures while jointly implementing the same health information technologies (HITs) to enhance medication care processes. The study hospitals implemented the same electronic health record, computerized provider order entry, pharmacy information systems, automated dispensing cabinets (ADC), and barcode medication administration systems. We conducted interviews and examined project documents to explore factors underlying the successful implementation of ADC and barcode medication administration across the network hospitals. These included a shared culture of collaboration; strategic sequencing of HIT component implementation; interface among HIT components; strategic placement of ADCs; disciplined use and sharing of workflow analyses linked with HIT applications; planning for workflow efficiencies; acquisition of adequate supply of HIT-related devices; and establishing metrics to monitor HIT use and outcomes.     

Data from clinical notes: a perspective on the tension between structure and flexible documentation

Clinical documentation is central to patient care. The success of electronic health record system adoption may depend on how well such systems support clinical documentation. A major goal of integrating clinical documentation into electronic heath record systems is to generate reusable data. As a result, there has been an emphasis on deploying computer-based documentation systems that prioritize direct structured documentation. Research has demonstrated that healthcare providers value different factors when writing clinical notes, such as narrative expressivity, amenability to the existing workflow, and usability. The authors explore the tension between expressivity and structured clinical documentation, review methods for obtaining reusable data from clinical notes, and recommend that healthcare providers be able to choose how to document patient care based on workflow and note content needs. When reusable data are needed from notes, providers can use structured documentation or rely on post-hoc text processing to produce structured data, as appropriate.