PHC Workgroup, 10/25/2007 DRAFT

Clinical Decision Support for Personalized Health Care

This document serves as a general summary of the Personalized Health Care (PHC) Workgroup’s September 17, 2007 meeting1 to discuss the issue of Clinical Decision Support (CDS). It identifies potential actions items and is intended as an overview, not as a technical document, to guide subsequent discussions about CDS. When the American Health Information Community (AHIC) first convened the PHC Workgroup in October of 2006, the Workgroup was charged not only with facilitating the incorporation of genetic information in the Electronic Health Record (EHR), but also with the deployment of analytical tools to support the use of this information. The September 17, 2007 meeting was the first step in responding to this charge and highlights the recognition that standards and interoperability should be important considerations in the business planning and development of CDS tools. The overarching principle is to improve the consumer’s health experience by taking into account the consumer’s personal preferences, evidence-based information on health interventions, and effective deployment of new genetic technologies, such as diagnostic and screening tests.

BACKGROUND

As rapid advances are occurring in the understanding of the interactions of genes and environmental factors that contribute mechanistically with disease and disease predisposition, the overall benefit of these new discoveries to consumers depends on their effective use in health care. With the accelerating pace of scientific discovery and development of new medical products based on genetic technologies, the time to integrate evidence for best practices in health care management has increased in parallel. Most formal medical and allied health education typically provides minimal training in applications of this new information, leaving many clinicians unable to understand or interpret genetic tests and information. This is compounded by the clinician’s inability to acquire this knowledge because of the current constraints and demands of clinical practice. In looking to the future and considering individualized approaches to managing health, a major challenge continues to be the effective evaluation of options for evidenced based-decisions. Although not unique to the realm of personalized health care practices, the increased complexity presented through the applications of genetic-based tests, coupled with predictive risk assessments provided by family and health history information, exemplifies the need for services, tools, and technologies to assist in consumer-clinician interactions. To address these emerging needs, CDS tools could become an important asset of the health information framework in clinical care in the future.

In order for health care to be truly personalized, the preferences of the consumer must be a key component of many health care decisions. Presentations by representatives of Geisinger Health System2 at the September 17 meeting highlighted the importance of the consumer’s preferences. This organization demonstrated that engaging the patient in their health, through reminders, report cards, educational materials, and goal setting, improves health outcomes. For example in the chronic care setting, the patient is the key caregiver, and is responsible for many of the decision-making processes. Therefore, supporting their needs and meeting their preference should always be a primary concern when discussing the design and deployment of CDS systems.

From a clinician’s viewpoint, an increasing amount of medical information must be gathered, interpreted, processed, and applied to maintain the most up-to-date best practice guidelines. For example, the clinician is expected to possess current working knowledge of thousands of potential adverse drug-drug interactions and know where to seek information about them. Additionally, pharmacogenomics3 is taking an increasingly important role in avoiding adverse events, determining the appropriate drug dose, and treatment selection. CDS tools have the potential to aid the clinician by integrating patient data, providing options for care, and improving workflow.

CDS is conceptualized as providing clinicians, staff, consumer, and other individuals with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care. It encompasses a variety of tools and interventions such as computerized alerts and reminders, clinical guidelines, order sets, patient data reports and dashboards, documentation templates, diagnostic support, and clinical workflow tools.4 Although not widely deployed in health care currently, CDS tools may support a variety of processes to improve health care quality by enabling more informed decisions. CDS resources may also increase clinicians’ effectiveness by augmenting their ability to use a greater array of information for improving the quality of care, avoid adverse events, provide actionable guidelines, and integrate newly discovered information into clinical practice. Designed as an electronic tool, many envision CDS resources augmenting the applications of EHRs. Existing CDS tools already play a role in PHC practices; however, these tools are currently not connected with EHRs, therefore limiting their utility. Examples include warfarin dosing tools 5, breast cancer risk assessment tools6, and the My Family Health Portrait 7 tool for recording family health history. While there is a substantial need for CDS to support widespread clinical use of genetic/genomic and family health history information, overarching CDS principles should be examined as there may not be major differences when considering genetic information relative to other applications of CDS tools. The PHC Workgroup should, therefore, integrate its CDS activities with other AHIC Workgroups’ activities so specific recommendations may not come solely from the PHC Workgroup.

PHC WORKGROUP ISSUES FOR FURTHER CONSIDERATION

In keeping with the mainstay of AHIC-based recommendations around interoperability and standards development, there are several issues that the Workgroup may wish to consider in more detail: clinician support, patient engagement and consumer empowerment, design of logical workflow, standard to support CDS, and possible pilot projects. Two considerations for the Department of Health and Human Services (HHS) are also included.

Clinician Support

With respect to PHC, CDS is most useful to a clinician when providing an interpretation of complex information at the appropriate time. The dosing of warfarin is a prime example. In an ideal scenario, when a clinician writes a prescription for warfarin he/she would be prompted to first order the test to determine the patient’s genetically determined drug-metabolism rate. The genetic test should preclude the dosing decision as it provides additional help in assessing the appropriate dose of warfarin. This is in contrast to the traditional means (trial and error) clinicians used in the past to establish the appropriate dose of warfarin. Avoiding adverse drug-drug interactions is another example of how CDS, when timed properly, can enhance a clinician’s ability to care for the patient. Upon writing a new prescription, the clinician could receive a notification that there might be an adverse reaction to other medicines the patient is taking, or even adverse reactions based on preexisting genetic testing data. This example illustrates that there are characteristics that suggest interdependencies of PHC and CDS and in some contexts makes them nearly synonymous.

Patient Engagement and Consumer Empowerment

Previous discussions of augmenting EHRs with CDS tools have focused exclusively on clinician use, but it is important to include consumer use of the tools. Consumer preferences for health services and methods for improving health literacy should be considered when CDS tools are developed. A shared decision-making model where patients provide better information at their level of understanding is powerful when the patient can influence treatments based on his/her own value system, especially in the context of preventive services. By engaging the consumer, some of the health care decision-making could become a shared responsibility with the clinician. The dynamics involved in patient engagement, through providing information when sought by the patient, explaining interventions to improve compliance, and incorporating patient preferences to improve uptake of preventative options, should be considered as well. When examining the example of diabetes management, increased patient control and compliance can be achieved by bundling specific testing services with patient reminders to improve the quality of decision-making. Likewise, it has been shown that individuals with a known elevated risk for colorectal cancer (CRC) are more willing to be screened. In general, rates for CRC screening in the population are low and many feel thatraising the overall uptake of CRC screening would have a major public health benefit. There is data to support that patients with increased risk of CRC (either by family history or genetic test) are more compliant with CRC screening recommendations. A CDS tool encompassing family history data could be designed to identify and advise those with increased risk, and to deliver general screening recommendations for those at average risk at the point of care. Both of these examples illustrate a possible point of intersection with the Consumer Empowerment Workgroup of the AHIC for shared decision-making and recommendations.

Design of Logical Workflow

If CDS is to be utilized by the clinician, health care providing system, and the consumer, these interventions need to fit logically in the natural workflow or thought flow of the individuals using the systems. Electronic health tools are increasingly becoming operational components of the modern health care experience. The transitions in health care are visible in the manner in which technology is commonly experienced by patients, as clinicians consult the internet for information during clinical interactions, use personal digital assistants (PDA) to access prescribing information, or view MRIs on computer screens. In order for consumers to be equal partners in the health care process, CDS tools should engage consumers rather than alienate them from the process. The Workgroup could consider what standards or best practice guidelines for workflow and display may be emerging through various standards development organizations. Through reaching a better understanding of why people chose to ignore or follow CDS suggested interventions, how to titrate the number of reminders to minimize ‘fatigue,’ how to present information in a consistent fashion to drive action, and how to build individual and organizational variations into widely deployable systems, best practices could emerge. Another important aspect of this is the human factors that are relevant to an individual’s ability to use represented information. This applies to the adaptability of human executive functions as they relate to formatting of computer displayed information, and the interactive aspects of engaging individuals with information exchange. In parallel, existing CDS systems should be examined to determine if they lead to improved outcomes or greater adherence to clinical guidelines, ascertain how existing CDS tools mightactually discourage users from taking that ‘next step’ to reach out to the literature, and examine what role clinicians and providers should play in the development and deployment of these systems.

Standard to Support CDS

Some consideration along the lines of the CDS roadmap include understanding the principles for sharing best practices guidelines, data exchange standards, guidelines for evidence development and common CDS tools, and establishing an updateable archive of this information. This process should be iterative, as the standards and evidence development process merits continual updating to remain current with changing technologies and science. Such a repository could avoid duplication of costly research efforts, enhance interoperability, and improve content exchange. In order to accomplish this, we need a better understanding of how to share common services in a repeatable, downloadable, and usable form. This could include examining working examples where multiple organizations have shared similar types of information, to demonstrate that a national repository would maximize output from current efforts and has the potential for success. A potential role for AHIC is to evaluate the infrastructure needs, governance, and analytical and administrative frameworks to establish such a resource.

Possible Pilot Projects

Pilot projects in PHC scenarios could focus on demonstrating how 'evidence based, just in time' CDS information can be delivered via the EHR at the point of care between patient and doctor. CDS should inform the encounter to achieve better quality and outcomes, both for disease management as well as preventive services. While the interactions of CDS and PHC are too new to envision development of best practices, efforts should be made to evaluate effectiveness. These should also demonstrate that effective execution of CDS tools results in improved care through examining whetherCDS drives appropriate use and positive changes in decision processes at the patient, provider, or system level. With regard to recommendations and use case development, primary care/ambulatory care scenarios were thought to be more highly valued as an area of need and guidance than institutional-based focus. Possible pilot project could include: the use of CDS to support family health history-based risk assessment in primary care; use of a Personal Health Record (PHR) to augment patient-provider interactions through uptake of CRC screening or other prevalent disease process; offering concentrated, evidence-based data ‘packets’into rural or community settings where there is often less exposure to research; and support of clinical decision-making around newborn screening using the example of a metabolic disorder.

HHS CONSIDERATIONS

Several areas may be beyond the scope of the PHC Workgroup’s charge to examine the health information exchange and interoperability aspects of genetic information. These issues are worth further discussions within HHS, other AHIC Workgroups, and National and Secretarial Advisory Committees.

Incentives for Development and Use of CDS Tools

Given the nascent stage of CDS development, some ideas and opportunities for favoring adoption to enhance quality of care were raised. If these tools can improve quality of care, to enhance CDS adoption for users, both providers and consumers, financial or other incentives should be adopted by government, health plans, and employers, to encourage their use. This may include Medicare/Medicaid pilot programs to look at potential applications of CDS tools. Incentives for EHR and software tools developers to incorporate CDS into their applications could also be addressed through FDA or small business programs. The case study on warfarin demonstrated the utility of the test and its applications in clinical practice, and could serve as a model. Significant challenges demonstrated in this case study showed the importance of workflow considerations, multi-organizational collaboration, and evidence development as a continuum in monitoring clinical practice behavior. Payers, researchers, and health care providers could share recommendations and best practices in interoperable formats to facilitate integration in vendor-based CDS systems or tools. To achieve this, these organizations may need to establish standards for how content is evaluated for accuracy and applicability through clinical advisory boards and evidence-based credibility measures.

Oversight of CDS Applications in Clinical Practice

CDS necessitates a rapid cycle, iterative process of modifications and continuous updates for improvements in care. As CDS tools connect diverse aspects of health care and overlap with various health care processes, they may intersect with a variety of regulatory and oversight organizations. Further clarity from these organizations may be needed to incent the development and deployment of CDS tools and systems.

SUMMARY AND FUTURE DIRECTIONS

A National Roadmap for CDS was published in 2006 detailing three key pillars to enhance health and health care through CDS.4 Future discussion regarding the relationship of CDS to PHC should be viewed in the context of these pillars. First, the best knowledge needs to be supplied when needed. This speaks to appropriate engagement of the consumer and the clinician during health care decision-making, as well as developing the standards to share knowledge and technologies. Second, CDS tools need a high level of adoption and effective use to realize improvements in health. Effective use should be enhanced by logically designing CDS tools to fit into health care processes, while incentives for developing tools and regulatory clarity would also improve their widespread adoption of personalized approaches to patient management. Third, CDS tools and general health knowledge should be reviewed and updated. Pilot projects to demonstrate best practices for sharing evidence or CDS tools would allow for a better understanding of this iterative process.

CDS tools may represent a partial solution to the information overload and quality issues discussed above. In the purview of the use of EHRs to augment patient-centric care, particularly with the addition of family history and genetic laboratory test information, CDS resources have the potential to address the many complexities of medical decision-making. At this point in time, there is a lack of understanding about the feasibility of CDS use for improving the workflow of clinical practice. There is also a substantial need for an evaluation of the impact that these tools and the decisions that they support have on health outcomes.