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406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF A standards-based centralized clinical decision support system illustrated using decision support for Congestive Heart Failure A group project submitted by Nicole Hawkins, Ravi Narayanan and Alan Zunamon for completion of coursework for MMI-406 (Decision Support Systems and Health Care) on June 03, 2012 1 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF Table of Contents Introduction ................................................................................................................................2 Stakeholders, Goals and Objectives ...........................................................................................2 Stakeholders ...............................................................................................................................2 Project Goals & Objectives .......................................................................................................2 Identification of Appropriate Intervention and Workflow for CHF ..........................................2 Information Systems Architecture and Knowledge Management .............................................2 Conceptual Architecture ............................................................................................................2 Guideline Knowledge Management ...........................................................................................2 Decision Support Usage Data Aggregation and Analysis .........................................................2 Information System Inventory ....................................................................................................2 Information and Communication Technology Infrastructure ....................................................2 Intervention Specification ..........................................................................................................2 Workflow Design/Site-specific Customization .........................................................................2 Implementation and Change Management ................................................................................2 Plan and transition process .......................................................................................................2 Resource needs for testing, implementation, validation ............................................................2 Measurement of CDSS Effect on Clinical Practice ...................................................................2 Frequency of Evaluation and Communication of Results..........................................................2 Conclusion .................................................................................................................................2 References ..................................................................................................................................2 2 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF Introduction Congestive heart failure (CHF) is a relatively common condition that develops over time where the heart cannot pump enough blood or fill with enough blood to meet the body’s demands. Approximately 5.8 million people in the United States have heart failure, which can be caused by high blood pressure, coronary heart disease, diabetes, cardiomyopathy or congenital heart defects (National Heart Lung and Blood Institute, 2012). An estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year and the number of deaths in the United States from this condition has more than doubled since 1979, averaging 250,000 annually (Heart Failure Society of America, n.d.). Furthermore, heart failure is more common in people 65 years of age and older, African Americans, individuals who are overweight, individuals who have had a heart attack, children with congenital heart defects and among men (National Heart Lung and Blood Institute, 2012). The outlook for patients diagnosed with heart failure is bleak: less than 50% of patients are living five years after their initial diagnosis and less than 25% are living 10 years after diagnosis (Heart Failure Society of America, n.d.). In 2009, there were 3,041,000 physician office visits with a primary diagnosis of CHF, 668,000 emergency department visits and 293,000 outpatient department visits for CHF (American Heart Association, 2012). In 2010, CHF cost the United States $39.2 billion in healthcare services, lost productivity and medications (Centers for Disease Control and Prevention, 2010). Projected total costs for healthcare related to CHF are expected to increase from $44.6 billion in 2015 to $97 billion in 2030 (American Heart Association, 2012). The adverse impact of CHF on patients, their families, and the costs associated with CHF-related healthcare can possibly be minimized via utilization of a clinical decision support system (CDSS) intervention. An intervention can provide current and relevant information at the point of care to support provider decision making to optimize treatment for CHF patients. While this paper will focus on the decision support of CHF condition, the CDSS solution itself is intended to support the decision support needs for multiple clinical conditions encounted by the provider organizations. The providers can use this decision support intervention to make adjustments in care management plans that will improve health outcomes for CHF patients. In addition, scenarios for usage of the CDSS intervention, the guideline to be used in the proposed CDSS intervention, the CDSS system architecture, potential benefits and challenges, the guideline integration process, and measurement of the CDSS impact on clinical practice will also be addressed in this paper. Stakeholders, Goals and Objectives Stakeholders The centralized knowledge management module of the CDSS described in this paper stores clinical CHF guidelines that can be utilized by providers in a large hospital healthcare system, such as emergency room physicians, nurses, internists and primary care physicians. Community based clinics, private cardiology practice groups, and integrated managed care organizations may also benefit from the CHF information contained in the CDSS. The proposed CDSS will affect many stakeholders; the stakeholder title, role, high level goals and individual clinical objectives related to the care of heart failure patients are in Table 1: 3 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON Stakeholder Role in the Project High Level Goals CENTRAL CDSS FOR CHF Clinical Objectives Chief Quality Officer Proponent, general quality leader Chief Nursing Officer Proponent or detractor, Patient and nursing general quality leader education Improve patient understanding of diet and lifestyle modifications Chief Medical Information Officer Proponent, advisor Develop CDSS tools to regarding development improve outcomes, of CDSS address info needs Provide relevant clinical information at point of care Chief of Cardiology Proponent, subject matter expert, custodian of sitespecific changes to central guidelines Improve care quality, appropriate sources of clinical guidelines Improve performance of individual clinicians CHF Program Director Cardiology champion Promote quality care, Reduce admissions, adherence to guidelines improve symptoms Chief Hospitalist Detractor, concerned about increased workload Improved quality of care, appropriate sources of clinical guidelines Reduce readmissions, improve clinical outcomes Internal Medicine Liaison Proponent, CHF education champion Early recognition and detection of disease, improve outcomes Increase patient awareness of risk factors and symptoms Patient Advocate Proponent, medical Increase patient record access & patient awareness and engagement empowerment Quality Proponent, evaluation Measurement and research studies Representative Promote quality care, Reduce admissions, adherence to guidelines improve symptoms, reduce mortality Participate in care process & communicate with provider Determine impact of Improve clinical outcomes CHF guideline use on via data analysis and morbidity and mortality dissemination 4 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON Stakeholder Clinical Knowledge Manager (Central Knowledge Repository) Role in the Project CENTRAL CDSS FOR CHF High Level Goals Proponent, analyze Ensure that the clinical available evidence and guidelines represent the the sources for best available evidence suitability to add to repository Clinical Objectives Assess quality of guideline and its representation in machineinterpretable format in the knowledge repository Table 1: Stakeholders impacted by a centralized CHF Decision Support System These stakeholders will determine if the CDSS guideline intervention is accepted and ultimately used within the organization. The CDSS team will actively seek stakeholder input and feedback throughout the implementation process – from guideline selection to interface design to final launch. Stakeholder suggestions will be used to make changes to guideline content in the central knowledge engine and modify plans for sitespecific customization in order to limit interference with normal workflow and enhance usability of the CDSS intervention. Project Goals & Objectives The specific clinical objectives are: 1. Use of beta-blockers in CHF with LV systolic dysfunction 2. Use of ACE-Inhibitors/ARBs in patients with CHF with LV systolic dysfunction 3. Measurement of ejection fraction in CHF patients 4. ICD counseling in patients with CHF with LV systolic dysfunction 5. Symptom assessment and management 6. Post-discharge followup appointment 7. Patient education Some of these objectives occur in the inpatient environment, some in the outpatient, and some in both. The goals are, in fact, measurable: e.g. percentage of patients receiving indicated therapy pre- and post-intervention; number of readmissions pre- and post-intervention, etc. One of the significant goals of the project is to explore the feasibility of using a central knowledge repository to implement a clinical decision support system in a multi-hospital environment. The objectives of this goal are: 1. Development of a computer-interpretable guideline management system that could be shared by multiple sites 2. Ability to customize guidelines for site-specific changes 5 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF 3. Keeping guidelines current at all sites by updating the central repository of guidelines 4. Integration of the guidelines with the clinical workflow in a way that avoids interruptions to the workflow to encourage productive use of the decision support aids 5. Use of existing and proposed standards for knowledge representation, validation, execution and communication with clinical system 6. Understanding aggregate trends in guideline use to help continuously improve the effectiveness of the guidelines Identification of Appropriate Intervention and Workflow for CHF We are proposing a decision support intervention that focuses on patients in a large integrated healthcare system with a diagnosis of congestive heart failure due to left ventricular systolic dysfunction. We have chosen this clinical group because it represents a large group of patients who have significant symptoms that affect quality of life, increase their risk of dying, result in frequent hospital admissions and use significant healthcare resources at great cost to our respective communities. Moreover, there is an abundance of data that suggests utilization of several interventions such as certain medications, procedures, and lifestyle changes can improve quality of life, lower heart failure mortality, and save money via reduced hospitalizations. Unfortunately, a large percentage of patients with congestive heart failure are not in compliance with recommended interventions for a wide variety of reasons. We start with a clinical group of patients identified from inpatient or outpatient encounters: discharge diagnosis, office visit diagnosis, or problem lists. The relevant diagnosis is congestive heart failure for all patients who have had documentation of their ejection fraction, evaluation and management of symptoms, education, and follow-up appointments. Those patients whose ejection fraction is less than 40% (the subgroup known as LVSD or left ventricular systolic dysfunction) are candidates for medications (certain beta-blockers and either ACE-inhibitors or ARBs), in addition to appropriate ICD counseling. Hospitalists and cardiologists are targeted as providers who must make sure the appropriate tests and interventions are ordered. Nurses are targeted primarily for educational interventions. Patients are targeted with surveys via the electronic medical record to test their understanding of their condition, the goals of therapy, adherence to therapy, and in the cases of non-compliance, what barriers exist. A central source of knowledge is chosen ideally because it represents the distillation of best practices based on clinical studies that are reviewed by experts in the respective fields. One such practical example is the ACCF/AHA/AMA-PCPI 2011 Performance Measures for Adults With Heart Failure. This document represents the work of multiple organizations including cardiologists, nurses, pharmacists, electrophysiologists, family physicians, and hospice/palliative care physicians. Thus many stakeholders have vetted the measures that are based on solid evidence, and have the support of the American Medical Association’s Physician Consortium for Practice Improvement. The knowledge content should be customizable for use by specific sites. For example, in a site that uses Epic Systems EHR, providers can use the “infobutton” to access more details about the interventions proposed. 6 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF For inpatients, the hospitalist prepares the discharge instructions which include medications, followup appointments, and appropriate testing. Patients with CHF on their problem list or discharge diagnosis can be evaluated by the system for relevant medications, measurement of ejection fraction, etc. Those patients who are deficient in one or more measures, would cause the system to trigger a reminder to the clinician. Nurses would be measured on how often they provide education to the patient at discharge on the importance of keeping follow-up appointments, medication adherence and other factors that will impact the patient’s health in the future. Furthermore, this CDSS intervention can be used outside of the regular patient visit to alert the clinician about patient deficiencies that may lead the clinician to either order or cancel orders for recommended tests and medications. Patients can be contacted via the EHR portal (assuming they are registered and have Internet access) after hospitalizations or office visits to survey satisfaction and compliance with these performance measures. Ultimately, most of these measures can be calculated prior to the initiation of this intervention and then after an appropriate interval, recalculated to look for evidence of any impact both in terms of the healthcare processes and actual outcomes, such as hospital admissions, readmissions and mortality. Information Systems Architecture and Knowledge Management Conceptual Architecture The core of the shared clinical decision support system consists of a central decision engine that can be accessed from any authorized clinic or facility through their clinical information systems or electronic medical records. The components of this system can be grouped into two parts – the knowledge engine and the knowledge adapter. Figure 1 provides a conceptual view of this architecture. The system architecture was influenced by the principles articulated in the review of the evolution of clinical decision support architectures (Wright & Sittig, 2008). One of the observations in that review was that earlier generations of decision support systems were limited in functionality because they were either stand-alone systems (resulting in manual re-entry of data) or were tightly integrated into clinical information systems (causing extensive changes to the system when guidelines needed to be revised). The optimal design would then be the separation of the clinical information system from that of the actual clinical guidelines and knowledge but retaining interoperability through standards based interfaces using service oriented architecture (SOA). There are generally two approaches for implementing such an architecture - one approach will expose a set of application programming interfaces (APIs) and let the clinical information systems interface with the knowledge repository using the APIs (e.g. SAGE model), and the other approach will let any clinical system interface with the knowledge repository through clinical system specific adapters (e.g. SEBASTIAN). There are challenges with either of these models as outlined by Wright and Sittig (2008), but with the progress made in adopting key HL7 standards for decision support interfaces, the SAGE model offers more promise and it is also not constrained by patents (as compared to SEBASTIAN). 7 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF Hence the centralized knowledge management module of our Clinical Decision Support (CDSS) system is influenced by the Shareable Active Guideline Environment (SAGE) Guideline Model (Tu et. al, 2007). Extensions to the SAGE model include additional workflow integration, site-specific customization of guidelines and guideline usage analytics capabilities. The knowledge engine consists of a central repository of guidelines, rules, standard order sets & calculators and a knowledge base to support clinicians with optimal and relevant information for informed decision making during diagnosis or treatment. The knowledge engine uses a central platform for representing clinical guidelines in machine interpretable format. Figure 1. System Architecture - Conceptual Diagram The knowledge adapter module interfaces with the Clinical Information System/EMR at each site for obtaining the patient’s clinical data and the workflow context to help identify the appropriate guideline through the knowledge engine. The knowledge adapter is essentially a workflow engine with standards-based interface to EMR and other clinical information systems at the local site. The knowledge adapter communicates with the knowledge engine through web services. A workflow event is invoked based on user input (e.g. infobutton) or a step in the workflow that requires evaluation of available appropriate guidelines. The (de-identified) patient-specific data needed to interpret the guideline are gathered by the knowledge adapter colocated within a clinical information system and translated into a virtual Medical Record (vMR), a proposed HL7 standard, and then sent to the knowledge engine for interpretation. vMR is a simplified version of the HL7 RIM model. The knowledge engine could then use this to execute guidelines and pre-populate standard or site-specific order sets. 8 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF Site-specific customization of a guideline and the context of its workflow can be done by any authorized user of the system and the knowledge engine maintains that version of the guideline. Guideline Knowledge Management There are four processes involved in the management of the central repository of knowledge to support clinical decision support - identification of (new or changes to) a guideline, its validation, translation into machine-interpretable format (including standard order sets), and notification of changes to custodians of site-specific customization of guidelines. Clinical experts (the Clinical Knowledge Manager role) identify and assess the available guidelines using standard criteria like the AGREE instruments. The accepted guidelines are then translated into computer interpretable format through a guideline editor. The centralized model allows the clinical experts to periodically evaluate and update the shared guideline repository with new evidence in a cost-effective way. Any site-specific modifications to the guidelines are versioned and maintained separately so that customized guidelines affected by any new evidence could be identified and their custodians notified. As mentioned earlier in this paper, this project has chosen to illustrate the functionality of the centralized decision support system through the American College of Cardiology Foundation (ACCF) guideline for heart failure. As defined in the system architecture, the interaction between the central decision support system and the clinical information system/Electronic Medical Record is managed through a knowledge adapter component at each site that implements the CDSS solution. This adapter is responsible for interfacing with the central knowledge engine at the appropriate workflow step to share the patient’s data necessary for execution of the guideline and providing the results in the form of alerts and modified/annotated order set items based on patient-specific information. In addition, context-aware infobuttons (Collins, 2012) will help the clinician look up additional relevant information on the guideline, e.g. CardioCompass for heart failure (Cardiosource, n.d.), or access risk calculators and patient education tools. Decision Support Usage Data Aggregation and Analysis The results of the workflow steps before and after the execution of a guideline or rule could be aggregated into a central repository and used along with relevant local data warehouse content to analyze the patterns of usage and correlate them to the outcomes or performance measures. This will help in refining the workflow and the guideline rules as well as educate clinicians on the effective use of the decision support tools. This process could be achieved without storage of personally identifiable information or provider organization proprietary data at the central repository through the use of cross-referenced record linkages generated at the local site. Information System Inventory Table 2 describes the components required to implement this clinical decision support system. 9 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON System Name Functionality CENTRAL CDSS FOR CHF Information Type Typical Users Notes Central Clinical Guideline System Knowledge Engine Knowledge acquisition, translation to computerinterpretable guidelines Guideline Interchange Format (GLIF), GELLO Guideline Expression Language, HL7 RIM, Diagnosis (ICD-9), Procedure (CPT), Clinical (SNOMED-CT), Lab (LOINC), Drugs (RxNorm) Medical Informatician, Knowledge Engineer Initial focus on guideline related to Heart Failure Knowledge Adapter Interfacing EMR and Hospital Information Systems with Knowledge Engine HL7, ICD-9, CPT, SNOMED-CT, LOINC, RxNorm, vMR (Virtual Medical Record), XPDL (XML Process Definition Language) Application Programmer Tighter integration of guideline with clinical workflow will help targeted, user specific interactions GLIF, GELLO, Workflow editor Medical Informatician, Clinicians Guideline Site-specific Customization customization user Console interface Decision Aggregated reporting Support Usage of guideline usage for Analytics measuring effectiveness of guidelines and refining guideline/workflow Medical Informatician, Clinicians, Reporting Analyst Clinical Guidelines National Repository of Guideline guidelines Clearinghouse Guideline definition Medical Informatician, Clinicians 10 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON System Name American College of Cardiology Foundation Functionality Heart Failure related clinical guidelines CENTRAL CDSS FOR CHF Information Type Typical Users Guideline definition Notes Medical Informatician, Clinicians Clinic/Hospital and Patient Management EpicCare/Epic Patient’s EMR, enter CPOE and order management Patient Record Clinicians Clinicare Hospital Information System Billing, Provider information Clinicians, Administrators Clarity Epic Reporting Module Patient Record Medical Informatician, Reporting Analyst, Application Programmer EDW Enterprise Data Warehouse that supports performance and quality reporting Integrated database of all clinical and administrative, financial data at the hospital Medical Informatician, Reporting Analyst EpicRx Inpatient Pharmacy System RxNorm, NDC Clinicians, Pharmacists EpicLab Clinical Laboratory Information System LOINC, Radiology Clinicians, Lab Reports (DICOM) Technicians Table 2: Information Systems Inventory Information and Communication Technology Infrastructure The computing environment at the hospitals and clinics include redundant, commodity servers based on open-source software stack (e.g. LAMP - Linux Operating System, Apache Web Server, MySQL Database, Perl/PHP Scripting Language), for fault-resilient and costeffective operations. 11 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF The centralized clinical decision support intervention that provides current evidencebased guidelines for treatment of CHF can be utilized in healthcare systems that have satellite hospitals or clinics. Satellite facilities must have the ability to connect with the main hospital in order to send and transmit data and access clinically relevant content and guidelines as proposed in this paper. A network will serve as the telecommunications link connecting the hospital and its satellite facilities. This network will consist of local area networks (LANs) at each satellite facility that are connected to the main hospital via a wide area network (WAN) and will use the Ethernet standard. The main hospital LAN will have a combination of wireless (to facilitate syncing of mobile devices and tablet PCs, if approved for use in the future) and wired connectivity (a redundant feature to ensure continued network operations in the event of a wireless failure). Each satellite LAN will be wireless and consist of a main server, port switches, printers, computers (desktop, laptop or both), and a router to connect to the main hospital and other satellite facilities. The number and type of server, switches, printers and computers will be determined by the number of staff at each facility, type of clinical services provided, operational requirements and budgetary allowances. Also, the WAN will utilize leased line circuits to connect satellite routers to the Internet Service Provider, other satellite facilities and the main hospital. Overseeing the network maintenance and modifications will be the network administrator located at the main hospital and two additional IT staff (number may vary depending on the size of the healthcare system and IT budget). The network administrator will be responsible for updating email and Internet anti-virus programs are updated regularly, perform monthly (or weekly) data backups, grant/deny user access to certain files/functions and remind users to change system passwords. Intervention Specification The application will improve compliance with performance measures that have been identified as being important for the care of patients with congestive heart failure due to left ventricular systolic dysfunction (CHF-LVSD). Clinicians will be notified regarding patients admitted to the hospital with the diagnosis of CHF. Order sets will be created that are linked to key performance measures allowing appropriate tests, medications, and educational interventions to be ordered. At discharge, a checklist will be provided which will allow the clinician to make additional orders, continue key medications, and arrange for appropriate out-patient testing and followup. In the office setting, these same types of patients will be identified and the clinician will have the opportunity to reinforce the importance of these measures. There will be links to information sources which can provide key references and support for these measures. Additionally, patients can be identified through the data warehouse who are not in compliance with the measures by linking diagnoses from their problem list with relevant medications. Patients can be notified via electronic messaging, letters, and phone calls to educate them regarding these measures and arrange for necessary testing and follow-up treatment. Sources such as the Agency for Healthcare Research and Quality(AHRQ), National Quality Forum(NQF), and the Heart Failure Society of America were reviewed. Ultimately the primary source for information chosen was the ACCF/AHA/AMA-PCPI 2011 Performance Measures for Adults With Heart Failure (ACCF/AHA 2011). This document was chosen because 12 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF it is the most recent and comprehensive source of information based on the input of multiple stakeholders as previously noted and reflects the standards of care in the United States rather than other countries. These performance measures were based on clinical guidelines published in 2005 and then updated in 2009 (ACCF/AHA 2009). Workflow Design/Site-specific Customization One example of how the intervention can work is via order sets used during a hospitalization. At the time of admission and/or discharge, order sets that include relevant tests, medications, educational activities, and follow-up can be created. While the knowledge that drives the order sets is linked to the central guidelines used as previously described, site-specific customization is allowed. A paper from the 1996 AMIA annual symposium addresses the issues related to using generic guidelines, but suggests that the guidelines can be made site-specific for a variety of reasons (Fridsma et al, 1996). Factors such as availability of specialists, testing facilities, nursing educators, costs, and others may all lead to some modifications, additions, or deletions to the generic guidelines. An example of what such an order set may look like is shown below. This example includes educational activity, medications, and testing that are all relevant for the patient with CHF. As the physician needs to write orders on admission and discharge, this approach is more desirable than annoying “best practice” alerts which interrupts the workflow or often leads to an override of the alert. The order set provides a tool that is in line with the physician’s workflow rather than forcing him/her to deviate from it. According to Kawamoto et al., 2005, the following four traits are highly desirable in gaining physcian acceptance and usability: 1. “Computer-based decision support is more effective than manual processes for decision support. 2. CDSS interventions that are presented automatically and fit into the workflow of the clinicians are more likely to be used. 13 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF 3. CDSS that recommends actions for the user to take are more effective than CDSS that simply provides assessments. 4. CDSS interventions that provide information at the time and place of decision-making are more likely to have an impact.” Regarding the maintenance of the central knowledge repository, Eta Berner included the following in a 2009 summary on CDSS: “What SOA (service-oriented architecture) allows is for the central site to maintain the knowledge but for local sites to develop systems that, in the background, can access it when needed. Ideally users should not be able to tell that they are getting information any differently Figure 3: CHF Order Set Example 2 Figure 2: CHF Order Set Example 1 than they would get information residing on their own computers. While this approach makes updating easier since it is done centrally, it is also likely to require expertise at the local level to integrate the CDS. In addition, obtaining consensus as to what should be included in a centralized system can be a challenge. Given the expense of knowledge management, and to some extent duplication of effort when one looks at the aggregate effort across health care 14 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF facilities, it has been advocated that some sort of national repository of knowledge that can be incorporated into a variety of CDS be developed.” (Berner, 2009) Thus there is an obvious advantage of depending on a centrally developed set of guidelines in order not to duplicate and “reinvent the wheel” in organizations across the country. However, there will need to be some type of local adaptation or the knowledge and guidelines will simply be unusable. The challenge is for each institution to figure out what their own resources and values are and to make the necessary choices to optimize guideline usage. Figures 2 and 3 are examples of possible configuration of Congestive Heart Failure Order Set. Implementation and Change Management Plan and transition process To integrate the current CHF guidelines into existing electronic medical record (EMR) systems, a change management plan is required. The plan will review technological capabilities, minimize disruption to clinician workflow, provide end-user training and education about the CHF intervention and facilitate and maintain communication between the implementation team and stakeholders throughout the integration process. After consulting with stakeholders and securing their support for the CHF guidelines integration project, an assessment of the current IT infrastructure and capacity, availability of IT staff, clinical staffing requirements and schedules, provider workflows, and end-user satisfaction with existing EMR systems and decision support interventions will be conducted. Much of this information will be obtained via meetings and individual discussions with the stakeholders involved (chief quality officer, chief nursing officer, chief medical information officer, chief of cardiology, cardiologists, hospitalists, nurses) and others (operations and quality improvement staff) who will be affected by this project. The assessment will determine if the healthcare organization has the technological resources to handle the integration and identify potential obstacles (from workplace culture, established procedures and/or legal issues) that could negatively impact the process. To minimize changes to the way work is conducted, the CDSS team will engage nurses, hospitalists and cardiologists as part of a workflow analysis to determine: the optimal point in the care process to deliver the guidelines, how much content should be displayed, the feasibility of utilizing an infobutton, mechanisms for overriding guidelines, the preferred format for reminder alerts when patients are not in compliance with one or more of the recommended CHF guidelines, the timing and type of reminder alerts delivered to the clinician outside of regular office hours and whether the patient population is likely to use an EMR portal to communicate with providers about guideline compliance. 15 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF To further mitigate impact on workflow and minimize unintended consequences, stakeholders will assist with the development of CHF use cases to pilot test the EMR system’s ability to properly identify patients not in compliance with CHF guidelines and provide information to the clinician when establishing a patient’s care management plan. During pilot testing, the CDSS team will observe clinician interaction with the decision support intervention, document recommendations for improvement and make additional changes prior to finalizing the design and securing approval to formally launch the CHF guidelines intervention. Potential challenges that may arise during the integration of the CHF guidelines include interoperability problems at the interface between the EMR system and the central Knowledge Engine that contains the guidelines, users that have no experience with the Guide Analytics system (or any other application) that generates aggregate reports of guideline usage and the possibility of system failure (inability to retrieve the CHF guideline information). The CDSS team will discuss interoperability with IT staff at the sites, who have knowledge of existing coding schemes in use, and make enhancements to the interface based on their recommendations. Meetings with quality measurement and/or clinical analytics staff are necessary to determine their experience with reporting and analytical applications. If staff have more experience using other applications, the CDSS team will review the options with administrative and finance staff to determine feasibility of using alternate reporting software applications. Finally, the CDSS team will create a contingency plan to handle system failure (due to electrical or hardware problems) that will likely consist of having a backup server for the knowledge engine, use of surge protectors and encouraging IT staff to review the demands on switches and routers in the transmission network as components are removed or added. In the initial phases of the integration project, monthly meetings with stakeholders and staff will be used for project updates and to elicit feedback that will be used to modify project activities and timelines, if necessary. As the implementation date approaches, communications will include weekly system wide emails, information flyers posted in break rooms, clinical departments, and administrative offices to remind staff of the impending CHF guidelines integration. The CDSS team, in collaboration with organizational leadership, will also conduct information sessions to discuss the purpose of the CHF guidelines integration project and how the decision support intervention will support the organizational mission to provide effective healthcare and the quality improvement objectives for cardiac patients. The CDSS team will work with operations staff to determine the best time to integrate the CHF guidelines into the central knowledge engine. In addition, one CDSS staff member will be responsible for site-specific guideline customization; this will ensure consistency in communications and guideline modification activities. The CDSS team will also survey end-users to identify problems with reminder alerts, data retrieval and guideline triggers and will make appropriate adjustments to the guideline model. 16 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF Resource needs for testing, implementation, validation Resources needed to integrate the CHF guidelines into the centralized knowledge engine include: 1. A medical/clinical informatics specialist who is has experience with the Guideline 2. 3. 4. 5. 6. 7. Interchange Format (GLIF) or equivalent computer-interpretable guidelines and execution environments, HIT standards (HL7), workflow markup languages XML Process Definition Language (XPDL); Clinicians who can validate guideline quality for conformance with AGREE guideline definition standards and clinicians familiar with the workflow processes, especially related to CHF; Software application developers with experience in programming environments (Java/J2EE or ASP/.Net), web services development, Epic application programming interfaces, cache data access, or Info Button configurations; Database Administrators that can manage the various databases an organization uses to collect and store patient information; Reporting analysts and developers that can create reports from Clarity, EDW and the database repository that provides information to the knowledge engine; Project Manager with expertise in managing complex, multi-stakeholder projects to plan and coordinate the activities of the CHF guideline integration project; and Technology infrastructure specialists to install and administer servers, manage hardware inventory and connections to the transmission network and monitor peripheral connections and functions. The CDSS team will be responsible for testing and validating the CHF guidelines in the knowledge engine with assistance from clinicians, application developers and technology infrastructure specialists. It is imperative that the correct guideline is delivered to the individual requesting it and that the decision rules or algorithms are correctly engineered to identify patients that are or are not in compliance with the CHF guideline. Measurement of CDSS Effect on Clinical Practice Measurement of specific elements related to the purpose and function of the CDSS intervention is required in order to determine how the intervention affects clinicians and patients and what modifications need to be made to improve the intervention and ensure its operation in accordance with organizational goals and objectives. Prior to implementation of the CHF guideline intervention, healthcare organizations should verify that they have the quantity and type of patient data necessary for pre and post intervention data analysis. In this scenario, organizations should have enough cardiac patients to meet statistical power requirements and generate analyses for cardiac-related data elements (beta blockers, ACE inhibitors, ARBs, ejection fraction, provider visits, hospital admissions, hospital readmissions, co-morbid conditions, etc). 17 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF Suggested structure, process, outcome and end user measures are described below; healthcare organizations may use these or construct additional measures relevant to their particular practice environment: Structure Measures 1. Types of healthcare organizations that implement CHF guideline (private practice, etc) 2. Which CHF guideline was implemented and why 3. Which healthcare organizations utilize infobuttons and which do not utilize infobuttons 4. Where and how infobuttons are displayed Process Measures 1. Which healthcare providers (nurse, cardiologist, internist, etc) access the guideline 2. When and how often healthcare providers access the guideline 3. Provider rationale for using (or not using) the guideline Outcome Measures 1. Use of beta blockers in CHF patients with LV systolic dysfunction (pre/post intervention) 2. Use of ACE inhibitors/ARBs in CHF patients with LV systolic dysfunction (pre/post intervention) 3. Number of readmissions (pre/post intervention) 4. Measurement of ejection fraction in CHF patients (pre/post intervention) 5. Frequency of patient discharge education provided by nurses (pre/post intervention) End User Measures 1. Survey physicians about impact on workflow, time spent reviewing guideline during patient visit 2. Survey nurses about usefulness/quality of guideline in patient discharge process and education efforts 3. Survey patients about satisfaction with care, understanding of condition and treatment options Frequency of Evaluation and Communication of Results Most healthcare organizations generate either quarterly or annual reports that summarize financial and operational activities, community health status and notable achievements for stakeholders. Depending on data analysis and quality measurement staffing resources, quarterly assessments of the measures previously described would be beneficial for administrative, management and clinical staff. Printing the measurement data in a quarterly report and/or presenting the measurement data at quarterly or annual healthcare system meetings is recommended. This information can also be posted on 18 OF 21 406 GROUP PROJECT HAWKINS NARAYANAN ZUNAMON CENTRAL CDSS FOR CHF internal employee websites. Evaluating CDSS performance will help organizations with their quality improvement efforts, specifically: determining if the CDSS intervention achieves targeted objectives, identifying any unintended consequences and establishing the value of the CDSS in terms of improving healthcare delivery and patient outcomes (Osheroff et al., 2012). Stakeholders that receive timely reports of CDSS impact on providers, patients, and outcomes and understand the methodology related to the evaluation and analyses are more likely to realize the importance of CDSS in the overall context of the organization’s mission and may be more supportive of future CDSS projects. Conclusion The primary advantage of the decision support intervention described in this report is that providers can select the CHF guideline appropriate for their practice that aligns with their clinical goals and objectives towards improving patient cardiovascular health. This site-specific customization confers a great degree of flexibility and allows providers to periodically evaluate and update the shared guideline repository with new evidence in a cost-effective way. Because CHF affects people of all ages, from children and young adults to the middle-aged and the elderly, there is a need for a targeted CDSS intervention (like the one described in this paper) that can distribute evidence-based CHF guidelines to a variety of healthcare organizations in a format that can be integrated into existing EMR systems to improve patient outcomes. As the American health care system continues to struggle with the rising costs from treating chronic, long-term diseases, more organizations will adopt CDSS to assist with the identification, management and treatment of patients, and many of these patients may have some form of cardiovascular disease, such as CHF. 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