Patient Care Systems & Patient Monitoring Lecture in a Nutshell

1. INFO-I530 (Foundation to Health Informatics) Patient Care Systems &Patient Monitoring Lecture #14

2. Lecture in a Nutshell • Patient Care • Concepts of Patient Care • Information to Support Patient Care • Historical Evolution of Patient-Care Systems • Current Research • Outlook for the Future • Patient Monitoring • What Is Patient Monitoring? • Historical Perspective • Data Acquisition and Signal Processing • Built-In Microcomputers • Arrhythmia Monitoring • Bedside Point of Care Laboratory Testing • Commercial Development of Computer-Based Monitoring • Information Management in the Intensive Care Unit • Current Issues in Patient Monitoring

3. Concepts of Patient Care • Patient care is an interdisciplinary process centered on the care recipient • The process of care begins with collecting data and assessing the patient’s current status in comparison to criteria or expectations of normality. • Cognitive processes specific to the discipline, diagnostic labels are applied, therapeutic goals are identified with timelines for evaluation, and therapeutic interventions are selected and implemented. • At specified intervals, the patient is reassessed, the effectiveness of care is evaluated, and therapeutic goals are adjusted as needed. • If the reassessment shows that the patient no longer needs care, services are terminated.

4. Concepts of Patient Care cont. The provision of nursing care

5. Concepts of Patient Care cont. • Although this linear flowchart helps to explain some aspects of the process of care, it is a gross simplification. For example if the patient is anxious the linear format will be modified. • Nonlinear quality of patient care poses challenges to informatics in the support of patient care and the capture of clinical data. • True interdisciplinary care is as different from the separate contributions of the various disciplines (Physician, Nurse, Nutritionist, Physical therapist, Occupational therapist and …) • Because patients receive services from multiple caregivers, someone must coordinate those services (case manager). • Caregivers are also involved in indirect-care activities such as teaching and supervising students, attending staff meetings, participating in continuing education.

6. Information to Support Patient Care • The framework described by Zielstorff delineates three information categories: • patient-specific data, which are those data about a particular patient acquired from a variety of data sources. • agency-specific data, which are those data relevant to the specific organization under whose auspices the health-care is provided. • domain information and knowledge, which is specific to the health-care disciplines. • The framework further identifies four types of information processes that information systems may apply to each of the three information categories: • Data acquisition • Data storage • Data transformation or processing • Presentation

7. Information to Support Patient Care cont. Framework described by Zielstorff

8. Information to Support Patient Care cont. • To support patient care, information systems must be geared to the needs of all the professionals involved in care: patient, agency, and domain. • These systems not only support each professional’s care of individual patients but also, through appropriate use of patient-specific information (care requirements), agency-specific information (caregivers and their responsibilities and agency policies and procedures), and domain information (guidelines). • Integrated systems — still an ideal today — would enhance our understanding of each patient’s situation and needs, improve decision-making, facilitate communications, aid coordination, and use clinical data to provide feedback for improving clinical processes.

9. Information to Support Patient Care cont. Examples of uses for atomic-level patient data collected once but used many times.

10. Historical Evolution of Patient-Care Systems • One of the first and most successful systems was the Technicon Medical Information System (TMIS), begun in 1965 as a collaborative project between Lockheed and El Camino Hospital in Mountain View, California. • Part of what changed users’ expectations for patient care systems has been the development and evolution of systems that support clinical decision making. The HELP system at LDS Hospital in Salt Lake City, Utah, provided decision support to physicians and nurses during the process of care (in addition to managing and storing data). • Other decision support integrated systems were Partners Health Care in Boston and at Vanderbilt University Medical Center in Nashville, Tennessee that have been translated into commercial systems. • Today, many commercially available information systems for patient care incorporate decision support, integration of information from multiple sources, care planning and documentation, organization of the clinician’s workflow, and support for care management.

11. Historical Evolution of Patient-Care Systems cont. continuum of care the creation of a single patient problem list Societal forces that have influenced the design and implementation of patient care systems.

12. Historical Evolution of Patient-Care Systems cont. • Patient-Care Systems • Patient-care systems in the hospital settings: • University of Missouri-Columbia System (Lindberg, 1965) • Problem-Oriented Medical Information System (PROMIS) (Weed, 1975) • The Tri-Service Medical Information System (TRIMUS) (Bickel, 1979) • The Health Evaluation Logical Processing (HELP) System (Kuperman et al., 1991) • The Decentralized Hospital Computer Program (DHCP) (Ivers & Timson, 1985) • Patient-care systems in ambulatory care: • The Computer-Stored Ambulatory Record (COSTAR) • The Regenstrief Medical Record System (McDonald, 1976) • The Medical Record (TMR) • Five sites that had won the Computer-based Patient Record Institute Davies’ Award: • LDS Hospital, Salt Lake City (LDSH) in 1995 • Brigham and Women’s Hospital, Boston (BWH) in 1996 • Wishard Memorial Hospital, Indianapolis (WMH) in 1997 • Queen’s Medical Center, Honolulu (QMC) in 1999 • Veteran’s Affairs Purget Sound Healthcare System, Seattle and Tacoma (VAPS) in 2000 • It is noteworthy that even in these sites that are widely recognized for their advanced clinical information systems, clinicians’ progress notes are not completely computer-based.

13. Historical Evolution of Patient-Care Systems cont. • Computerized Notes • The publication of the Institute of Medicine’s reports To Err is Human (2000) and Crossing the Quality Chasm (2001) resulted in increasing demands from health care providers for information systems that reduce errors in patient care. • “Closed loop” medication systems use technologies such as bar codes and decision support to guard against errors. • Decision support systems offer “best practice” guidelines, protocols, and order sets as a starting point for planning individualized patient care. • Finding ways to phase the transition from older systems to newer and more functional ones is a major challenge to health informatics • It is vital that the data standards support the care delivery and evaluation processes of the variety of healthcare professionals who participate in patient care. • If patient-care systems are to be effective in supporting better care, healthcare professionals must possess the informatics competencies to use the systems.

14. Historical Evolution of Patient-Care Systems cont. Computerized Notes

15. Current Research • Friedman (1995) proposed a typology of the science in medical informatics: • Formulation of Models: Formulating models for acquisition, representation, processing, display, or transmission of biomedical information or knowledge (standards development organizations (SDOs)) • Development of Innovative Systems: Developing innovative computer-based systems, using these models, that deliver information or knowledge to healthcare providers (Brigham Integrated Computing System (BICS), Vanderbilt University Medical Center) • Implementation of Systems: Installing such systems and then making them work reliably in functioning healthcare environments. Five key factors associated with successful implementation: • having organizational leadership, commitment, and vision • improving clinical processes and patient care • involving clinicians in the design and modification of the system • maintaining or improving clinical productivity • building momentum and support amongst clinicians. • Study of the Effects of Systems: Studying the effects of these systems on the reasoning and behavior of health-care providers, as well as on the organization and delivery of health care.

16. Outlook for the Future • Patient-care systems are changing in two ways: • First, legacy systems designed primarily for charge capture and other administrative functions are being replaced by systems designed to support and improve clinical practice, as well as to send clinical data to the various locations where these data are needed for practice, management, and research. • Second, systems designed to support each discipline separately are yielding to those based on integrated, interdisciplinary concepts of care. • Research is continuing to develop structured clinical languages, standards, and data models.

17. What Is Patient Monitoring? • Patient monitoring can be rigorously defined as: “repeated or continuous observations or measurements of the patient, his or her physiological function, and the function of life support equipment, for the purpose of guiding management decisions, including when to make therapeutic interventions, and assessment of those interventions” • In the past, most clinical data were in the form of heart and respiratory rates, blood pressures, and flows, but today they include integrating data from bedside instruments which measure blood gases, chemistry, and hematology as well as integrating data from many sources outside the intensive-care unit (ICU).

18. What Is Patient Monitoring? cont. A nurse at a patient’s ICU bedside. Above the nurse’s head is the bedside monitor which measures and displays key physiological data, above her left hand is an IV pump connected to a Medical Information Bus (MIB), to her right are two screens of a patient ventilator and to the far right is a bedside computer terminal used for data entry and data review.

19. What Is Patient Monitoring? cont. • There are at least five categories of patients who need physiological monitoring: • Patients with unstable physiological regulatory systems; for example, a patient whose respiratory system is suppressed by a drug overdose or anesthesia • Patients with a suspected life-threatening condition; for example, a patient who has findings indicating an acute myocardial infarction (heart attack) • Patients at high risk of developing a life-threatening condition; for example, patients immediately after open-heart surgery or a premature infant whose heart and lungs are not fully developed • Patients in a critical physiological state; for example, patients with multiple trauma or septic shock. • Mother and baby during the labor and delivery process.

20. What Is Patient Monitoring? cont. • Purposes for patient monitoring in ICU or related units: • To acquire physiological data frequently or continuously, such as blood pressure readings • To communicate information from data-producing systems to remote locations (e.g., laboratory and radiology departments) • To store, organize, and report data • To integrate and correlate data from multiple sources • To provide clinical alerts and advisories based on multiple sources of data • To function as a decision-making tool that health professionals may use in planning the care of critically ill patients • To measure the severity of illness for patient classification purposes • To analyze the outcomes of ICU care in terms of clinical effectiveness and cost effectiveness

21. Historical Perspective • Since the 1920s, the four vital signs—temperature, respiratory rate, heart rate, and arterial blood pressures—have been recorded in all patient charts. • The development of transducers and electronic instrumentation during World War II dramatically increased the number of physiological variables that could be monitored. The early bedside monitors were built around “bouncing-ball” or conventional oscilloscopes and analog-computer technology. • Simultaneously, a new trend emerged; some nurses moved away from the bedside to a central console where they could monitor the ECG and other vital-sign reports from many patients. • Systems with database functions, report-generation systems, and some decision-making capabilities are usually called computer-based patient monitors. • As monitoring capabilities expanded, physicians and nurses soon were confronted with a bewildering number of instruments; they were threatened by data overload.

22. Historical Perspective cont. Close-up display of the screen of a modern bedside monitor showing physiological waveforms and numerical values

23. Data Acquisition and Signal Processing • There are virtually no bedside monitors or ventilators marketed today that do not use at least one microcomputer. Block diagram of a modern Bedside Monitor

24. Data Acquisition and Signal Processing cont. • The sampling rate is an important factor that affects the correspondence between an analog signal and that signal’s digital representation. Electrocardiogram (first and second traces), arterial pressure (third trace), and pulmonary-artery pressure (fourth trace) recorded from a patient’s bedside

25. Data Acquisition and Signal Processing cont. The sampling rate of the analog-to-digital converter determines the quality of the ECG. The ECG is sampled at 500 measurements per second.

26. Data Acquisition and Signal Processing cont. The sampling rate of the analog-to-digital converter determines the quality of the ECG. The ECG is sampled at 100 measurements per second.

27. Data Acquisition and Signal Processing cont. The sampling rate of the analog-to-digital converter determines the quality of the ECG. The ECG is sampled at 50 measurements per second.

28. Data Acquisition and Signal Processing cont. The sampling rate of the analog-to-digital converter determines the quality of the ECG. The ECG is sampled at 25 measurements per second.

29. Built-In Microcomputers • Built-in microcomputers have the following advantages over their analog predecessors: • The digital computer’s ability to store patient waveform information such as the ECG permits sophisticated pattern recognition and physiological signal feature extraction. • Signal quality from multiple ECG leads can now be monitored and interference noise minimized. • Physiological signals can be acquired more efficiently by converting them to digital form early in the processing cycle (eliminating the manual calibration step). • Transmission of digitized physiological waveform signals is easier and more reliable. • Selected data can be retained easily if they are digitized. • Measured variables, such as heart rate and blood pressure, can be graphed over prolonged periods to aid with detection of life-threatening trends. • Alarms from bedside monitors are now much “smarter” and raise fewer false alarms (ignoring signal artifacts) but false alarms are still very prevalent. • Systems can be upgraded easily (no hardware replacement – ROM based apps)

30. Arrhythmia Monitoring • Electrocardiographic arrhythmia analysis is one of the most sophisticated and difficult of the bedside monitoring tasks. • The newest bedside monitors, in contrast, have built-in arrhythmia-monitoring systems. These computers generally use a 32-bit architecture, waveform templates, realtime feature extraction and template correlation. • Wave Form Classification: A beat-classification scheme compares the waveform of each incoming beat with that of one or more clinically relevant waveform classes already established for the patient. Detecting and identifying pacemaker signals poses special problems because their “spikes” are very narrow to detect. • Full-Disclosure and Multilead ECG Monitoring: Contemporary central monitors combine the advantages of digital waveform analysis as described above with high-capacity disk drives to store one or more days worth of continuous waveform data, including ECG. Multilead monitors now offer the opportunity to monitor ST segment changes.

31. Arrhythmia Monitoring cont. “Full disclosure” ECG display. This system stores continuous waveforms for 48 hours along with arrhythmia information.

32. Bedside Point of Care Laboratory Testing • Development has miniaturized both the blood-analysis cartridge and the blood-analysis machine to the point that the entire analysis system consists of a small plug-in module to a bedside physiological monitor. • Many laboratory tests, including pH, PO2, PCO2, HCO3, electrolytes, glucose, ionized calcium, other chemistries, hemoglobin, and hematocrit, can be performed in 2 minutes using two or three drops of blood. • These laboratory results obtained at the bedside are also automatically transmitted through the monitoring network and hospital’s backbone network to the laboratory computer system Blood analysis point of care device and a bedside physiological monitor.

33. Commercial Development of Computer-Based Monitoring • The user community is faced with bedside monitors that function like “mini” patient-data-management systems because of the lack of standardized communication protocols. • Major companies are Philips Medical Systems with its CareVue system, GE Medical Systems formerly Marqueette Electronics with its Centricity Clinical Information system, and Eclipsys (formerly EMTEK) with its Continuum 2000 computerized charting application. • With most medical images now available in digital format it is now convenient for care providers to have fast and convenient access to medical images via the web.

34. Information Management in the Intensive Care Unit • Physicians generally prescribe complicated therapy for such patients. As a result, enormous numbers of clinical data accumulate. • Professionals may miss important events and trends if the accumulated data are not presented in a compact, well-organized form. • Continuity of care is especially important for critically ill patients (interdisciplinary approach). Each step in this transmission process is subject to delay and error. The medical record is the principal instrument for ensuring the continuity of care for patients. • Information management roles in the ICU: • Computer-Based Charting • Calculation of Derived Variables • Decision-Making Assistance • Response by Nurses and Physicians

35. Information Management in the Intensive Care Unit cont. • Computer-Based Charting • Data from several sources, not just from the traditional physiological monitoring devices, must be communicated to and integrated into a unified medical record to permit effective decision-making and treatment in the ICU. • A large percentage of the data collected comes from what are typically manual tasks, such as administering a medication or auscultating breath or heart sounds. • Because the computer-based ICU record is stored in the system, it is readily available for research purposes. • To meet the clinical management needs required by critically ill patients as well as to provide an adequate legal record, most patient data-management systems generate a variety of reports. • Computer based charting also prepares weekly reports that summarize the data for each of the past seven 24-hour periods.

36. Information Management in the Intensive Care Unit cont. Block diagram showing the six major areas in which healthcare professionals interact with computer-based ICU charting to make patient care more effective and efficient.

37. Information Management in the Intensive Care Unit cont. CareVue QuickLook Summary Display. The content and appearance of the QuickLook display can be configured for each clinical area.

38. Information Management in the Intensive Care Unit cont. CareVue medication administration record (MAR) display. All medications are charted dose by dose in this system.

39. Information Management in the Intensive Care Unit cont. • Calculation of Derived Variables • Increased sophistication of hemodynamic, renal, and pulmonary monitoring resulted in the need to calculate derived parameters. • Decision-Making Assistance • We now have the opportunity to use the computer to assist staff in the complex task of medical decision-making in the ICU. For example HELP computer system at the LDS Hospital in Salt Lake City has been used effectively to assist in ICU antibiotic use decision-making. • The so called “antibiotic assistant” provides recommendations as to the specific antibiotic recommended for a specific patient and further recommends the dose to be given and the mode of delivery (for example IV) also based on the patient’s size and renal function. • The HELP decision-making system has been used in the following areas: Interpretation of data, Alerts, Diagnoses and Treatment suggestions.

40. Information Management in the Intensive Care Unit cont. Display of a screen from the Antibiotic Assistant at LDS Hospital

41. Information Management in the Intensive Care Unit cont. A Blackberry™ alphanumeric pager displays a real-time alert message for a serum potassium level of 2.8 mg/dl.

42. Information Management in the Intensive Care Unit cont. A Blackberry™ alphanumeric pager displays an alert for a potentially serious drug allergy at Cedars-Siani Medical Center

43. Information Management in the Intensive Care Unit cont. • Response by Nurses and Physicians • The goals of automation were (1) to facilitate the acquisition of clinical data, (2) to improve the content and legibility of medical documentation, and (3) to increase the efficiency of the charting process so that nurses could devote more time to direct patient care. • However the studies have not shown improvements in the efficiency of information management by ICU nurses. The lack of demonstrable time savings may be due to several factors: • First, the new system affected only selected aspects of the nursing process. • Second, the computer-based charting system is not yet comprehensive; nurses still hand write some data in the patient chart. • Third, nurses do not always take advantage of the capabilities of the charting system. • Fourth, the intervals of time saved may have been too small to be measured using the work-sampling methods employed in the studies. • Fifth, these small savings in time are easily absorbed into other activities.

44. Current Issues in Patient Monitoring • Data Quality and Data Validation • A system must provide feedback at various levels to verify correct operation, to carry out quality control, and to present intermediate and final results. • Some cross validation between signals is possible, but this process is performed by very few of the bedside monitors in use today. • Built in noise-rejection algorithms to improve the quality of the data presented • Manual charting process not only makes it impossible to follow what is going on with the patient – for example, if a vasoactive drug caused the blood pressure to stabilize, but can also lead to major treatment errors IV Charting comparison – Delay time between when an IV drip rate actually occurred and it was manually charted by a nurse in the ICU.

45. Current Issues in Patient Monitoring cont. • Continuous Versus Intermittent Monitoring • We must sample the signal at a rate of at least twice the rate of the maximum frequency of interest in the signal (the Nyquist frequency) Thus, for an ECG, the sampling rate should be at least 200 measurements per second. • The overriding concerns in determining sampling rate are how rapidly the parameter can change, and how long before a dangerous change will result in irreversible damage. • To provide data that a human can interpret, however, a bedside monitor usually updates its display every 3 seconds. • Data Recording: Frequency and Quantity • The newer central stations, however, record digitized waveforms to hard disk on a continuous basis, and theoretically these data could be archived with the patient’s electronic chart or printed out for a paper chart. • Will it improve the quality of patient care? Or will it simply increase the cost of care?

46. Current Issues in Patient Monitoring cont. • Invasive Versus Noninvasive Monitoring • The development of inexpensive light-emitting diodes (LED), small solid-state light detectors, and new computer methods made possible, for example, the development of the pulse oximeter, an exciting example of noninvasive monitoring technology • Integration of Patient-Monitoring Devices • Each bed-side patient support device has its own display and, because each comes from a different manufacturer, each is designed as a standalone unit. • Due to the large number and variety of medical devices available and to the peculiar data formats, it is impractical to interface the growing number of bedside devices to computers by building special software and hardware interfaces. • Automated data capture from bedside medical devices is now possible using the IEEE MIB (Institute of Electrical and Electronic Engineers - Medical Information Bus) 1073 communications standards

47. Current Issues in Patient Monitoring cont. Block diagram of a distributed-database ICU system with networking.

48. Current Issues in Patient Monitoring cont. • Closed-Loop Therapy • It can be argued that pacemakers and implantable defibrillators are such devices. Despite automated blood infusion therapy after open-heart surgery, very few examples exist of successful similar work. • Treatment Protocols • As in other areas of medical practice, there is considerable interest in developing standard treatment protocols to improve the consistency, quality, and cost effectiveness of critical-care settings. • The HELP (Health Evaluation Through Logical Processing) system automatically generates therapeutic instructions regarding ventilator management to healthcare providers based on data input by the laboratory and by physicians, nurses, and respiratory therapists. • The antibiotic-assistant program acquires data from the rich coded database of the HELP system and provides “consultation” to physicians ordering antibiotics for patients who have or who are suspected of having an infection.

49. Current Issues in Patient Monitoring cont. • Efficacy of Care in the Intensive-Care Unit • Intensive-care-unit care is expensive. 15 to 20 percent of the nation’s hospital budget, or almost 1 percent of the gross national product, was spent for ICU care. • The ethical implications of withholding potentially beneficial care from patients in the control group of a randomized clinical trial make such studies almost impossible to perform. • Responsible Use of Medical Software • Use of medical software has become ubiquitous, especially in the ICU. • The Food and Drug Administration (FDA) has called for discussions about further regulating of such software. • The American Medical Informatics Association (AMIA) and others have made recommendations about how such software should be monitored and evaluated

50. Current Issues in Patient Monitoring cont. • Integration of Bioinformatics and Genomics with Critical Care • Up to now the goal of monitoring has been to measure the degree of injury and to prevent further injury, rather than to measure “repair”. • Culturing and subsequent determination of the sensitivity of an appropriate antibiotic can take days. With the ability to detect bacterial DNA we should be able to detect and identify the active bacteria using genetic markers. • Consensus Conference on Critical-Care Medicine • 1983 consensus conference organized by the National Institutes of Health. Technical difficulties, errors in data interpretation, and increasing interventions caused by continuous monitoring are potential nosocomial hazards for ICU patients. ICUs should: • All ICUs should be capable of arrhythmia monitoring, Invasive monitoring should be performed safely, Generated data should be correct, Derived data should be interpreted properly, Therapy should be employed safely, Access to laboratory data should be rapid and comprehensive, Enteral (tube-feeding) and parenteral (IV) nutritional-support services should be available and Titrated therapeutic interventions with infusion pumps should be available.