Implementation of a pharmacogenomics consult service to support the INGENIOUS trial.

Hospital systems increasingly utilize pharmacogenomic testing to inform clinical prescribing. Successful implementation efforts have been modeled at many academic centers. In contrast, this report provides insights into the formation of a pharmacogenomics consultation service at a safety-net hospital, which predominantly serves low-income, uninsured, and vulnerable populations. The report describes the INdiana GENomics Implementation: an Opportunity for the UnderServed (INGENIOUS) trial and addresses concerns of adjudication, credentialing, and funding.

Prerequisites to implementing a pharmacogenomics program in a large health-care system.

Pharmacogenomics (PGx) technology is advancing rapidly; however, clinical adoption is lagging. The Indiana Institute of Personalized Medicine (IIPM) places a strong focus on translating PGx research into clinical practice. We describe what have been found to be the key requirements that must be delivered in order to ensure a successful and enduring PGx implementation within a large health-care system.

Open-label randomized trial of torsemide compared with furosemide therapy for patients with heart failure.

PURPOSE: Because the bioavailability of oral furosemide is erratic and often incomplete, we tested the hypothesis that patients with heart failure who were treated with torsemide, a predictably absorbed diuretic, would have more favorable clinical outcomes than would those treated with furosemide. PATIENTS AND METHODS: We conducted an open-label trial of 234 patients with chronic heart failure (mean [+/- SD] age, 64 +/- 11 years) from an urban public health care system. Patients received oral torsemide (n = 113) or furosemide (n = 121) for 1 year. The primary endpoint was readmission to the hospital for heart failure. Secondary endpoints included readmission for all cardiovascular causes and for all causes, numbers of hospital days, and health-related quality of life. RESULTS: Compared with furosemide-treated patients, torsemide-treated patients were less likely to need readmission for heart failure (39 [32%] vs. 19 [17%], P <0.01) or for all cardiovascular causes (71 [59%] vs. 50 [44%], P = 0.03). There was no difference in the rate of admissions for all causes (92 [76%] vs. 80 [71%], P = 0.36). Patients treated with torsemide had significantly fewer hospital days for heart failure (106 vs. 296 days, P = 0.02). Improvements in dyspnea and fatigue scores from baseline were greater among patients treated with torsemide, but the differences were statistically significant only for fatigue scores at months 2, 8, and 12. CONCLUSIONS: Compared with furosemide-treated patients, torsemide-treated patients were less likely to be readmitted for heart failure and for all cardiovascular causes, and were less fatigued. If our results are confirmed by blinded trials, torsemide may be the preferred loop diuretic for patients with chronic heart failure.

A computerized reminder system to increase the use of preventive care for hospitalized patients.

BACKGROUND: Although they are effective in outpatient settings, computerized reminders have not been proved to increase preventive care in inpatient settings. METHODS: We conducted a randomized, controlled trial to determine the effects of computerized reminders on the rates at which four preventive therapies were ordered for inpatients. During an 18-month study period, a computerized system processed on-line information for all 6371 patients admitted to a general-medicine service (for a total of 10,065 hospitalizations), generating preventive care reminders as appropriate. Physicians who were in the intervention group viewed these reminders when they were using a computerized order-entry system for inpatients. RESULTS: The reminder system identified 3416 patients (53.6 percent) as eligible for preventive measures that had not been ordered by the admitting physician. For patients with at least one indication, computerized reminders resulted in higher adjusted ordering rates for pneumococcal vaccination (35.8 percent of the patients in the intervention group vs. 0.8 percent of those in the control group, P<0.001), influenza vaccination (51.4 percent vs. 1.0 percent, P< 0.001), prophylactic heparin (32.2 percent vs. 18.9 percent, P<0.001), and prophylactic aspirin at discharge (36.4 percent vs. 27.6 percent, P<0.001). CONCLUSIONS: A majority of hospitalized patients in this study were eligible for preventive measures, and computerized reminders significantly increased the rate of delivery of such therapies.

The effect of discussions about advance directives on patients' satisfaction with primary care.

BACKGROUND: Discussions of end-of-life care should be held prior to acute, disabling events. Many barriers to having such discussions during primary care exist. These barriers include time constraints, communication difficulties, and perhaps physicians' anxiety that patients might react negatively to such discussions. OBJECTIVE: To assess the impact of discussions of advance directives on patients' satisfaction with their primary care physicians and outpatient visits. DESIGN: Prospective cohort study of patients enrolled in a randomized, controlled trial of the use of computers to remind primary care physicians to discuss advance directives with their elderly, chronically ill patients. SETTING: Academic primary care general internal medicine practice affiliated with an urban teaching hospital. PARTICIPANTS: Six hundred eighty-six patients who were at least 75 years old, or at least 50 years old with serious underlying disease, and their 87 primary care physicians (57 residents, 30 faculty general internists) participated in the study. MEASUREMENTS AND MAIN RESULTS: We assessed patients' satisfaction with their primary care physicians and visits via interviews held in the waiting room after completed visits. Controlling for satisfaction at enrollment and physician, patient, and visit factors, discussing advance directives was associated with greater satisfaction with the physician (P =.052). At follow-up, the strongest predictor of satisfaction with the primary care visit was having previously discussed advance directives with that physician (P =.004), with a trend towards greater visit satisfaction when discussions were held during that visit (P =.069). The percentage of patients scoring a visit as "excellent" increased from 34% for visits without prior advance directive discussions to 51% for visits with such discussions (P =.003). CONCLUSIONS: Elderly patients with chronic illnesses were more satisfied with their primary care physicians and outpatient visits when advanced directives were discussed. The improvement in visit satisfaction was substantial and persistent. This should encourage physicians to initiate such discussions to overcome communication barriers might result in reduced patient satisfaction levels.

The Regenstrief Medical Record System: a quarter century experience.

Entrusted with the records for more than 1.5 million patients, the Regenstrief Medical Record System (RMRS) has evolved into a fast and comprehensive data repository used extensively at three hospitals on the Indiana University Medical Center campus and more than 30 Indianapolis clinics. The RMRS routinely captures laboratory results, narrative reports, orders, medications, radiology reports, registration information, nursing assessments, vital signs, EKGs and other clinical data. In this paper, we describe the RMRS data model, file structures and architecture, as well as recent necessary changes to these as we coordinate a collaborative effort among all major Indianapolis hospital systems, improving patient care by capturing city-wide laboratory and encounter data. We believe that our success represents persistent efforts to build interfaces directly to multiple independent instruments and other data collection systems, using medical standards such as HL7, LOINC, and DICOM. Inpatient and outpatient order entry systems, instruments for visit notes and on-line questionnaires that replace hardcopy forms, and intelligent use of coded data entry supplement the RMRS. Physicians happily enter orders, problems, allergies, visit notes, and discharge summaries into our locally developed Gopher order entry system, as we provide them with convenient output forms, choice lists, defaults, templates, reminders, drug interaction information, charge information, and on-line articles and textbooks. To prepare for the future, we have begun wrapping our system in Web browser technology, testing voice dictation and understanding, and employing wireless technology.

Canopy computing: using the Web in clinical practice.

The rain forest canopy is a seamless web through which arboreal creatures efficiently move to reach the edible fruits without any attention to the individual trees. Individual health care computer systems are rich with patient data, but rather than a canopy linking all the trees in the forest, the data "fruit" come from a diverse forest of individual computer "trees"-laboratory systems, word processing systems, pharmacy systems, and the like. These different sources of patient information are difficult or impossible to reach by individual physicians, especially from their offices. The World Wide Web and other standardization technology provide physicians and their institutions the tools needed for seamless and secure access to their patients' data and to medical information, when and where they need it. We and others have adopted these tools to combine independent sources of clinical data. Physicians who assist in the purchase of clinical information systems should demand products in their practice settings that are Web enabled, use standard coding systems, and communicate with other computer systems via broadly accepted protocols.

Effectiveness of computer-generated reminders for increasing discussions about advance directives and completion of advance directive forms. A randomized, controlled trial.

BACKGROUND: Physicians can increase the rate of completion of advance directive forms by discussing directives with their patients, but the means by which physicians can be induced to initiate these discussions are unclear. Computer-generated reminders have been shown to increase physician compliance with practice guidelines. OBJECTIVE: To determine the effects of computer-generated reminders to physicians on the frequency of advance directive discussions between patients and their primary caregivers and the frequency of consequent establishment of advance directives. DESIGN: Randomized, controlled trial with a 2 x 2 factorial design. SETTING: An outpatient general medicine practice associated with an urban public hospital. PARTICIPANTS: Participants were 1) 1009 patients who were at least 75 years of age or were at least 50 years of age with serious underlying disease and 2) 147 primary care physicians (108 housestaff and 39 faculty). INTERVENTION: Computer-generated reminders that recommended discussion of one or both of two types of advance directives compared with no reminders. MEASUREMENTS: Discussions about advance directives, determined by patient interviews after all scheduled patient-physician outpatient encounters, and completed advance directive forms. The study period was approximately 1 year. RESULTS: Physicians who did not receive reminders (controls) discussed advance directives with 4% of the study patients compared with 24% for physicians who received both types of reminders (adjusted odds ratio, 7.7 [95% CI, 3.4 to 18]; P < 0.001). Physicians who did not receive reminders completed advance directive forms with only 4% of their study patients compared with 15% for physicians who received both types of reminders (adjusted odds ratio, 7.0 [CI, 2.9 to 17]; P < 0.001). Overall, 45% of patients with whom advance directives were discussed completed at least one type of advance directive. CONCLUSIONS: Simple computer-generated reminders aimed at primary caregivers can increase the rates of discussion of advance directives and completion of advance directive forms among elderly outpatients with serious illnesses.

The promise of computerized feedback systems for diabetes care.

Feedback control is an important mechanism for reaching a targeted goal. Biologic examples range from achieving the appropriate blood pressure level to glycemia control. Computer-based feedback control systems have many potential applications in medicine. Closed-loop systems directly sense the state of the patient and then deliver an intervention without human action. Closed-loop systems have been used to control postoperative fluid infusion, reduce malignant hypertension to a reasonable range through nitroprusside infusions, and control continuous insulin infusions-in effect, an artificial pancreas. Sensory problems have limited the direct application of closed-loop systems to date; most current medical uses of computer-based feedback control are open loop, where a human is interposed between the suggested intervention and the delivered treatment. Because many variables important to the management of diabetes are objective, many opportunities exist for open-loop control in diabetes management. Open-loop systems have already been used to suggest insulin dosage adjustments and treatment for hypercholesterolemia and to remind physicians of various mellitus. However, existing applications have only scratched the surface. Many more facets of diabetes management could be standardized and assisted by open-loop control systems if the management rules could be more exactly specified, a task requiring substantial time commitments by diabetologists. Efforts to translate existing knowledge bases into precise guidelines will be helpful, but new primary studies and decision analyses are needed to define the optimal use of some interventions.