ABSTRACT
OBJECTIVE: To determine whether cholecystokinin-octapeptide (CCK-OP) would prevent or ameliorate parenteral nutrition-associated cholestasis (PNAC) among high-risk neonates treated with total parenteral nutrition. STUDY DESIGN: This was a multicenter, double-blind, randomized, controlled trial conducted between 1996 and 2001. PATIENTS: Neonates at risk for the development of PNAC included very low birth weight neonates and those with major surgical conditions involving the gastrointestinal tract. SETTING: Tertiary care hospitals. INTERVENTION: Patients were randomized to receive CCK-OP (0.04 mug/kg per dose, twice daily) or placebo. Eligible infants were all <30 days of age. Patients were enrolled within 2 weeks after birth or within 7 days after surgery. OUTCOME MEASURES: The primary outcome measure was conjugated bilirubin (CB) levels, which were measured weekly. Secondary outcome measures included incidence of sepsis, times to achieve 50% and 100% of energy intake through the enteral route, number of ICU and hospital days, mortality rate, and incidences of biliary sludge and cholelithiasis. RESULTS: A total of 243 neonates were enrolled in the study. CCK-OP administration did not significantly affect CB levels (1.76 +/- 3.14 and 1.93 +/- 3.31 mg/dL for CCK-OP and placebo groups, respectively; mean +/- SD). Secondary outcome measures also were not significantly affected by the study drug. CONCLUSIONS: Use of CCK-OP failed to reduce significantly the incidence of PNAC or levels of CB. CCK-OP had no effect on other secondary measures and should not be recommended for the prevention of PNAC.
Subject(s)
Cholestasis/prevention & control , Infant, Premature, Diseases/prevention & control , Infant, Very Low Birth Weight , Parenteral Nutrition, Total/adverse effects , Sincalide/therapeutic use , Bilirubin/blood , Cholestasis/etiology , Double-Blind Method , Gallbladder/diagnostic imaging , Humans , Infant, Newborn , Infant, Premature , Infant, Premature, Diseases/etiology , Treatment Failure , UltrasonographyABSTRACT
OBJECTIVE: To describe the development of a pragmatic low-cost medical information system that reduces errors in the ordering of total parenteral nutrition (TPN) in the newborn intensive care unit at the Johns Hopkins Hospital. METHODS: We designed an online total parenteral nutrition order entry system (TPNCalculator) using Internet technologies. Utilization, impact on medical errors, and user satisfaction were evaluated prior to and immediately after introduction of TPNCalculator (intervention 1) and after 2 years (intervention 2). RESULTS: Total software development time was 3 weeks. The number of orders was similar during the 3 periods: 0.39 orders per patient per day (N = 557) were received compared with 0.35 and 0.43 orders per patient per day (N = 471 and N = 656) in 2 intervention periods. During the control period, an average of 10.8 errors were detected per 100 TPN orders compared with 4.2 per 100 orders in the first intervention period (61% reduction of error rate) and 1.2 per 100 orders after 2 years and some redesign of TPNCalculator (89% reduction of error rate). We found a reduction in the following types of problems (intervention 1; intervention 2): calculation errors (100%; 100%), osmolality outside the allowed range (88%; 91%), and other knowledge problems (84%; 100%). There was a 35% increase in the number of incomplete forms in the first intervention period and a 100% reduction in the second. Rapid cycle development was used in the development of this application. Users of the system were enthusiastic and supportive and compared it favorably to the previous paper-based system. CONCLUSION: Low-cost, pragmatic approaches using Internet technology in the design of medical information systems can reduce medical errors and might pose a viable option for the prevention of adverse drug events.
Subject(s)
Clinical Pharmacy Information Systems , Drug Therapy, Computer-Assisted , Medication Errors/prevention & control , Medication Systems, Hospital , Parenteral Nutrition, Total , Baltimore , Hospitals, University , Humans , Infant, Newborn , Intensive Care Units, Neonatal , Medication Errors/statistics & numerical data , Parenteral Nutrition, Total/adverse effects , Personnel, Hospital , Surveys and Questionnaires , User-Computer InterfaceABSTRACT
OBJECTIVE: 1. To reduce errors in the ordering of total parenteral nutrition (TPN) in the Newborn Intensive Care Unit (NICU) at the Johns Hopkins Hospital (JHH). 2. To develop a pragmatic low-cost medical information system to achieve this goal. METHODS: We designed an online total parenteral nutrition order entry system (TPNCalculator) using Internet technologies. Total development time was three weeks. Utilization, impact on medical errors and user satisfaction were evaluated. RESULTS: During the control period, 0.39 orders per patient per day (N=557) were received compared to 0.35 orders per patient per day (N=471) in the intervention period (NS). There was no significant difference in the percentage of late (incomplete by order deadline) TPN orders. During the control period, an average of 10.8 errors were detected per 100 TPN orders compared to 4.2 per 100 orders in the intervention period (61% reduction of error rate; p < 0.01). We found a reduction in the following types of problems: Calculation errors (100%), osmolality issues (87%) and other knowledge problems (84%). There was a 35% increase in the number of incomplete forms. Users of the system were enthusiastic and supportive and compared it favorably to the prior paper based system. CONCLUSION: Low-cost, pragmatic approaches utilizing Internet technology in the design of medical information systems can reduce medical errors and might pose a viable option for the prevention of adverse drug events.
