An interventional study of Informatics Alert/Nurse/physician responders in Diabetes, sponsored by Washington University School of Medicine. Completed. Per ClinicalTrials.gov, last updated 2014-06-20.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
The purpose of the project is to improve in-patient safety by lowering the risk of severe hypoglycemia (low blood sugar) for patients with diabetes on insulin therapy and to improve communication between healthcare providers.
The procedures of the study are:
This prospective nonrandomized intervention study involved inpatients admitted to 6 designated intervention and 8 designated control acute medicine divisions at Barnes-Jewish Hospital in St Louis, the academic teaching hospital of Washington University School of Medicine, from August 2011 through December 2011. The study population consisted of patients cared for on either the control or intervention floors who were receiving anti-diabetic medications during their hospital stay. The study was approved by the Washington University Medical Center institutional review board, and included a waiver of consent for all patients.
The pharmacy informatics system was programmed with the previously-developed hypoglycemia alert parameters to identify those patients at high risk of hypoglycemia based on real-time patient information (7). Patients were identified as high risk on intervention floors if insulin or an oral anti-hyperglycemic agent was prescribed, if their hypoglycemia informatics-generated risk score was greater than 35, and if they had a capillary or venous blood glucose level of ≤90 mg/dL. The risk score of 35 was the value that corresponded to 50% sensitivity for a subsequent blood glucose \< 60 mg/ dl and a 75% sensitivity for a blood glucose \< 40 mg/ dL. Patients were assigned to categories based on the division that they were admitted to and risk score algorithm.
The electronic alert was sent to division-specific charge nurses via a pager. Fourteen charge nurses on intervention divisions were trained to assess the alert, interview the patient, identify an alternate dosing strategy and collaborate with the patient's physicians. These trained nurses were available on intervention divisions Monday through Friday from 0700 to 1700. Control patients (HR-) were identified as high risk on control divisions based on the same criteria as intervention patients. The control patients' charts were reviewed upon discharge of the patient by a certified diabetes nurse educator on the research team who evaluated the number of hypoglycemic episodes in these patients as well as physician recognition of increased risk and whether appropriate changes were made to the patient orders in response to a low or down-trending blood glucose levels.
Nurses and physicians caring for patients on study divisions provided informed consent to participate in the study. Nurses' satisfaction with the alert process and physician interaction was assessed with a collaboration scale that was completed after each alert as well as a post study satisfaction scale (9). Nurses and physicians provided informed consent to participate.
640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's enrollment of 390 is above the median of 29 across 471 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alert/Nurse and Physician Intervention
Other: Informatics Alert/Nurse/physician responders
Incidence of Severe Hypoglycemia
The incidence of Severe Hypoglycemia (\<40mg/dl) in patients after receiving a PES Hypoglycemia Risk Alert until discharge from the hospital in both intervention and control groups.
Time frame: from time of the Pharmacy Expert System (PES) alert until discharge of the patient from the hospital, an average of 3-5 days
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine