Preventing Hypoglycemia

June 19, 2014 updated by: Washington University School of Medicine

Prevention of Hypoglycemia and Insulin Errors in Barnes-Jewish Hospital Inpatients

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:

  • the hospital patient information system [Pharmacy Event System,(PES)] will generate for healthcare providers a real-time risk alert of severe hypoglycemia (low blood sugar)
  • the real-time PES risk alert will be sent via a beeper to the patient's charge nurse
  • the charge nurse will follow the specific guidelines in the alert for assessment of the patient's care and insulin regimen
  • the charge nurse will then notify the physician of the patient's assessment and of the recommendation for change/no change in insulin regimen and/or clinical care
  • the alerted charge nurse and physician will complete a collaboration scale

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria for participating charge nurses and physicians is the insulin management educational classes and the pre/post quiz. No exclusion criteria.

Exclusion Criteria:

  • No exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Informatics Real-Time Alert
Alert/Nurse and Physician Intervention
Other: Informatics Alert/Nurse/physician responders
NO_INTERVENTION: control-no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Severe Hypoglycemia
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
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.
from time of the Pharmacy Expert System (PES) alert until discharge of the patient from the hospital, an average of 3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Garry Tobin, MD, Washington University School of Medicine St. Louis, Missouri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (ESTIMATE)

August 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201104182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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