Using Informatics to Enhance Care of Older Emergency Department Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 27, 2006

Last Updated Date

April 8, 2009

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

Proportion of older ED patients who receive a potentially inappropriate medication [ Time Frame: During discharge home from the ED ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00297869 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Proportion of ED patients who receive an excessive dose of a medication that requires dosage adjustment for renal insufficiency [ Time Frame: During discharge home from the ED ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Using Informatics to Enhance Care of Older Emergency Department Patients

Official Title ^†

Computer-Assisted Decision Support to Increase the Safety of Prescribing to Older Emergency Department Patients

Brief Summary

The subjects in this study are physicians working in the Wishard Emergency Department. The purpose of this study is to measure the extent to which information technology (i.e.-computers) improves emergency department care. The objective of our study is to evaluate the use of informatics in the emergency department and specifically to determine if computer reminder systems: 1) reduce the number of unsafe medications prescribed to older adults, 2) assist in more safely dosing of medications to adults of all ages, and 3) increase influenza immunization of eligible older patients in the emergency department.

Interventions: The interventions in this study are computer reminders. When releasing patients from the emergency department, physicians currently write all release orders, including prescriptions, on a computer order entry system that is linked to the Regenstrief Medical Record System. The computerized order entry system will be programmed so that physicians randomized (randomly placed) into the intervention group, the group that will receive the intervention, they will receive one of three types of reminders:

The medication prescribed is generally considered unsafe for use in older patients. The reminder will then list appropriate alternatives for this medication.
The dose of the prescribed medication is excessive and should be adjusted for the patient's creatinine clearance (or kidney function).
This patient may be eligible for influenza vaccination.

The physician will then choose to order or disregard the recommendation. The computer system will automatically record what the physician selected to do. The general outcome of interest is the extent to which the electronic reminders successfully improved physician practice in the emergency department setting. This outcome will be compared to physicians who were randomized to the group that did not receive the reminders (the control group).

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study

Condition ^†

Elderly; Renal Insufficiency

Intervention ^†

Procedure: Computer-Assisted Decision Support

Study Arms / Comparison Groups

Experimental: Electronic warnings when providers prescribe a potentially inappropriate medication or an excessively dosed medication (based on estimated creatinine clearance)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

954

Completion Date

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

The subjects of this study will be physician providers and residents and medical students practicing under the supervision of a faculty emergency physician. Specific study subjects will include emergency medicine faculty physicians; emergency medicine and internal medicine residents; emergency medicine, surgery, and internal medicine interns; and medical students taking care of patients in our emergency department.

Exclusion Criteria:

We will not include the members of the research team in this study.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Kevin M. Terrell, DO, MS

317-423-5600

kterrell@regenstrief.org

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297869

Responsible Party

Dr. Kevin M. Terrell, Indiana University

Secondary IDs ^††

2004 Jahnigen Career Award

Study Sponsor ^†

Indiana University School of Medicine

Collaborators ^††

Investigators ^†

Principal Investigator:

Kevin M. Terrell, DO, MS

Indiana University School of Medicine

Information Provided By

Indiana University

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.