Improving Safety by Basic Computerizing Outpatient Prescribing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091038
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : April 5, 2010
Brigham and Women's Hospital
Information provided by:
Indiana University

Brief Summary:
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.

Condition or disease Intervention/treatment Phase
Adverse Drug Events Other: Basic Clinical Decision Support Other: Routine Care Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Safety by Basic Computerizing Outpatient Prescribing
Study Start Date : August 2001
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Routine Care
Usual care of patients in the ambulatory setting
Other: Routine Care
Routine Care
Experimental: Basic Clinical Decision Support
Providers use basic clinical decision support
Other: Basic Clinical Decision Support
The computerized physician order entry (CPOE) intervention provides physicians with a menu of medications from the formulary, default doses, and a range of potential doses for each medication. Physicians were required to enter dosage, route, and frequency for all orders. Also, CPOE ensured that all orders were legible and included the prescribing physician's signature. For a number of medications, the system displayed relevant laboratory results on the screen at the time of ordering. Other features included consequent orders, which are orders that should follow from other orders, and drug-allergy checking, drug-drug interaction checking, and drug-laboratory checking. This included checking for the most frequent drug allergies, about 80 carefully selected drug-drug interactions, and several drug-laboratory combinations

Primary Outcome Measures :
  1. Adverse Drug Events [ Time Frame: 6 months ]
    Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review

  2. Medical Errors [ Time Frame: 6 months ]
    Medical Errors are identified through a computerized surveillance system with structured human review

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All

Inclusion Criteria:

  • provider practicing at sites implementing order entry with basic clinical decision support using either the longitudinal medical record (LMR) or Medical Gopher

Exclusion Criteria:

  • provider or practice unwilling to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091038

United States, Indiana
Wishard Helath Services
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Partner's Healthcare
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Indiana University
Brigham and Women's Hospital
Principal Investigator: Joseph M Overhage, MD, PhD Indiana University
Principal Investigator: David Bates, MD Brigham and Women's Hospital
Principal Investigator: Tejal Gandhi, MD Brigham and Women's Hospital
Principal Investigator: Andrew Seger, PharmD Brigham and Women's Hospital

Responsible Party: Joseph M Overhage, Indiana University Identifier: NCT01091038     History of Changes
Other Study ID Numbers: 0008-44
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: April 5, 2010
Last Verified: March 2010

Keywords provided by Indiana University:
Adverse drug events
medical errors
computerized physician order entry
clinical decision support

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders