Improving Safety by Basic Computerizing Outpatient Prescribing

October 11, 2023 updated by: Indiana University
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

228

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Wishard Helath Services
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Partner's Healthcare

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
Medical Errors
Time Frame: 6 months
Medical Errors are identified through a computerized surveillance system with structured human review
6 months

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

Brigham and Women's Hospital

Investigators

  • Principal Investigator: David Bates, MD, Brigham and Women's Hospital
  • Principal Investigator: Joseph M Overhage, MD, PhD, Indiana University
  • Principal Investigator: Tejal Gandhi, MD, Brigham and Women's Hospital
  • Principal Investigator: Andrew Seger, PharmD, Brigham and Women's Hospital

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

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, 2001

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimated)

March 23, 2010

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0008-44

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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