Improving Safety by Basic Computerizing Outpatient Prescribing

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01091038
First received: March 19, 2010
Last updated: April 1, 2010
Last verified: March 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Safety by Basic Computerizing Outpatient Prescribing

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Adverse Drug Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review

  • Medical Errors [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Medical Errors are identified through a computerized surveillance system with structured human review


Enrollment: 228
Study Start Date: August 2001
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091038

Locations
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
Investigators
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
  More Information

Publications:
Responsible Party: Joseph M Overhage, Indiana University
ClinicalTrials.gov Identifier: NCT01091038     History of Changes
Other Study ID Numbers: 0008-44
Study First Received: March 19, 2010
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014