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

March 19, 2010
April 1, 2010
August 2001
August 2007   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01091038 on ClinicalTrials.gov Archive Site
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Improving Safety by Basic Computerizing Outpatient Prescribing
Improving Safety by Basic Computerizing Outpatient Prescribing

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Adverse Drug Events
  • 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
  • Other: Routine Care
    Routine Care
  • Placebo Comparator: Routine Care
    Usual care of patients in the ambulatory setting
    Intervention: Other: Routine Care
  • Experimental: Basic Clinical Decision Support
    Providers use basic clinical decision support
    Intervention: Other: Basic Clinical Decision Support
Hope C, Overhage JM, Seger A, Teal E, Mills V, Fiskio J, Gandhi TK, Bates DW, Murray MD. A tiered approach is more cost effective than traditional pharmacist-based review for classifying computer-detected signals as adverse drug events. J Biomed Inform. 2003 Feb-Apr;36(1-2):92-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01091038
0008-44
No
Joseph M Overhage, Indiana University
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
Indiana University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP