Improving Safety by Basic Computerizing Outpatient Prescribing
Primary Purpose
Adverse Drug Events
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Basic Clinical Decision Support
Routine Care
Sponsored by
About this trial
This is an interventional health services research trial for Adverse Drug Events focused on measuring Adverse drug events, medical errors, computerized physician order entry, clinical decision support
Eligibility 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
Sites / Locations
- Wishard Helath Services
- Partner's Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Routine Care
Basic Clinical Decision Support
Arm Description
Usual care of patients in the ambulatory setting
Providers use basic clinical decision support
Outcomes
Primary Outcome Measures
Adverse Drug Events
Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review
Medical Errors
Medical Errors are identified through a computerized surveillance system with structured human review
Secondary Outcome Measures
Full Information
NCT ID
NCT01091038
First Posted
March 19, 2010
Last Updated
October 11, 2023
Sponsor
Indiana University
Collaborators
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01091038
Brief Title
Improving Safety by Basic Computerizing Outpatient Prescribing
Official Title
Improving Safety by Basic Computerizing Outpatient Prescribing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University
Collaborators
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Events
Keywords
Adverse drug events, medical errors, computerized physician order entry, clinical decision support
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Care
Arm Type
Placebo Comparator
Arm Description
Usual care of patients in the ambulatory setting
Arm Title
Basic Clinical Decision Support
Arm Type
Experimental
Arm Description
Providers use basic clinical decision support
Intervention Type
Other
Intervention Name(s)
Basic Clinical Decision Support
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine Care
Intervention Description
Routine Care
Primary Outcome Measure Information:
Title
Adverse Drug Events
Description
Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review
Time Frame
6 months
Title
Medical Errors
Description
Medical Errors are identified through a computerized surveillance system with structured human review
Time Frame
6 months
10. Eligibility
Sex
All
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Overhage, MD, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Bates, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tejal Gandhi, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Seger, PharmD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wishard Helath Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Partner's Healthcare
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14552850
Citation
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. doi: 10.1016/s1532-0464(03)00059-5.
Results Reference
background
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Improving Safety by Basic Computerizing Outpatient Prescribing
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