Improving Safety by Basic Computerizing Outpatient Prescribing

NCT01091038 | Completed Phase 2

• 1 other identifier: 0008-44
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Adverse Drug Events

Keywords

Adverse drug events; medical errors; computerized physician order entry; clinical decision support

Outcome Measures

Primary Outcomes (2)

• Adverse Drug Events

  Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review

  6 months

• Medical Errors

  Medical Errors are identified through a computerized surveillance system with structured human review

  6 months

Study Arms (2)

Routine Care

PLACEBO COMPARATOR

Usual care of patients in the ambulatory setting

Other: Routine Care

Basic Clinical Decision Support

EXPERIMENTAL

Providers use basic clinical decision support

Other: Basic Clinical Decision Support

Interventions

Basic Clinical Decision Support OTHER

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

Basic Clinical Decision Support

Routine Care OTHER

Routine Care

Routine Care

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• provider or practice unwilling to participate

Sponsors & Collaborators

• Indiana University: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Wishard Helath Services

Indianapolis, Indiana, 46202, United States

Location

Partner's Healthcare

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 14552850 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 23, 2010
• Study Start: August 1, 2001
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

US (2)