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NCT00013143 Clinical Trial

Patient Profiling and Provider Feedback to Reduce Adverse Drug Events

Adverse Drug Events Clinical Trial

Official title:
Patient Profiling and Provider Feedback to Reduce Adverse Drug Events

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00013143
Other study ID # SAF 99-144
Secondary ID
Status Completed
Phase N/A
First received March 14, 2001
Last updated April 6, 2015
Start date June 2001
Est. completion date January 2003

Study information
Verified date February 2007
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Adverse drug events (ADE) present a unique focus for error reduction. Computerized provider order entry, with embedded clinical decision support, has great promise in reducing medication errors but preventable adverse drug events may still occur despite such systems.

Description:

Background:

Adverse drug events (ADE) present a unique focus for error reduction. Computerized provider order entry, with embedded clinical decision support, has great promise in reducing medication errors but preventable adverse drug events may still occur despite such systems.

Objectives:

The purpose of the study was to evaluate whether adding medication profiling (by using a retrospective drug utilization review program) to computerized provider order entry with embedded order checks (drug alerts) reduces the incidence of adverse drug events.

Methods:

Medication profiles mainly focused on possible drug-drug and drug-disease interactions, with some drug duplications. To do the medication profiles we licensed a proprietary computerized retrospective drug utilization review system. We randomly assigned over 900 patients to Usual Care or Provider Feedback. For patients in the latter group, selected providers were contacted by letter with pertinent information; electronic mail was used for follow-up contact. Clinical and other relevant data was retrospectively abstracted from the medical records for up to one year from the last medication profile for all patients. This was done by a pharmacist reviewer, using a study-derived instrument, and blinded to patient assignment. ADE incidence is the primary outcome of interest, with other outcomes such as ADE severity and preventability also assessed. We also developed and implemented provider surveys in pre- and post-profiling periods.

Status:

Pre and post survey results published. Adjunct study on clinical actions as a result of drug alerts published. Main study (profiling): manuscript in proces.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date January 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patient must be alive

- patient must be currently active in GLA system

- medication for which alert was generated must be currently active

- patient provider must not be Peter Glassman

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Behavioral:
• Patient risk profiling (potential ADEs) w/provider feedback

Locations
Country Name City State
United States VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Glassman PA, Belperio P, Lanto A, Simon B, Valuck R, Sayers J, Lee M. The utility of adding retrospective medication profiling to computerized provider order entry in an ambulatory care population. J Am Med Inform Assoc. 2007 Jul-Aug;14(4):424-31. Epub 20 — View Citation

Glassman PA, Belperio P, Simon B, Lanto A, Lee M. Exposure to automated drug alerts over time: effects on clinicians' knowledge and perceptions. Med Care. 2006 Mar;44(3):250-6. Erratum in: Med Care. 2007 Sep;45(9):912. — View Citation

Glassman PA, Simon B, Belperio P, Lanto A. Improving recognition of drug interactions: benefits and barriers to using automated drug alerts. Med Care. 2002 Dec;40(12):1161-71. — View Citation

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