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OpenTrials
Completed

NCT Number: NCT00013143

Patient Profiling and Provider Feedback to Reduce Adverse Drug Events

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.

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient risk profiling (potential ADEs) w/provider feedback

Behavioral

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Mar 16, 2001
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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