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Patient Profiling and Provider Feedback to Reduce Adverse Drug Events

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013143
First received: March 14, 2001
Last updated: February 6, 2014
Last verified: February 2007
  Purpose

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.


Condition Intervention
Adverse Drug Events
Behavioral: Patient risk profiling (potential ADEs) w/provider feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: Patient Profiling and Provider Feedback to Reduce Adverse Drug Events

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 1200
Study Start Date: June 2001
Study Completion Date: January 2003
Arms Assigned Interventions
Arm 1 Behavioral: Patient risk profiling (potential ADEs) w/provider feedback

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00013143

Locations
United States, California
VA Greater Los Angeles Health Care System
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Peter A. Glassman, MBBS MSc VA Greater Los Angeles Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013143     History of Changes
Other Study ID Numbers: SAF 99-144
Study First Received: March 14, 2001
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on November 20, 2014