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Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00229671
Recruitment Status : Unknown
Verified September 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was:  Recruiting
First Posted : September 30, 2005
Last Update Posted : September 30, 2005
Brigham and Women's Hospital
Boston Children’s Hospital
The Commonwealth Fund
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)

Brief Summary:
The purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. Further, we wish to determine the effectiveness of a computerized physician order entry (CPOE) system in reducing errors.

Condition or disease Intervention/treatment Phase
Pediatric Patients With a Variety of Medical Conditions. Device: Computerized Physician Order Entry Not Applicable

Detailed Description:

This study has the following 2 goals:

Aim 1: To determine the rates, types, and predictors of medication errors and ADEs.

Aim 2: To perform a trial assessing the effectiveness of an intervention (CPOE) on reducing serious medication errors.

We hypothesize that:

  1. Medication errors and ADEs are frequent in ambulatory pediatrics.
  2. Presence of the following predictors will be associated with higher error rates: cultural, racial, socioeconomic, educational, and linguistic barriers to communication, understanding, and successful completion of prescribed therapies; complex medical or chronic medical conditions; complex medication regimens; non-physician providers with limited clinical experience; high provider workloads; and complex prescription refill systems.
  3. Prevention strategies, including both technology-based and behavioral/ human factors-based interventions, will be effective and cost-effective in reducing rates of serious medication errors (defined as preventable ADEs and non-intercepted potential ADEs).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ambulatory Medication Errors and Adverse Drug Events (ADEs) in Pediatrics
Study Start Date : September 2001
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Medication Errors
  2. Adverse Drug Events

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pediatric providers at the participating office practices during the study period as well as the parents of the patients of these providers.

Exclusion Criteria:

  • Pediatric providers or patients at other office practices.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00229671

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Contact: Carol Keohane 617 525 6660

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Carol Keohane    617-525-6669   
Contact: Rainu Kaushal    212 746 1703   
Principal Investigator: Rainu Kaushal         
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Brigham and Women's Hospital
Boston Children’s Hospital
The Commonwealth Fund
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Principal Investigator: Rainu Kaushal Brigham and Women's Hospital

Layout table for additonal information Identifier: NCT00229671     History of Changes
Other Study ID Numbers: 5P01HS011534-03 ( U.S. AHRQ Grant/Contract )
2002-P-000544/41; BWH
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: September 30, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders