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

Not Applicable

Completed

• Conditions: Pediatric ALL
• Interventions: Other: Survey 2; Other: Survey 1

• Registration Number: NCT00229671
• Lead Sponsor: Weill Medical College of Cornell University

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.

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).

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2004-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-30
• Status Verified: 2018-06
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6341

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who completed Survey 1	Survey 2	Patients with prescriptions under 21 whose parents complete survey 1 will be given survey 2
Patients with prescriptions under 21	Survey 1	Pediatric visits with prescriptions. These patients parents will be given survey 1.

Primary Outcome Measures

Name	Time	Method
Medication Errors	July 2002- August 2003

Secondary Outcome Measures

Name	Time	Method
Adverse Drug Events	July 2002- August 2003

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States