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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Pediatric ALL

Treatments: Other: Survey 2; Other: Survey 1

Study type: Interventional

Funder types: Other

Identifiers

NCT00229671

2002-P-000544/41 ( BWH;Registry Identifier)

5P01HS011534-03

Details and patient eligibility

About

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.

Full 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).

Enrollment: 6,341 patients

Sex: All

Ages: 1 day to 21 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,341 participants in 2 patient groups

Patients with prescriptions under 21

Experimental group

Description:

Pediatric visits with prescriptions. These patients parents will be given survey 1.

Treatment:

Other: Survey 1

Patients who completed Survey 1

Experimental group

Description:

Patients with prescriptions under 21 whose parents complete survey 1 will be given survey 2

Treatment:

Other: Survey 2