NCT00229671

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,341 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 1 Day – 21 Years
• Healthy volunteers: Accepted

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).

Conditions

• Pediatric ALL

Interventions

Type	Name	Description
OTHER	Survey 1	During the initial survey, we reviewed dispensed medications by having parents of patients with prescriptions under 21 read the medication label. We then asked questions about potential side effects, method of medication administration, communication regarding the medication with the pharmacist and the health care provider, and demographic information. Research assistants underwent several weeks of training to ensure a standardized approach to surveys.
OTHER	Survey 2	If the parent completed the initial survey, we attempted a second survey 2 months after the index visit to capture persistent symptoms. Surveys were translated and back translated into Spanish and Cambodian and conducted by fluent bilingual interviewers. Surveys were pretested and revised based on 2 focus groups of parents representing a broad array of socioeconomic backgrounds.

Timeline

• Start date: 2001-09-01
• Primary completion: 2004-07-01
• Completion: 2005-07-01
• First posted: 2005-09-30
• Last updated: 2019-11-25

Locations

1 site across 1 country: United States