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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00229671
Enrollment
6341
Registered
2005-09-30
Start date
2001-09-30
Completion date
2005-07-31
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric ALL

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).

Interventions

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.

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.

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
The Commonwealth Fund
CollaboratorOTHER
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

We performed a prospective cohort study of patients under age 21 from 6 office practices. Data collection methodologies included duplicate prescription review, 2 surveys, and chart review. All data were reviewed for medication errors, including those with the potential for harm (near misses) and those that actually caused harm (preventable ADEs). In addition, data were reviewed for harm from medications that were not associated with an error (nonpreventable ADEs). All ADEs were further characterized according to types and potential prevention strategies.

Eligibility

Sex/Gender
ALL
Age
1 Days to 21 Years
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.

Design outcomes

Primary

MeasureTime frame
Medication ErrorsJuly 2002- August 2003

Secondary

MeasureTime frame
Adverse Drug EventsJuly 2002- August 2003

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026