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Completed

NCT Number: NCT00229671

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

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.

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 day–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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:

  • Medication errors and ADEs are frequent in ambulatory pediatrics.
  • 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.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey 1

Other

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.

Survey 2

Other

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.

Primary outcomes

  1. Medication Errors

    Time frame: July 2002- August 2003

Secondary outcomes

  1. Adverse Drug Events

    Time frame: July 2002- August 2003

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • The Commonwealth Fund

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2005
First posted
Sep 30, 2005
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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