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

NCT00229671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6341

Last updated 2019-11-25

No results posted yet for this study

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.

Conditions

  • Pediatric ALL

Interventions

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Boston Children's Hospital

    collaborator OTHER

  • The Commonwealth Fund

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Rainu Kaushal · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2004-07-31
Completion
2005-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00229671 on ClinicalTrials.gov