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

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

Study Overview

• Status: Completed
• Conditions: Pediatric ALL
• Intervention / Treatment: Other: Survey 1; Other: Survey 2

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).

• Study Type: Interventional
• Enrollment (Actual): 6341
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with prescriptions under 21; Pediatric visits with prescriptions. These patients parents will be given survey 1.	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.
Experimental: Patients who completed Survey 1; Patients with prescriptions under 21 whose parents complete survey 1 will be given survey 2	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Medication Errors	July 2002- August 2003

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Drug Events	July 2002- August 2003

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Boston Children's Hospital; Brigham and Women's Hospital; The Commonwealth Fund
• Investigators: Principal Investigator: Rainu Kaushal, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2001
• Primary Completion (Actual): July 1, 2004
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: September 28, 2005
• First Submitted That Met QC Criteria: September 28, 2005
• First Posted (Estimate): September 30, 2005

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 5P01HS011534-03 (U.S. AHRQ Grant/Contract); 2002-P-000544/41; BWH (Registry Identifier: Medication Errors)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No