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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229671
• Other study ID #: 5P01HS011534-03
• Secondary ID: 2002-P-000544/41
• Status: Completed
• Phase: N/A
• Start date: September 2001
• Est. completion date: July 2005

Study information

• Verified date: June 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6341
• Est. completion date: July 2005
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Pediatric ALL

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Boston Children’s Hospital, Brigham and Women's Hospital, The Commonwealth Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Errors		July 2002- August 2003
Secondary	Adverse Drug Events		July 2002- August 2003