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

NCT00229671 | Completed DMC

• 2 other identifiers: 5P01HS011534-032002-P-000544/41; BWH
• Study Type: interventional
• Target: 6,341
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• Medication Errors

  July 2002- August 2003

Secondary Outcomes (1)

• Adverse Drug Events

  July 2002- August 2003

Study Arms (2)

Patients with prescriptions under 21

EXPERIMENTAL

Pediatric visits with prescriptions. These patients parents will be given survey 1.

Other: Survey 1

Patients who completed Survey 1

EXPERIMENTAL

Patients with prescriptions under 21 whose parents complete survey 1 will be given survey 2

Other: Survey 2

Interventions

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.

Patients with prescriptions under 21

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.

Patients who completed Survey 1

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric providers at the participating office practices during the study period as well as the parents of the patients of these providers.

You may not qualify if:

• Pediatric providers or patients at other office practices.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Brigham and Women's Hospital: collaborator
• Boston Children's Hospital: collaborator
• The Commonwealth Fund: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rainu Kaushal

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 30, 2005
• Study Start: September 1, 2001
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2005
• Last Updated: November 25, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)