Clinical trial NCT00229671: Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics
Official title: Ambulatory Medication Errors and Adverse Drug Events (ADEs) in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Boston Children's Hospital
name: The Commonwealth Fund
First posted: 2005-09-30
Enrollment: 6341
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Errors
timeFrame: July 2002- August 2003
Secondary outcomes:
measure: Adverse Drug Events
timeFrame: July 2002- August 2003
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Rainu Kaushal
role: PRINCIPAL_INVESTIGATOR
References: