Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Collaborators:
Brigham and Women's Hospital
Children's Hospital Boston
The Commonwealth Fund
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00229671
First received: September 28, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pediatric Patients With a Variety of Medical Conditions. |
Device: Computerized Physician Order Entry |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Ambulatory Medication Errors and Adverse Drug Events (ADEs) in Pediatrics |
Resource links provided by NLM:
Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):
Primary Outcome Measures:
- Medication Errors
- Adverse Drug Events
| Estimated Enrollment: | 30000 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | July 2005 |
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:
- Medication errors and ADEs are frequent in ambulatory pediatrics.
- 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.
- 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| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229671
Contacts
| Contact: Carol Keohane | 617 525 6660 | ckeohane@partners.org |
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02120 | |
| Contact: Carol Keohane 617-525-6669 ckeohane@partners.org | |
| Contact: Rainu Kaushal 212 746 1703 rkaushal@partners.org | |
| Principal Investigator: Rainu Kaushal | |
Sponsors and Collaborators
Brigham and Women's Hospital
Children's Hospital Boston
The Commonwealth Fund
Investigators
| Principal Investigator: | Rainu Kaushal | Brigham and Women's Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00229671 History of Changes |
| Other Study ID Numbers: | 5 P01 HS11534-03, 2002-P-000544/41; BWH |
| Study First Received: | September 28, 2005 |
| Last Updated: | September 28, 2005 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Drug Toxicity Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on June 18, 2013