Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.

Condition or disease	Intervention/treatment	Phase
Medication Errors	Behavioral: computerized physician order entry	Not Applicable

Detailed Description:

This is a prospective cohort study at Children's Hospital and Brigham and Women's Hospital (BWH), before and after the introduction of two distinct interventions. The first intervention at Children's Hospital was the introduction of clinical pharmacists on inpatient pediatric wards to target errors at the stages of physician ordering and nurse transcription. The second intervention is technological: the introduction of physician computer order entry at the BWH neonatal intensive care unit (NICU). This intervention will most effectively target errors at the stage of physician ordering, and secondarily address errors at the stage of pharmacy dispensing and nurse transcription. Data on serious medication errors will be collected pre and post each intervention.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
Study Start Date :	February 2000
Actual Primary Completion Date :	May 2006
Actual Study Completion Date :	May 2007

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Introduction of A Clinical Pharmacist	Behavioral: computerized physician order entry
Experimental: Technological	Behavioral: computerized physician order entry

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. serious medication errors

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients in the BWH NICU in the study pods during the study period

Exclusion Criteria:

• Patients in other units, non-study pods, or outside of the study period

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Brigham and Women's Hospital

National Patient Safety Foundation

Boston Children’s Hospital

Investigators

Principal Investigator:	Rainu Kaushal	BWH

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Rainu Kaushal, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00153205 History of Changes
Other Study ID Numbers:	2005-P-000322/1; BWH
First Posted:	September 12, 2005
Last Update Posted:	February 16, 2017
Last Verified:	February 2017

Keywords provided by Rainu Kaushal, MD, Brigham and Women's Hospital:

medication errors; medical records systems, computerized; patient safety