Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies

Tracking Information
First Submitted Date ICMJE	September 8, 2005
First Posted Date ICMJE	September 12, 2005
Last Update Posted Date	February 16, 2017
Study Start Date ICMJE	February 2000
Actual Primary Completion Date	May 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 8, 2005)	serious medication errors
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00153205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
Official Title ICMJE	Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Medication Errors
Intervention ICMJE	Behavioral: computerized physician order entry
Study Arms	Placebo Comparator: Introduction of A Clinical Pharmacist Intervention: Behavioral: computerized physician order entry; Experimental: Technological Intervention: Behavioral: computerized physician order entry
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: February 14, 2017)	0
Original Enrollment ICMJE; (submitted: September 8, 2005)	1000
Actual Study Completion Date	May 2007
Actual Primary Completion Date	May 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00153205
Other Study ID Numbers ICMJE	2005-P-000322/1; BWH
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rainu Kaushal, MD, Brigham and Women's Hospital
Study Sponsor ICMJE	Brigham and Women's Hospital
Collaborators ICMJE	National Patient Safety Foundation; Boston Children’s Hospital
Investigators ICMJE	Principal Investigator: Rainu Kaushal BWH
PRS Account	Brigham and Women's Hospital
Verification Date	February 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP