Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies

This study has been withdrawn prior to enrollment.

Sponsor:

Collaborators:

National Patient Safety Foundation

Boston Children’s Hospital

Information provided by (Responsible Party):

Rainu Kaushal, MD, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT00153205

First received: September 8, 2005

Last updated: February 14, 2017

Last verified: February 2017

History of Changes

Purpose

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	Intervention
Medication Errors	Behavioral: computerized physician order entry


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Children's Health Medication Errors

U.S. FDA Resources

Further study details as provided by Rainu Kaushal, MD, Brigham and Women's Hospital:

Primary Outcome Measures:

serious medication errors


Enrollment:	0
Study Start Date:	February 2000
Study Completion Date:	May 2007
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Introduction of A Clinical Pharmacist	Behavioral: computerized physician order entry
Experimental: Technological	Behavioral: computerized physician order entry

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153205

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


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
Study First Received:	September 8, 2005
Last Updated:	February 14, 2017

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


medication errors medical records systems, computerized patient safety

ClinicalTrials.gov processed this record on September 21, 2017

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