Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
February 14, 2017 updated by: Rainu Kaushal, MD, Brigham and Women's Hospital
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Introduction of A Clinical Pharmacist
|
|
|
Experimental: Technological
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
serious medication errors
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rainu Kaushal, BWH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2000
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
February 16, 2017
Last Update Submitted That Met QC Criteria
February 14, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 2005-P-000322/1; BWH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.