Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
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ClinicalTrials.gov Identifier: NCT00153205 |
Recruitment Status
:
Withdrawn
First Posted
: September 12, 2005
Last Update Posted
: February 16, 2017
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Sponsor:
Brigham and Women's Hospital
Collaborators:
National Patient Safety Foundation
Boston Children’s Hospital
Information provided by (Responsible Party):
Rainu Kaushal, MD, Brigham and Women's Hospital
Tracking Information | ||||
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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 |
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 |
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Condition ICMJE | Medication Errors | |||
Intervention ICMJE | Behavioral: computerized physician order entry | |||
Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Investigators ICMJE |
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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 |