Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Brigham and Women's Hospital
Collaborators:
National Patient Safety Foundation
Boston Children’s Hospital
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00153205
First received: September 8, 2005
Last updated: May 3, 2010
Last verified: May 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | May 3, 2010 | ||||
| Start Date ICMJE | February 2000 | ||||
| Estimated Primary Completion Date | February 2011 (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 Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Medication Errors | ||||
| Intervention ICMJE | Device: computerized physician order entry | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | February 2011 | ||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Child, Adult, Senior | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| 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 | ||||
| Plan to Share Data | Not Provided | ||||
| IPD Description | Not Provided | ||||
| Responsible Party | Rainu Kaushal, Brigham & Women's Hospital | ||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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