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| Tracking Information | |||||
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| First Received Date ICMJE | April 4, 2007 | ||||
| Last Updated Date | April 5, 2007 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00457600 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | ParentLink: Better and Safer Emergency Care for Children | ||||
| Official Title ICMJE | ParentLink: Better and Safer Emergency Care for Children | ||||
| Brief Summary | The emergency department (ED) constitutes a high-risk environment for errors and poor quality of care. Pediatric patients are at increased risk of medical errors. We postulate that implementation of a patient-centered health information technology - ParentLink - can address system-level deficiencies and the unique “just-in-time” information needs of ED physicians and the parents of ill children. The proposed work delivers an innovative product – an electronic interface linked to a pediatric knowledge base that integrates parent-derived data with best practices for safe and effective emergency care across common pediatric disease conditions: otitis media, urinary tract infections, asthma, and head trauma. The study has two aims, the first of which addresses critical gaps in data capture: to evaluate the completeness and accuracy of information on symptoms, disease condition, medications and allergies generated by parents using ParentLink versus information documented by ED physicians and nurses, using structured telephone interviews as a gold standard. The second aim measures the ParentLink’s impact on ED patient safety and quality, specifically: a) the error rate for ordering and prescribing of medications during ED care, and b) the percent of ED visits that adhere to national evidence-based guidelines. Parentlink will be rigorously evaluated in a clinical trial at two diverse ED sites and will use a sequential, non-randomized observational design with two intervention and two control periods to measure the effects of ParentLink on data capture and safety and quality of patient care. |
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| Detailed Description | |||||
| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Longitudinal, Defined Population, Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: patient-driven health IT product | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 3000 | ||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00457600 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CHB-R01HS014947 | ||||
| Study Sponsor ICMJE | Children's Hospital Boston | ||||
| Collaborators ICMJE | South Shore Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital Boston | ||||
| Verification Date | January 2007 | ||||
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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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