Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children
NCT ID: NCT04192799
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1997 participants
INTERVENTIONAL
2020-02-01
2023-07-31
Brief Summary
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Detailed Description
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To achieve these Aims, a stepped-wedge cluster randomized controlled trial at three geographically diverse hospitals in the United States will be conducted, randomizing primary and urgent care practices in the hospitals' catchment area to cross over to the direct admission intervention at four time points. Linear models with random effects for clusters and time period fixed effects will be used to evaluate outcomes associated with the direct admission intervention. To examine for heterogeneity of treatment effects, interactions between direct admission and a priori-specified subgroups will be examined.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Direct Admission
Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit.
Direct admission
Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
ED Admission
Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit.
ED admission
Process of pediatric admission is through the emergency department
Interventions
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Direct admission
Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
ED admission
Process of pediatric admission is through the emergency department
Eligibility Criteria
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Inclusion Criteria
* gastroenteritis
* dehydration
* skin and soft tissue infection
* urinary tract infection/pyelonephritis
* pneumonia
* viral infection not otherwise specified
* influenza
Exclusion Criteria
* with planned admissions (i.e., chemotherapy)
* admitted to non-pediatric hospital medicine services (i.e., intensive care)
* transferred from other hospitals
30 Days
17 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Nationwide Children's Hospital
OTHER
Providence Health & Services
OTHER
University of Pittsburgh
OTHER
Dartmouth College
OTHER
Seattle Children's Hospital
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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JoAnna K. Leyenaar
Vice Chair of Research and Associate Professor, Department of Pediatrics
Principal Investigators
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JoAnna K Leyenaar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center; Geisel School of Medicine at Dartmouth
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Providence Regional Medical Center - Everett
Everett, Washington, United States
Countries
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References
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Leyenaar JK, McDaniel CE, Acquilano SC, Schaefer AP, Bruce ML, O'Malley AJ. Comparative effectiveness of direct admission and admission through emergency departments for children: a randomized stepped wedge study protocol. Trials. 2020 Nov 30;21(1):988. doi: 10.1186/s13063-020-04889-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IHS-2018C2-12902-IC
Identifier Type: -
Identifier Source: org_study_id
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