Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children

NCT ID: NCT04192799

Last Updated: 2024-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1997 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-07-31

Brief Summary

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At a national level, emergency departments (EDs) serve as the portal of hospital admission for 75% of hospitalized children. The remainder occur via direct admission, defined as admission to hospital without first receiving care in the hospital's ED. The overall goals of this research are to: (i) implement pediatric direct admission systems at 3 hospitals, (ii) compare the timeliness of healthcare delivery for children who are admitted directly and through emergency departments, (iii) determine which patient populations achieve the greatest benefits from direct admission, and (iv) identify barriers and facilitators of successful implementation.

Detailed Description

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The Specific Aims of this research are to: (i) Determine the effect of a pediatric direct admission system on timeliness of healthcare provision (the investigator's primary outcome), family experience of care, and rates of clinical deterioration compared to hospital admission beginning in the ED; (ii) Identify the pediatric populations and conditions that experience the greatest benefits from direct admission; and (iii) Through interviews with key informants, identify barriers to and facilitators of implementing standardized direct admission processes.

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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Hospitalization Child Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

stepped-wedge cluster randomized controlled trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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.

Group Type EXPERIMENTAL

Direct admission

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

ED admission

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

ED admission

Process of pediatric admission is through the emergency department

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Child has one of the following presenting diagnoses:

* gastroenteritis
* dehydration
* skin and soft tissue infection
* urinary tract infection/pyelonephritis
* pneumonia
* viral infection not otherwise specified
* influenza

Exclusion Criteria

Ineligible children include those:

* with planned admissions (i.e., chemotherapy)
* admitted to non-pediatric hospital medicine services (i.e., intensive care)
* transferred from other hospitals
Minimum Eligible Age

30 Days

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Providence Health & Services

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Dartmouth College

OTHER

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JoAnna K. Leyenaar

Vice Chair of Research and Associate Professor, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Providence Regional Medical Center - Everett

Everett, Washington, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 33256850 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IHS-2018C2-12902-IC

Identifier Type: -

Identifier Source: org_study_id

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