Clinical trial NCT04192799: Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children
Official title: Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization
Child Health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Nationwide Children's Hospital
name: Providence Health & Services
name: University of Pittsburgh
name: Dartmouth College
name: Seattle Children's Hospital
First posted: 2019-12-10
Enrollment: 1997
Sex: ALL
Minimum age (years): 30
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: stepped-wedge cluster randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Timeliness of Clinical Care - Initial Therapeutic Management
timeFrame: within 6 hours of hospital admission
measure: Timeliness of Clinical Care - Initial Clinical Assessment
timeFrame: within 6 hours of hospital admission
measure: Timeliness of Clinical Care - Initial Diagnostic Testing
timeFrame: within 6 hours of hospital admission
Secondary outcomes:
measure: Number of Participants With Clinical Deterioration
timeFrame: within 6 hours of arrival on the inpatient unit
measure: Pediatric Hospitalization Admission Survey of Experience (PHASE)
timeFrame: Within 72 hours of hospital admission
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Everett
country: United States
facility: Providence Regional Medical Center - Everett
state: Washington
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center; Geisel School of Medicine at Dartmouth
name: JoAnna K Leyenaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.