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

NCT04192799 | Completed Results

• 1 other identifier: IHS-2018C2-12902-IC
• Study Type: interventional
• Target: 1,997
• Locations: 1 country
• Sites: 3

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.

Conditions

Hospitalization; Child Health

Outcome Measures

Primary Outcomes (3)

• Timeliness of Clinical Care - Initial Therapeutic Management

  Length of time from arrival at the hospital until time of first antibiotics, IV placement, fluid administration, or other medications

  within 6 hours of hospital admission

• Timeliness of Clinical Care - Initial Clinical Assessment

  Length of time from arrival at the hospital until first time when at least 3 vital signs were documented; if missing, time of initial brief nursing assessment

  within 6 hours of hospital admission

• Timeliness of Clinical Care - Initial Diagnostic Testing

  Length of time from arrival at the hospital until time of initial labs and/or imaging, including "standing orders" for diagnostic testing in emergency departments

  within 6 hours of hospital admission

Secondary Outcomes (2)

• Number of Participants With Clinical Deterioration

  within 6 hours of arrival on the inpatient unit

• Pediatric Hospitalization Admission Survey of Experience (PHASE)

  Within 72 hours of hospital admission

Study Arms (2)

Direct Admission

EXPERIMENTAL

Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit.

Behavioral: Direct admission

ED Admission

ACTIVE COMPARATOR

Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit.

Behavioral: ED admission

Interventions

Direct admission BEHAVIORAL

Process of pediatric admission is through admission directly into the pediatric hospital medicine unit

Direct Admission

ED admission BEHAVIORAL

Process of pediatric admission is through the emergency department

ED Admission

Eligibility Criteria

• Age: 30 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Nationwide Children's Hospital: collaborator
• Providence Health & Services: collaborator
• University of Pittsburgh: collaborator
• Dartmouth College: collaborator
• Seattle Children's Hospital: collaborator

Study Sites (3)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Providence Regional Medical Center - Everett

Everett, Washington, 98201, United States

Location

Related Publications (1)

• 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.

  PMID: 33256850 DERIVED

Limitations and Caveats

This study was implemented six weeks prior to the COVID-19 pandemic, which led to unprecedented changes to healthcare. Early in the pandemic, closures of primary care clinics, transitions to telehealth, and low ED volumes may have decreased DA access and improved relative timeliness of ED care. Throughout the study, pandemic-associated staffing challenges, shortages of bed availability, and pediatric unit closures (which were observed nationally) continued to impact the project.

Results Point of Contact

• Title: Stephanie Acquilano, Research Project Director
• Organization: The Dartmouth Institute for Health Policy & Clinical Practice

stephanie.acquilano@dartmouth.edu

603-646-5937

Study Officials

• JoAnna K Leyenaar, MD, PhD

  Dartmouth-Hitchcock Medical Center; Geisel School of Medicine at Dartmouth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research and Associate Professor, Department of Pediatrics

Model Details: stepped-wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: February 1, 2020
• Primary Completion: April 30, 2023
• Study Completion: July 31, 2023
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)