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

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.

Study Overview

• Status: Completed
• Conditions: Hospitalization; Child Health
• Intervention / Treatment: Behavioral: Direct admission; Behavioral: ED admission

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.

• Study Type: Interventional
• Enrollment (Actual): 1997
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center - Everett

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Direct Admission; Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit.	Behavioral: Direct admission; Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
Active Comparator: ED Admission; Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit.	Behavioral: ED admission; Process of pediatric admission is through the emergency department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Deterioration	Transfer for pediatric intensive care or rapid response calls	within 6 hours of arrival on the inpatient unit
Pediatric Hospitalization Admission Survey of Experience (PHASE)	Standardized closed-ended survey questions regarding parent-reported experience of hospital admission with respect to the admission process, communication with families, communication between providers, and the hospital space; composite measure on 0-1 scale, with higher scores indicating better family experience	Within 72 hours of hospital admission

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; University of Pittsburgh; Seattle Children's Hospital; Nationwide Children's Hospital; Dartmouth College; Providence Regional Medical Center
• Investigators: Principal Investigator: JoAnna K Leyenaar, MD, PhD, Dartmouth-Hitchcock Medical Center; Geisel School of Medicine at Dartmouth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: IHS-2018C2-12902-IC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No