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

Hospitalization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192799
• Other study ID #: IHS-2018C2-12902-IC
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Stephanie C Acquilano, MA
• Phone: 603-848-4742
• Email: stephanie.c.acquilano[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1696
• Est. completion date: October 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Health
• Emergencies
• Hospitalization

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Providence Regional Medical Center - Everett	Everett	Washington
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute, Providence Regional Medical Center, Seattle Children's Hospital, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeliness of clinical care	Length of time from arrival at the hospital until initiation of definitive clinical care.	within 6 hours of hospital admission
Secondary	Rate of clinical deterioration	Transfer for pediatric intensive care, rapid response calls	within 6 hours of hospital admission
Secondary	High turnover hospitalization	Total length of stay in the hospital of less than 12 and/or 24 hours	within 24 hours of hospital admission
Secondary	Family hospital admission experience	Standardized closed-ended survey questions re. 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 0-100 scale, with higher scores indicating better family experience	Within 72 hours of hospital admission