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Completed

NCT Number: NCT04192799

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.

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Key information

Conditions

Hospitalization Child Health

Age range

30 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct admission

Behavioral

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

ED admission

Behavioral

Process of pediatric admission is through the emergency department

Primary outcomes

  1. Timeliness of Clinical Care - Initial Therapeutic Management

    Time frame: within 6 hours of hospital admission

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

  2. Timeliness of Clinical Care - Initial Clinical Assessment

    Time frame: within 6 hours of hospital admission

    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

  3. Timeliness of Clinical Care - Initial Diagnostic Testing

    Time frame: within 6 hours of hospital admission

    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

Secondary outcomes

  1. Number of Participants With Clinical Deterioration

    Time frame: within 6 hours of arrival on the inpatient unit

    Transfer for pediatric intensive care or rapid response calls

  2. Pediatric Hospitalization Admission Survey of Experience (PHASE)

    Time frame: Within 72 hours of hospital admission

    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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College
  • Nationwide Children's Hospital
  • Patient-Centered Outcomes Research Institute
  • Providence Health & Services
  • Seattle Children's Hospital
  • University of Pittsburgh

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2019
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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