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

Primary Purpose

Hospitalization, Child Health

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct admission
ED admission
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospitalization

Eligibility Criteria

30 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's HospitalRecruiting
  • UPMC Children's Hospital of PittsburghRecruiting
  • Providence Regional Medical Center - EverettRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Direct Admission

ED Admission

Arm Description

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

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

Outcomes

Primary Outcome Measures

Timeliness of clinical care
Length of time from arrival at the hospital until initiation of definitive clinical care.

Secondary Outcome Measures

Rate of clinical deterioration
Transfer for pediatric intensive care, rapid response calls
High turnover hospitalization
Total length of stay in the hospital of less than 12 and/or 24 hours
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

Full Information

First Posted
December 6, 2019
Last Updated
July 31, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, Nationwide Children's Hospital, Providence Regional Medical Center, University of Pittsburgh, Dartmouth College, Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04192799
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, Nationwide Children's Hospital, Providence Regional Medical Center, University of Pittsburgh, Dartmouth College, Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospitalization, Child Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
stepped-wedge cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1696 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct Admission
Arm Type
Experimental
Arm Description
Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit.
Arm Title
ED Admission
Arm Type
Active Comparator
Arm Description
Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit.
Intervention Type
Behavioral
Intervention Name(s)
Direct admission
Intervention Description
Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
Intervention Type
Behavioral
Intervention Name(s)
ED admission
Intervention Description
Process of pediatric admission is through the emergency department
Primary Outcome Measure Information:
Title
Timeliness of clinical care
Description
Length of time from arrival at the hospital until initiation of definitive clinical care.
Time Frame
within 6 hours of hospital admission
Secondary Outcome Measure Information:
Title
Rate of clinical deterioration
Description
Transfer for pediatric intensive care, rapid response calls
Time Frame
within 6 hours of hospital admission
Title
High turnover hospitalization
Description
Total length of stay in the hospital of less than 12 and/or 24 hours
Time Frame
within 24 hours of hospital admission
Title
Family hospital admission experience
Description
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
Time Frame
Within 72 hours of hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie C Acquilano, MA
Phone
603-848-4742
Email
stephanie.c.acquilano@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnna K Leyenaar, MD, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center; Geisel School of Medicine at Dartmouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie M Lauden, MD
Email
Steph.Lauden@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Ryan Bode, MD
First Name & Middle Initial & Last Name & Degree
Alex Kemper, MD
First Name & Middle Initial & Last Name & Degree
Christine Schmerge, MD
First Name & Middle Initial & Last Name & Degree
Stephanie Lauden, MD
First Name & Middle Initial & Last Name & Degree
Guliz Erdem, MD
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvia Choi, MD
Email
choiss1@upmc.edu
First Name & Middle Initial & Last Name & Degree
Allison Fleischer, MD
Email
allison.fleischer@chp.edu
First Name & Middle Initial & Last Name & Degree
Amy Houtrow, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sylvia Choi, MD
First Name & Middle Initial & Last Name & Degree
Allison Fleischer, MD
Facility Name
Providence Regional Medical Center - Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrie McDaniel, DO
Email
Corrie.McDaniel@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Corrie McDaniel, MD
First Name & Middle Initial & Last Name & Degree
Kimberly Arthur, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33256850
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.
Results Reference
derived

Learn more about this trial

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

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