HospitalizationNCT04192799

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

A study testing Direct admission and ED admission in people with Hospitalization and Child Health, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 days to 17 years
Conditions the study is for: Hospitalization, Child Health
What is being tested?: Direct admission and ED admission
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,997 participants
Where: 3 sitesUnited States
Study dates: 1 Feb 2020to 31 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 days to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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.

Read the 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.

Conditions: Hospitalization, Child Health
Being tested: Direct admission, ED admission

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct admissionBehavioural
Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
ED admissionBehavioural
Process of pediatric admission is through the emergency department

Study groups in NCT04192799
Study group	Role	What they receive
Direct Admission	Experimental	Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Receives: Behavioral: Direct admission
ED Admission	Active comparator	Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. Receives: Behavioral: ED admission

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: within 6 hours of hospital admission

Secondary outcomes (2)

Number of Participants With Clinical Deterioration
Transfer for pediatric intensive care or rapid response calls
Measured: 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
Measured: Within 72 hours of hospital admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202031 Jul 2023

First posted10 Dec 2019
Study start1 Feb 2020
Primary completion30 Apr 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HospitalizationStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: stepped-wedge cluster randomized controlled trial
Masking: None (open label)
Enrolment: 1,997 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04192799
Sponsor's protocol ID: IHS-2018C2-12902-IC
Status last verified: Aug 2024
First submitted: 6 Dec 2019
Last updated: 21 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 33256850

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
Osteomyelitis
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)

All Hospitalization trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children
ClinicalTrials.gov ID: NCT04192799
Acronym / sponsor ID: IHS-2018C2-12902-IC
Conditions: Hospitalization, Child Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,997 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, Nationwide Children's Hospital, Providence Health & Services, University of Pittsburgh, Dartmouth College, Seattle Children's Hospital
Study start: 1 Feb 2020 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 10 Dec 2019 (actual)
Results: Posted 21 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: stepped-wedge cluster randomized controlled trial

Arm	Type	Receives
Direct Admission	Experimental	Behavioral: Direct admissionReferring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit.
ED Admission	Active comparator	Behavioral: ED admissionChildren initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit.

Who may qualify

Ages: 30 days to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

gastroenteritis
dehydration
skin and soft tissue infection
urinary tract infection/pyelonephritis
pneumonia

Key exclusion criteria (4 listed)

with planned admissions (i.e., chemotherapy)
admitted to non-pediatric hospital medicine services (i.e., intensive care)
transferred from other hospitals

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Direct admissionProcess of pediatric admission is through admission directly into the pediatric hospital medicine unit	Behavioural	Direct Admission
ED admissionProcess of pediatric admission is through the emergency department	Behavioural	ED Admission

Primary outcome

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
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
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

2 secondary outcomes

Number of Participants With Clinical Deterioration
Time frame: within 6 hours of arrival on the inpatient unit
Pediatric Hospitalization Admission Survey of Experience (PHASE)
Time frame: Within 72 hours of hospital admission

Results and safety

Results posted to the registry on 21 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Periods 1-4 With Direct Admission Intervention	134	134
Sequence 2: Periods 2-4 With Direct Admission Intervention	0	0
Sequence 3: Periods 3-4 With Direct Admission Intervention	0	0
Sequence 4: Period 4 With Direct Admission Intervention	0	0

Primary outcome: Timeliness of Clinical Care - Initial Therapeutic Management

Time frame: within 6 hours of hospital admission. Median (Inter-Quartile Range). Unit: minutes

Measure	Direct Admission n = 139	ED Admission n = 1786
Value	142 (96.5 to 209.5)	153 (85 to 258)

Direct Admission vs ED Admission: Mean Ratio: 0.74 (95% CI 0.65 to 0.85), p <0.001, Gamma Regression with Log Link Function

Population analysed: These analyses include only those admissions that occurred following each clinic's respective DA program start date and for whom data were obtained.

Primary outcome: Timeliness of Clinical Care - Initial Clinical Assessment

Time frame: within 6 hours of hospital admission. Median (Inter-Quartile Range). Unit: minutes

Measure	Direct Admission n = 145	ED Admission n = 1852
Value	25 (19 to 31)	13 (7 to 30)

Direct Admission vs ED Admission: Mean Ratio: 1.12 (95% CI 1.06 to 1.19), p <0.001, Gamma Regression with Log Link Function

Population analysed: These analyses include all admissions that occurred following each clinic's respective DA program start date.

Primary outcome: Timeliness of Clinical Care - Initial Diagnostic Testing

Time frame: within 6 hours of hospital admission. Median (Inter-Quartile Range). Unit: minutes

Measure	Direct Admission n = 141	ED Admission n = 1,805
Value	120.5 (83 to 171)	99 (48 to 186)

Direct Admission vs ED Admission: Mean Ratio: 0.93 (95% CI 0.80 to 1.09), p = 0.37, Gamma Regression with Log Link Function

Population analysed: These analyses include only those admissions that occurred following each clinic's respective DA program start date and for whom data were obtained.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 hours (first 6 hours post inpatient admission). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Direct Admission	0 of 145 (0%)	0 of 145 (0%)	0 of 145
ED Admission	0 of 1,852 (0%)	0 of 1,852 (0%)	0 of 1,852

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33256850Leyenaar 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.
Individual participant dataSharing planned: No

Related trials for Hospitalization

Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
Osteomyelitis
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JoAnna K Leyenaar, MD, PhD principal investigator

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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Direct admission and ED admission in people with Hospitalization and Child Health, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timeliness of Clinical Care - Initial Therapeutic Management (time frame: within 6 hours of hospital admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04192799, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.