NCT01775033

Brief Summary

The overall goal of this project is to develop and evaluate an organized, regional system of pediatric emergency care in rural western Pennsylvania.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

January 21, 2013

Last Update Submit

October 25, 2016

Conditions

Keywords

PediatricsEmergency medical servicesEmergency TreatmentTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Average distance from home to the nearest facility with specialized pediatric emergency care capabilities

    This population-based outcome will act as a measure of access and relates to HRSA Maternal Child Health Bureau performance measure AHS-8 and AHS-9 (access to pre-hospital EMS and wait times)

    One-year

Secondary Outcomes (4)

  • Incidence of emergency transfers to CHP after an index community ED visit

    90 days

  • Incidence of emergency transfers to CHP that do not result in a hospital admission

    90 days

  • Total health care encounters outside the county within three months after an index community ED visit

    90 days

  • Mortality after an index community ED visit for specified high-risk conditions (trauma, sepsis, and in the chronic disease population)

    90 days

Study Arms (2)

Multicomponent intervention

EXPERIMENTAL

Hospitals in the experimental arm will receive a four-component intervention that integrates local education, community outreach, telemedicine and protocolized triage and transport

Other: Multicomponent intervention

Control

NO INTERVENTION

Hospitals in the control arm will receive usual care.

Interventions

Develop, implement and evaluate an organized system of regional pediatric emergency care in rural Western Pennsylvania using four pillars: education, community, protocolized triage and transport, and telemedicine.

Multicomponent intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pennsylvania
  • Medicaid beneficiary
  • Less than or equal to 18 years of age

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (2)

  • Lorch SA, Myers S, Carr B. The regionalization of pediatric health care. Pediatrics. 2010 Dec;126(6):1182-90. doi: 10.1542/peds.2010-1119. Epub 2010 Nov 1.

    PMID: 21041285BACKGROUND
  • Berger E. Growing pains: Report notes pediatric emergencies need greater emphasis. Ann Emerg Med. 2006 Aug;48(2):143-4. doi: 10.1016/j.annemergmed.2006.06.024. No abstract available.

    PMID: 16953527BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeremy M Kahn, MD, MS

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Critical Care, Medicine and Health Policy & Management

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 24, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations