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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775033
Other study ID # H3AMC24076
Secondary ID
Status Completed
Phase N/A
First received January 21, 2013
Last updated October 25, 2016
Start date June 2012
Est. completion date June 2016

Study information

Verified date October 2016
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


Description:

The OUTREACH project will develop, implement and evaluate an organized system of regional pediatric emergency care in rural western Pennsylvania. Toward that end the investigators have developed three broad goals: (1) to define the key barriers and potential solutions to regionalized pediatric emergency care through community stakeholder engagement; (2) to implement a regionalized system of pediatric emergency care using education, community outreach and telemedicine; and (3) evaluate the impact of the system on health care access and outcomes for rural children. The investigators will implement the intervention in a sample of rural hospitals in Pennsylvania using a staggered roll-out design, and compare outcomes of children seen in these hospitals to similar matched hospitals in the state, using Pennsylvania state Medicaid data to evaluate the impact of the intervention.


Other known NCT identifiers
  • NCT02306408

Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Pennsylvania

- Medicaid beneficiary

- Less than or equal to 18 years of age

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Multicomponent intervention
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.

Locations

Country Name City State
United States University of Pittburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Berger E. Growing pains: Report notes pediatric emergencies need greater emphasis. Ann Emerg Med. 2006 Aug;48(2):143-4. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Incidence of emergency transfers to CHP after an index community ED visit 90 days No
Secondary Incidence of emergency transfers to CHP that do not result in a hospital admission 90 days No
Secondary Total health care encounters outside the county within three months after an index community ED visit 90 days No
Secondary Mortality after an index community ED visit for specified high-risk conditions (trauma, sepsis, and in the chronic disease population) These outcomes will address our goal to increase child health and related to the HRSA Maternal Child Health Bureau performance measures MICH-1,2 and 3 90 days No
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