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Regionalized Pediatric Emergency Care in Rural Pennsylvania (OUTREACH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Jeremy Kahn, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01775033
First received: January 21, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Emergencies [Disease/Finding]
 Other: Multicomponent intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Regionalized Pediatric Emergency Care in Rural Pennsylvania: the Optimizing Utilization and Rural Emergency Access for Children Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Average distance from home to the nearest facility with specialized pediatric emergency care capabilities [ Time Frame: One-year ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Incidence of emergency transfers to CHP after an index community ED visit [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Incidence of emergency transfers to CHP that do not result in a hospital admission [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Total health care encounters outside the county within three months after an index community ED visit [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Mortality after an index community ED visit for specified high-risk conditions (trauma, sepsis, and in the chronic disease population) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 5000
Study Start Date: June 2012
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multicomponent intervention
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
No Intervention: Control
Hospitals in the control arm will receive usual care.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775033

Locations
United States, Pennsylvania
University of Pittburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Health Resources and Services Administration (HRSA)
Investigators
Study Director: Jeremy M Kahn, MD, MS University of Pittsburgh
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jeremy Kahn, Associate Professor of Critical Care, Medicine and Health Policy & Management, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01775033     History of Changes
Other Study ID Numbers: H3AMC24076
Study First Received: January 21, 2013
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pediatrics
Emergency medical services
Emergency Treatment
Telemedicine

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013