We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Regionalized Pediatric Emergency Care in Rural Pennsylvania (OUTREACH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01775033
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Emergencies Other: Multicomponent intervention

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2012
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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.
No Intervention: Control
Hospitals in the control arm will receive usual care.


Outcome Measures

Primary Outcome Measures :
  1. Average distance from home to the nearest facility with specialized pediatric emergency care capabilities [ Time Frame: One-year ]
    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 :
  1. Incidence of emergency transfers to CHP after an index community ED visit [ Time Frame: 90 days ]
  2. Incidence of emergency transfers to CHP that do not result in a hospital admission [ Time Frame: 90 days ]
  3. Total health care encounters outside the county within three months after an index community ED visit [ Time Frame: 90 days ]
  4. Mortality after an index community ED visit for specified high-risk conditions (trauma, sepsis, and in the chronic disease population) [ Time Frame: 90 days ]
    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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
Obsolete Identifiers: NCT02306408
Other Study ID Numbers: H3AMC24076
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes