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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:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Jeremy Kahn, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE January 21, 2013
First Posted Date  ICMJE January 24, 2013
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE June 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01775033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
  • Incidence of emergency transfers to CHP after an index community ED visit [ Time Frame: 90 days ]
  • Incidence of emergency transfers to CHP that do not result in a hospital admission [ Time Frame: 90 days ]
  • Total health care encounters outside the county within three months after an index community ED visit [ Time Frame: 90 days ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regionalized Pediatric Emergency Care in Rural Pennsylvania
Official Title  ICMJE Regionalized Pediatric Emergency Care in Rural Pennsylvania: the Optimizing Utilization and Rural Emergency Access for Children Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Emergencies
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Multicomponent intervention
  • No Intervention: Control
    Hospitals in the control arm will receive usual care.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
5000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775033
Other Study ID Numbers  ICMJE H3AMC24076
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeremy Kahn, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Health Resources and Services Administration (HRSA)
Investigators  ICMJE
Study Director: Jeremy M Kahn, MD, MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP