Patient Navigation for Medicaid Frequent ED Users

This study has been completed.
Information provided by (Responsible Party):
Yale University Identifier:
First received: February 20, 2013
Last updated: July 14, 2015
Last verified: July 2015
A large proportion of frequent ED users have Medicaid insurance. The purpose of this study is to evaluate the effectiveness of patient navigation for reducing Emergency Department (ED) visits and hospitalizations and improving patient-centered outcomes (e.g., self-reported health status, quality of life, access/barriers to care) among Medicaid patients who are high utilizers of the ED, as well as to identify best practices for engaging and providing healthcare services to underserved patients using patient navigation. This study will address needs that have been identified within the New Haven community and the local healthcare system, contribute to knowledge and literature surrounding the use of patient navigation to improve care for underserved patients and improve health system efficiency, and inform the design and development of programs that address these needs both locally and in other communities.

Condition Intervention
Chronic Illness
Behavioral: Patient Navigator
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Patient Navigation to Improve Care and Reduce Costs for High Utilizers of the Emergency Department

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Number of ED visits [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Additional outcomes include number of hospitalizations, number of outpatient visits, and outpatient imaging utilization.

Secondary Outcome Measures:
  • Number of hospitalizations [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Number of outpatient visits [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Costs by analyzing global use with Medicaid claims data [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2013
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient Navigator Behavioral: Patient Navigator
Patients in the intervention group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH), a local non-profit organization that coordinates the provision of donated medical care and services to underserved patients through a network of participating hospitals and volunteer physicians.
Active Comparator: Standard of Care Other: Standard of Care


Ages Eligible for Study:   18 Years to 62 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 4-18 ED visits per year
  • Frequent ED users
  • age 18 to 62
  • Medicaid insurance only
  • Those living in the greater New Haven area (i.e. having a zip code that matches that)

Exclusion Criteria:

  • the current visit for primary psychiatric or substance abuse
  • more than 50% of all ED visits in the past year for primary psychiatric or substance abuse.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01797068

United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States
Sponsors and Collaborators
Yale University
  More Information

Responsible Party: Yale University Identifier: NCT01797068     History of Changes
Other Study ID Numbers: UL1RR024139 
Study First Received: February 20, 2013
Last Updated: July 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes processed this record on May 26, 2016