Patient Navigation for Medicaid Frequent ED Users

March 26, 2020 updated by: Yale University

Patient Navigation to Improve Care and Reduce Costs for High Utilizers of the Emergency Department

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Navigator
Patients in the experimental group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH).
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
Patients in the active comparator group will experience the usual intake process in the ED setting.
Other: Standard of Care
Patients in the standard of care group will experience the usual intake process in the ED setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of ED visits
Time Frame: One Year
Additional outcomes include number of hospitalizations, number of outpatient visits, and outpatient imaging utilization.
One Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of hospitalizations
Time Frame: One Year
One Year
Number of outpatient visits
Time Frame: One Year
One Year
Costs by analyzing global use with Medicaid claims data
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1007007154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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