NCT01797068

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

March 30, 2020

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

February 20, 2013

Last Update Submit

March 26, 2020

Conditions

Keywords

HEALTHCARE UTILIZATIONED UTILIZATIONPRIMARY CARE UTILIZATIONPATIENT NAVIGATIONUNDERSERVED POPULATIONSHEALTH DISPARITIES

Outcome Measures

Primary Outcomes (1)

  • Number of ED visits

    Additional outcomes include number of hospitalizations, number of outpatient visits, and outpatient imaging utilization.

    One Year

Secondary Outcomes (3)

  • Number of hospitalizations

    One Year

  • Number of outpatient visits

    One Year

  • Costs by analyzing global use with Medicaid claims data

    One year

Study Arms (2)

Patient Navigator

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

Patients in the active comparator group will experience the usual intake process in the ED setting.

Other: Standard of Care

Interventions

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.

Patient Navigator

Patients in the standard of care group will experience the usual intake process in the ED setting.

Standard of Care

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, United States

Location

MeSH Terms

Conditions

Chronic Disease

Interventions

Patient NavigationStandard of Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Last Updated

March 30, 2020

Record last verified: 2016-11

Locations