NCT04125433

Brief Summary

Working through regional Accountable Care Organizations (ACO) the sponsor will establish a 2-year pilot project to demonstrate that early recognition and intervention in the various Social Determinant of Health (SDoH) domains can reduce avoidable Emergency Department (ED) visits by high utilizers. The regional ACO's will contract with Medicaid Managed Care Plans to assign traditional high ED utilizing members to the pilot project. Members will be offered enhanced peer facilitated care management services connecting members with available SDoH community based services. Members fitting our eligibility criteria will self-select by way of completing a pilot project consent form.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

October 10, 2019

Last Update Submit

October 11, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Adoption and Use of IT Platform

    Change in Number of Participating Agencies That Contribute Data to the IT System

    Months 6, 12, 18, 24

  • Change in Engagement of Medicaid Member Participants with Peer Integration Care Services

    The change in acceptance by Medicaid Members of Peer Integrated Care Services

    Months 0, 3, 6, 9, 12, 15, 18, 21, 24

  • Change in Total Cost of Care for Participating Members

    Change in cost trend for participating members. Pre-study vs. study period.

    Month 0, Month 24

Secondary Outcomes (1)

  • Change in Emergency Room Visits by Participating Members

    Month 0, 6, 12,18,24

Study Arms (1)

Medicaid Emergency Department High Utilizers

EXPERIMENTAL

This Arm will include the following individuals * Up to 400 Adults age 18 to 65 * New York State Medicaid Managed Care Members * Have utilized emergency department services 6 or more times in a 12-month period * Have been assigned to the Pilot Project by their Medicaid Managed Care Plan

Behavioral: Peer Integrated Care Services

Interventions

The project employs a two level intervention to include Peer Support Specialist (PSS) and Community Health Advocate (CHA). Contact and engagement with participating members will be through both direct intervention in the emergency department as well as in the community for prevention visits and follow up. Peers and Community Health Advocates will address Behavioral and Social Determinants of Health (SDoH) concerns through a coordinated intervention supported by a common IT Medicaid member tracking platform. This research project will determine the feasibility of deploying a single shared IT platform that will include referral, appointment completion, and intervention outcome data. Project staff will develop a relationship with the members improving member access and engagement with community-based services. The project will determine the impact on total cost of care through redirecting study participants to community resources rather than return visits to the emergency department.

Medicaid Emergency Department High Utilizers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18 to 65
  • New York State Medicaid Managed Care Members
  • Have utilized emergency department services 6 or more times in a 12-month period
  • Have been assigned to the Pilot Project by their Medicaid Managed Care Plan

You may not qualify if:

  • Individuals not assigned by a Managed Care Organization meeting the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern New York Rural Behavioral Health Institute

Saranac Lake, New York, 12983, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Robert Cawley, BBA

    Northern NY Rural Behavioral Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: In this study a Medicaid Managed Care Plan will identify up to 400 plan members who have visited an emergency department greater than 6 time in a 12-month period. These individuals will receive enhanced integrated peer care services and will be tracked across health and social service venues using a single IT platform. This study will examine the impact of this intervention on total cost of care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

August 1, 2020

Primary Completion

June 30, 2022

Study Completion

August 30, 2022

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations