We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

IT to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits

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: NCT04125433
Recruitment Status : Unknown
Verified October 2019 by Northern New York Rural Behavioral Health Institute.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Northern New York Rural Behavioral Health Institute

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.

Condition or disease Intervention/treatment Phase
Mental Health Issue Substance Use Disorders Behavioral: Peer Integrated Care Services Not Applicable

Detailed Description:
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 by Peer Support Specialist (the peer) as well as in the community for prevention visits and follow up by both the peer and Community Health Advocate. These well-positioned Peers and Community Health Advocates will address Behavioral and Social Determinants of Health (SDoH) concerns through a highly 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 trusting relationship with the members and will improve member access and engagement with community-based services. The project will also seek to determine the impact on total cost of care through redirecting study participants to community resources that are more appropriate, and less expensive than return visits to the emergency department.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Information Technology to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 30, 2022

Arm Intervention/treatment
Experimental: Medicaid Emergency Department High Utilizers

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
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.




Primary Outcome Measures :
  1. Change in Adoption and Use of IT Platform [ Time Frame: Months 6, 12, 18, 24 ]
    Change in Number of Participating Agencies That Contribute Data to the IT System

  2. Change in Engagement of Medicaid Member Participants with Peer Integration Care Services [ Time Frame: Months 0, 3, 6, 9, 12, 15, 18, 21, 24 ]
    The change in acceptance by Medicaid Members of Peer Integrated Care Services

  3. Change in Total Cost of Care for Participating Members [ Time Frame: Month 0, Month 24 ]
    Change in cost trend for participating members. Pre-study vs. study period.


Secondary Outcome Measures :
  1. Change in Emergency Room Visits by Participating Members [ Time Frame: Month 0, 6, 12,18,24 ]
    Change in rate of Emergency Department utilization by participating members.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125433


Contacts
Layout table for location contacts
Contact: Barry Brogan, MAPP 518-891-9460 barry@behaviorhealthnet.orh
Contact: Robert Cawley, BBA 518-891-9460 robert@behaviorhealthnet.org

Locations
Layout table for location information
United States, New York
Northern New York Rural Behavioral Health Institute
Saranac Lake, New York, United States, 12983
Contact: Barry Brogan, MAPP    518-891-9460    barry@behaviorhealthnet.org   
Contact: Robert Cawley, BBA    518-891-9460    robert@behaviorhealthnet.org   
Sponsors and Collaborators
Northern New York Rural Behavioral Health Institute
Investigators
Layout table for investigator information
Principal Investigator: Robert Cawley, BBA Northern NY Rural Behavioral Health Institute
Layout table for additonal information
Responsible Party: Northern New York Rural Behavioral Health Institute
ClinicalTrials.gov Identifier: NCT04125433    
Other Study ID Numbers: NCBHNPIC
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Substance-Related Disorders
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders