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

• ClinicalTrials.gov Identifier: NCT04125433
• Recruitment Status: Unknown
• First Posted: October 14, 2019
• Last Update Posted: October 14, 2019
• Sponsor: Northern New York Rural Behavioral Health Institute
• Information provided by (Responsible Party): Northern New York Rural Behavioral Health Institute

Tracking Information

• First Submitted Date: October 10, 2019
• First Posted Date: October 14, 2019
• Last Update Posted Date: October 14, 2019
• Estimated Study Start Date: August 1, 2020
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 11, 2019)

• 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
• 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
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 11, 2019)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: IT to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
• Official Title: Use of Information Technology to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Mental Health Issue
• Substance Use Disorders

Intervention

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.

Study Arms

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

Intervention: Behavioral: Peer Integrated Care Services

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 11, 2019): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2022
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04125433
• Other Study ID Numbers: NCBHNPIC
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Northern New York Rural Behavioral Health Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Northern New York Rural Behavioral Health Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Cawley, BBA; Northern NY Rural Behavioral Health Institute

• PRS Account: Northern New York Rural Behavioral Health Institute
• Verification Date: October 2019