- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125433
IT to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
October 11, 2019 updated by: Northern New York Rural Behavioral Health Institute
Use of Information Technology to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
400
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 Contact
- Name: Barry Brogan, MAPP
- Phone Number: 518-891-9460
- Email: barry@behaviorhealthnet.orh
Study Contact Backup
- Name: Robert Cawley, BBA
- Phone Number: 518-891-9460
- Email: robert@behaviorhealthnet.org
Study Locations
-
-
New York
-
Saranac Lake, New York, United States, 12983
- Northern New York Rural Behavioral Health Institute
-
Contact:
- Robert Cawley, BBA
- Phone Number: 518-891-9460
- Email: robert@behaviorhealthnet.org
-
Contact:
- Barry Brogan, MAPP
- Phone Number: 518-891-9460
- Email: barry@behaviorhealthnet.org
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medicaid Emergency Department High Utilizers
This Arm will include the following individuals
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Months 6, 12, 18, 24
|
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
|
Months 0, 3, 6, 9, 12, 15, 18, 21, 24
|
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.
|
Month 0, Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Month 0, 6, 12,18,24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert Cawley, BBA, Northern NY Rural Behavioral Health Institute
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 (Anticipated)
August 1, 2020
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
August 30, 2022
Study Registration Dates
First Submitted
October 10, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 14, 2019
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
October 11, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCBHNPIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Substance Use Disorders
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use Disorder | Cocaine Use DisorderUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Substance Use Disorders | Cannabis Use | Alcohol Use, UnspecifiedUnited States
-
Woebot HealthNational Institute on Drug Abuse (NIDA); Stanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingSubstance Use | Substance Use Disorders | Substance DependenceUnited States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Wake Forest University Health SciencesNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Opioid Use | Drug Use | Substance MisuseUnited States
-
Centre for Addiction and Mental HealthUniversity of Missouri, St. LouisCompletedSubstance Use Disorders | Alcohol Use DisorderCanada
-
Istanbul UniversityCompletedSubstance Use | Substance Use Disorders | Substance AbuseTurkey
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)CompletedPTSD | Alcohol Use Disorders | Substance Use DisordersUnited States
Clinical Trials on Peer Integrated Care Services
-
Illinois Institute of TechnologyArizona State University; Thresholds Inc.RecruitingMental Disorder | Physical IllnessUnited States
-
Illinois Institute of TechnologyNational Institute on Minority Health and Health Disparities (NIMHD); ACCESS... and other collaboratorsCompletedObesity | Mental DisorderUnited States
-
Shanghai 6th People's HospitalUniversity of North Carolina, Chapel Hill; Merck FoundationCompletedPreDiabetes | Type2 DiabetesChina
-
University of California, San FranciscoBill and Melinda Gates Foundation; Kenya Medical Research Institute; Ibis Reproductive... and other collaboratorsCompletedHIV Infections | Unintended PregnancyKenya
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
University of WashingtonPatient-Centered Outcomes Research InstituteActive, not recruitingPTSD | Physical InjuryUnited States
-
Oklahoma State UniversityMakerere University; Lutheran World Federation; Nestlé Foundation for the Study...CompletedInfant MalnutritionUganda
-
University of Wisconsin, MadisonPatient-Centered Outcomes Research Institute; Community Place; Jewish Family... and other collaboratorsCompletedHospitalization | Emergency Room | Wellness ProgramsUnited States
-
University of California, San FranciscoCenters for Disease Control and Prevention; Kenya Medical Research InstituteCompletedHIV InfectionsKenya
-
Health Resources and Services Administration (HRSA)University of Pennsylvania; University of California, Davis; University of Rochester and other collaboratorsCompleted