Mental Health IssueNCT04125433
IT to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
A study testing Peer Integrated Care Services in people with Mental Health Issue and Substance Use Disorders, run by Northern New York Rural Behavioral Health Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Health Issue, Substance Use Disorders
- What is being tested?
- Peer Integrated Care Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals not assigned by a Managed Care Organization meeting the above criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern New York Rural Behavioral Health Institute
Saranac Lake, New York, 12983
Barry Brogan, MAPP, 518-891-9460, barry@behaviorhealthnet.org
Robert Cawley, BBA, 518-891-9460, robert@behaviorhealthnet.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue, Substance Use Disorders
- Being tested
- Peer Integrated Care Services
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Integrated Care ServicesBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Peer Integrated Care Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adoption and Use of IT Platform
Change in Number of Participating Agencies That Contribute Data to the IT System
Measured: 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
Measured: 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.
Measured: Month 0, Month 24
Secondary outcomes (1)
Change in Emergency Room Visits by Participating Members
Change in rate of Emergency Department utilization by participating members.
Measured: Month 0, 6, 12,18,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Aug 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern New York Rural Behavioral Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cawley, BBA, Principal investigator, Northern NY Rural Behavioral Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125433
- Sponsor's protocol ID
- NCBHNPIC
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Information Technology to Support Integration of Social Determinant of Health Services to Reduce Avoidable Emergency Department Visits
- ClinicalTrials.gov ID
- NCT04125433
- Acronym / sponsor ID
- NCBHNPIC
- Conditions
- Mental Health Issue, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Northern New York Rural Behavioral Health InstituteUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medicaid Emergency Department High Utilizers | Experimental | Behavioral: Peer Integrated Care ServicesThis 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals not assigned by a Managed Care Organization meeting the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Integrated Care ServicesThe 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. | Behavioural | Medicaid Emergency Department High Utilizers |
Primary outcome
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.
1 secondary outcome
Change in Emergency Room Visits by Participating Members
Time frame: Month 0, 6, 12,18,24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Cawley, BBA principal investigator
Northern NY Rural Behavioral Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Integrated Care Services in people with Mental Health Issue and Substance Use Disorders, run by Northern New York Rural Behavioral Health Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barry Brogan, MAPP (518-891-9460, barry@behaviorhealthnet.orh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adoption and Use of IT Platform (time frame: Months 6, 12, 18, 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.