Telehealth Care-Coordination for Mental Illness

(BHH Trial)

Overseen By George Unick, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Psychiatric medications

Disqualifiers: Unable to have Medherent device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the Medherent platform, a telehealth service that helps people with serious mental illnesses manage their medications and health care. It targets those who often miss their medications and have poor health outcomes. The platform provides remote support to improve their health and reduce hospital visits.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be prescribed psychiatric medications, it seems likely that you will continue your current medication regimen.

What data supports the effectiveness of the treatment Medherent in the Telehealth Care-Coordination for Mental Illness trial?

Research shows that telehealth programs using psychological techniques, like ScriptAssist, can improve medication adherence and reduce emergency visits for people with serious mental illness. Additionally, care coordination, which integrates care across different providers, is recognized as crucial for improving mental health services. ^{1 2 3 4 5}

Is telehealth care-coordination for mental illness safe for humans?

Telehealth care for mental illness, including services like Medherent, generally involves safety planning and protocols to manage risks, such as suicide risk, during virtual treatment. Studies highlight the importance of having emergency protocols and safety measures in place, which are adapted from best practices and guidelines to ensure patient safety during telehealth sessions. ^{6 7 8 9 10}

How is the treatment Medherent unique for mental illness?

Medherent is unique because it combines telehealth care-coordination with medication management, allowing patients to receive mental health support remotely. This approach can improve access to care and ensure consistent treatment adherence, which is particularly beneficial for individuals with severe mental illness who may face barriers to in-person visits. ^{2 4 11 12 13}

Research Team

George Unick

Principal Investigator

University of Maryland

Eligibility Criteria

This trial is for adults aged 18-80 with Serious Mental Illness (SMI) who are prescribed psychiatric medications and receive services from a participating community mental health agency. They must be willing to have the Medherent device in their residence, either as current users or new participants.

Inclusion Criteria

I am taking medication for a mental health condition.

Sample 2: Willing or able to authorize to have the Medherent device in your residence

Serious Mental Illness Diagnosis

Exclusion Criteria

Unable to have the Medherent device in residence

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Medherent medication management platform and receive telehealth care-coordination services

12 months

Monthly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Medherent

Trial Overview The study tests the Medherent medication management platform along with additional telehealth care-coordination services aimed at improving health outcomes for individuals with SMI living in community settings.

Participant Groups

Group I: New Medherent Experimental Treatment 1 Intervention

Group using Medherent Device with added interventional components.

Group II: Usual Care Active Control 1 Intervention

Usual Care: no intervention elements.

Group III: Existing Medherent Active Control 1 Intervention

Group using the Medherent Device with no added intervention components.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of telephone counseling on antipsychotic adherence and emergency department utilization. [2018]

2. England pubmed.ncbi.nlm.nih.gov

EPA guidance on the quality of mental health services: A systematic meta-review and update of recommendations focusing on care coordination. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Telephone-based psychiatric referral-care management intervention health outcomes. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Care coordination as a collaborative element of recovery oriented services for persons with severe mental illness. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of telephone-based referral care management, a brief intervention to improve psychiatric treatment engagement. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Suicide risk management during clinical telepractice. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Home-based telemental healthcare safety planning: what you need to know. [2012]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Suicide after contact with a national digital mental health service. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Socially Distanced Emergencies: Clinicians' Experience with Tele-behavioral Health Safety Planning. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Mental health telephone triage: managing psychiatric crisis and emergency. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Telemental Health and the Management of Psychosis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Integrating mental health specialty services via telehealth. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Tele-mental Health Transitions for Pennsylvania Coordinated Specialty Care Programs for Early Psychosis During the COVID-19 Pandemic. [2023]