Thrive Intervention for Mental Illness

(THRIVE-SMI Trial)

Overseen By Kelvin Amenyedor, MD,MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under age 18

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

267 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Thrive Intervention treatment for mental illness?

The i-THRIVE model, which is part of the Thrive Intervention, has been used in over 70 areas in England to improve child and adolescent mental health services by providing a more integrated and needs-led service model. This approach has shown potential to increase access and involvement of patients with services, suggesting it could be effective for mental illness treatment. ^{1 2 3 4 5}

How is the Thrive Intervention for Mental Illness different from other treatments?

The Thrive Intervention is unique because it uses a peer-led approach, where individuals with similar experiences guide patients in managing their health and accessing care. This method focuses on improving self-management and healthcare utilization, which is different from traditional treatments that may not emphasize peer support and navigation. ^{3 6 7 8 9}

What is the purpose of this trial?

This study aims to evaluate the THRIVE clinical pathway at HUP-Cedar, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. The study will assess clinician/administrator perspectives on the pathway's feasibility, appropriateness, and acceptability and analyze referral patterns and post-discharge outcomes. The objectives are: 1. To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness. 2. To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care. Participants will be referred to home care services during hospitalization and seen by a home care nurse within 48 hours post-discharge. A discharging physician or Advanced Practice Provider will oversee care for 30 days or until a primary care or specialist visit. The Care Coordination Team will hold weekly case conferences for 30 days post-discharge to address both health and mental health needs. The study will compare outcomes of Medicaid-insured patients, including those with serious mental illness, to those receiving usual care.

Research Team

Jacqueline M Brooks Carthon, PhD,RN

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults with Medicaid insurance in Pennsylvania who have been hospitalized and agree to home care. It's designed to help those, especially with serious mental illness, transition after hospitalization.

Inclusion Criteria

I am covered by Medicaid.

Residing in the state of Pennsylvania

Experienced a hospitalization at study hospital

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intensive post-discharge case management and care coordination through the THRIVE intervention

4 weeks

Weekly case conferences

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of readmissions and ED visits

30 days

Qualitative Study

Interviews conducted to gather perceptions of the THRIVE clinical pathway and identify barriers and facilitators

18 months

Treatment Details

Interventions

• Thrive Intervention

Trial Overview The THRIVE clinical pathway is being tested. It includes a home care nurse visit within 48 hours of discharge and ongoing care coordination for 30 days, aiming to reduce readmissions and emergency visits compared to standard care.

Participant Groups

Group I: THRIVE Intervention Experimental Treatment 1 Intervention

THRIVE Intervention 1-month intensive post discharge case management and care coordination

Group II: Usual Care Active Control 1 Intervention

Discharge to home without intensive post-acute case management or care coordination.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Findings from Research

The i-THRIVE Programme is being implemented in over 70 areas in England to transform child and adolescent mental health services (CAMHS) using a needs-based care model, with a cohort study design comparing 10 i-THRIVE sites to 10 comparator sites.

This study aims to evaluate the effectiveness of the i-THRIVE model in improving mental health care for children and young people, potentially leading to significant improvements in service delivery and patient involvement if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for a multi-site cohort study to evaluate child and adolescent mental health service transformation in England using the i-THRIVE model. A, M., K, LB., E, S., et al.[2023]

In a study involving 147 clients with severe mental illness and substance use disorders, specialized treatments like behavioral skills training and case management led to significant improvements in psychosocial functioning, including better residential stability and work outcomes, as well as reductions in substance use symptoms.

The study also found that clients used fewer acute mental health services over time while increasing their engagement with outpatient and case management services, indicating a shift towards more stable and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating changes in symptoms and functioning of dually diagnosed clients in specialized treatment. Jerrell, JM., Ridgely, MS.[2019]

The Bridge intervention, a peer-led health navigator program, significantly reduced emergency room visits among 144 individuals with serious mental illnesses, showing its effectiveness in improving healthcare access.

While the intervention did not affect overall inpatient or outpatient service use, the reduction in emergency room visits suggests that it may help individuals manage their health more effectively and avoid crisis situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service Use by Medicaid Recipients With Serious Mental Illness During an RCT of the Bridge Peer Health Navigator Intervention. Kelly, EL., Hong, B., Duan, L., et al.[2021]

The American Association of Community Psychiatrists has developed guidelines aimed at improving continuity of care for individuals with severe behavioral health issues, emphasizing the importance of consistent treatment engagement.

These guidelines provide a framework for creating transition plans and evaluating service quality, which can help address the common problem of fragmented care in mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Association of Community Psychiatrists' principles for managing transitions in behavioral health services. Sowers, WE., Rohland, B.[2007]

The transition to Tennessee's TennCare Partners program led to a significant increase in the odds of patients losing continuity of antipsychotic therapy, with a multivariate odds ratio of 1.18, indicating a higher risk of missed treatment days.

Patients requiring more intensive treatment, such as depot injections or those with a history of hospitalization for psychosis, experienced the most pronounced negative effects, with a mean reduction of 14.4 days in antipsychotic therapy during follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a mental health "carve-out" program on the continuity of antipsychotic therapy. Ray, WA., Daugherty, JR., Meador, KG.[2019]

The Connected Care program significantly reduced mental health hospitalizations among adult Medicaid beneficiaries with serious mental illness, showing a decrease from 41.1 to 39.6 per 1000 members per month, while the comparison group experienced an increase.

Additionally, the program led to a nearly 10% reduction in all-cause readmissions within 30 days for the Connected Care group, highlighting its effectiveness in improving care coordination and potentially enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connected Care: improving outcomes for adults with serious mental illness. Schuster, JM., Kinsky, SM., Kim, JY., et al.[2018]

The Bridge intervention, which involved peer health navigation for individuals with serious mental illness, led to significant improvements in health outcomes, including fewer pain and health symptoms after 6 months.

Participants in the Bridge group showed a marked shift in healthcare utilization, with a greater preference for primary care providers over emergency rooms, indicating a positive change in their approach to seeking medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot test of a peer navigator intervention for improving the health of individuals with serious mental illness. Kelly, E., Fulginiti, A., Pahwa, R., et al.[2022]

The study analyzed eight research articles to understand the care transition for individuals with mental disorders in Brazil, highlighting unique challenges and opportunities in this process.

Factors influencing care transition include specific characteristics of mental health care, varying perspectives that can either facilitate or hinder the transition, and relevant Brazilian legislation affecting these processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition of Care for Individuals with Mental Disorders in Brazil: A Contextual Analysis. Silva, LACD., Paiva, RM., Faustino, SLF., et al.[2023]

After transitioning to dual Medicare/Medicaid coverage, adults with serious mental illness in Missouri and South Carolina showed a significant increase in outpatient care use, rising from 4% to 9% over 12 months.

Increased dual coverage was associated with higher rates of emergency department visits and inpatient admissions, suggesting that while access to care improved, it also raised concerns about the complexity of navigating two insurance programs and potential pent-up demand for services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of the Transition From Medicaid to Medicare on Health Care Use for Adults With Mental Illness. Burns, ME., Huskamp, HA., Smith, JC., et al.[2019]

References

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

A protocol for a multi-site cohort study to evaluate child and adolescent mental health service transformation in England using the i-THRIVE model. [2023]

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

Evaluating changes in symptoms and functioning of dually diagnosed clients in specialized treatment. [2019]

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

Service Use by Medicaid Recipients With Serious Mental Illness During an RCT of the Bridge Peer Health Navigator Intervention. [2021]

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

American Association of Community Psychiatrists' principles for managing transitions in behavioral health services. [2007]

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

Effect of a mental health "carve-out" program on the continuity of antipsychotic therapy. [2019]

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

Connected Care: improving outcomes for adults with serious mental illness. [2018]

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

A pilot test of a peer navigator intervention for improving the health of individuals with serious mental illness. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Transition of Care for Individuals with Mental Disorders in Brazil: A Contextual Analysis. [2023]

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

The Effects of the Transition From Medicaid to Medicare on Health Care Use for Adults With Mental Illness. [2019]