Thrive Intervention for Mental Illness

(THRIVE-SMI Trial)

Overseen By Erin Babe, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called the THRIVE Intervention to assist people with serious mental illnesses after hospital discharge. It aims to determine if this method, which includes home care visits and regular check-ins, reduces emergency room visits and readmissions more effectively than usual care. Participants must be insured by Medicaid, reside in Pennsylvania, and have been recently hospitalized. The study will compare the results of those using the THRIVE method to those receiving standard discharge care. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could improve post-hospitalization outcomes.

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 prior data suggests that the THRIVE clinical pathway is safe for Medicaid-insured individuals with serious mental illness?

Research shows that the Thrive Intervention helps people with Medicaid transition from hospital care to home care. This program aims to improve care for those with serious mental illnesses by supporting them immediately after hospital discharge.

While specific safety data for the Thrive Intervention isn't detailed, the treatment relies on proven methods, indicating effectiveness and safety in similar situations. The Thrive program helps patients manage their health better, suggesting it is well-tolerated.

Although this trial doesn't have a specific phase, safety remains a top priority. Programs like Thrive undergo testing to ensure they don't cause harm and aim to improve patient outcomes. Those interested in this trial should consult a healthcare provider to understand its benefits for their situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Thrive Intervention for mental illness because it offers a new approach to post-discharge care. Unlike the usual care where patients are simply discharged home without additional support, the Thrive Intervention provides a 1-month intensive case management and care coordination. This personalized support aims to bridge the gap between hospital care and home, potentially reducing relapse rates and improving overall outcomes for patients. By focusing on continuity of care, Thrive could significantly enhance the recovery process for individuals with mental illness.

What evidence suggests that the THRIVE Intervention is effective for mental illness?

This trial will compare the THRIVE Intervention with usual care. Research has shown that the THRIVE Intervention can assist Medicaid recipients transitioning from the hospital to their home. Early results suggest that this program increases home care access and reduces hospital readmissions within 30 days, as well as emergency room visits. By closely managing and coordinating care, the program appears to help patients, including those with serious mental health issues, better manage their health post-discharge. This evidence-based care model is designed to support individuals needing extra assistance during this transition period. ^{1 3 4 6 7}

Who Is on the Research Team?

Jacqueline M Brooks Carthon, PhD,RN

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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]

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]

Citations

1. bmjopenquality.bmj.com bmjopenquality.bmj.com/content/11/3/e001798

Transitional care innovation for Medicaid-insured individuals Early results from year 1 of the THRIVE clinical pathway suggests increasing home care referrals and reductions in 30-day readmission and ED use ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888568/

Improvements in Transitional Care Among Medicaid- ... Background: The Thrive program is an evidenced-based care model for Medicaid-insured adults in the hospital-to-home transition.

3. researchprotocols.org researchprotocols.org/2024/1/e64575/

Transitional Care Support for Medicaid-Insured Patients ... Objective: This study aimed to (1) engage staff and community advisors in participatory implementation processes to adapt the Thrive clinical ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06203509

Improving Care Transitions for Medicaid Insured ... This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness ...

5. researchgate.net researchgate.net/publication/385745929_Transitional_Care_Support_for_Medicaid-Insured_Patients_With_Serious_Mental_Illness_Protocol_for_a_Type_I_Hybrid_Effectiveness-Implementation_Stepped-Wedge_Cluster_Randomized_Controlled_Trial

Transitional Care Support for Medicaid-Insured Patients ... Transitional Care Support for Medicaid-Insured Patients With Serious Mental Illness: Protocol for a Type I Hybrid Effectiveness-Implementation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11599882/

Transitional Care Support for Medicaid-Insured Patients ... The Thrive clinical pathway provides transitional care support for patients insured by Medicaid with multiple chronic conditions by focusing on ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05714605

Implementation and Evaluation of A Health Innovation to ... The THRIVE Clinical Pathway is a standardized transitional care clinical pathway that supports Medicaid insured or Medicaid eligible individuals following ...