Collaborative Care for Substance Use and Mental Health Disorders

Overseen By Oluwaseun Falade-Nwulia, MBBS, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Lacking capacity to consent

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: 12

Duration: 12 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a peer-led support system, Peer Supported Collaborative Care, can improve treatment for individuals with both HIV and issues related to substance use or mental health. Participants will be randomly assigned to either continue with their usual HIV care or work with a peer-case manager to address substance use or mental health challenges. The trial aims to determine if added peer support enhances engagement in care and overall management of these conditions. Ideal candidates for this trial are individuals who receive HIV care, have positive screenings for mental health or substance use issues, and are not currently receiving treatment for these conditions. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative care strategies that could enhance their treatment experience.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that participants are not currently receiving treatment for mental health or substance use disorders.

What prior data suggests that this peer-supported collaborative care model is safe for integrating treatment into HIV care settings?

Research has shown that the peer-supported collaborative care model is generally well-received. Studies have found that this approach can improve access to care and treatment outcomes for individuals with mental health and substance use issues. Although specific safety data from clinical trials for this exact setup is lacking, the collaborative care model has been used successfully in various settings without significant reports of harm.

This type of care involves a team, including a peer case manager, to support individuals. It helps manage mental health and substance use disorders by providing ongoing care and support. It is important to understand that this trial does not test a new drug or medical procedure, but rather a care model. Therefore, the safety concerns differ. The aim is to improve the quality and availability of care, not to introduce new medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Peer Supported Collaborative Care for substance use and mental health disorders because it offers a comprehensive, team-based approach to treatment. Unlike standard treatments that often rely solely on medical professionals, this method includes peer case managers who provide ongoing support, making it more personalized and community-oriented. The approach integrates mental health and substance use disorder care directly into HIV primary care, utilizing motivational interviewing and evidence-based interventions, which could enhance patient engagement and adherence. This innovative model aims to improve outcomes by addressing both mental health and substance use disorders simultaneously and more holistically.

What evidence suggests that the Peer Supported Collaborative Care model is effective for integrating treatment for substance use and mental health disorders into HIV care settings?

Research has shown that the Peer Supported Collaborative Care model, which participants in this trial may receive, can enhance treatment for mental health and substance use issues. Studies have found that this approach improves access to mental health services and leads to better treatment outcomes. In this trial, the collaborative care team includes a peer case manager and an addiction psychiatrist who work together to support patients. This teamwork often results in improved mental health and substance use outcomes. With several professionals involved, patients receive more comprehensive care, which is linked to better health results. ^{1 3 4 5 6}

Who Is on the Research Team?

Oluwaseun Falade-Nwulia, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-99 receiving HIV care who aren't currently treated for mental health or substance use disorders. They must speak English and have screened positive for these disorders at the Bartlett HIV clinic.

Inclusion Criteria

accessing HIV care at the Bartlett HIV clinic

Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score>10), General Anxiety Disorder (GAD-7) (score>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons.

I am not currently receiving treatment for any mental health or substance use issues.

Exclusion Criteria

I am unable to make medical decisions for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either usual care or a peer-supported collaborative care model for mental health and substance use disorder treatment integrated into HIV care settings

12 months

Initial visit and ongoing care management

Follow-up

Participants are monitored for changes in mental health and substance use disorder outcomes and HIV virologic suppression

12 months

Survey at enrollment and 12 months later

What Are the Treatments Tested in This Trial?

Interventions

• Peer Supported Collaborative Care

Trial Overview The study tests a peer-led collaborative care model versus usual clinical care to integrate treatment for substance use and mental health into HIV care settings. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

Group I: Collaborate Care (CC) Model Experimental Treatment 1 Intervention

For patients randomized to the CC arm, in addition to the provider being alerted to the positive Mental Health and Substance Use Disorder screener, the patient will also be assigned to a peer case manager (P-CM). The P-CM will provide longitudinal care for the patient as part of their care management case load. The collaborative care support team will include the P-CM, a consultant addiction psychiatrist and the patient's HIV provider who will implement a stepped care program consisting of: 1) an initial assessment, determination of and implementation of an individualized care plan to provide; 2) psychosocial and medication adherence support; 3) evidence-based brief intervention incorporating motivational interviewing informed strategies; 4) measurement-based care for Mental Health and Substance Use Disorder provided directly by the HIV primary care provider or in collaboration with specialty Mental Health and Substance Use Disorder services.

Group II: Usual Care (UC) Active Control 1 Intervention

For patients randomized to the UC referral arm, the patient's HIV provider will receive an electronic alert of the patient's positive screen for a Mental Health and Substance Use Disorder. The patient will not be contacted by the P-CM. The provider, at their discretion, will initiate referral to the psychiatry service available onsite. For patients with Substance Use Disorder, providers refer to the in-clinic Substance Use Disorder treatment program that is managed by a nurse practitioner with Substance Use Disorder care experience. Once referred, the patient is seen by the nurse practitioner (separate from the HIV provider) who manages prescription of and assessment of adherence to buprenorphine, including monitoring of urine toxicology results with support from an addiction counselor. The Bartlett Clinic runs 2 substance use groups weekly and has processes for referral to a higher level of Substance Use Disorder care at offsite Substance Use Disorder treatment programs.

Peer Supported Collaborative Care is already approved in United States for the following indications:

Approved in United States as Collaborative Care Model for:

• Substance Use Disorders
• Mental Health Disorders
• HIV Care

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The Collaborative Care model effectively integrates primary care and behavioral health teams to treat depression among adults experiencing homelessness, addressing their complex health needs in a primary care setting.

Case studies from a Federally Qualified Health Center in Downtown Miami illustrate the potential benefits of this model, such as improved treatment outcomes, while also highlighting challenges in implementation for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Poverty Barrier in Collaborative Care for Adults Experiencing Homelessness: A Case-Based Report. Cabán-Alemán, C., Iobst, S., Luna, AM., et al.[2022]

Individuals with mental illness are leading a movement to promote whole health and wellness in mental health care, emphasizing the importance of advocacy and integrated care models.

Wellness-oriented peer approaches, such as those provided by peer-support specialists and wellness coaches, can effectively complement traditional medical models to enhance health outcomes for people with mental and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated care: wellness-oriented peer approaches: a key ingredient for integrated care. Swarbrick, MA.[2013]

The Collaborative Care (CC) model was successfully implemented in a nurse-managed health center in Chicago, serving 166 patients in its first year, with 22% achieving depression treatment goals and 47% for anxiety.

This model not only improved patient outcomes by addressing both mental and physical health needs but also enhanced the collaboration between primary care providers and behavioral health specialists, boosting the confidence of family nurse practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care: Integrating Behavioral Health Into the Primary Care Setting. Reising, V., Diegel-Vacek, L., Dadabo, L., et al.[2023]

Collaborative care models (CCMs) effectively integrate mental health and medical care in primary care settings, improving patient outcomes through team-based interventions and support systems.

CCMs are cost-efficient and can enhance care for various mental health conditions, but their successful implementation depends on aligning financial incentives and adapting to different practice settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health collaborative care and its role in primary care settings. Goodrich, DE., Kilbourne, AM., Nord, KM., et al.[2022]

The implementation of the Collaborative Care Model in primary care has been supported by new fee-for-service payment codes introduced in 2018, allowing for reimbursement of care team members' time spent on collaborative care activities.

Challenges exist with the current time-based billing system, prompting recommendations for refinements, such as changing the reimbursement cycle from a calendar month to a 30-day period and adopting new codes for smaller time increments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Payment for Collaborative Mental Health Care in Primary Care. Wolk, CB., Alter, CL., Kishton, R., et al.[2023]

A collaborative care model was evaluated in rural Virginia to improve access to both behavioral health and primary care services, addressing the shortage of psychiatric specialists and the overlap of chronic illnesses with psychiatric conditions.

The study emphasized the importance of advanced practice nursing roles and enhanced collaboration among healthcare providers, recommending evidence-based interventions and wellness programs to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to Clinical Practice. Parks, MD.[2020]

Peer support specialists (PSSs) are being integrated into primary care settings to enhance patient activation and access to care, but face challenges such as role confusion and inadequate administrative support, as identified in interviews with 25 stakeholders.

Key facilitators for successful implementation of PSSs in primary care include strong administrative support, team cohesion, and stakeholder buy-in, which are essential for both initial integration and long-term maintenance of peer support programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived barriers and facilitators to implementation of peer support in Veterans Health Administration Primary Care-Mental Health Integration settings. Shepardson, RL., Johnson, EM., Possemato, K., et al.[2021]

The qualitative evaluation of the COMET trial, involving 24 care providers, highlighted that while collaborative care models improved referral processes and fostered communication, significant challenges remained due to communication issues and unclear professional roles.

Care providers expressed a need for better resources and remuneration for collaborative activities, indicating that enhancing interprofessional understanding and clarifying roles are crucial for the success of collaborative and stepped care models in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do care providers evaluate collaboration? - qualitative process evaluation of a cluster-randomized controlled trial of collaborative and stepped care for patients with mental disorders. Maehder, K., Werner, S., Weigel, A., et al.[2021]

Mental health peer support is recognized as an effective method to enhance mental health services, improve patient outcomes, and reduce costs, as highlighted in Canada's mental health strategy.

The study identifies key strategies for integrating peer support into clinical settings, such as gradual implementation, building support among staff, and prioritizing patient-centered care, which can help overcome challenges in adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating mental health peer support in clinical settings: Lessons from Canada and Norway. Mulvale, G., Wilson, F., Jones, S., et al.[2019]

Both the integrated multidisciplinary collaborative care (IMCC) and the shifted outpatient collaborative care (SOCC) models showed improvements in community functioning and residential stability among 142 men experiencing homelessness and mental illness over a 12-month period.

There were no significant differences in outcomes between the two models, indicating that both approaches may be effective in providing mental health care to homeless populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of an integrated collaborative care model vs. a shifted outpatient collaborative care model on community functioning, residential stability, and health service use among homeless adults with mental illness: a quasi-experimental study. Stergiopoulos, V., Schuler, A., Nisenbaum, R., et al.[2022]

The study identified effective supervision strategies for peer providers in behavioral health, emphasizing the importance of access to multiple supervisors and both formal and informal support systems.

Key lessons included the need for ongoing role negotiation and collaboration in addressing challenges, which helps to clarify roles and enhance the value of peer specialists in delivering interventions for individuals with serious mental illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies and Lessons Learned for Supporting and Supervising Peer Specialists. Stefancic, A., Bochicchio, L., Tuda, D., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04601064

Peer Supported Collaborative Care Mental Health and ... This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9803502/

Collaborative mental health care: A narrative review - PMC Several randomized controlled trials have demonstrated that Collaborative Care increases access to mental health care and is more effective and ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833893

Integrated Collaborative Care for Youths With Mental ... These results suggest that the ICCT model is associated with improved youth functioning and mental health and substance use outcomes that are no different from ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353489/

An International Review of the Collaborative Care Model ... The collaborative care model (CCM) was created to improve the delivery of mental health care and is reported to improve access, enhance treatment outcomes, and ...

5. apa.org apa.org/health/behavioral-integration-fact-sheet

Behavioral Health Integration Fact Sheet Data to support the PCBH model · PCBH improves the patient/family experience of care (satisfaction with care) · PCBH improves patient outcomes (improves ...

6. samhsa.gov samhsa.gov/resource/ebp/integrated-models-behavioral-health-primary-care

Integrated Models for Behavioral Health and Primary Care This list of resources, put forth by the SAMHSA-HRSA Center for Integrated Health Solutions (CIHS), assists providers in integrating primary and behavioral ...