Strategies for Substance Use Disorder

(STUN II Trial)

Recruiting at 2 trial locations

Overseen By Leslie Brouwer, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Ongoing conflicting programs

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

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to enhance how primary care clinics screen and intervene for substance use disorders. It tests various combinations of support strategies, such as practice facilitation (assisting clinics in improving procedures), learning collaboratives (sharing knowledge among clinics), and performance incentives (rewards for meeting goals). Clinic staff in leadership roles, like lead physicians or practice managers, who do not already participate in similar programs, might be suitable candidates. The goal is to identify the most effective strategy for clinics to better address substance use issues. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in primary care, potentially improving patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that these strategies for improving substance use disorder interventions are safe?

Research shows that practice facilitation, learning collaboratives, and performance incentives are generally low-risk and well-tolerated by participants. These methods aim to improve processes and provide support rather than introduce new medications or medical procedures, thus carrying fewer risks.

Studies on learning collaboratives have shown improvements in mental health care and substance use outcomes. By sharing knowledge and discussing cases, these collaboratives ensure participant safety. Performance incentives, which offer financial rewards for meeting specific goals, have been used in health care to encourage positive outcomes. This approach is generally safe as it does not involve direct patient interventions. However, evidence on their cost-effectiveness in helping people stop substance use remains limited.

Overall, these strategies emphasize collaboration and motivation without posing major safety concerns for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these strategies for treating Substance Use Disorder because they focus on enhancing practice methods rather than introducing new medications. Unlike traditional treatments that often rely on medication or therapy alone, these approaches incorporate Practice Facilitation, which offers personalized support to healthcare practices. Additionally, Learning Collaborative sessions provide ongoing, interactive education and problem-solving with experts, while Performance Incentives motivate practices by rewarding achievement of specific goals. Together, these methods aim to improve the delivery of care and patient outcomes by supporting and empowering healthcare providers.

What evidence suggests that this trial's strategies could be effective for substance use disorders?

This trial tests different strategies to improve the treatment of substance use disorders in primary care. Participants in one arm will receive Practice Facilitation, which past studies have shown increases the use of treatments for substance use disorders. Another arm will combine Practice Facilitation with Performance Incentives, as research shows that adding rewards, like financial bonuses, can further improve results by encouraging clinics to meet specific goals. A third arm will include Practice Facilitation and a Learning Collaborative, where healthcare professionals learn and share experiences, which has been effective in improving mental health care in primary care settings. The final arm will test the combination of Practice Facilitation, Learning Collaborative, and Performance Incentives, which may offer even greater benefits by boosting teamwork and motivation among clinic staff. These strategies aim to make the screening and treatment of substance use disorders more effective and accessible. ^{3 6 7 8 9}

Who Is on the Research Team?

Daniel E Jonas, MD, MPH

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for staff at primary care practices who are involved in screening and interventions for substance use disorders. It's not specified who can't join, but typically those with conflicts of interest or inability to participate fully might be excluded.

Inclusion Criteria

Clinic staff members from primary care practices who provide care for adult patients and have a leadership role within the practice (e.g. lead physician, practice manager, lead medical assistant/nurse, clinical champion)

Exclusion Criteria

Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of evidence-based screening and interventions for substance use disorders using various strategies

12 months

Monthly virtual sessions and practice facilitation

Follow-up

Participants are monitored for the effectiveness of the implementation strategies

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Learning Collaborative
• Performance Incentives
• Practice Facilitation

Trial Overview The STUN II Trial is testing four strategies to improve handling of substance use disorders in primary care: practice facilitation (PF), PF with a learning collaborative (LC), PF with performance incentives (PI), and the combination of all three methods.

How Is the Trial Designed?

Group I: Practice Facilitation + Performance Incentives Experimental Treatment 2 Interventions

Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter.

Group II: Practice Facilitation + Learning Collaborative + Performance Incentives Experimental Treatment 3 Interventions

Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A. Performance Incentives: Practices will receive a maximum total of $6,000 based on their performance during the 12-month implementation period. They will have the opportunity to receive up to $1,500 per quarter if they reach performance milestones for the quarter.

Group III: Practice Facilitation + Learning Collaborative Experimental Treatment 2 Interventions

Practice Facilitation (PF): Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months. Learning Collaborative (LC): Virtual LC sessions will be held monthly and will include participants presenting anonymized cases to clinical experts, targeted brief didactics related to the content of the cases, and time for open discussion and Q\&A.

Group IV: Practice Facilitation Only Active Control 1 Intervention

Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.

Learning Collaborative is already approved in United States for the following indications:

Approved in United States as Learning Collaborative for:

• Depression
• Anxiety
• Stress-related Problems
• Mental Health Wellness

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Ohio Association of Community Health Centers (OACHC)

Collaborator

Trials

1

Recruited

140+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Bon Secours Mercy Health (BSMH)

Collaborator

Trials

1

Recruited

140+

Published Research Related to This Trial

The Massachusetts initiative successfully expanded the Office-Based Opioid Treatment with buprenorphine (OBOT-B) model to 14 community health centers, increasing the number of physicians authorized to prescribe buprenorphine by 375% over three years.

This collaborative care model, which emphasizes the role of nurses alongside physicians, effectively improved access to treatment for opioid use disorders, leading to a significant rise in patient admissions to these health centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers. LaBelle, CT., Han, SC., Bergeron, A., et al.[2018]

Pro-social messaging significantly increased the response rate of primary care providers to participate in a learning collaborative for treating opioid use disorder, with a 47.5% higher response compared to the control group, especially in areas with higher opioid overdose death rates.

Financial incentives had a modest effect on response rates, indicating that emphasizing the social impact of treatment may be more effective in encouraging provider participation in training programs for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging primary care providers to expand the opioid use disorder workforce. Domino, ME., Sylvia, S., Green, S.[2023]

Financial incentives and client-specific feedback were tested in Washington State to improve substance use treatment quality, but these interventions did not significantly enhance client engagement after outpatient admissions across various demographics.

The lack of effectiveness may be attributed to external factors such as the transition to a managed care system and agency-specific challenges like staff turnover, suggesting that interventions need to consider broader systemic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influencing quality of outpatient SUD care: Implementation of alerts and incentives in Washington State. Garnick, DW., Horgan, CM., Acevedo, A., et al.[2018]

Value-based payment (VBP) significantly improved the fidelity of the Collaborative Care Model (CCM) in community health clinics, with increases in fidelity ranging from 9% to 30% compared to periods without VBP.

Patients exposed to VBP had a 45% higher chance of achieving clinically significant improvement in depression symptoms, indicating that VBP not only enhanced implementation fidelity but also positively impacted patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value-based payment in implementing evidence-based care: the Mental Health Integration Program in Washington state. Bao, Y., McGuire, TG., Chan, YF., et al.[2022]

A learning collaborative involving 28 physician practices in Vermont led to significant improvements in the provision of buprenorphine for opioid use disorders, with 85.7% physician engagement and notable reductions in practice variation.

While the overall number of patients receiving buprenorphine increased only slightly by 3.4%, four out of seven quality-improvement measures showed statistically significant enhancements, indicating that this collaborative approach can effectively engage physicians and improve treatment consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Learning Collaborative Strategy With Office-based Practices to Increase Access and Improve Quality of Care for Patients With Opioid Use Disorders. Nordstrom, BR., Saunders, EC., McLeman, B., et al.[2023]

In a study of 112 addiction health service programs in low-income minority communities, coordination with mental health providers increased from 43% in 2011 to 66% in 2013, and with public health services from 31% to 54%, indicating improved integration over time.

Programs that had culturally responsive resources and strong community linkages were more likely to achieve high coordination, suggesting that leadership and funding play crucial roles in enhancing service delivery in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Coordination of Addiction Health Services Organizations with Mental Health and Public Health Services. Guerrero, EG., Andrews, C., Harris, L., et al.[2018]

A program in Maine successfully created collaboratives of mental health and substance abuse providers, improving coordinated treatment for individuals with both psychiatric and substance use disorders.

Surveys conducted one and two years after the program's establishment showed significant increases in interagency referrals, joint client assessments, and collaborative training efforts among providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interagency collaboration in services for people with co-occurring mental illness and substance use disorder. Ridgely, MS., Lambert, D., Goodman, A., et al.[2006]

The study developed a new collaborative care model called CLARO, specifically designed to improve treatment for patients with co-occurring opioid use disorders (OUD) and mental health issues like depression and PTSD, using input from a diverse team of stakeholders.

Twelve key adaptations were made to the traditional collaborative care approach, including the use of community health workers and modified training protocols, aimed at enhancing the model's effectiveness and acceptability in low-resource healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Osilla, KC., Dopp, AR., Watkins, KE., et al.[2022]

A study involving stakeholder input identified increasing combination treatment rates (antidepressants plus psychotherapy) as a key goal for improving depression care in a managed behavioral healthcare organization.

The feasibility test of an incentive-based program showed that while it raised awareness among clinicians, challenges such as administrative barriers and limited clinical data may hinder widespread adoption of these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A collaborative approach to identifying effective incentives for mental health clinicians to improve depression care in a large managed behavioral healthcare organization. Meredith, LS., Branstrom, RB., Azocar, F., et al.[2021]

Citations

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A multisector community-engaged collaborative for mental ... This research study will evaluate the effectiveness of a multisectoral community-engaged collaborative for task-sharing mental health care.

2. researchgate.net researchgate.net/publication/384150654_A_multisector_community-engaged_collaborative_for_mental_health_integration_in_primary_care_and_housing_developments_Protocol_for_a_stepped-wedge_randomized_controlled_trial_the_Harlem_Strong_Program

A multisector community-engaged collaborative for mental ... A multisector community-engaged collaborative for mental health integration in primary care and housing developments: Protocol for a stepped- ...

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A multisector community-engaged collaborative for mental ... This research study will evaluate the effectiveness of a multisectoral community-engaged collaborative for task-sharing mental health care.

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A systematic review of task-sharing interventions for ... This review synthesizes the evidence on the effectiveness of task-sharing interventions for SU and SUDs outcomes in LMICs.

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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 ...

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Multisector Task-Sharing to Improve Mental Health in Harlem ... A multisector task-sharing collaborative in addressing the inter-related problems of mental health disorders, poverty, and housing instability.