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

Trial Summary

What is the purpose of this trial?

The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for substance use disorder?

The Massachusetts Collaborative Care Model, which involves a team approach with nurses and doctors, has been effective in expanding treatment for opioid use disorders in community health centers. This model increased the number of doctors able to prescribe buprenorphine by 375% and significantly boosted patient admissions, showing promise for similar collaborative care strategies in treating substance use disorders. ^{1 2 3 4 5}

Is the treatment strategy for substance use disorder safe for humans?

The research articles reviewed do not provide specific safety data for the treatment strategies mentioned, such as Learning Collaborative or Community-Engaged Multisector Collaborative Care Model, in humans. ^{1 3 4 6 7}

How is the Strategies for Substance Use Disorder treatment different from other treatments?

This treatment is unique because it combines a collaborative care model with performance incentives and practice facilitation, focusing on teamwork among healthcare providers to improve care for substance use disorders. It emphasizes coordination between mental health and substance use services, which is often lacking in traditional treatments. ^{3 4 5 8 9}

Research Team

Daniel E Jonas, MD, MPH

Principal Investigator

Ohio State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Value-based payment in implementing evidence-based care: the Mental Health Integration Program in Washington state. [2022]

2. Netherlands 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. [2023]

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

Interagency collaboration in services for people with co-occurring mental illness and substance use disorder. [2006]

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

Nudging primary care providers to expand the opioid use disorder workforce. [2023]

5. United States 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. [2018]

6. United States 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. [2021]

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

Influencing quality of outpatient SUD care: Implementation of alerts and incentives in Washington State. [2018]

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

Improving Coordination of Addiction Health Services Organizations with Mental Health and Public Health Services. [2018]

9. England 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. [2022]