The STop UNhealthy Substance Use Now Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Percent of adults screened for substance use disorder
研究概览
简要总结
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
详细描述
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
Specific aim 1 (primary aim) will compare the effect of learning collaborative (LC) participation, performance incentives (PI), or their combination, with practice facilitation (PF) only, on implementation of evidence-based screening for SUDs.
Specific aim 2 (secondary aim) will compare the effect of LC participation, PI, or their combination, with PF only, on implementation of evidence-based interventions for SUDs, including (a) brief counseling, (b) medications (e.g., buprenorphine, naltrexone) and adherence to them, and (c) referral to specialty care.
Specific aims 1 and 2 will produce fundamentally important evidence about the comparative effectiveness of PF, PF+LC, PF+PI, and PF+LC+PI strategies on uptake of evidence-based screening and interventions for SUD when delivered to primary care practices.
Specific aim 3 (exploratory aim) will use a longitudinal mixed-methods evaluation to assess the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate). Aim 3 will generate scientific knowledge about mechanisms of change (why and how the various strategies work) in primary care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study
研究组 & 干预措施
Practice Facilitation Only
Practice Facilitation: Practices will receive up to 2 hours of direct practice facilitation services per month for 12 months.
干预措施: Practice Facilitation (PF) (Other)
Practice Facilitation + Learning Collaborative
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.
干预措施: Practice Facilitation (PF) (Other)
Practice Facilitation + Learning Collaborative
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.
干预措施: Learning Collaborative (LC) (Other)
Practice Facilitation + Performance Incentives
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.
干预措施: Performance Incentives (PI) (Other)
Practice Facilitation + Performance Incentives
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.
干预措施: Practice Facilitation (PF) (Other)
Practice Facilitation + Learning Collaborative + Performance Incentives
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.
干预措施: Practice Facilitation (PF) (Other)
Practice Facilitation + Learning Collaborative + Performance Incentives
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.
干预措施: Learning Collaborative (LC) (Other)
Practice Facilitation + Learning Collaborative + Performance Incentives
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.
干预措施: Performance Incentives (PI) (Other)
结局指标
主要结局
Percent of adults screened for substance use disorder
时间窗: 12 months
Percent of people aged 18 and older who are screened for substance use disorder using a validated screening tool
Number of adults screened for substance use disorder
时间窗: 12 months
Number of people aged 18 and older who are screened for substance use disorder using a validated screening tool
次要结局
- Percentage of adults who received any evidence-based intervention for substance use disorder(12 months)
- Percentage of adults who received medication for substance use disorder, including alcohol use disorder(12 months)
- Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment(24 months)
- Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment(12 months)
- Percent of adults with a positive screen for substance use disorder(24 months)
- Number of adults with a positive screen for substance use disorder(24 months)
- Number of adults screened for substance use disorder(24 months)
- Percent of adults screened for substance use disorder(24 months)
- Percentage of adults who received brief counseling for substance use disorder(12 months)
- Number of adults who received brief counseling for substance use disorder(24 months)
- Percentage of adults who received medication for substance use disorder(24 months)
- Number of adults who received any evidence-based intervention for alcohol use disorder(24 months)
- Number of adults who received medication for alcohol use disorder(24 months)
- Percentage of adults who received medication for alcohol use disorder(12 months)
- Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment(12 months)
- Number of adults referred to specialty care for alcohol use disorder(24 months)
- Number of adults who received any evidence-based intervention for substance use disorder(24 months)
- Number of adults who received medication for substance use disorder(24 months)
- Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment(24 months)
- Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder(24 months)
- Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder(12 months)
- Number of adults with alcohol use disorder(24 months)
- Percentage of adults with alcohol use disorder(12 months)
- Percentage of adults who received any evidence-based intervention for alcohol use disorder(12 months)
- Percentage of adults referred to specialty care for alcohol use disorder(12 months)
- Number of adults who received brief counseling for alcohol use disorder(24 months)
- Percentage of adults who received brief counseling for alcohol use disorder(12 months)
- Percent of adults with a positive screen for substance use disorder(12 months)
- Number of adults with a positive screen for substance use disorder(12 months)
- Number of adults who received any evidence-based intervention for substance use disorder(12 months)
- Percentage of adults who received any evidence-based intervention for substance use disorder(24 months)
- Number of adults who received brief counseling for substance use disorder(12 months)
- Percentage of adults who received brief counseling for substance use disorder(24 months)
- Number of adults who received medication for substance use disorder(12 months)
- Number of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment(12 months)
- Percentage of adults who received medication for substance use disorder, including alcohol use disorder, and adhered to 6 months of treatment(24 months)
- Number of adults referred to specialty care for substance use disorder and/or alcohol use disorder(12 months)
- Percentage of adults referred to specialty care for substance use disorder and/or alcohol use disorder(24 months)
- Number of adults with alcohol use disorder(12 months)
- Percentage of adults with alcohol use disorder(24 months)
- Number of adults who received any evidence-based intervention for alcohol use disorder(12 months)
- Percentage of adults who received any evidence-based intervention for alcohol use disorder(24 months)
- Number of adults who received brief counseling for alcohol use disorder(12 months)
- Percentage of adults who received brief counseling for alcohol use disorder(24 months)
- Number of adults who received medication for alcohol use disorder(12 months)
- Percentage of adults who received medication for alcohol use disorder(24 months)
- Number of adults who received medication for alcohol use disorder and adhered to 6 months of treatment(12 months)
- Percentage of adults who received medication for alcohol use disorder and adhered to 6 months of treatment(24 months)
- Number of adults referred to specialty care for alcohol use disorder(12 months)
- Percentage of adults referred to specialty care for alcohol use disorder(24 months)
研究者
Dan.Jonas
Director and Professor, Division of General Internal Medicine
Ohio State University