跳至主要内容
临床试验/NCT06524232
NCT06524232招募中不适用

The STop UNhealthy Substance Use Now Trial

Ohio State University6 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
144
试验地点
6
主要终点
Number 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

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

结局指标

主要结局

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

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

次要结局

  • 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)
  • 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 screened for substance use disorder(24 months)
  • Percent of adults screened for substance 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)
  • Percentage of adults who received any evidence-based intervention for substance use disorder(12 months)
  • Number of adults who received brief counseling for substance use disorder(24 months)
  • Percentage of adults who received brief counseling for substance use disorder(12 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan.Jonas

Director and Professor, Division of General Internal Medicine

Ohio State University

研究点 (6)

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