Methadone Patient Access to Collaborative Treatment (MPACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,080
- 试验地点
- 2
- 主要终点
- Time to treatment cessation
研究概览
简要总结
The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.
It will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.
详细描述
This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:
AIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.
AIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.
AIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Staff providing methadone treatment services at the enrolled opioid treatment programs
排除标准
- •Patients receiving methadone treatment at the enrolled opioid treatment programs
研究组 & 干预措施
MPACT Intervention
Enrolled clinic staff will be exposed to the MPACT intervention components over the trial period. This includes accredited training, clinic self assessment, reflective supervision for counseling/peer/case management staff, and wellness education with navigation to trauma symptoms assessment and resources including trauma treatment. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.
干预措施: MPACT (Other)
Control for MPACT
Enrolled clinic staff will not receive any portion of the intervention. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.
结局指标
主要结局
Time to treatment cessation
时间窗: 18 months
Time to treatment cessation (tolerance of 30 days)
In Treatment- Point in time
时间窗: 18 months
Point in time in treatment (0 day, 30 day, 60, day, 90 day)
Days in Treatment to treatment interruption
时间窗: 18 months
Time (days) to treatment interruption
Number of patients reporting opioid overdoses while in methadone treatment
时间窗: 18 months
Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.
Missed doses
时间窗: 20 months
Missed methadone doses in the last 30 days
次要结局
- Number of staff experiencing vicarious (work related) stress(18 months)
- Number of patients and staff experiencing post traumatic stress symptoms(18 months)