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Integrated Collaborative Care for Substance Use Disorders (SUMMIT)

2017年4月25日 更新者:RAND

Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS, integrated collaborative care (ICC) and education and resources (E&R). The investigators hypothesize that ICC will be more effective than E&R in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes.

Results from our study will help providers choose between two different strategies and advance the field of implementation research.

研究概览

详细说明

Most individuals with opiate and alcohol-use disorders (OAUD) do not receive treatment. Primary care is an ideal setting in which to deliver OAUD treatment, yet evidence-based OAUD treatment is rarely provided.

Barriers to delivery include insufficient organizational support and lack of provider role models and clinical support. The investigators propose to evaluate the effectiveness of two strategies for increasing use of evidence-based treatment for OAUD within primary care: integrated collaborative care (ICC) and education and resources (E&R). While both strategies provide primary care practices with the same clinical information, ICC addresses these barriers by including organizational and technical support for delivering evidence-based care. ICC is grounded in the chronic care model and includes a behavioral health provider working as part of the care team.

Essential elements of ICC strategy include a decision support component to help providers with complex patients, and a restructuring of the delivery and clinical information systems to support the delivery of evidence-based care. Our approach to implementing ICC is based on the organizational transformation model and quality improvement. The investigators define the E&R strategy as providing printed educational materials and access to resources along with provider education. Both strategies are designed to increase the delivery of two evidence-based practices: motivational enhancement therapy and medication assisted therapy.

The investigators propose a 5-year mixed methods study and will conduct a RCT, with randomization occurring at the level of the care team and patient. The investigators partner with 5 Venice Family Clinic (VFC) clinics, two hospitals in LA County, and COPE Health Solutions. VFC is a large federally qualified health center (FQHC) and the largest free clinic in the United States. Our approach includes document review, focus groups, interviews, and surveys for obtaining data on the adoption process and implementation outcomes; analysis of patient records and patient surveys on service system and patient outcomes; and analysis of provider financial records and patient records and surveys for estimating costs. The investigators will enroll 400 patients with an OAUD diagnosis and follow them at 3 and 12 months. Our specific aims are: 1) To measure the process and extent of ICC and E&R implementation; 2) To test the effectiveness of ICC compared to an E&R strategy in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes; and 3) To estimate provider costs for each strategy. The investigators define implementation outcomes as measures of the acceptability, adoption, appropriateness, feasibility, and sustainability of evidence-based OAUD treatment. The investigators define service system outcomes as 1) process measures of treatment quality and 2) treatment co-morbidities. The investigators define patient outcomes as hospital readmissions, OAUD outcomes, patient functioning, negative consequences from substance use, and unmet need. The investigators define cost outcomes as start-up costs, operating costs and medical/psychiatric cost offsets.

研究类型

介入性

注册 (实际的)

397

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Santa Monica、California、美国、90405
        • Venice Family Clinic-Simms Mann Health Center
      • Venice、California、美国、90291
        • Venice Family Clinic-Rose lAvenue

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • opiate or alcohol use disorder
  • not currently in substance use disorder treatment
  • past 30 day use of alcohol or opioids
  • English or Spanish speaking

Exclusion Criteria:

  • co-morbid severe mental illness
  • medically unstable

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:ICC
Integrated collaborative care
有源比较器:E&R
Education and Resources--enhanced usual care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
unmet need
大体时间:past 6 months
Of those identified as screening positive for an opiate or alcohol use disorder, proportion who did not receive treatment for their substance use
past 6 months
abstinent from alcohol and opioid use, past 30 days
大体时间:past 30 days
change in abstinence from alcohol and opioid use between baseline and 6 month follow up
past 30 days
negative consequences related to substance use
大体时间:past 3 months
SIP-AD frequency questionnaire
past 3 months
Functioning
大体时间:past 4 weeks
change in SF-12 between baseline and follow up
past 4 weeks
Engagement
大体时间:30 days of initiation
Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle
30 days of initiation
initiation
大体时间:Within 14 days of index visit
Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit
Within 14 days of index visit
heavy alcohol use
大体时间:6 months
among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days
6 months

次要结果测量

结果测量
措施说明
大体时间
Proportion initiating Brief therapy
大体时间:6 months
Proportion initiating brief therapy within 6 months
6 months
Proportion initiating MAT
大体时间:6 months
Proportion initiating MAT within 6 months, among those eligible for MAT, and if N's are large enough, stratified by type of MAT
6 months
abstinence from alcohol, opioids and all other drugs in the previous 30 days
大体时间:collected at six months at the past 30 days
abstinence from alcohol, opioids and all other drugs in the past 30 days
collected at six months at the past 30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年6月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2017年1月1日

研究注册日期

首次提交

2013年3月11日

首先提交符合 QC 标准的

2013年3月12日

首次发布 (估计)

2013年3月13日

研究记录更新

最后更新发布 (实际的)

2017年4月27日

上次提交的符合 QC 标准的更新

2017年4月25日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01DA034266 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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