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临床试验/NCT01810159
NCT01810159已完成不适用

Integrated Collaborative Care for Substance Use Disorders

RAND4 个研究点 分布在 1 个国家目标入组 397 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
397
试验地点
4
主要终点
negative consequences related to substance use

研究概览

简要总结

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.

详细描述

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
Single (Outcomes Assessor)

盲法说明

We used an R software random number generator to randomly assign eligible participants to either CC or usual care. We used a concealed randomization protocol where neither participant nor researcher (outside of the statistician doing the randomization) was aware of the randomization until after the baseline interview. None of the participants or providers was blinded to treatment allocation after randomization. Interviewers were blinded to treatment allocation

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

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

排除标准

  • co-morbid severe mental illness
  • medically unstable

结局指标

主要结局

negative consequences related to substance use

时间窗: past 3 months

SIP-AD frequency questionnaire

unmet need

时间窗: 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

heavy alcohol use

时间窗: 6 months

among people at baseline with heavy alcohol use, proportion with heavy alcohol use in past 30 days

abstinent from alcohol and opioid use, past 30 days

时间窗: past 30 days

change in abstinence from alcohol and opioid use between baseline and 6 month follow up

initiation

时间窗: Within 14 days of index visit

Washington Circle initiation indicator--at least one SUD-related visit within 14 days of index visit

Functioning

时间窗: past 4 weeks

change in SF-12 between baseline and follow up

Engagement

时间窗: 30 days of initiation

Proportion with at least 2 SUD-related visits within 30 days of initiation, Washington Circle

次要结局

  • Proportion initiating MAT(6 months)
  • Proportion initiating Brief therapy(6 months)
  • abstinence from alcohol, opioids and all other drugs in the previous 30 days(collected at six months at the past 30 days)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (4)

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