Integrated Collaborative Care for Substance Use Disorders
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
- 否
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)
