Retention and Re-Engagement in Treatment for Addiction Following Serious Injection Related Infections (RETAIN): A Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participant recruitment rates
研究概览
简要总结
This project is a pilot study of an adapted intervention of an existing Opioid Use Disorder (OUD) treatment retention intervention called Recovery Management Checkups (RMC). This intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (SIRI) based on the findings from a prior qualitative study from the principal investigator. This project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy.
Hospitalizations for SIRIs are a unique entry point for patients to start their recovery journey with medications for OUD (MOUD), but many people do not remain on long-term treatment, despite evidence that indicates MOUDs reduce death and re-hospitalization after SIRIs.
The study objectives are to:
- Assess the implementation feasibility of the adapted RMC model for patients with SIRI and OUD.
- Establish preliminary estimates of intervention efficacy.
- Make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials.
Findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years of age
- •Able to provide Informed Consent
- •Admitted to Boston Medical Center on any inpatient unit for an active serious injection related infection (SIRI) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended
排除标准
- •Not able to give informed consent
- •Cognitive ability (defined through Research Assistant (RA) determination)
- •Inability to complete assessments in English or Spanish (defined through RA determination).
- •Exclusion for any reason under PI discretion
- •Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
- •In police custody or expecting incarceration
研究组 & 干预措施
RETAIN intervention
Participants randomized to the RETAIN intervention will receive Motivational Interviewing targeted to their clinical concerns and personalized support tailored to each participants' specific needs determined by their answers to intake questions.
干预措施: RETAIN (Other)
Control
Control arm participants will be offered different videos or podcast episodes that are unrelated to the study topics of infections, substance use, overdose, and medication management.
干预措施: Unrelated videos (Other)
结局指标
主要结局
Participant recruitment rates
时间窗: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Participant recruitment rates will be calculated by dividing the number of participants enrolled by the number of eligible patients identified.
Feasibility of the RETAIN Intervention based on completion of study visits
时间窗: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
The rates of completion of study visits will be calculated by dividing the number of completed study visits by the total number of study visits.
Acceptability of the RETAIN Intervention
时间窗: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) which is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean and higher scores are associated with better acceptability.
Number of days on medications for opioid disorder (MOUD)
时间窗: Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge
The timeline follow back (TLFB) method will be used to assess this outcome based on self-report.
次要结局
- Number of days of antibiotic completion(Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge)
- Number of days of Opioid use(Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge)
- Number of Hospitalizations(Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge)
- Number of uncleaned injections(Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge)
- Number of unmonitored opioid use(Baseline while hospitalized, then 2 weeks, 6 weeks, 3 months, and 6 months after discharge)
- MOUD stigma(Baseline while hospitalized, and 6 month after discharge)