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临床试验/NCT03999450
NCT03999450已完成不适用

Preventing Premature Death Among Hospital Patients With Serious Opioid-Related Infection (SORI): A Phase 1 Pilot Study

University of Rochester2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Percentage of participants who report intervention acceptability

研究概览

简要总结

The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.

详细描述

We will recruit 30 SORI inpatients ages 18-plus admitted to the University of Rochester Medical Center (URMC). We will administer a battery of validated assessments of substance use, overdose history and risk, opioid-related infection, and suicidal behavior at baseline and approximately 2- and 4-week follow-ups. We will assess both forms of overdose (unintentional, intentional - i.e., suicidal behavior) because each is common in intravenous drug users and they require systematic assessment to disentangle. All recruited individuals will receive one-to-three MI sessions as they begin the MAT that is part of standard hospital care. Patients will be offered computer-based CBT, which they will complete on the unit at their convenience. The CBT program records duration of use of the treatment modules, enabling us to track patients' level of CBT treatment participation. Patient-completed intervention feedback forms and treatment completion will be examined after 15 subjects have participated. Based on this feedback, we will pilot an adapted (MI plus CBT) treatment manual, obtaining additional feedback on acceptability. We will assess psychopathy, a constellation of stable traits and potentially important moderator of treatment effects, at baseline. We will assess potential mediators (i.e., motivation to change, self-regulation) using validated measures at baseline and at approximately 2- and 4-weeks post-discharge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Age 18 or older
  • Willing to provide contact information (e.g., email, phone, address)
  • Presence of SORI, including endocarditis, osteomyelitis, septic arthritis, epidural abscess, or serious bacteremia
  • Hospital length of stay estimated at > 3 weeks
  • Admitted to URMC and seen by the Toxicology Consult Team. Providers will be informed of inclusion/exclusion requirements so that they can make an informed decision about whether a patient may be approached.

排除标准

  • Non-English speaking
  • Unwilling to provide informed consent; unable to provide informed consent or participate in study procedures due to lack of comprehension, medical barriers (e.g., intubated), or behavioral (e.g., violence) or severe psychiatric problems (e.g., florid psychosis). Capacity to provide informed consent will be determined by their treatment team or other provider consult team as appropriate. This serves a dual function of both basing consent capacity on the most accurate and current medical information, as well as keeping their treatment team informed of any research involvement of their patient.
  • Note that patients may be ineligible initially but become eligible due to stabilization during hospitalization, at which point we would then proceed as usual with the identification and recruitment process. We will seek to recruit every SORI admission who meets eligibility criteria within the recruitment timeframe.

结局指标

主要结局

Percentage of participants who report intervention acceptability

时间窗: week 4

Written and verbal feedback will be collected from participants.

Change in mean readiness

时间窗: baseline to 2 weeks

A readiness ruler with a scale of 1- 10 where higher numbers indicate better health outcomes will be used to to assess motivation to change illicit substance use.

Change in mean self-regulation

时间窗: baseline to 2 weeks

The Self-Regulation Questionnaire is a 63 item questionnaire with each question rated at a 5-point likert scale. \> 239 High (intact) self-regulation capacity (top quartile) 214-238 Intermediate (moderate) self-regulation capacity (middle quartiles) \< 213 Low (impaired) self-regulation capacity (bottom quartile)

Percentage of participants who completed the week 4 follow up assessments

时间窗: week 4

The percentage of participants who completed the week 4 follow up assessments.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Swogger

Associate Professor

University of Rochester

研究点 (2)

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