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临床试验/NCT02525731
NCT02525731已完成不适用

Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Patient Cohort Component

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
2
主要终点
Opioid misuse (Current Opioid Misuse Measure)

研究概览

简要总结

The TEACH patient cohort will characterize a clinic sample of HIV-infected patients on chronic opioid therapy (COT) by describing basic demographics and health status, including characteristics of pain (severity and interference), aberrant behaviors/misuse of COT, substance use and trust/satisfaction with providers. In addition, data on a subset of participants will be used to supplement analysis of secondary outcomes for the TEACH randomized controlled trial (RCT), an intervention study directed at COT providers (outlined in a separate Clinical Trials Protocol Registration and Results (PRS) summary).

详细描述

The TEACH patient cohort study is multi-site and will be conducted at Boston Medical Center and Grady Memorial Hospital. It will involve recruiting and consenting HIV-infected patients on chronic opioid therapy (COT) to be participants in an observational study. The patient cohort will characterize a clinic sample of HIV-infected patients on COT by describing basic demographics and health status, including characteristics of pain (severity and interference), aberrant behaviors/misuse of COT, substance use and trust/satisfaction with providers. Participation in the study will involve completing one baseline and one follow-up assessment. The follow-up assessment will take place approximately 12 months after the baseline assessment. Both the baseline and follow-up assessments will be conducted at the clinical site, and a single signed consent form will be obtained for both visits. A similar assessment instrument will be used at baseline and follow-up. Additional health information will be collected from the medical record.

There are two distinct components to the TEACH study. The patient cohort component, which is outlined in this Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV clinic on COT to be participants in an observational study. The intervention, outlined in a separate Clinical Trials PRS summary, will involve consenting physicians as participants in a randomized controlled trial of an intervention and, via a waiver of informed consent, extracting patient level data on the physicians' patients from the electronic medical record. Data on a subset of observational cohort participants will be used to supplement analysis of secondary outcomes for the intervention (i.e. those patients whose providers were enrolled).

The TEACH patient cohort component seeks to inform physicians and other providers about patients who use chronic opioid therapy, including valuable information on the effect of the COT prescriber-directed intervention on patients. This knowledge will guide both prescribers and patients in improving care and reducing risks associated with chronic opioid therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient is HIV-infected
  • Patient receives care in the HIV clinic at participating sites
  • Patient is on chronic opioid therapy (e.g. 3 or more opioid prescriptions written at least 21 days apart in the prior 6 months)
  • Patient is at least 18 years of age
  • Patient can provide contact information for at least two contacts to assist with follow-up
  • Patient has a home or mobile telephone
  • Patient speaks English

排除标准

  • Patient plans to move from area within 12 months
  • Patient is unable to consent or understand interview (determined by trained research staff)

结局指标

主要结局

Opioid misuse (Current Opioid Misuse Measure)

时间窗: Participants will be followed up to one year

Pain severity in the past week (Brief Pain Inventory)

时间窗: Participants will be followed up to one year

次要结局

  • Pain interference in the past week (Brief Pain Inventory)(Participants will be followed up to one year)
  • Number of days of drug use in the past 30 days (Addiction Severity Index)(Participants will be followed up to one year)
  • Any emergency department visit to seek opioids (medical chart review and interview)(Participants will be followed up to one year)
  • Trust in provider (Physician Trust Scale)(Participants will be followed up to one year)
  • Satisfaction with COT (questions created)(Participants will be followed up to one year)

研究者

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

Jeffrey Samet

Chief of General Internal Medicine

Boston Medical Center

研究点 (2)

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