此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

原住民社区的阿片类药物和疼痛治疗 (OPTIC) 试验 (OPTIC)

2026年11月4日 更新者:University of New Mexico

原住民社区阿片类药物和疼痛治疗 (OPTIC) 试验:实施筛查和简短干预

The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.

研究概览

详细说明

Given the health disparities in AI/AN populations and lack of access to quality care for comorbid chronic pain and opioid misuse/OUD, the proposed study seeks to build upon the strong relationships between the research team and the AI/AN communities. There is a dearth of prior research examining chronic pain, opioid misuse/OUD, and other comorbid conditions (mood disorders, anxiety disorders, other SUD) in AI/AN populations. Using CBPR methods, the investigators will work with the OPTIC Collaborative Board to develop a culturally centered implementation intervention to improve screening and brief interventions with AI/AN clients with chronic pain and opioid misuse/OUD (Phase I, Aim 1). Specifically, in collaboration with the community partners and the OPTIC Collaborative Board, the investigators will develop a provider training to increase provider skills and self-efficacy to focus conversations on managing chronic pain (rather than trying to eliminate it) and improving client functioning within cultural frameworks of wellbeing. The goal is to develop, implement, and evaluate culturally centered implementation strategies to increase screening and brief intervention for chronic pain, opioid misuse/OUD in clinics serving AI/AN communities. The investigators will conduct a type III effectiveness-implementation trial over the course of 24 months at each clinical site utilizing EMR data and longitudinal staff surveys to test the implementation outcomes (Phase II, Aim 2) as well as patient surveys to test effectiveness outcomes (Phase II, Aim 3) . The investigators hypothesize that the culturally centered approach will increase rates of screening and brief intervention, and ultimately improve outcomes among AI/AN clients with chronic pain and OUD who receive treatment in primary care. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder for the purpose of identifying areas of treatment needs, and examining the efficacy of a provider-level implementation intervention delivered at the sites from which our participants will be sampled.

研究类型

介入性

注册 (估计的)

225

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Kamilla L Venner, PhD
  • 电话号码:5059252300
  • 邮箱:kamilla@unm.edu

研究联系人备份

学习地点

    • California
      • Arcata、California、美国、95521
        • 招聘中
        • Clinic Site A (blinded pending tribal approval)
        • 接触:
    • Minnesota
      • Minneapolis、Minnesota、美国、55404
        • 尚未招聘
        • Clinic Site C (blinded pending tribal approval)
        • 接触:
    • Washington
      • Toppenish、Washington、美国、98948
        • 尚未招聘
        • Clinic Site B (blinded pending tribal approval)
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Willing and able to provide informed consent
  • have English comprehension and proficiency
  • receiving services at one of our participating study sites
  • report current chronic pain and/or opioid misuse/opioid use disorder
  • self-identify as American Indian/Alaska Native

Exclusion Criteria:

  • if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Pre-Intervention

Baseline prior to any involvement with the project

无干预:Intervention

A workgroup for each clinic meets for approximately 6 months to select the specific goals for the clinic to be targeted during the implementation phase.

有源比较器:Implementation

Evidence-based implementation strategies are put into practice for approximately 6 months.

Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients

无干预:Sustainment

Measuring the degree to which the clinic maintains the implementation phase goals.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
大体时间:6 months (or duration of implementation phase)

Derived from electronic medical records

6 months (or duration of implementation phase)
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
大体时间:6 months (or duration of sustainment phase)

Derived from electronic medical records

6 months (or duration of sustainment phase)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Matthew R Pearson, PhD、University of New Mexico

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年6月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2024年8月19日

首先提交符合 QC 标准的

2024年8月19日

首次发布 (实际的)

2024年8月22日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2303044342
  • RM1DA055301 (美国 NIH 拨款/合同)
  • 2206007094 (其他标识符:University of New Mexico)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Each Tribal partner has would need to agree to have their data shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅