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Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support (OPTI)

2017年6月29日 更新者：Karen Seal、San Francisco Veterans Affairs Medical Center
The investigators propose to develop a novel intervention that targets the system (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain management alternatives.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The investigators will develop and test the acceptability, feasibility, and preliminary efficacy of a Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain. Specifically, after honing the intervention, the investigators will conduct a pilot randomized controlled trial of Collaborative Care/Motivational Interviewing in 100 veterans (ages 18 and older) with chronic pain in primary care who are prescribed opioid pain medications and exhibit at least one "high-risk" opioid use behavior (e.g. obtaining early opioid refills, etc.). Using ATHENA-OT decision support, PCPs will make guideline-concordant recommendations to all enrolled study patients and initiate a Pain Care Plan. Veterans randomized to Collaborative Care, will have one MI session with their assigned study Care Manager followed by 3 Care Manager-delivered telephone MI/monitoring sessions; patients randomized to the Attention Control arm will have one brief session with their assigned Care Manager, followed by 3 Care Manager-delivered neutral telephone sessions

研究类型

介入性

注册 (实际的)

100

阶段

  • 阶段1

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。

学习地点

  • 美国
    • California
      • San Francisco、California、美国、94121
        • San Francisco VA Medical Center

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:

  • Current Male or Female patient at San Francisco VA Medical Center or affiliated VA clinics
  • Must be older than 18 years
  • Chronic musculoskeletal pain of at least 6 months duration and
  • Prescribed one or more opioid pain medication for more than three months and
  • Evidence of being a high-risk opioid user as determined by PI, electronic medical record, and study measures

Exclusion Criteria:

  • Non-English speakers
  • Plans to relocate within 6 months; not able to come to San Francisco VA Medical Center for three in-person visits
  • Cancer or other terminal illness involving palliative care with opioid medications
  • Serious or untreated mental illness

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：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Attention Control
The neutral 10-15 minute visit with the Care Manager will consist of a brief review of ATHENA-OT safety education and the patient's Pain Care Plan. The CM will answer patient questions, but will avoid using Motivational Interviewing communication. The Care Manager will review upcoming telephone check-in and assessment sessions.
行为的：注意力控制
实验性的：Collaborative Care
Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain.
行为的：动机面试

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
To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.
大体时间：20 weeks post baseline
  • PCPs and the CM in the Collaborative Care arm will report greater self-efficacy in communicating ATHENA-OT pain management recommendations and in developing a Pain Care Plan with chronic pain patients
  • The CM will conduct MI communication with high fidelity.
  • Veterans in the Collaborative Care arm will report greater satisfaction with pain-related care.
20 weeks post baseline

次要结果测量

结果测量
措施说明
大体时间
To preliminarily evaluate the efficacy of ATHENA-OT decision support plus Collaborative Care (CC) to improve prescription opioid safety and adherence to non-opioid pain management alternatives among primary care patients.
大体时间：20 weeks post baseline

Compared to ATHENA-OT plus Attention Control:

H2.a. Veterans randomized to Collaborative Care (CC) will be more likely to achieve a decrease in opioid risk behavior that is sustained during an 8-week post-intervention period of no contact.

H2.b. Veterans randomized to CC are more likely to initiate and sustain ≥ 1 non-opioid strategies.

H2.c. Veterans randomized to CC are more likely to report sustained improvements in pain disability.

H2.d. Substance use disorders and treatment will moderate CC efficacy; Care Manager MI-consistent communication in the CC arm will correlate with reduced opioid risk behavior in veterans.
20 weeks post baseline

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。

赞助

San Francisco Veterans Affairs Medical Center

合作者

National Center for Complementary and Integrative Health (NCCIH)

调查人员

  • 首席研究员：Karen Seal, MD, MPH、SFVAMC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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

2014年11月1日

初级完成 (实际的)

2017年6月12日

研究完成 (实际的)

2017年6月12日

研究注册日期

首次提交

2014年8月25日

首先提交符合 QC 标准的

2014年9月2日

首次发布 (估计)

2014年9月3日

研究记录更新

最后更新发布 (实际的)

2017年7月2日

上次提交的符合 QC 标准的更新

2017年6月29日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 13-11892
  • R34AT008319-01 (美国 NIH 拨款/合同)

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.

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