Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain (CHOACOT)
研究概览
地位
详细说明
Up to 20% of HIV patients receive prescriptions for chronic opioid therapy (COT) to treat chronic pain. This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. This would be the first theoretically-driven, empirically-tested intervention that specifically attends to the difficult issues around chronic pain and opioid prescription in HIV clinical practice.
This project will develop a collaborative, brief, behavioral consultation intervention targeting misuse of prescribed opioids in older HIV+ adults. The intervention, CHOACOT (Consultation for HIV+ Older Adults on Chronic Opioid Therapy), will consist of:
- three meetings between the Behavioral Health Specialist (BHS) and the patient
- two brief consultations between the BHC and the HIV-PCP
- a joint meeting of the patient, BHC, and HIV-PCP.
To achieve our aims, we will develop CHOACOT beginning with an iterative open trial (n=10). Next, we will conduct a pilot randomized clinical trial (n=30) of CHOACOT versus enhanced Treatment-As-Usual. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes. The specific aims are:
Aim 1. Develop and refine CHOACOT so that it meets standards of feasibility and acceptability for HIV PCPs, BHCs, and participants;
1a. To develop and field test a CHOACOT BHC manual;
1b. To develop a reliable measure of BHC manual adherence;
1c. To develop and field-test BHC training and supervision procedures. Aim 2. Refine research procedures (e.g., consent and randomization processes, assessment procedures), and establish their feasibility and acceptability to participants while confirming recruitment goal targets.
Misuse of prescribed opioids is the primary outcome. Secondary outcomes are problematic use of substances with a high potential for lethality when used with COT (benzodiazepines, cocaine, alcohol, heroin), ARV adherence, viral load, pain, psychosocial functioning, patient-provider alliance, and treatment satisfaction and acceptability.
This line of work could lead to the incorporation into HIV care of a theoretically-driven and empirically-tested brief intervention for older HIV patients who are prescribed opioids for chronic pain and for whom there is concern about opioid misuse.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Rhode Island
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Providence、Rhode Island、美国、02906
- Butler Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV patients with a physician at the enrollment site;
- Age 50 or older;
- Chronic pain (pain duration for at least six months);
- Daily use of an opioid analgesic, prescribed by an HIV-PCP at the study site, for at least the past 90 days;
- Patients endorse "feeling at risk of losing their pain medication prescription," or that they are "unhappy with how they and their doctors are working together to manage their pain";
- Patient-rated Addictions Behavior Checklist score > 3, as a recommended cut-point indicating opioid misuse.
Exclusion Criteria:
- Current, severe psychiatric symptoms requiring immediate clinical attention;
- Inability to understand English;
- Cognitive impairment severe enough to interfere with ability to actively participate in CHOACOT.
学习计划
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Active
Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).
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This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
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安慰剂比较:Health Education
Participants in this arm will receive study sessions about various health topics.
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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 |
|---|---|---|
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opioid use
大体时间:4 months
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opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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quality of the patient-provider relationship
大体时间:4 months
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quality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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4 months
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pain
大体时间:4 months
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pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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4 months
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problematic use of other substances
大体时间:4 months
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problematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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4 months
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antiretroviral adherence
大体时间:4 months
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antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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4 months
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psychosocial functioning
大体时间:4 months
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psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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4 months
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合作者和调查者
调查人员
- 首席研究员:Michael Stein, MD、Butler Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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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