Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- opioid use
研究概览
简要总结
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 (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. The intervention will involve meetings between the BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. 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.
详细描述
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;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active
Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).
干预措施: Choacot: Behavioral Intervention for Chronic Opioid Use (Behavioral)
Health Education
Participants in this arm will receive study sessions about various health topics.
干预措施: Health Education (Other)
结局指标
主要结局
opioid use
时间窗: 4 months
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
次要结局
- antiretroviral adherence(4 months)
- psychosocial functioning(4 months)
- quality of the patient-provider relationship(4 months)
- pain(4 months)
- problematic use of other substances(4 months)
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital