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临床试验/NCT04539821
NCT04539821已完成不适用

Virtual Pain Care for High Risk Veterans on Opioids During COVID19 (and Beyond)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer

研究概览

简要总结

The COVID-19 pandemic is exacerbating the challenges faced by Veterans at risk of opioid overdose including Veterans prescribed moderate-to-high dose long-term opioid therapy (LTOT) whose usual treatment resources and coping strategies may be inaccessible. This project combines established VA care components to deploy and evaluate virtual models of care for Veterans on high-risk LTOT to meet the dual challenges of maintaining social distancing and delivery high quality care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligible participants must currently receive LTOT for chronic pain at 50 mg morphine equivalent daily dose

排除标准

  • •Exclusion criteria at baseline are:
  • •dementia diagnosis or moderate-severe cognitive impairment
  • •unstable or severe untreated psychiatric disorder or medical disease that requires hospitalization
  • •documentation of suspected controlled substance diversion
  • •inability to communicate by phone

研究组 & 干预措施

VCPM

Other

VCPM is a multi-component intervention consisting of already-established care processes and materials. First, the patient is mailed or emailed (based on their preference) an informational packet prior to intake appointment. Second, using the collaborative medication management model established in VHA,3 the intake appointment is led by the CPS using a standardized intake evaluation. The CPS and physician design a plan presented to the patient. If BUP switch is offered and accepted, the physician completes additional brief evaluations, including a history, medication review, treatment planning, and discussion of other VCPM components, using two-way audio-video visits (with telephone as a back-up).

干预措施: VCPM (Other)

结局指标

主要结局

The Number of Patients Who Agree to Change in Their Opioid Regimen, Including Buprenorphine Transfer

时间窗: 30 days

Using shared decision-making with Veterans, we will based the measure on clinical reports of patient change in opioid regimen. This would be tapering (reducing opioid dose), discontinuation, or transfer to buprenorphine. Any reduction or change was considered positive for change, even if the patients returned to their initial dose. The number of patients who agree to change their opioid regimen provides a realistic indicator of overall feasibility/acceptability.

次要结局

  • Number of Participants Retained in Care at End of Study(60 days)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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