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临床试验/NCT03707886
NCT03707886Unknown不适用

Pain SMART: Shared Medical Appointments to Refocus Treatment

VA Connecticut Healthcare System2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Feasibility of participant recruitment

研究概览

简要总结

The proposed study will test whether a shared medical appointment for Veterans with chronic pain is feasible and acceptable to veteran patients and their providers. The shared medical appointment, called Pain SMART (Shared Medical Appointments to Refocus Treatment), is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain. The overall goal of Pain SMART is to improve pain care for Veterans. Veterans will be randomized in equal numbers to either attend a Pain SMART visit or to receive educational information in the mail. The primary outcome of this pilot study is whether or not the shared medical appointment is feasible and acceptable to patients and providers.

详细描述

Objectives: The primary purpose of this study is to understand the feasibility and acceptability of a shared medical appointment for patients with chronic pain called Pain SMART (Shared Medical Appointments to Refocus Treatment).

Intervention: The overall goal of Pain SMART is to increase the use of evidenced-based pain management strategies including pain self-management and other non-pharmacological pain management approaches. Pain SMART is a brief one-visit shared medical appointment delivered by primary care team members (e.g., primary care providers) and a behavioral health specialist (e.g., a clinical health psychologist). Pain SMART uses motivational interviewing to enhance effective and mutually rewarding communication among providers and Veterans to increase pain self-management, including uptake of non-pharmacological approaches to pain management, to ultimately enhance quality of care and Veteran functioning.

Study Participants: Primary care providers/staff will be recruited to participate in Pain SMART visits as shared medical appointment facilitators. Additionally, up to 80 veterans with chronic pain will be recruited.

Research Design: This study is a randomized pilot study in which Veteran participants are randomized to attend Pain SMART or to a minimally enhanced usual care condition (i.e., receive an educational brochure via mail). Veteran participants will be randomized in equal numbers to both conditions. Data collected from Veteran participants at baseline and three months following baseline; data will also be collected from primary care participants regarding their experience with Pain SMART. Data collection will include quantitative measures (e.g., information regarding pain and pain management approaches used) and qualitative measures (e.g., interviews about participants' experiences with Pain SMART).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Veteran Inclusion Criteria:
  • Receives primary care from provider at VA Connecticut who is participating in the study
  • Prescribed an opioid for chronic pain

排除标准

  • Active suicidal ideation
  • Psychotic disorder
  • Active consult to opioid reassessment clinic at VA Connecticut

研究组 & 干预措施

Pain SMART (Intervention Arm)

Experimental

The Intervention Arm will be invited to participate in a one-time group intervention, Pain SMART

干预措施: Pain SMART (Behavioral)

Minimally Enhanced Usual Care

Placebo Comparator

The Minimally Enhanced Usual Care group will receive educational information via mail.

干预措施: minimally enhanced usual care (Other)

结局指标

主要结局

Feasibility of participant recruitment

时间窗: 3 months

ability to recruit Veterans to enroll in the study and attend group, as evidenced by randomizing 80 veterans over the study period and by having at least 60% of veterans randomized to attend the group show up to to the group

次要结局

  • Pain management strategies used - Chronic Pain Coping Inventory(3 months)

研究者

发起方
VA Connecticut Healthcare System
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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