跳至主要内容
临床试验/NCT05906784
NCT05906784已完成不适用

Pilot Phase of Group-based Integrative Pain Management: A Multi-level Approach to Address Intersectional Stigma and Social Isolation in Diverse Primary Care Safety Net Patients With Chronic Pain

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年4月28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
Percentage of Eligible Patients Who Are Randomized

研究概览

简要总结

Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed pilot study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients.

详细描述

Background: The proposed pilot study seeks to address chronic pain disparities in racially diverse, socioeconomically disadvantaged individuals by optimizing multimodal pain management provided in primary care safety net clinics. Multilevel barriers exist in primary care settings where socioeconomically disadvantaged patients are most often treated. Lack of access to multimodal and nonpharmacologic care at the organizational level alongside provider bias and other forms of discrimination at the interpersonal level contribute to unequal assessment, treatment, and quality of pain care. Stigmatization cross-cuts all levels and is closely linked with social isolation common among individuals with chronic pain. Group-based models are a promising multilevel approach to increase access to non-pharmacologic therapies, address time constraints that contribute to disparities in pain care, improve patient-clinician communication, and provide social support among safety net patients with chronic pain.

Methods: This pilot study uses mixed methods and a pragmatic 2x2 randomized factorial trial to test two group-based models: integrative group medical visits (IGMV) and group acupuncture. Study interventions include 12 weekly sessions based on existing protocols tested in primary care safety net settings. IGMV includes pain education, social and behavioral support, and mind-body approaches (meditation, yoga). Group acupuncture uses responsive manualization, allowing for a standardized yet individualized treatment. During this pilot study, a panel of national experts and patient stakeholders will refine and optimize the structure, process, and content of IGMV aimed at reducing social isolation and intersectional stigma as part of pain management. Interventions will be piloted in 40 English or Spanish speaking patients with chronic pain at two primary care safety net clinics. Study procedures will be tested and adapted for a larger scale trial. The larger study will test the hypotheses that compared with usual care, each study intervention improves pain interference and social isolation (primary outcomes), and that the two combined have synergistic effects mediated by increased social support and decreased impact of intersectional stigma among safety net patients with chronic pain.

Significance: Multilevel approaches are needed to advance health equity in pain management. The proposed study will contribute to knowledge of group-based integrative pain management co-located in primary care to address disparities in pain care for socioeconomically vulnerable populations. The study receives support from the Helping to End Addiction Long-term® (HEAL) Initiative (https://heal.nih.gov/).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Investigator)

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

  • adults aged > 18
  • fluency in English or Spanish;
  • panelled to a primary care provider at one of the study clinics;
  • diagnosis of chronic pain (> 3 months);
  • had a primary care visit for chronic pain within the past six months;
  • ability to provide a phone number;
  • able to participate in groups;
  • intent to be available for up to 24 weeks.

排除标准

  • current anticoagulant use
  • active cancer treatment
  • inability to provide informed consent due to mental illness or cognitive impairment.

研究组 & 干预措施

usual care

No Intervention

Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy.

group acupuncture

Experimental

Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting.

干预措施: group acupuncture (Other)

Integrative Group Medical Visits (IGMV)

Experimental

IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support.

干预措施: Integrative Group Medical Visits (Other)

group acupuncture and IGMV

Experimental

Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above.

干预措施: Integrative Group Medical Visits (Other)

group acupuncture and IGMV

Experimental

Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above.

干预措施: group acupuncture (Other)

结局指标

主要结局

Percentage of Eligible Patients Who Are Randomized

时间窗: Randomization

Percentage of patients with confirmed eligibility who are randomized

次要结局

  • Percentage of Randomized Participants Who Complete the Study(3-month follow up)
  • Intervention Adherence(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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