Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Maria Chao, DrPH, MPA
Headshot of Maria Chao
Maria Chao

Description

Summary

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 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.

Official Title

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

Details

Background: The proposed 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 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. In collaboration with primary care safety net clinics, the investigators will recruit and randomize 360 participants to (1) IGMV, (2) group acupuncture, (3) both, or (4) neither (usual care, waitlist control). IGMV includes pain education, social and behavioral support, and mind-body approaches (meditation, yoga). Participants randomized to IGMV will initiate groups once enough participants for a cohort have enrolled (8-12 patients). Group acupuncture uses responsive manualization, allowing for a standardized yet individualized treatment. Participants randomized to group acupuncture will initiate 12 weeks of treatment once baseline is completed. Study participants will be asked to complete a total of 3 assessments: a pre-test (baseline), post-test at 3-months, and final follow-up 6 months after baseline.

The investigators will test the hypotheses that compared with usual care, group acupuncture and IGMV improve pain outcomes among racially and ethnically diverse, low-income patients with chronic pain. Our co-primary outcomes of interest are changes in pain impact from baseline to three months (a composite score of pain intensity, pain interference, and physical function) and social support in chronic pain.

Secondary outcomes include: pain interference, pain intensity, physical function, depression, anxiety, sleep, social functioning, global physical, mental, and social well-being using National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) measures. The investigators will also examine intervention effects on social isolation, internalized stigma of chronic pain, and experiences of discrimination. The investigators will also conduct focus groups and semi-structured interviews to further understand patient experiences with pain management, patient-clinician relationships, and clinical care in primary care safety net settings.

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/).

Keywords

Chronic Pain, health equity, integrative health, nonpharmacologic pain management, stigma, social isolation, primary care, group medical visits, Group Acupuncture, Integrative Group Medical Visits

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Received group-based pain management in the past 3 months
  • Received acupuncture treatment for pain in the past 3 months
  • Active cancer treatment
  • Inability to provide informed consent due to mental illness or cognitive impairment

Location

  • Tom Waddell Urban Health Clinic
    San Francisco California 94102 United States

Lead Scientist at UCSF

  • Maria Chao, DrPH, MPA
    Maria T. Chao, DrPH, MPA is a professor at the University of California San Francisco’s Osher Center for Integrative Health and the Division of General Internal Medicine at Zuckerberg San Francisco General Hospital.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06327542
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated