Clinical trial NCT06327542: Group-based Integrative Pain Management in Primary Care Safety Net Clinics
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: health equity
integrative health
nonpharmacologic pain management
stigma
social isolation
primary care
group medical visits
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-03-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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/).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function.
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Social support and Pain Questionnaire (SPQ)
timeFrame: Baseline, 12 weeks, and 24 weeks
Secondary outcomes:
measure: Change in average pain intensity on the 0-10 numeric rating scale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference.
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Internalized Stigma of Chronic Pain (ISCP) survey
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC)
timeFrame: 12 weeks and 24 weeks
measure: Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in experiences of discrimination in healthcare
timeFrame: Baseline, 12 weeks, and 24 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Tom Waddell Urban Health Clinic
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maria Chao, DrPH, MPA
role: PRINCIPAL_INVESTIGATOR
References: