Clinical trial NCT05906784: Group-based Integrative Pain Management (IPMP+ Pilot)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2023-06-18
Enrollment: 44
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 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.

Detailed description: 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/).

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:

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

Primary outcomes:
measure: Percentage of Eligible Patients Who Are Randomized
timeFrame: Randomization
Secondary outcomes:
measure: Percentage of Randomized Participants Who Complete the Study
timeFrame: 3-month follow up
measure: Intervention Adherence
timeFrame: 12 weeks
Other outcomes:
measure: Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey
timeFrame: 3-month follow up
measure: Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey
timeFrame: 3-month follow up
measure: Social Support in Chronic Pain Scale
timeFrame: 3-month follow up
measure: Average Pain Intensity on the 0-10 Numeric Rating Scale
timeFrame: 3-month follow up
measure: Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC)
timeFrame: 3-month follow up
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: