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
Overview
- Phase
- N/A
- Intervention
- Usual Care
- Conditions
- Chronic Pain
- Sponsor
- University of California, San Francisco
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function.
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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/).
Investigators
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
Arms & Interventions
Usual Care
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. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit.
Group Acupuncture
Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records.
Intervention: Group Acupuncture
Integrative Group Medical Visits (IGMV)
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. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials.
Intervention: Integrative Group Medical Visits
Group Acupuncture and IGMV
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.
Intervention: Group Acupuncture
Group Acupuncture and IGMV
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.
Intervention: Integrative Group Medical Visits
Outcomes
Primary Outcomes
Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function.
Time Frame: Baseline, 12 weeks, and 24 weeks
Self-reported pain impact will be measured as a composite score of pain intensity, pain interference and physical function. These scores are summed to create Pain Impact, which ranges from 3-50, with higher scores indicating greater impact of pain on one's life, capturing overall day-to-day physical function, the impact of pain on ability to do regular life tasks, and the intensity of pain experienced.
Change in Social support and Pain Questionnaire (SPQ)
Time Frame: Baseline, 12 weeks, and 24 weeks
Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social support and Pain Questionnaire (SPQ). Total scores range from 0 to 24, with higher scores indicating greater levels of social support.
Secondary Outcomes
- Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC)(12 weeks and 24 weeks)
- Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form(Baseline, 12 weeks, and 24 weeks)
- Change in experiences of discrimination in healthcare(Baseline, 12 weeks, and 24 weeks)
- Change in average pain intensity on the 0-10 numeric rating scale(Baseline, 12 weeks, and 24 weeks)
- Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 12 weeks, and 24 weeks)
- Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale(Baseline, 12 weeks, and 24 weeks)
- 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.(Baseline, 12 weeks, and 24 weeks)
- Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9)(Baseline, 12 weeks, and 24 weeks)
- Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2)(Baseline, 12 weeks, and 24 weeks)
- Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b(Baseline, 12 weeks, and 24 weeks)
- Change in Internalized Stigma of Chronic Pain (ISCP) survey(Baseline, 12 weeks, and 24 weeks)
- Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a(Baseline, 12 weeks, and 24 weeks)