DOI: 10.3886/icpsr39497.v1
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, San Francisco, 2023
title: Version 1

description: 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. This pilot study tests 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.

The primary objective of this study is to evaluate the feasibility of key study design features for a randomized clinical trial of group-based integrative pain management in primary care safety clinics. Parameters of interest are feasibility of randomization and retention of participants, and intervention fidelity and adherence. A secondary objective of the study is to evaluate assessment procedures in preparation for a larger scale 2x2 factorial trial of group acupuncture and integrative group medical visits.
description: This was a pilot study using a 2x2 factorial randomized clinical trial design. The pilot tested two 12-week group-based models: group acupuncture and integrative group medical visits (IGMV). All participants received usual care and were randomized to group acupuncture, IGMV, both, or waitlist control. Quality and variability of data at baseline and 3-month follow up were assessed for pain-related outcomes. Data includes patient-reported outcomes, qualitative interviews, focus groups, and observations to assess multilevel individual, interpersonal and organizational outcomes.
description: Response Rates: Of the 91 primary care safety net patients who were confirmed eligible, 44 consented to study participation and were randomized.
description: Presence of Common Scales: 
Patient Reported Outcomes Measurement Information System (PROMIS)
Generalized Anxiety Disorder-2 (GAD-2)
Patient Health Questionnaire-2 (PHQ-2)
Tobacco Alcohol Prescription medications and other Substance (TAPS)
description: Researchers aimed to recruit n=40 English or Spanish-speaking adults with chronic pain for 3 or more months receiving care in San Francisco Department of Public Health primary care clinics. Final enrollment was n=44 randomized participants.
description: Datasets: 
DS0: Study-Level Files
DS1: Survey Analysis Data
DS2: Demographics Data
DS3: Focus Group Memos
DS4: Interview Memos
description: English and Spanish speaking patients with chronic pain at primary care safety net clinics in San Francisco, CA.
description: coded on-site observation; face-to-face interview; on-site questionnaire; telephone interview; web-based surveyThe Survey Analysis Data (Dataset 1) contains data for all 44 randomized study participants in a repeated measures (longitudinal) format. There is one record per study time point (baseline and 3 month follow up) per participant. The participant identifier (ID) is a unique number for each participant, created for the purposes of data sharing and does not correspond to the study participant identification numbers used during study operations.In order to de-identify the data, while there are 44 records in the Demographics Data (Dataset 2) and 44 unique participants in the study, all data columns have been sorted in random order such that data rows contain data from multiple individuals and the data can only be used to create summary statistics on column data (in separate summaries for each variable).