Mixed Methods Study Protocol_Chronic Pain and Marginalized Populations

• Conditions: Chronic Pain; Marginalization, Social
• Interventions: Other: No interventions

• Registration Number: NCT03945877
• Lead Sponsor: High Point University

Brief Summary

A mixed-methods sequential explanatory design study. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. The second qualitative phase will use focus group will elucidate, confirm, and more richly describe the findings from the first phase.

Detailed Description

Background: The global epidemic of chronic musculoskeletal pain (CMP) is an intractable issue adversely impacting gross domestic products and costing billions in lost productivity. The expansion of CMP occurs concurrently with historical global mass population movements. Geopolitical negative and racist rhetoric have arisen in response to increased immigration rates. CMP is an invisible disease decoupled from normal tissue healing and results from the complex interplay of biological and psychological processing. Different theoretical models of CMP development now include potential demographic and socio-cultural factors. CMP occurs disproportionately in populations at risk for marginalization, including women, non-Caucasians, immigrants, and people experiencing increased socioeconomic deprivation. The same marginalized populations also are at greater risk for limited access to healthcare and demonstrate worse functional limitations, outcomes, and quality of life. Aims: The primary aims are 1) to characterize self-reported features in people who have CMP and experience marginalization and 2) to interpret the pain experience for marginalised populations of people who have CMP. Methods: A mixed-methods sequential explanatory design study will be used. The first quantitative phase will be a multi-language survey that includes questions related to pain status, patient beliefs, pain interference/social support, and perspective on healthcare utilization. Latent class analysis (LCA) will be used to generate experience-based subgroups in CMP. Focus group will elucidate, confirm, and more richly describe the findings from the first phase. Discussion: Results from this study will be used to inform clinical conversations with patients who have CMP and experience marginalization. By increasing awareness of the potential influences on the clinical conversation, we hope to build opportunities to address inequities in CMP management.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• English, Spanish, and Arabic-speaking adults living in the Piedmont Triad, NC

Exclusion Criteria

• declined to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arabic-speaking Community Members	No interventions	Survey respondents
English-speaking Community Members	No interventions	Survey respondents
Spanish-speaking Community Members	No interventions	Survey respondents

Primary Outcome Measures

Name	Time	Method
Qualitative: Focus groups	November 2018-December 2019	Semi-structured interview data obtained from focus groups
Quantitative: Community surveys	February 2017-September 2017	Demographic data; Survey data

Trial Locations

Locations (1)

High Point University; 🇺🇸 High Point, North Carolina, United States