Clinical trial NCT03945877: Mixed Methods Study Protocol_Chronic Pain and Marginalized Populations
Official title: Chronic Musculoskeletal Pain Experiences in Marginalized Populations: A Mixed Methods Study Protocol for Understanding the Impact of Geopolitical, Historical, and Societal Influences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Marginalization, Social
Lead sponsor: High Point University
Sponsor class: OTHER
Collaborators: name: University of Otago
First posted: 2019-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English-speaking adults who answer the phone and consent to participate. Spanish and Arabic-speaking adults who consent to participate in an in-person survey.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* declined to participate

Primary outcomes:
measure: Quantitative: Community surveys
timeFrame: February 2017-September 2017
measure: Qualitative: Focus groups
timeFrame: November 2018-December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point University
state: North Carolina
Study officials:
affiliation: High Point University and University of Otago
name: Alicia Emerson, PT, DPT, MS
role: PRINCIPAL_INVESTIGATOR
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