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Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders

Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05871268
Enrollment
106
Registered
2023-05-23
Start date
2023-12-01
Completion date
2025-03-03
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preferred Level of Involvement in Decision Making LEP Patients

Brief summary

Understanding a patient's decision-making preference can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.

Detailed description

Effective communication between patients and physicians is critical to successful health outcomes. Limited English proficiency (LEP) is defined by the U.S. Census Bureau as anyone who reported speaking English less than very well. There are more than 25 million people (approximately 1 in 11 Americans) with LEP in the United States.1 LEP patients are among the most vulnerable populations. The language barrier experienced by LEP patients hinders effective communication, impedes access to care, and impacts health care delivery.6 Research has shown that LEP patients are likely to consume more health care services7; however, they receive lower quality of care and have poorer outcomes compared to English-proficient patients on various measures: understanding of treatment plans and diseases processes, satisfaction, and incidence of medical errors.3,5, This language-based inequity in LEP patients also hampers shared decision-making, a process in which physicians and patients make decisions together, balancing the risks and benefits with patient preferences and values.6-7 Shared decision-making is encouraged by the Institute of Medicine and US Preventative Services to foster patient autonomy and engagement.6 Similarly, the American College of Obstetricians and Gynecologists emphasizes the importance of creating a partnership with patients.7 Research indicates that patients want to be more involved in the decision-making process but might feel that they do not have the capability to do so.8 Furthermore, the ability of patients to engage in the shared decision-making process also depends on their health literacy. It is estimated that one-third to one-half of the U.S. adult population has low health literacy or a limited capacity to obtain, process, and understand the basic health information and services needed to make informed health decisions.8 While low health literacy affects individuals across the spectrum of socio-demographics, it disproportionately affects those with LEP.9 A knowledge gap exists in our understanding of LEP patients' roles in decision-making since most research on decision-making itself often excludes non-English speakers from study participation. The few published reports in the oncology literature have suggested that Latinas experience barriers to informed treatment decision-making related to literacy, language, and acculturation.2,8 Hawley ST et al. (2008), in a survey of 2030 women with breast cancer, found that Spanish-preferred Latinas were more likely to report too little involvement, higher dissatisfaction, and more regrets compared to English-preferred Latinas, African Americans, and Caucasians.9 Research has shown that patients who take a more active role in their care are often more satisfied, have a better understanding of treatment plans, and experience greater improvement in health and patient-centered outcomes than do passive patients.10 Therefore, understanding these preferences, particularly in an LEP population, is necessary to meet patients' decision-making expectations, navigate discussions about treatment options, and increase patient satisfaction with the decision-making process.

Interventions

The patients' pre-visit Control Preference Scale response are shared with their physician.

OTHERUsual Care

The patients' pre-visit Control Preference Scale response are not shared with their physician.

Sponsors

Loyola University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

The control group will have usual care, meaning that the physician will NOT see the patient's survey results. The patient is blinded to randomization and will not know whether or not the physician is aware of their preferred level of shared decision making.

Intervention model description

Spanish speaking women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Present to Loyola Urogynecology clinic for their initial evaluation and identify as Spanish-speaking (as primary language) * Agree tp complete the study questionnaires * Must be at least 18 years of age * Must be able to read, speak and write in Spanish

Exclusion criteria

* Established patients at Loyola's Urogynecology clinic * Unable to complete the study questionnaires * Less than 18 years of age * Unable to read, speak and write in Spanish

Design outcomes

Primary

MeasureTime frameDescription
To compare Limited English Proficiency patients' preferred roles with actual roles in decision-making and determine how this is altered by the physicians' awareness of the patients' preferred roles.1 day visitThe Control Preference Scale assesses patients preferences for involvement in decision-making. The scale ranks patients preferences for involvement in their healthcare as either active, collaborative, or passive. Patients' CPS responses will be compared between the interventions and usual care cohorts.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026