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

NCT ID: NCT05871268

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-03-03

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.

Conditions

Preferred Level of Involvement in Decision Making LEP Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Physician Awareness

The physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group.

Group Type: EXPERIMENTAL

Physician Awareness

Intervention Type: OTHER

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

Usual Care

The physician will not have access to the pre-visit Control Preference Scale survey results for women assigned to this group.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

Physician Awareness

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

Intervention Type: OTHER

Usual Care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Thythy Pham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thythy Pham, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola Medical Center

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

References

Crawford MJ, Rutter D, Manley C, Weaver T, Bhui K, Fulop N, Tyrer P. Systematic review of involving patients in the planning and development of health care. BMJ. 2002 Nov 30;325(7375):1263. doi: 10.1136/bmj.325.7375.1263.

Reference Type: BACKGROUND

PMID: 12458240 (View on PubMed)

Sung VW, Raker CA, Myers DL, Clark MA. Treatment decision-making and information-seeking preferences in women with pelvic floor disorders. Int Urogynecol J. 2010 Sep;21(9):1071-8. doi: 10.1007/s00192-010-1155-8. Epub 2010 Apr 28.

Reference Type: BACKGROUND

PMID: 20424822 (View on PubMed)

Westbay LC, Adams W, Barnes HC, Gevelinger M, McKee D, Fitzgerald CM, Acevedo-Alvarez M, Mueller ER, Pham TT. How Involved Do Patients Want to Be in the Medical Decision-Making at the Initial Urogynecology Clinic Visit? Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):153-159. doi: 10.1097/SPV.0000000000001157.

Reference Type: BACKGROUND

PMID: 35272322 (View on PubMed)

Keating NL, Guadagnoli E, Landrum MB, Borbas C, Weeks JC. Treatment decision making in early-stage breast cancer: should surgeons match patients' desired level of involvement? J Clin Oncol. 2002 Mar 15;20(6):1473-9. doi: 10.1200/JCO.2002.20.6.1473.

Reference Type: BACKGROUND

PMID: 11896094 (View on PubMed)

de Moissac D, Bowen S. Impact of Language Barriers on Quality of Care and Patient Safety for Official Language Minority Francophones in Canada. J Patient Exp. 2019 Mar;6(1):24-32. doi: 10.1177/2374373518769008. Epub 2018 Apr 18.

Reference Type: BACKGROUND

PMID: 31236448 (View on PubMed)

Bischoff A, Denhaerynck K. What do language barriers cost? An exploratory study among asylum seekers in Switzerland. BMC Health Serv Res. 2010 Aug 23;10:248. doi: 10.1186/1472-6963-10-248.

Reference Type: BACKGROUND

PMID: 20731818 (View on PubMed)

Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/

Reference Type: BACKGROUND

PMID: 25009856 (View on PubMed)

Hawley ST, Fagerlin A, Janz NK, Katz SJ. Racial/ethnic disparities in knowledge about risks and benefits of breast cancer treatment: does it matter where you go? Health Serv Res. 2008 Aug;43(4):1366-87. doi: 10.1111/j.1475-6773.2008.00843.x. Epub 2008 Apr 1.

Reference Type: BACKGROUND

PMID: 18384361 (View on PubMed)

Other Identifiers

217125

Identifier Type: -

Identifier Source: org_study_id