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

Sponsor
Loyola University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05871268
Collaborator
(none)
106
1
2
18
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physician Awareness
  • Other: Usual Care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Spanish speaking women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation.Spanish speaking women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation.
Masking:
Single (Participant)
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.
Primary Purpose:
Health Services Research
Official Title:
Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physician Awareness

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

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

Active Comparator: Usual Care

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

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

Outcome Measures

Primary Outcome Measures

  1. 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 visit]

    The 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loyola University Medical Center Maywood Illinois United States 60153

Sponsors and Collaborators

  • Loyola University

Investigators

  • Principal Investigator: Thythy Pham, MD, Loyola Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thythy Pham, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier:
NCT05871268
Other Study ID Numbers:
  • 217125
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2023