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

March 8, 2024 updated by: Thythy Pham, Loyola University
Understanding a patient's decision-making preference can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mary Tulke, RN
  • Phone Number: 708-476-2186
  • Email: mtulke@luc.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
1 day visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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