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

Primary Purpose

Preferred Level of Involvement in Decision Making LEP Patients

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician Awareness
Usual Care
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Preferred Level of Involvement in Decision Making LEP Patients

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physician Awareness

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2023
Last Updated
October 2, 2023
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT05871268
Brief Title
Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders
Official Title
Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preferred Level of Involvement in Decision Making LEP Patients

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Spanish speaking women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation.
Masking
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.
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physician Awareness
Arm Type
Experimental
Arm Description
The physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
The physician will not have access to the pre-visit Control Preference Scale survey results for women assigned to this group.
Intervention Type
Other
Intervention Name(s)
Physician Awareness
Intervention Description
The patients' pre-visit Control Preference Scale response are shared with their physician.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
The patients' pre-visit Control Preference Scale response are not shared with their physician.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 day visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Tulke, RN
Phone
708-476-2186
Email
mtulke@luc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thythy Pham, MD
Phone
708-216-7903
Email
Thythy.pham@lumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thythy Pham, MD
Organizational Affiliation
Loyola Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Tulke, RN
Phone
708-216-2067
Email
mtulke@luc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12458240
Citation
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.
Results Reference
background
PubMed Identifier
20424822
Citation
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.
Results Reference
background
PubMed Identifier
35272322
Citation
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.
Results Reference
background
PubMed Identifier
11896094
Citation
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.
Results Reference
background
PubMed Identifier
31236448
Citation
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.
Results Reference
background
PubMed Identifier
20731818
Citation
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.
Results Reference
background
PubMed Identifier
25009856
Citation
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/
Results Reference
background
PubMed Identifier
18384361
Citation
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.
Results Reference
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Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders

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