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

NCT05871268 | Completed

• 1 other identifier: 217125
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Preferred Level of Involvement in Decision Making LEP Patients

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Physician Awareness

EXPERIMENTAL

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

Other: Physician Awareness

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

Physician Awareness OTHER

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

Physician Awareness

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (8)

• 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.

  PMID: 12458240 BACKGROUND

• 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.

  PMID: 20424822 BACKGROUND

• 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.

  PMID: 35272322 BACKGROUND

• 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.

  PMID: 11896094 BACKGROUND

• 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.

  PMID: 31236448 BACKGROUND

• 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.

  PMID: 20731818 BACKGROUND

• 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/

  PMID: 25009856 BACKGROUND

• 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.

  PMID: 18384361 BACKGROUND

Study Officials

• Thythy Pham, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: December 1, 2023
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: September 9, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)