Preferred Level of Involvement in Decision Making LEP PatientsNCT05871268
Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders
A study testing Physician Awareness in people with Preferred Level of Involvement in Decision Making LEP Patients, run by Loyola University at 1 site in United States.
Trial summary
Understanding a patient's decision-making preference can help physicians meet their expectations and may increase patient satisfaction with the decision-making process. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Preferred Level of Involvement in Decision Making LEP Patients
- What is being tested?
- Physician Awareness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Understanding a patient's decision-making preference can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.
Read the 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.
- Being tested
- Physician Awareness, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician AwarenessOther
The patients' pre-visit Control Preference Scale response are shared with their physician.
Usual CareOther
The patients' pre-visit Control Preference Scale response are not shared with their physician.
| Study group | Role | What they receive |
|---|---|---|
| Physician Awareness | Experimental | The physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Dec 2023
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Preferred Level of Involvement in Decision Making LEP PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Spanish speaking women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thythy Pham, Loyola University
- Investigators
- Thythy Pham, MD, Principal investigator, Loyola Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871268
- Sponsor's protocol ID
- 217125
- Status last verified
- Sep 2024
- First submitted
- 12 May 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12458240Sung 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.
PubMed 20424822Westbay 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.
PubMed 35272322Keating 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.
PubMed 11896094de 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.
PubMed 31236448Bischoff 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.
PubMed 20731818Institute 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/
PubMed 25009856Hawley 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.
PubMed 18384361
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Health Disparities Gap in Decision-Making Among Limited English Proficient (LEP) Patients With Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT05871268
- Acronym / sponsor ID
- 217125
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Spanish speaking women will be randomly assigned to physician awareness or treatment as usual (control) using a 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Physician Awareness | Experimental | Other: Physician AwarenessThe physician will have access to the pre-visit Control Preference Scale survey results for women assigned to this group. |
| Usual Care | Active comparator | Other: Usual CareThe physician will not have access to the pre-visit Control Preference Scale survey results for women assigned to this group. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician AwarenessThe patients' pre-visit Control Preference Scale response are shared with their physician. | Other | Physician Awareness |
| Usual CareThe patients' pre-visit Control Preference Scale response are not shared with their physician. | Other | Usual Care |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 12458240Crawford 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.
- Background: PubMed 20424822Sung 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.
- Background: PubMed 35272322Westbay 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.
- Background: PubMed 11896094Keating 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.
- Background: PubMed 31236448de 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.
- Background: PubMed 20731818Bischoff 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.
- Background: PubMed 25009856Institute 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/
- Background: PubMed 18384361Hawley 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thythy Pham, MD principal investigator
Loyola Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Awareness in people with Preferred Level of Involvement in Decision Making LEP Patients, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871268, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.