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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03470194
Other study ID # H00013745
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date June 15, 2019

Study information

Verified date March 2021
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine if In-person interpreters increases patient satisfaction of URGYN office visits compared to the use of phone interpreter services for Limited English Proficient (LEP) patients


Description:

This study is a randomized controlled trial. Patients presenting to the UMass Memorial UROGYN clinic will be screened for eligibility using the inclusion and exclusion criteria. LEP patients will be identified as patients that initiate conversation in a non-English language and are only able to communicate adequately regarding their medical problem in a non-English language. After patients have been seen for their scheduled office visit, they will be invited to participate in the study. Once the patient has agreed to participate in the study the participant will be randomized. Study assignment will be revealed using sequentially numbered sealed opaque envelopes. Randomization will be performed using software and a block randomization scheme to yield a 50% chance of having an in-person interpreter. Those assigned to the control group will receive phone translation services and the experimental group will have in person interpreters. At the subsequent visit, demographic information will be collected and patients will then receive interpretation services from the phone or an in-person interpreter.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date June 15, 2019
Est. primary completion date June 10, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - LEP speaking Spanish and Portuguese female patients presenting to the U Mass UROGYN clinic with or without Ad-hoc interpreters - Spanish and Portuguese speaking female patients with LEP presenting to the U Mass UROGYN clinic for an office visit of any type Exclusion Criteria: - Unable to provide consent - Under 18 years of age - Pregnant women - Prisoners - LEP subjects who decline interpreter services - Non -Spanish or Non - Portuguese speaking subjects - Patients with cognitive impairment - Visually or hearing impaired patients - Patients not requiring a follow up appointment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interpretation Modality: In Person
Use of In-Person interpretation support for LEP participant during clinical appointment
Interpretation Modality: Telephonic
Use of telephonic interpretation support for LEP participant during clinical appointment

Locations

Country Name City State
United States U Mass Memorial Hospital Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Patient satisfaction will be measured by a 14 - item questionnaire. The questionnaire was created, validated, and used in a previous study from the field of Emergency medicine. There are 3 subscales assessing patient satisfaction with interpreter, nursing, and physician. Satisfaction with interpreters was calculated using the summation index of 4 items. Satisfaction with physician and nursing communication was measure by a summated index of 5 items that measure increasing level of satisfaction with a likert scale. Answers ranged from 1 to 4 where 4 equaled "strongly agree" and 1 equaled "strongly disagree". All items were weighted on a 100 point scale to facilitate interpretation of the means. A lower score means less satisfaction/greater dissatisfaction and a higher score indicates more satisfaction/less dissatisfaction. Immediately assessed after office visit
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