Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial (SIPI)
Primary Purpose
Pelvic Floor Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpretation Modality: In Person
Interpretation Modality: Telephonic
Sponsored by
About this trial
This is an interventional health services research trial for Pelvic Floor Disorders focused on measuring Quality Care, Access to health care, Interpretation services
Eligibility Criteria
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
Sites / Locations
- U Mass Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Interpretation Modality: In person
Interpretation Modality: Telephonic
Arm Description
Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit
Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03470194
First Posted
December 22, 2017
Last Updated
March 9, 2021
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT03470194
Brief Title
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial
Acronym
SIPI
Official Title
Urogynecological Office Visits and Patient Satisfaction of Limited English-Proficient Patients With Phone Interpreter Services Compared to In-Person Interpreters: Randomized Controlled Trial (SIPI)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Massachusetts, Worcester
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
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders
Keywords
Quality Care, Access to health care, Interpretation services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interpretation Modality: In person
Arm Type
Active Comparator
Arm Description
Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit
Arm Title
Interpretation Modality: Telephonic
Arm Type
Active Comparator
Arm Description
Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit
Intervention Type
Other
Intervention Name(s)
Interpretation Modality: In Person
Intervention Description
Use of In-Person interpretation support for LEP participant during clinical appointment
Intervention Type
Other
Intervention Name(s)
Interpretation Modality: Telephonic
Intervention Description
Use of telephonic interpretation support for LEP participant during clinical appointment
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
Immediately assessed after office visit
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Flynn, MD
Organizational Affiliation
UMass Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
U Mass Memorial Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32649326
Citation
Taylor DL, Sierra T, Maheshwari D, Hall C, Leung K, Flynn M. Satisfaction With Telephone Versus In-Person Interpretation Services in Limited English-Proficient Urogynecology Patients: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):388-392. doi: 10.1097/SPV.0000000000000880.
Results Reference
derived
Learn more about this trial
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial
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