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Evaluating Patient Satisfaction of UROGYN Office Visits With Different Type of Interpretation Services. (SIPI)

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ClinicalTrials.gov Identifier: NCT03470194
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Flynn, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE December 22, 2017
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
Patient satisfaction [ Time Frame: Immediately assessed after office visit ]
Patient satisfaction will be measured by a 14 - item questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Patient Satisfaction of UROGYN Office Visits With Different Type of Interpretation Services.
Official Title  ICMJE Urogynecological Office Visits and Patient Satisfaction of Limited English-Proficient Patients With Phone Interpreter Services Compared to In-Person Interpreters: Randomized Controlled Trial (SIPI)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Pelvic Floor Disorders
Intervention  ICMJE
  • Other: Interpretation Modality: In Person
    Use of In-Person interpretation support for LEP participant during clinical appointment
  • Other: Interpretation Modality: Telephonic
    Use of telephonic interpretation support for LEP participant during clinical appointment
Study Arms  ICMJE
  • Active Comparator: Interpretation Modality: In person
    Participants assigned to this group will use an in person interpreter for the duration of the UROGYN office visit
    Intervention: Other: Interpretation Modality: In Person
  • Active Comparator: Interpretation Modality: Telephonic
    Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit
    Intervention: Other: Interpretation Modality: Telephonic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2018)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2019
Estimated Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Danielle I Taylor, DO 5083349840 danielle.taylor@umassmemorial.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03470194
Other Study ID Numbers  ICMJE H00013745
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Flynn, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Flynn, MD UMass Worcester
PRS Account University of Massachusetts, Worcester
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP