Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Other: Interpretation Modality: In Person Other: Interpretation Modality: Telephonic Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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)
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Other: Interpretation Modality: In Person
Use of In-Person interpretation support for LEP participant during clinical appointment
Active Comparator: Interpretation Modality: Telephonic
Participants assigned to this group will use a phone interpreter for the duration of the UROGYN office visit
 Other: Interpretation Modality: Telephonic
Use of telephonic interpretation support for LEP participant during clinical appointment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: Immediately assessed after office visit ]
    Patient satisfaction will be measured by a 14 - item questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470194


Contacts
Layout table for location contacts
Contact: Danielle I Taylor, DO 5083349840 danielle.taylor@umassmemorial.org

Locations
Layout table for location information
United States, Massachusetts
U Mass Memorial Hospital Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Danielle l Taylor, DO    508-334-9840    danielle.taylor@umassmemorial.org   
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Layout table for investigator information
Principal Investigator: Michael Flynn, MD UMass Worcester
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Michael Flynn, Chief, Division of Female Pelvic Medicine & Reconstructive Surgery, Associate Professor of Obstetrics & Gynecology, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03470194    
Other Study ID Numbers: H00013745
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Flynn, University of Massachusetts, Worcester:
Quality Care
Access to health care
Interpretation services
Additional relevant MeSH terms:
Layout table for MeSH terms
Pelvic Floor Disorders
Pregnancy Complications