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Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare (Impact of VRI)

Primary Purpose

Deafness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Video Remote Interpretation
Sponsored by
University of Geneva, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Deafness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Uses Colombian Sign Language as the preferred language. Enough sensorimotor, cognitive and communication skills to communicate independently with health personnel Exclusion Criteria: Does not communicate using sign language. Additional impairments which affect language development or the use of sign language. Refusal of the participant's representative(s) to participate in the study, Refusal of the participant's representative(s) to participate in a modality of the study,

Sites / Locations

  • Clinica Nuestra Senora de la Paz
  • Hospital Universitario Mayor Mederi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental VRI sign language interpretation

Experimental: primo control

Arm Description

Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication

Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication

Outcomes

Primary Outcome Measures

Communication outcomes
The score of a selected' scale assesses A: creating a good interpersonal relationship, B: exchanging information, and C: Making treatment-related decisions that involve the patients in decision-making. The results of the scale will be asses using descriptive analytics (Fisher exact test will be applied to compare the 2 groups) Multiple regression analysis will be applied using demographic data and health indicators.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2023
Last Updated
July 25, 2023
Sponsor
University of Geneva, Switzerland
Collaborators
Universidad del Rosario, Hospital Universitario Mayor Mederi, Clinica Nuestra Senora de la Paz
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1. Study Identification

Unique Protocol Identification Number
NCT05966623
Brief Title
Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare
Acronym
Impact of VRI
Official Title
Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare: Linking Disability Studies With Empirical Challenges of Public Health Research
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 14, 2023 (Anticipated)
Primary Completion Date
July 14, 2024 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland
Collaborators
Universidad del Rosario, Hospital Universitario Mayor Mederi, Clinica Nuestra Senora de la Paz

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
This is a randomise study that looks at what is the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors versus the 'available standard of care of the usual communication tools, including informal interpretation, lip or note reading, using their mobile phones to contact a formal or informal interpreter, for Deaf patients aged 18 and older in Bogota Colombia
Detailed Description
Background and Rationale: In-person or VRI sign language interpretation is largely unavailable. In a scoping review, the researchers identified a knowledge gap regarding the quality of interpretation and training in sign language interpretation for health care. The researchers also found that this area is under-researched, and the evidence is scant. All available evidence came from high-income countries, which is particularly problematic given that most DHH persons live in low- and middle-income countries. Thus, the available literature shows that VRI may enable deaf users to overcome interpretation barriers and can potentially improve communication outcomes between them and health personnel within health care services. For VRI to be acceptable, sign language users require a VRI system supported by devices with large screens and a reliable internet connection, as well as qualified interpreters trained in medical interpretation. There is no clear data on the availability of VRI or in-person interpretation. Given the cost, VRI may be more available than in person. Available data tend to focus on assessing personal references of Deaf users in regards to interpretation, as well as interpreters' preferences and maximising recourses allocation. Objective(S): To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota, Colombia. Explanation for choice of comparator In-person or VRI sign language interpretation is largely unavailable. Thus, there is no clear data on the magnitude of the availability gap of VRI or in-person interpretation. In-person qualified sign language interpretation in the healthcare setting tends to be described as the ideal standard of service provision. Thus, it is largely unavailable even in HIC. The assumption is based upon minimal available evidence on the personal preferences of Deaf persons in the USA. There is no evidence that in-person interpretation is efficient in the context of weaker infrastructure, such as low sign language literacy rates across Deaf persons, lack of standard qualification of interpreters and lack of interpreters and sustainable financing in HIC. To my knowledge, there is no study assessing DPC while using sign language interpretation. Given the cost, VRI may be more sustainable than in-person. Assessing the efficiency of VRI versus the standard of care would be d of more value, given that there is no other effective intervention to compare.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm Intervention Experimental VRI sign language interpretation Participants will be welcome from their entry point to the hospital, they will attend a general check-up with a GP or other services and be provided with VRI until they leave Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication Experimental: primo control Participants get welcome at the entry point of the hospital, they will attend a general check-up with a GP or other services and they are not provided with by the study with VRI Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication
Masking
None (Open Label)
Masking Description
Single-blinded - The researcher needs to learn before the patient comes to the hospital as VRI needs to be organised. Thus, they will only know if the participants shall be assigned to the intervention or control group after the patient agrees to take part. Double blinding is not feasible as interpreters will not be available 24x7.
Allocation
Randomized
Enrollment
183 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental VRI sign language interpretation
Arm Type
Experimental
Arm Description
Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication
Arm Title
Experimental: primo control
Arm Type
No Intervention
Arm Description
Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication
Intervention Type
Other
Intervention Name(s)
Video Remote Interpretation
Intervention Description
To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota Colombia.
Primary Outcome Measure Information:
Title
Communication outcomes
Description
The score of a selected' scale assesses A: creating a good interpersonal relationship, B: exchanging information, and C: Making treatment-related decisions that involve the patients in decision-making. The results of the scale will be asses using descriptive analytics (Fisher exact test will be applied to compare the 2 groups) Multiple regression analysis will be applied using demographic data and health indicators.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Uses Colombian Sign Language as the preferred language. Enough sensorimotor, cognitive and communication skills to communicate independently with health personnel Exclusion Criteria: Does not communicate using sign language. Additional impairments which affect language development or the use of sign language. Refusal of the participant's representative(s) to participate in the study, Refusal of the participant's representative(s) to participate in a modality of the study,
Facility Information:
Facility Name
Clinica Nuestra Senora de la Paz
City
Bogota
ZIP/Postal Code
110831
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexie Vallejo Silva, MD, MSc
Email
alexie.vallejo@urosario.edu.co
First Name & Middle Initial & Last Name & Degree
Jonathan Irreño Sotomonte, MD,
Email
Jonathan.Irreño@urosario.edu.co
Facility Name
Hospital Universitario Mayor Mederi
City
Bogotá
ZIP/Postal Code
111411
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Carlos Venegas, MD,
Phone
5715600520
Email
luis.venegas@mederi.com.co

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare

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