Sign Here: How to Conduct Informed Consent With Deaf Individuals

Cultural Competency Clinical Trial

Official title:

Sign Here: How to Conduct Informed Consent With Deaf Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268055
• Other study ID #: H00021294
• Secondary ID: 5R21DC019216
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research is to create a training film for hearing healthcare providers to teach them how to competently and sensitively interact with Deaf patients. In Year 1, focus groups will be facilitated to elicit feedback that will inform video production of the training film. In Year 2, film production will take place, as well as an RCT to test the feasibility and preliminary efficacy of the new training intervetion.

Description:

The U.S. Deaf community - a minority group of more than 500,000 people who use American Sign Language (ASL) - is one of the most understudied and underserved populations within our nation's healthcare system. Reasons for this underrepresentation include lack of language access in healthcare and research settings, as well as communal feelings of mistrust toward the medical community. For example, healthcare providers and clinical researchers follow a medical model to "cure" or "fix" deafness, whereas most Deaf people do not want to be fixed, but rather to be respected as a cultural and linguistic minority group.

To begin to rectify this mistrust and underrepresentation, the informed consent process has been suggested as a key area of intervention. From 2016 - 2018, our team produced a film to train research personnel to effectively interact with Deaf research participants during the informed consent process. The intervention was designed through a two-year collaboration with the local Deaf community - community forums, focus groups, and an intervention development team inclusive of Deaf researchers, filmmakers, and laypeople.

In 2022, our team conducted a second series of focus groups with key stakeholders to refine, expand, and tailor a new version of the Sign Here training film for healthcare providers. Filmmaking is currently underway. In April 2023, we will launch a randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of the new training intervention. Eighty healthcare providers, medical students, and nursing students will be randomized to receive (1) the Sign Here training film or (2) an "intervention as usual" condition (i.e., standard written guidance on how to communicate with Deaf patients in healthcare settings). Primary outcomes are provider cultural competence, communication skill, and ability to build trust, which will be tested via virtual simulation with a Deaf standardized patient.

Results will potentially validate a product of immediate value - a highly-accessible, easy-to-disseminate training film to promote the inclusion of Deaf people in our nation's healthcare system. Results will also inform the design of a large, multi-institution study to explore the real-world scalability of the Sign Here training film in medical schools across the U.S.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18+

• current or recent engagement in informed consent for treatment

• access to an informed consent form that can be used for a simulated informed consent session

• We will also screen participants' self-reported level of experience with Deaf people, as we aim to recruit participants with little-to-no prior experience interacting with Deaf people to reflect the most probable real-word encounter that a Deaf person would have when receiving healthcare services.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cultural Competency

Intervention

Other:
• "Sign Here" training intervention
Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings.
• Intervention as usual
"Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf)

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Brown University, National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare Provider Cultural Competency	A validated scale used to measure provider cultural competence.	immediate post-intervention
Primary	Ask, Understand, Remember Assessment	A validated scale used to measure participants' communication skill.	immediate post-intervention
Primary	Wake Forest Physician Trust Scale	A validated scale used to measure the ability to build trust with the standardized patient/participant.	immediate post-intervention
Secondary	Assessment of Intervention Understanding & Retention	A ten-question multiple choice test to assess their understanding and retention of intervention content.	immediate post-intervention
Secondary	Self-Rating of Simulation	Participants complete a self-assessment using the validated scales described above to rate their conduct of culturally-appropriate informed consent in the simulation and are also asked to provide feedback on the study experience.	immediate post-intervention