Sign Here: How to Conduct Informed Consent With Deaf Individuals

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sign Here: How to Conduct Informed Consent With Deaf Individuals

Conditions
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Cultural Competency

Intervention / Treatment
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* Other: Sign Here training intervention
* Other: Intervention as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sign Here training intervention<br>Participants randomized to the experimental condition will view the new Sign Here training film for healthcare providers. | Other: Sign Here training intervention<br>* Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings.<br>|
| Other: Intervention as usual<br>Participants randomized to intervention as usual will review Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings (https://archive.ada.gov/hospcombrprt.pdf) | Other: Intervention as usual<br>* Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings (https://archive.ada.gov/hospcombrprt.pdf)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Provider Cultural Competency | A validated scale used to measure provider cultural competence. | immediate post-intervention | 
| Ask, Understand, Remember Assessment | A validated scale used to measure participants' communication skill. | immediate post-intervention | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Intervention Understanding & Retention | A ten-question multiple choice test to assess their understanding and retention of intervention content. | immediate post-intervention | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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informed consent, simulation, Deaf, cultural competence