Clinical trial NCT05268055: Sign Here: How to Conduct Informed Consent With Deaf Individuals
Official title: Sign Here: How to Conduct Informed Consent With Deaf Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cultural Competency
Keywords: informed consent
simulation
Deaf
cultural competence
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Brown University
First posted: 2022-03-07
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 a randomized clinical trial (RCT) to test the feasibility and preliminary efficacy of the new training intervention.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* age 18+
* self-identification as a healthcare provider, medical student, or nursing student
* 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

Primary outcomes:
measure: Healthcare Provider Cultural Competency
timeFrame: post-intervention, up to one month
measure: Ask, Understand, Remember Assessment
timeFrame: post-intervention, up to one month
measure: Wake Forest Physician Trust Scale
timeFrame: post-intervention, up to one month
Secondary outcomes:
measure: Assessment of Intervention Understanding & Retention
timeFrame: post-intervention, up to one month
measure: Self-Rating of Simulation
timeFrame: post-intervention, up to one month
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: melissa.anderson@umassmed.edu
name: Melissa L Anderson
role: PRINCIPAL_INVESTIGATOR
References: