Cultural CompetencyNCT05268055
Sign Here: How to Conduct Informed Consent With Deaf Individuals
A study testing "Sign Here" training intervention and Intervention as usual in people with Cultural Competency, run by University of Massachusetts, Worcester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cultural Competency
- What is being tested?
- "Sign Here" training intervention and Intervention as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Cultural Competency
- Being tested
- "Sign Here" training intervention, Intervention as usual
- Keywords
- informed consent, simulation, Deaf, cultural competence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Sign Here" training interventionOther
Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings.
Intervention as usualOther
"Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf)
| Study group | Role | What they receive |
|---|---|---|
| "Sign Here" training intervention | Experimental | Participants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers. Receives: Other: "Sign Here" training intervention |
| Intervention as usual | Other | 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) Receives: Other: Intervention as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Provider Cultural Competency
A validated scale used to measure provider cultural competence. Total scores range from 9 to 63, with higher scores indicative of higher levels of cultural competency.
Measured: post-intervention, up to one month
Ask, Understand, Remember Assessment
A validated scale used to measure participants' communication skill. Total scores range from 4 to 16, with higher scores indicating better communication skills.
Measured: post-intervention, up to one month
Wake Forest Physician Trust Scale
A validated scale used to measure the ability to build trust with the standardized patient/participant. Total scores range from 10 to 50, with higher scores indicating greater ability to build trust.
Measured: post-intervention, up to one month
Secondary outcomes (2)
Assessment of Intervention Understanding & Retention
A ten-question multiple choice test to assess their understanding and retention of intervention content. Total scores range from 0 to 28, with higher scores indicating greater comprehension and retention.
Measured: post-intervention, up to one month
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.
For the Healthcare Provider Cultural Competency scale, total scores range from 9 to 63, with higher scores indicating a better outcome.
For the Ask, Understand, Remember Assessment, total scores range from 4 to 16, with higher scores indicating a better outcome.
For the Wake Forest Physician Trust Scale, total scores range from 10 to 50, with higher scores indicating a better outcome.
Measured: post-intervention, up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start3 May 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cultural CompetencyStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Brown University
- Responsible party
- Principal investigator, Melissa L. Anderson, University of Massachusetts, Worcester
- Investigators
- Melissa L Anderson, Principal investigator, melissa.anderson@umassmed.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268055
- Sponsor's protocol ID
- H00021294
- Other IDs
- 5R21DC019216
- Status last verified
- Nov 2024
- First submitted
- 23 Feb 2022
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sign Here: How to Conduct Informed Consent With Deaf Individuals
- ClinicalTrials.gov ID
- NCT05268055
- Acronym / sponsor ID
- H00021294
- Conditions
- Cultural Competency
- Keywords
- informed consent, simulation, Deaf, cultural competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Brown University
- Study start
- 3 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Sign Here" training intervention | Experimental | Other: "Sign Here" training interventionParticipants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers. |
| Intervention as usual | Other | Other: Intervention as usualParticipants 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Sign Here" training interventionTraining film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings. | Other | "Sign Here" training intervention |
| Intervention as usual"Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf) | Other | Intervention as usual |
Primary outcome
Healthcare Provider Cultural Competency
Time frame: post-intervention, up to one month
A validated scale used to measure provider cultural competence. Total scores range from 9 to 63, with higher scores indicative of higher levels of cultural competency.
Ask, Understand, Remember Assessment
Time frame: post-intervention, up to one month
A validated scale used to measure participants' communication skill. Total scores range from 4 to 16, with higher scores indicating better communication skills.
Wake Forest Physician Trust Scale
Time frame: post-intervention, up to one month
A validated scale used to measure the ability to build trust with the standardized patient/participant. Total scores range from 10 to 50, with higher scores indicating greater ability to build trust.
2 secondary outcomes
Assessment of Intervention Understanding & Retention
Time frame: post-intervention, up to one month
Self-Rating of Simulation
Time frame: post-intervention, up to one month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa L Anderson principal investigator
melissa.anderson@umassmed.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Sign Here" training intervention and Intervention as usual in people with Cultural Competency, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Provider Cultural Competency (time frame: post-intervention, up to one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.