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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DC019216 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| Brown University | OTHER |
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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 a randomized clinical trial (RCT) to test the feasibility and preliminary efficacy of the new training intervention.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Sign Here" training intervention | Experimental | Participants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Sign Here" training intervention | Other | Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | post-intervention, up to one month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | post-intervention, up to one month |
| Self-Rating of Simulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa L Anderson | melissa.anderson@umassmed.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
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Of the 325 healthcare providers, medical students, and nursing students who were screened, 208 met inclusion criteria, consented to participate in the study, and were subsequently randomized to condition. Study participants were either healthcare professionals or students in healthcare professions. The Deaf standardized patient who participated in outcome simulations was a trained member of our research team, not a study participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | "Sign Here" Training Intervention | Participants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers. "Sign Here" training intervention: Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings. |
| FG001 | Intervention as Usual | 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) Intervention as usual: "Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | "Sign Here" Training Intervention | Participants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers. "Sign Here" training intervention: Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Enrolled participants who reviewed their assigned training intervention and completed the study simulation session. | Posted | Mean | Standard Deviation | score on a scale | post-intervention, up to one month |
|
through study completion, an average of 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Sign Here" Training Intervention | Participants randomized to the experimental condition will view the new "Sign Here" training film for healthcare providers. "Sign Here" training intervention: Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings. |
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Small sample size may have affected the power of our statistical analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa L. Anderson, PhD | UMass Chan Medical School | 508-856-5820 | melissa.anderson@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2022 | Nov 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Intervention as usual | Other | "Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf) |
|
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. |
| post-intervention, up to one month |
| Intervention as Usual |
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) Intervention as usual: "Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Intervention as Usual |
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) Intervention as usual: "Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf) |
|
|
|
| Primary | 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. | Enrolled participants who reviewed their assigned training intervention and completed the study simulation session. | Posted | Mean | Standard Deviation | score on a scale | post-intervention, up to one month |
|
|
|
|
| Primary | 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. | Enrolled participants who reviewed their assigned training intervention and completed the study simulation session. | Posted | Mean | Standard Deviation | score on a scale | post-intervention, up to one month |
|
|
|
|
| Secondary | 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. | Enrolled participants who reviewed their assigned training intervention and completed the study simulation session. | Posted | Mean | Standard Deviation | score on a scale | post-intervention, up to one month |
|
|
|
|
| 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. 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. | Enrolled participants who reviewed their assigned training intervention and completed the study simulation session. | Posted | Mean | Standard Deviation | score on a scale | post-intervention, up to one month |
|
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Intervention as Usual | 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) Intervention as usual: "Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings" (https://archive.ada.gov/hospcombrprt.pdf) | 0 | 105 | 0 | 15 | 0 | 105 |
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| Participants less than age 33 |
|
|
| Participants age 33 and greater |
|
|
| 0.075 |
| Superiority |
| Group comparison of participants age 33 and greater. | t-test, 2 sided | 0.015 | Superiority |
| Participants less than age 33 |
|
|
| Participants age 33 and greater |
|
|
| 0.151 |
| Superiority |
| Group comparison of participants age 33 and greater. | t-test, 2 sided | 0.033 | Superiority |
| Participants less than age 33 |
|
|
| Participants greater than age 33 |
|
|
| 0.893 |
| Superiority |
| Group comparison of participants age 33 and greater. | t-test, 2 sided | 0.160 | Superiority |
| Wake Forest Physician Trust Scale (participant self-rating) |
|
| t-test, 2 sided |
| 0.493 |
| Superiority |
| Group comparison of self-rating scores on the Wake Forest Physician Trust Scale. | t-test, 2 sided | 0.085 | Superiority |