Cultural Competency
Conditions
Keywords
informed consent, simulation, Deaf, cultural competence
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.
Interventions
OTHERSign Here training intervention
Training film to educate healthcare providers to competently and sensitively interact with Deaf patients in healthcare settings.
Communicating with People Who Are Deaf or Hard of Hearing in Hospital Settings (https://archive.ada.gov/hospcombrprt.pdf)
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Brown University
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Provider Cultural Competency | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Intervention Understanding & Retention | post-intervention, up to one month | 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. |
| Self-Rating of Simulation | post-intervention, up to one month | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| 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) | 105 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 68 | 68 |
| Overall Study | Withdrawal by Subject | 12 | 8 |
Baseline characteristics
| Characteristic | Sign Here Training Intervention | Total | Intervention as Usual |
|---|---|---|---|
| Age, Continuous | 40.94 years STANDARD_DEVIATION 11.78 | 41.36 years STANDARD_DEVIATION 12.64 | 41.77 years STANDARD_DEVIATION 13.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 14 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 194 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 22 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 168 Participants | 84 Participants |
| Sex/Gender, Customized Gender Female | 85 Participants | 171 Participants | 86 Participants |
| Sex/Gender, Customized Gender Male | 18 Participants | 36 Participants | 18 Participants |
| Sex/Gender, Customized Gender Other | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 105 |
| other Total, other adverse events | 0 / 103 | 0 / 105 |
| serious Total, serious adverse events | 0 / 103 | 0 / 15 |
Outcome results
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.
Time frame: post-intervention, up to one month
Population: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sign Here Training Intervention | Ask, Understand, Remember Assessment | All participants | 12.5 score on a scale | Standard Deviation 2.9 |
| Sign Here Training Intervention | Ask, Understand, Remember Assessment | Participants less than age 33 | 14.4 score on a scale | Standard Deviation 1.3 |
| Sign Here Training Intervention | Ask, Understand, Remember Assessment | Participants age 33 and greater | 10.8 score on a scale | Standard Deviation 3 |
| Intervention as Usual | Ask, Understand, Remember Assessment | All participants | 13.5 score on a scale | Standard Deviation 2.2 |
| Intervention as Usual | Ask, Understand, Remember Assessment | Participants less than age 33 | 13.2 score on a scale | Standard Deviation 1.8 |
| Intervention as Usual | Ask, Understand, Remember Assessment | Participants age 33 and greater | 13.7 score on a scale | Standard Deviation 2.6 |
Comparison: Group comparison of participants less than age 33.p-value: 0.075t-test, 2 sided
Comparison: Group comparison of participants age 33 and greater.p-value: 0.015t-test, 2 sided
Comparison: Group comparison of all participants.p-value: 0.2t-test, 2 sided
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.
Time frame: post-intervention, up to one month
Population: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sign Here Training Intervention | Healthcare Provider Cultural Competency | All participants | 40.5 score on a scale | Standard Deviation 14 |
| Sign Here Training Intervention | Healthcare Provider Cultural Competency | Participants less than age 33 | 48.7 score on a scale | Standard Deviation 8.3 |
| Sign Here Training Intervention | Healthcare Provider Cultural Competency | Participants aged 33 and greater | 33.0 score on a scale | Standard Deviation 14.2 |
| Intervention as Usual | Healthcare Provider Cultural Competency | All participants | 42.7 score on a scale | Standard Deviation 11 |
| Intervention as Usual | Healthcare Provider Cultural Competency | Participants less than age 33 | 41.3 score on a scale | Standard Deviation 9.1 |
| Intervention as Usual | Healthcare Provider Cultural Competency | Participants aged 33 and greater | 44.3 score on a scale | Standard Deviation 13 |
Comparison: Group comparison of all participants.p-value: 0.525t-test, 2 sided
Comparison: Group comparison of participants less than age 33.p-value: 0.045t-test, 2 sided
Comparison: Group comparison of participants age 33 and greater.p-value: 0.046t-test, 2 sided
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.
Time frame: post-intervention, up to one month
Population: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sign Here Training Intervention | Wake Forest Physician Trust Scale | All participants | 36.4 score on a scale | Standard Deviation 9.5 |
| Sign Here Training Intervention | Wake Forest Physician Trust Scale | Participants less than age 33 | 41.6 score on a scale | Standard Deviation 5.2 |
| Sign Here Training Intervention | Wake Forest Physician Trust Scale | Participants age 33 and greater | 31.6 score on a scale | Standard Deviation 10.2 |
| Intervention as Usual | Wake Forest Physician Trust Scale | All participants | 39.1 score on a scale | Standard Deviation 6.9 |
| Intervention as Usual | Wake Forest Physician Trust Scale | Participants less than age 33 | 38.4 score on a scale | Standard Deviation 5.7 |
| Intervention as Usual | Wake Forest Physician Trust Scale | Participants age 33 and greater | 39.8 score on a scale | Standard Deviation 8.2 |
Comparison: Group comparison of all participants.p-value: 0.246t-test, 2 sided
Comparison: Group comparison of participants less than age 33.p-value: 0.151t-test, 2 sided
Comparison: Group comparison of participants age 33 and greater.p-value: 0.033t-test, 2 sided
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.
Time frame: post-intervention, up to one month
Population: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sign Here Training Intervention | Assessment of Intervention Understanding & Retention | All participants | 22.1 score on a scale | Standard Deviation 2.5 |
| Sign Here Training Intervention | Assessment of Intervention Understanding & Retention | Participants less than age 33 | 21.9 score on a scale | Standard Deviation 1.9 |
| Sign Here Training Intervention | Assessment of Intervention Understanding & Retention | Participants greater than age 33 | 22.3 score on a scale | Standard Deviation 3 |
| Intervention as Usual | Assessment of Intervention Understanding & Retention | All participants | 21.2 score on a scale | Standard Deviation 2.7 |
| Intervention as Usual | Assessment of Intervention Understanding & Retention | Participants less than age 33 | 21.8 score on a scale | Standard Deviation 2.1 |
| Intervention as Usual | Assessment of Intervention Understanding & Retention | Participants greater than age 33 | 20.5 score on a scale | Standard Deviation 3.2 |
Comparison: Group comparison of all participants.p-value: 0.212t-test, 2 sided
Comparison: Group comparison of participants less than age 33.p-value: 0.893t-test, 2 sided
Comparison: Group comparison of participants age 33 and greater.p-value: 0.16t-test, 2 sided
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.
Time frame: post-intervention, up to one month
Population: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sign Here Training Intervention | Self-Rating of Simulation | Healthcare Provider Cultural Competency (participant self-rating) | 42.6 score on a scale | Standard Deviation 5.8 |
| Sign Here Training Intervention | Self-Rating of Simulation | Ask, Understand, Remember Assessment (participant self-rating) | 12.7 score on a scale | Standard Deviation 2.5 |
| Sign Here Training Intervention | Self-Rating of Simulation | Wake Forest Physician Trust Scale (participant self-rating) | 37.7 score on a scale | Standard Deviation 4.3 |
| Intervention as Usual | Self-Rating of Simulation | Healthcare Provider Cultural Competency (participant self-rating) | 41.9 score on a scale | Standard Deviation 8.1 |
| Intervention as Usual | Self-Rating of Simulation | Ask, Understand, Remember Assessment (participant self-rating) | 13.2 score on a scale | Standard Deviation 2.1 |
| Intervention as Usual | Self-Rating of Simulation | Wake Forest Physician Trust Scale (participant self-rating) | 39.9 score on a scale | Standard Deviation 4.7 |
Comparison: Group comparison of self-rating scores on the Healthcare Provider Cultural Competence measure.p-value: 0.752t-test, 2 sided
Comparison: Group comparison of self-rating scores on the Ask, Understand, Remember Assessment.p-value: 0.493t-test, 2 sided
Comparison: Group comparison of self-rating scores on the Wake Forest Physician Trust Scale.p-value: 0.085t-test, 2 sided