Trial Outcomes & Findings for Sign Here: How to Conduct Informed Consent With Deaf Individuals (NCT NCT05268055)
NCT ID: NCT05268055
Last Updated: 2024-11-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
post-intervention, up to one month
Results posted on
2024-11-27
Participant Flow
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.
Participant milestones
| Measure |
"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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
105
|
|
Overall Study
Reviewed Training Intervention
|
51
|
56
|
|
Overall Study
Scheduled Study Simulation Session
|
35
|
38
|
|
Overall Study
Completed Study Simulation Session
|
23
|
29
|
|
Overall Study
COMPLETED
|
23
|
29
|
|
Overall Study
NOT COMPLETED
|
80
|
76
|
Reasons for withdrawal
| Measure |
"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.
|
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
68
|
68
|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
Baseline Characteristics
Sign Here: How to Conduct Informed Consent With Deaf Individuals
Baseline characteristics by cohort
| Measure |
"Sign Here" Training Intervention
n=103 Participants
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.
|
Intervention as Usual
n=105 Participants
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)
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.94 years
STANDARD_DEVIATION 11.78 • n=99 Participants
|
41.77 years
STANDARD_DEVIATION 13.48 • n=107 Participants
|
41.36 years
STANDARD_DEVIATION 12.64 • n=206 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
85 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
171 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
168 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: post-intervention, up to one monthPopulation: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
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.
Outcome measures
| Measure |
"Sign Here" Training Intervention
n=23 Participants
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.
|
Intervention as Usual
n=29 Participants
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)
|
|---|---|---|
|
Healthcare Provider Cultural Competency
All participants
|
40.5 score on a scale
Standard Deviation 14.0
|
42.7 score on a scale
Standard Deviation 11.0
|
|
Healthcare Provider Cultural Competency
Participants less than age 33
|
48.7 score on a scale
Standard Deviation 8.3
|
41.3 score on a scale
Standard Deviation 9.1
|
|
Healthcare Provider Cultural Competency
Participants aged 33 and greater
|
33.0 score on a scale
Standard Deviation 14.2
|
44.3 score on a scale
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: post-intervention, up to one monthPopulation: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
A validated scale used to measure participants' communication skill. Total scores range from 4 to 16, with higher scores indicating better communication skills.
Outcome measures
| Measure |
"Sign Here" Training Intervention
n=23 Participants
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.
|
Intervention as Usual
n=29 Participants
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)
|
|---|---|---|
|
Ask, Understand, Remember Assessment
Participants age 33 and greater
|
10.8 score on a scale
Standard Deviation 3.0
|
13.7 score on a scale
Standard Deviation 2.6
|
|
Ask, Understand, Remember Assessment
All participants
|
12.5 score on a scale
Standard Deviation 2.9
|
13.5 score on a scale
Standard Deviation 2.2
|
|
Ask, Understand, Remember Assessment
Participants less than age 33
|
14.4 score on a scale
Standard Deviation 1.3
|
13.2 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: post-intervention, up to one monthPopulation: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
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.
Outcome measures
| Measure |
"Sign Here" Training Intervention
n=23 Participants
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.
|
Intervention as Usual
n=29 Participants
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)
|
|---|---|---|
|
Wake Forest Physician Trust Scale
All participants
|
36.4 score on a scale
Standard Deviation 9.5
|
39.1 score on a scale
Standard Deviation 6.9
|
|
Wake Forest Physician Trust Scale
Participants less than age 33
|
41.6 score on a scale
Standard Deviation 5.2
|
38.4 score on a scale
Standard Deviation 5.7
|
|
Wake Forest Physician Trust Scale
Participants age 33 and greater
|
31.6 score on a scale
Standard Deviation 10.2
|
39.8 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: post-intervention, up to one monthPopulation: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
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.
Outcome measures
| Measure |
"Sign Here" Training Intervention
n=23 Participants
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.
|
Intervention as Usual
n=29 Participants
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)
|
|---|---|---|
|
Assessment of Intervention Understanding & Retention
All participants
|
22.1 score on a scale
Standard Deviation 2.5
|
21.2 score on a scale
Standard Deviation 2.7
|
|
Assessment of Intervention Understanding & Retention
Participants greater than age 33
|
22.3 score on a scale
Standard Deviation 3.0
|
20.5 score on a scale
Standard Deviation 3.2
|
|
Assessment of Intervention Understanding & Retention
Participants less than age 33
|
21.9 score on a scale
Standard Deviation 1.9
|
21.8 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: post-intervention, up to one monthPopulation: Enrolled participants who reviewed their assigned training intervention and completed the study simulation session.
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.
Outcome measures
| Measure |
"Sign Here" Training Intervention
n=23 Participants
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.
|
Intervention as Usual
n=29 Participants
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)
|
|---|---|---|
|
Self-Rating of Simulation
Healthcare Provider Cultural Competency (participant self-rating)
|
42.6 score on a scale
Standard Deviation 5.8
|
41.9 score on a scale
Standard Deviation 8.1
|
|
Self-Rating of Simulation
Ask, Understand, Remember Assessment (participant self-rating)
|
12.7 score on a scale
Standard Deviation 2.5
|
13.2 score on a scale
Standard Deviation 2.1
|
|
Self-Rating of Simulation
Wake Forest Physician Trust Scale (participant self-rating)
|
37.7 score on a scale
Standard Deviation 4.3
|
39.9 score on a scale
Standard Deviation 4.7
|
Adverse Events
"Sign Here" Training Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place