Trial Outcomes & Findings for Effect of Clear Masks on Patient Satisfaction With Communication (NCT NCT05088603)
NCT ID: NCT05088603
Last Updated: 2024-07-29
Results Overview
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question #1 of the CG-CAHPS is "Did this provider explain things in a way that was easy to understand?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
COMPLETED
NA
72 participants
Day 1 Post Surgery
2024-07-29
Participant Flow
Participant milestones
| Measure |
Clear Mask
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
Standard Mask
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
35
|
|
Overall Study
COMPLETED
|
31
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Clear Mask
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
Standard Mask
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
1
|
Baseline Characteristics
Effect of Clear Masks on Patient Satisfaction With Communication
Baseline characteristics by cohort
| Measure |
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
n=99 Participants
|
68.5 years
n=107 Participants
|
69.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, non-Hispanic
|
31 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown/Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Indication for DBS
Dystonia
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Indication for DBS
Essential Tremor
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Indication for DBS
Parkinson's Disease
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
HHIE -S Overall Score
|
0 units on a scale
n=99 Participants
|
7 units on a scale
n=107 Participants
|
4 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 Post SurgeryPopulation: All randomized subjects who were not excluded due to a protocol deviation.
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question #1 of the CG-CAHPS is "Did this provider explain things in a way that was easy to understand?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 1 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryPopulation: All randomized subjects who were not excluded due to a protocol deviation
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 2 "Did this provider listen carefully to you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 2 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
33 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryPopulation: Missing one participant response to this question
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 3 "Did this provider seem to know the important information about your medical history?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=30 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 3 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
32 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryQuestionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 4 "Did this provider show respect for what you had to say?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 4 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
34 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryQuestionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 5 "Did this provider spend enough time with you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 5 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
32 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryQuestionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 6 "Did this provider demonstrate empathy?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 6 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
32 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryQuestionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 7 "How comfortable do you feel trusting the provider's decisions?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 7 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryQuestionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 8 "Did you understand what you were being asked to do?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=30 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 8 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
30 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryQuestionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 9 "How satisfied are you with the procedure thus far overall?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 9 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
26 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryParticipants were asked "What was your impression of the doctor's mask" with 1 meaning "Strongly Disliked" and 4 meaning "Strongly Liked". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=30 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=26 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response Score of 4 to Question 10 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 1 Post SurgeryParticipants were asked "What comments do you have about the doctor's mask." The free text responses were categorized as positive/negative/neutral. Outcome is count of positive responses.
Outcome measures
| Measure |
Standard Mask
n=34 Participants
Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.
|
Clear Mask
n=31 Participants
Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.
Clear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
|
|---|---|---|
|
Number of Participants With a Positive Response to Question 11 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
|
2 Participants
|
9 Participants
|
Adverse Events
Clear Mask
Standard Mask
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kyle Fargen
Atrium Health Wake Forest Baptist Health Department of Neurosurgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place