Communication, Patient Satisfaction
Conditions
Keywords
clear mask, neurological condition, deep brain stimulation, brain surgery, neurology
Brief summary
The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks. For some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.
Detailed description
All participants scheduled for a DBS phase I surgery will be contacted via telephone in the days prior to their scheduled surgery to discuss the possibility of study participation. This will be done to give the participant time to consider study participation in order to avoid delays the morning of surgery. The morning of surgery the participant will be approached in pre-operative holding room to discuss participation in the study and if amenable sign consent for participation. This discussion will inform the participant that minor changes are being made in an attempt to improve the participant experience, but limited information will be shared to reduce potential bias that might result from the participant knowing what is being studied.
Interventions
DEVICEClear Mask
The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The neurologist will wear the mask type assigned by randomization for the duration of involvement in the surgery. At the conclusion of the neurologist's interaction with the participant, the participant will be asked a series of questions to evaluate the communication experience. This step will be performed by another member of the study team (not the participating neurologist) who will read from the questionnaire and record the participant's responses. During questioning, the neurologist will step out of the operating room to reduce potential bias from the participants answering subjective questions in front of the neurologist.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients electing to undergo deep brain stimulator placement * Patient in whom general anesthesia is not planned for stimulator target localization
Exclusion criteria
* Patients who do not give consent * Patients who do not undergo DBS placement * Patients who are blind or have a severe visual impairment * Non-English speaking patients (i.e., patients for whom an interpreter would be needed to conduct the intra-operative assessment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 Post Surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 Post Surgery | 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. |
| 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 | Day 1 Post Surgery | Questionnaire 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. |
| 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 | Day 1 Post Surgery | Questionnaire 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. |
| 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 | Day 1 Post Surgery | Questionnaire 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. |
| 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 | Day 1 Post Surgery | 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. |
| 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 | Day 1 Post Surgery | Questionnaire 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. |
| 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 | Day 1 Post Surgery | Questionnaire 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. |
| 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 | Day 1 Post Surgery | Participants 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. |
| 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 | Day 1 Post Surgery | Participants 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. |
| 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 | Day 1 Post Surgery | Questionnaire 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 34 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 1 |
Baseline characteristics
| Characteristic | Total | Clear Mask | Standard Mask |
|---|---|---|---|
| Age, Continuous | 69.0 years | 69.0 years | 68.5 years |
| HHIE -S Overall Score | 4 units on a scale | 0 units on a scale | 7 units on a scale |
| Indication for DBS Dystonia | 3 Participants | 3 Participants | 0 Participants |
| Indication for DBS Essential Tremor | 21 Participants | 9 Participants | 12 Participants |
| Indication for DBS Parkinson's Disease | 41 Participants | 19 Participants | 22 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown/Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White, non-Hispanic | 64 Participants | 31 Participants | 33 Participants |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 47 Participants | 19 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 34 |
| other Total, other adverse events | 0 / 31 | 0 / 34 |
| serious Total, serious adverse events | 0 / 31 | 0 / 34 |
Outcome results
Primary
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
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.
Time frame: Day 1 Post Surgery
Population: All randomized subjects who were not excluded due to a protocol deviation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 |
| Standard Mask | 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 |
p-value: 0.106Fisher Exact
Secondary
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
Participants 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 20 Participants |
| Standard Mask | 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 |
p-value: 0.159Fisher Exact
Secondary
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
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.
Time frame: Day 1 Post Surgery
Population: All randomized subjects who were not excluded due to a protocol deviation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 31 Participants |
| Standard Mask | 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 |
p-value: 0.99Fisher Exact
Secondary
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
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.
Time frame: Day 1 Post Surgery
Population: Missing one participant response to this question
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 28 Participants |
| Standard Mask | 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 |
p-value: 0.99Fisher Exact
Secondary
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
Questionnaire 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 31 Participants |
| Standard Mask | 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 |
Secondary
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
Questionnaire 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 31 Participants |
| Standard Mask | 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 |
p-value: 0.529Fisher Exact
Secondary
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
Questionnaire 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 29 Participants |
| Standard Mask | 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 |
p-value: 0.99Fisher Exact
Secondary
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
Questionnaire 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 |
| Standard Mask | 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 |
p-value: 0.502Fisher Exact
Secondary
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
Questionnaire 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 29 Participants |
| Standard Mask | 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 |
p-value: 0.431Fisher Exact
Secondary
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
Questionnaire 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 27 Participants |
| Standard Mask | 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 |
p-value: 0.434Fisher Exact
Secondary
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
Participants 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.
Time frame: Day 1 Post Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clear Mask | 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 | 9 Participants |
| Standard Mask | 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 |
p-value: 0.051Fisher Exact