Effect of Clear Masks on Patient Satisfaction With Communication

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery

Conditions
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Communication, Patient Satisfaction

Intervention / Treatment
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* Device: Clear Mask


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clear Mask<br>Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject. | Device: Clear Mask<br>* The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.<br>|
| No Intervention: Standard Mask<br>Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Response to Question 1 on Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) | 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 | Day 1 Post Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Responses to Questions 2-10 of CG-CAHPS | Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. | Day 1 Post Surgery | 
| Difference in Responses to Free Text Question on CG-CAHPS | The free text responses will be categorized as positive/negative/neutral. | Day 1 Post Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clear mask, neurological condition, deep brain stimulation, brain surgery, neurology