Clinical trial NCT05088603: Effect of Clear Masks on Patient Satisfaction With Communication
Official title: The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Patient Satisfaction
Keywords: clear mask
neurological condition
deep brain stimulation
brain surgery
neurology
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Day 1 Post Surgery
Secondary outcomes:
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
measure: 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
timeFrame: Day 1 Post Surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Wesley Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: