Effect of Clear Masks on Patient Satisfaction With Communication

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

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.

Study Overview

• Status: Completed
• Conditions: Communication; Patient Satisfaction
• Intervention / Treatment: Device: Clear Mask

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Clear Mask; The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 Post Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery
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.	Day 1 Post Surgery

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Wesley Hsu, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: deep brain stimulation; neurology; clear mask; neurological condition; brain surgery
• Other Study ID Numbers: IRB00077199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No