Effect of Clear Masks on Patient Satisfaction With Communication

Not Applicable

Completed

Conditions: Communication
Patient Satisfaction

Interventions: Device: Clear Mask

Registration Number: NCT05088603

Lead Sponsor: Wake Forest University Health Sciences

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clear Mask	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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.
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.