Effect of Clear Masks on Patient Satisfaction With Communication

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05088603

Collaborator

(none)

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Communication Patient Satisfaction	Device: Clear Mask	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Difference in Response to Question 1 on Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) [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"

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT05088603

Other Study ID Numbers:

IRB00077199

First Posted:

Oct 22, 2021

Last Update Posted:

Dec 8, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Wake Forest University Health Sciences

clear mask

neurological condition

deep brain stimulation

brain surgery

neurology

Study Results

No Results Posted as of Dec 8, 2021