Effect of Clear Masks on Patient Satisfaction With Communication

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088603
• Other study ID #: IRB00077199
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communication
• Patient Satisfaction

Intervention

Device:
• Clear Mask
The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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