Effect of Clear Masks on Patient Satisfaction With Communication

NCT05088603 | Completed Results FDA Device

• 1 other identifier: IRB00077199
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication; Patient Satisfaction

Keywords

clear mask; neurological condition; deep brain stimulation; brain surgery; neurology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Clear Mask

EXPERIMENTAL

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

Standard Mask

NO INTERVENTION

Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.

Interventions

Clear Mask DEVICE

The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.

Clear Mask

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients electing to undergo deep brain stimulator placement
• Patient in whom general anesthesia is not planned for stimulator target localization

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Communication; Patient Satisfaction

Condition Hierarchy (Ancestors)

Behavior; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Dr. Kyle Fargen
• Organization: Atrium Health Wake Forest Baptist Health Department of Neurosurgery

kfargen@wakehealth.edu

336-716-6702

Study Officials

• Wesley Hsu, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 22, 2021
• Study Start: November 16, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 29, 2024
• Results First Posted: July 18, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)