Clinical trial NCT04595695: The Effect of Clear Masks in Improving Patient Relationships
Official title: The Effect of Clear Masks in Improving Patient Relationships
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Trust
Covid19
Surgery
Keywords: Masks
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into typical covered mask versus transparent mask worn by the surgeon.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the effect of wearing masks that hide a surgeon's facial features versus one that shows them. New patients with no prior relationship with the surgeon will be asked questions regarding communication and trust with the surgeon.

Detailed description: Surgeons within the University of North Carolina Department of Surgery will be recruited via an email list-serve. This recruitment email will describe the study and have the consent attached. If the surgeons are interested in participating they will respond to the email and sign the consent form.

The project personnel will arrange to attend their clinic that has new patients scheduled. A random group generator will be used to randomize the patients. The surgeons will be provided either a transparent mask that demonstrates their full facial features or their typical mask that covers their mouth, for each new patient visit. Following each visit, the surgeon will tell the project personnel that they are complete and the project personnel will enter the room, introduce the project, obtain verbal consent (enroll the patient) and if agreeable, provide a brief verbal survey to the patient. The survey will entail confidential questions regarding basic demographics, surgeon communication and trust, as well as an impression of the masks. Survey answers will be Likert scale and open ended. Patients will also be given a debriefing form at the completion of their participation. Surgeons will be asked their impression of the mask at the completion of their participation. All data will be kept confidential on password protected devices.

If patients do not agree to the study they will not be included. If surgeons feel uncomfortable at any point they may withdraw from the study. Any patient demonstrating concerning symptoms of an infection will not be included in the study.

The investigators expect to recruit 10 surgeons, with 10 patients each, totally 100 patients (50 in each arm, clear vs. covered mask). Using Mann-Whitney U test, data will be analyzed for differences in responses between the two groups. Demographic data for both the patient and surgeon will also be analyzed. Patient comments will be qualitatively analyzed for themes by trained researchers.

Eligibility criteria: Inclusion Criteria Surgeon:

* Faculty within Department of Surgery at the University of North Carolina at Chapel Hill
* Must be English speaking
* Plans to see new in person visits in clinic

Exclusion Criteria Surgeon:

* None

Inclusion Criteria Patient:

* At least 18 years old
* Can understand and speak English without the use of an interpreter
* Has capacity to make independent medical decisions

Exclusion Criteria Surgeon:

* Has a prior relationship with the surgeon
* Has symptoms of a respiratory infection (cough, shortness of breath, fever)

Primary outcomes:
measure: Patient Mask Preference Quantitative
timeFrame: During 1-minute survey assessed immediately after clinic visit completion
measure: Patient Mask Preference Qualitative
timeFrame: During 1-minute survey assessed immediately after clinic visit completion
measure: Patient Survey Scores Evaluating Surgeon Communication Skills
timeFrame: During 1-minute survey assessed immediately after clinic visit completion
measure: Patient Survey Scores Describing Trust in the Surgeon
timeFrame: During 1-minute survey assessed immediately after clinic visit completion
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill Department of Surgery
name: Ian Kratzke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kratzke IM, Rosenbaum ME, Cox C, Ollila DW, Kapadia MR. Effect of Clear vs Standard Covered Masks on Communication With Patients During Surgical Clinic Encounters: A Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):372-378. doi: 10.1001/jamasurg.2021.0836.