The Effect of Clear Masks in Improving Patient Relationships

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Communication; Surgery; Trust
• Intervention / Treatment: Behavioral: Transparent mask; Behavioral: Typical surgical covered mask

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transparent Mask; Surgeons will be provided a transparent mask for use during in-person clinic visits with a new patient. Otherwise, visits will be conducted as per usual and the patient will be surveyed immediately after the visit.	Behavioral: Transparent mask; A transparent mask worn by the surgeons in customary fashion will be used.; Other Names: ClearMask
ACTIVE_COMPARATOR: Covered Mask; Surgeons will be instructed to wear a typical, covered mask for the in-person clinic visit with a new patient. The visit will be conducted as it typically would, and the patient will be surveyed immediately after the visit.	Behavioral: Typical surgical covered mask; A standard covered surgical mask worn by the surgeons in in customary fashion will be used.; Other Names: Halyard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Mask Preference Quantitative	Using a Likert scale question evaluating patient preference for the type of mask (What was your impression of the surgeon's mask? "Did not like the mask", "somewhat did not like the mask", "somewhat liked the mask", "completely liked the mask", scored as 1 to 4 with higher score indicating greater preference).	During 1-minute survey assessed immediately after clinic visit completion
Patient Mask Preference Qualitative	Patients will be asked for their comments about the surgeon's mask and these will be immediately transcribed.	During 1-minute survey assessed immediately after clinic visit completion
Patient Survey Scores Evaluating Surgeon Communication Skills	Using Likert scale questions evaluating patient perception of surgeon communication, taken from the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) healthcare survey, each scored 1-4 with higher number indicating greater communication skills, from "not at all", "somewhat", "mostly" to "completely". This will include 6 questions evaluating communication skills with identical answer choices. Each participants total score will range from 6 to 24 with higher indicating better communication skills.	During 1-minute survey assessed immediately after clinic visit completion
Patient Survey Scores Describing Trust in the Surgeon	Using Likert scale questions evaluating patient trust of the surgeon, asked, "How comfortable do you feel trusting this surgeon's decisions". Answer choices are score 1 - 4 with 4 indicating great trust, from "Completing uncomfortable", "somewhat uncomfortable", "somewhat comfortable", "completely comfortable"	During 1-minute survey assessed immediately after clinic visit completion

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Ian Kratzke, MD, University of North Carolina at Chapel Hill Department of Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2020
• Primary Completion (ACTUAL): November 12, 2020
• Study Completion (ACTUAL): December 14, 2020

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Masks
• Other Study ID Numbers: 20-2229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Surgeon-identifying information will only be available to the primary investigator and will not be shared. Patient-identifying information will not be collected beyond basic demographics. Patient quotations may be published but will not be identifiable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No