The Effect of Clear Masks in Improving Patient Relationships

Not Applicable

Completed

• Conditions: Communication; Trust; Covid19; Surgery
• Interventions: Behavioral: Transparent mask; Behavioral: Typical surgical covered mask

• Registration Number: NCT04595695
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2020-09-03
• Status Verified: 2020-10
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Primary Completion: 2020-11-12
• Study Completion: 2020-12-14
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transparent Mask	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.
Covered Mask	Typical surgical 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.

Primary Outcome Measures

Name	Time	Method
Patient Survey Scores Evaluating Surgeon Communication Skills	During 1-minute survey assessed immediately after clinic visit completion	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.
Patient Mask Preference Quantitative	During 1-minute survey assessed immediately after clinic visit completion	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).
Patient Mask Preference Qualitative	During 1-minute survey assessed immediately after clinic visit completion	Patients will be asked for their comments about the surgeon's mask and these will be immediately transcribed.
Patient Survey Scores Describing Trust in the Surgeon	During 1-minute survey assessed immediately after clinic visit completion	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"

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States