The Effect of Clear Masks in Improving Patient Relationships

NCT ID: NCT04595695

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-03
• Study Completion Date: 2020-12-14

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.

Conditions

Communication; Trust; Covid19; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transparent mask

Intervention Type: BEHAVIORAL

A transparent mask worn by the surgeons in customary fashion will be used.

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.

Group Type: ACTIVE_COMPARATOR

Typical surgical covered mask

Intervention Type: BEHAVIORAL

A standard covered surgical mask worn by the surgeons in in customary fashion will be used.

Interventions

Transparent mask

A transparent mask worn by the surgeons in customary fashion will be used.

Intervention Type: BEHAVIORAL

Typical surgical covered mask

A standard covered surgical mask worn by the surgeons in in customary fashion will be used.

Intervention Type: BEHAVIORAL

Other Intervention Names

ClearMask; Halyard

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• None

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Kratzke, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill Department of Surgery

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33704389 (View on PubMed)

Other Identifiers

20-2229

Identifier Type: -

Identifier Source: org_study_id