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OpenTrials
Completed

NCT Number: NCT04595695

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.

Completed

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Key information

Conditions

Communication Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Surgery Trust Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transparent mask

Behavioral

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

Other names: ClearMask

Typical surgical covered mask

Behavioral

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

Other names: Halyard

Primary outcomes

  1. Patient Mask Preference Quantitative

    Time frame: 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).

  2. Patient Mask Preference Qualitative

    Time frame: 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.

  3. Patient Survey Scores Evaluating Surgeon Communication Skills

    Time frame: 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.

  4. Patient Survey Scores Describing Trust in the Surgeon

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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