CommunicationNCT04595695
The Effect of Clear Masks in Improving Patient Relationships
A study testing Transparent mask and Typical surgical covered mask in people with Communication and Trust, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Trust, Covid19
- What is being tested?
- Transparent mask and Typical surgical covered mask
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
- Has a prior relationship with the surgeon
- Has symptoms of a respiratory infection (cough, shortness of breath, fever)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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
- Being tested
- Transparent mask, Typical surgical covered mask
- Keywords
- Masks
- Medical subject headings
- Communication, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transparent maskBehavioural
Also called ClearMask
A transparent mask worn by the surgeons in customary fashion will be used.
Typical surgical covered maskBehavioural
Also called Halyard
A standard covered surgical mask worn by the surgeons in in customary fashion will be used.
| Study group | Role | What they receive |
|---|---|---|
| Transparent Mask | Experimental | 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. Receives: Behavioral: Transparent mask |
| Covered Mask | Active comparator | 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. Receives: Behavioral: Typical surgical covered mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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"
Measured: During 1-minute survey assessed immediately after clinic visit completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start3 Sep 2020
- Primary completion12 Nov 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into typical covered mask versus transparent mask worn by the surgeon.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Kratzke, MD, Principal investigator, University of North Carolina at Chapel Hill Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595695
- Sponsor's protocol ID
- 20-2229
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 33704389
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clear Masks in Improving Patient Relationships
- ClinicalTrials.gov ID
- NCT04595695
- Acronym / sponsor ID
- 20-2229
- Conditions
- Communication, Trust, Covid19, Surgery
- Keywords
- Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized into typical covered mask versus transparent mask worn by the surgeon.
| Arm | Type | Receives |
|---|---|---|
| Transparent Mask | Experimental | Behavioral: Transparent maskSurgeons 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 | Active comparator | Behavioral: Typical surgical covered maskSurgeons 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- None
- Has a prior relationship with the surgeon
- Has symptoms of a respiratory infection (cough, shortness of breath, fever)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transparent maskAlso: ClearMaskA transparent mask worn by the surgeons in customary fashion will be used. | Behavioural | Transparent Mask |
| Typical surgical covered maskAlso: HalyardA standard covered surgical mask worn by the surgeons in in customary fashion will be used. | Behavioural | Covered Mask |
Primary outcome
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).
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.
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.
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 33704389Kratzke 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Kratzke, MD principal investigator
University of North Carolina at Chapel Hill Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transparent mask and Typical surgical covered mask in people with Communication and Trust, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Mask Preference Quantitative (time frame: During 1-minute survey assessed immediately after clinic visit completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.