CommunicationNCT05088603
Effect of Clear Masks on Patient Satisfaction With Communication
A study testing Clear Mask in people with Communication and Patient Satisfaction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Communication, Patient Satisfaction
- What is being tested?
- Clear Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients electing to undergo deep brain stimulator placement
- Patient in whom general anesthesia is not planned for stimulator target localization
Who cannot join
- Patients who do not give consent
- Patients who do not undergo DBS placement
- Patients who are blind or have a severe visual impairment
- Non-English speaking patients (i.e., patients for whom an interpreter would be needed to conduct the intra-operative assessment)
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery
The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks.
For some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.
Read the detailed description
All participants scheduled for a DBS phase I surgery will be contacted via telephone in the days prior to their scheduled surgery to discuss the possibility of study participation. This will be done to give the participant time to consider study participation in order to avoid delays the morning of surgery. The morning of surgery the participant will be approached in pre-operative holding room to discuss participation in the study and if amenable sign consent for participation. This discussion will inform the participant that minor changes are being made in an attempt to improve the participant experience, but limited information will be shared to reduce potential bias that might result from the participant knowing what is being studied.
- Conditions
- Communication, Patient Satisfaction
- Being tested
- Clear Mask
- Keywords
- clear mask, neurological condition, deep brain stimulation, brain surgery, neurology
- Medical subject headings
- Communication, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear MaskDevice
The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Clear Mask | Experimental | Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject. Receives: Device: Clear Mask |
| Standard Mask | No intervention | Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Positive Response Score of 4 to Question 1 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question #1 of the CG-CAHPS is "Did this provider explain things in a way that was easy to understand?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Secondary outcomes (10)
Number of Participants With a Positive Response Score of 4 to Question 2 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 2 "Did this provider listen carefully to you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 3 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 3 "Did this provider seem to know the important information about your medical history?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 4 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 4 "Did this provider show respect for what you had to say?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 5 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 5 "Did this provider spend enough time with you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 6 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 6 "Did this provider demonstrate empathy?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 7 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 7 "How comfortable do you feel trusting the provider's decisions?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 8 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 8 "Did you understand what you were being asked to do?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 9 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question 9 "How satisfied are you with the procedure thus far overall?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 10 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Participants were asked "What was your impression of the doctor's mask" with 1 meaning "Strongly Disliked" and 4 meaning "Strongly Liked". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Number of Participants With a Positive Response to Question 11 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Participants were asked "What comments do you have about the doctor's mask." The free text responses were categorized as positive/negative/neutral. Outcome is count of positive responses.
Measured: Day 1 Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start16 Nov 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The neurologist will wear the mask type assigned by randomization for the duration of involvement in the surgery. At the conclusion of the neurologist's interaction with the participant, the participant will be asked a series of questions to evaluate the communication experience. This step will be performed by another member of the study team (not the participating neurologist) who will read from the questionnaire and record the participant's responses. During questioning, the neurologist will step out of the operating room to reduce potential bias from the participants answering subjective questions in front of the neurologist.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wesley Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088603
- Sponsor's protocol ID
- IRB00077199
- Status last verified
- Sep 2023
- First submitted
- 13 Oct 2021
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery
- ClinicalTrials.gov ID
- NCT05088603
- Acronym / sponsor ID
- IRB00077199
- Conditions
- Communication, Patient Satisfaction
- Keywords
- clear mask, neurological condition, deep brain stimulation, brain surgery, neurology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks.
For some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.
Detailed description
All participants scheduled for a DBS phase I surgery will be contacted via telephone in the days prior to their scheduled surgery to discuss the possibility of study participation. This will be done to give the participant time to consider study participation in order to avoid delays the morning of surgery. The morning of surgery the participant will be approached in pre-operative holding room to discuss participation in the study and if amenable sign consent for participation. This discussion will inform the participant that minor changes are being made in an attempt to improve the participant experience, but limited information will be shared to reduce potential bias that might result from the participant knowing what is being studied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The neurologist will wear the mask type assigned by randomization for the duration of involvement in the surgery. At the conclusion of the neurologist's interaction with the participant, the participant will be asked a series of questions to evaluate the communication experience. This step will be performed by another member of the study team (not the participating neurologist) who will read from the questionnaire and record the participant's responses. During questioning, the neurologist will step out of the operating room to reduce potential bias from the participants answering subjective questions in front of the neurologist.
| Arm | Type | Receives |
|---|---|---|
| Clear Mask | Experimental | Device: Clear MaskSubjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject. |
| Standard Mask | No intervention | –Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients electing to undergo deep brain stimulator placement
- Patient in whom general anesthesia is not planned for stimulator target localization
Key exclusion criteria (4 listed)
- Patients who do not give consent
- Patients who do not undergo DBS placement
- Patients who are blind or have a severe visual impairment
- Non-English speaking patients (i.e., patients for whom an interpreter would be needed to conduct the intra-operative assessment)
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 |
|---|---|---|
| Clear MaskThe clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth. | Device | Clear Mask |
Primary outcome
Number of Participants With a Positive Response Score of 4 to Question 1 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Questionnaire measures the subject's satisfaction and experience with his or her physician and/or physician practice. Question #1 of the CG-CAHPS is "Did this provider explain things in a way that was easy to understand?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.
10 secondary outcomes
Number of Participants With a Positive Response Score of 4 to Question 2 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 3 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 4 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 5 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 6 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 7 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 8 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 9 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response Score of 4 to Question 10 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Number of Participants With a Positive Response to Question 11 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire
Time frame: Day 1 Post Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Wesley Hsu, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Mask in people with Communication and Patient Satisfaction, run by Wake Forest University Health Sciences 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 2 inclusion and 4 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 29 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Positive Response Score of 4 to Question 1 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire (time frame: Day 1 Post Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2024.