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临床试验/NCT04595695
NCT04595695已完成不适用

The Effect of Clear Masks in Improving Patient Relationships

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Patient Survey Scores Evaluating Surgeon Communication Skills

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

Patients will not know that their surgeon is participating in a research study. Visits will be completed as they typically would with the surgeon wearing a mask.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Patient Survey Scores Evaluating Surgeon Communication Skills

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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"

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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