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临床试验/NCT05088603
NCT05088603已完成不适用

The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年11月16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
72
试验地点
2
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Patients electing to undergo deep brain stimulator placement
  • Patient in whom general anesthesia is not planned for stimulator target localization

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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(Day 1 Post Surgery)
  • 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(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(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(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(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(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(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(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(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(Day 1 Post Surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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