Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of providers who expressed they understood how to complete the Pediatric Sedation State Scale and University of Michigan Sedation Scale with provided instructions as measured by a qualitative interview
研究概览
简要总结
This study will conduct qualitative interviews to provide evidence for the content validity and comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia to facilitate a diagnostic or surgical procedure. Information gained from this study will inform the use of the measure in studies that are part of the PTN.
详细描述
The primary objective of this study is to assess the content validity and physician understanding of the Pediatric Sedation State Scale (PSSS) and the University of Michigan Sedation Scale (UMSS) via cognitive interviewing methods. Qualitative Interviewers will conduct 1 hour, phone-based cognitive interviews with clinicians to assess physicians' comprehension of items and response options on clinician reported pediatric sedation scales and clinician evaluation of the relevance of the scale to capture sedation levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a practicing clinician in a clinical care environment
- •Cares for pediatric patients >50% of their time
- •Treats or works with pediatric patients who are sedated/anesthetized for diagnostic and/or therapeutic procedures
- •Holds one of the following titles/positions
- •Anesthesiologist
- •Pediatric critical care physician
- •Clinical pharmacist (PharmD)
- •Nurse anesthetist
- •Nurse practitioner
- •Physician assistant
- •Nurse (with a BSN/RN or higher)
- •Is over the age of 18 years
- •Can speak English
- •Is capable of giving informed verbal consent
排除标准
- •Lack of access to a telephone for interview
结局指标
主要结局
Number of providers who expressed they understood how to complete the Pediatric Sedation State Scale and University of Michigan Sedation Scale with provided instructions as measured by a qualitative interview
时间窗: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed. The Pediatric Sedation State Scale requires that a physician choose a level from 1 - 5 that corresponds to the patient's sedation level. The University of Michigan Sedation Scale requires that a physician choose a sedation level from 1 - 4 that corresponds to the patient's sedation level. The scales will not be completed by clinicians and will not be scored. The content of the qualitative interview is the "measure". The scales are not the measure in this study.
Number of providers who expressed they agreed that all medically important levels of sedation are captured by the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview
时间窗: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.
Number of providers who expressed they understood individual sedation levels specified on the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview
时间窗: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.
Number of providers who expressed any difficulty with comprehension of any of the text contained in the Pediatric Sedation State Scale or University of Michigan Sedation Scale as measured by a qualitative interview
时间窗: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed. The Pediatric Sedation State Scale requires that a physician choose a level from 1 - 5 that corresponds to the patient's sedation level. The University of Michigan Sedation Scale requires that a physician choose a sedation level from 1 - 4 that corresponds to the patient's sedation level. The scales will not be completed by clinicians and will not be scored. The content of the qualitative interview is the "measure". The scales are not the measure in this study.
次要结局
未报告次要终点