ClinRO Sedation Validation

Completed

• Conditions: Pediatric Sedation

• Registration Number: NCT03956342
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04-15
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Is a practicing clinician in a clinical care environment

2. Cares for pediatric patients >50% of their time

3. Treats or works with pediatric patients who are sedated/anesthetized for diagnostic and/or therapeutic procedures

4. Holds one of the following titles/positions

   1. Anesthesiologist
   2. Pediatric critical care physician
   3. Clinical pharmacist (PharmD)
   4. Nurse anesthetist
   5. Nurse practitioner
   6. Physician assistant
   7. Nurse (with a BSN/RN or higher)

5. Is over the age of 18 years

6. Can speak English

7. Is capable of giving informed verbal consent

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Exclusion Criteria

1. Lack of access to a telephone for interview

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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	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	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	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.

Trial Locations

Locations (1)

Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space; 🇺🇸 Durham, North Carolina, United States