Clinical trial NCT03956342: ClinRO Sedation Validation
Official title: Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Sedation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
First posted: 2019-05-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be practicing clinicians in a clinical care environment for whom \>50% of their patients are sedated/anesthetized for diagnostic and/or therapeutic procedures. Clinicians may be an anesthesiologist, pediatric critical care physician, clinical pharmacist, physician assistant, nurse anesthetist, nurse practitioner, or other nurse with a BSN or higer.

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.

Eligibility criteria: 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

Exclusion Criteria:

1. Lack of access to a telephone for interview

Primary outcomes:
measure: 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
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
measure: 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
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space
state: North Carolina
Study officials:
affiliation: Duke University
name: Christina Zigler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Bryce B Reeve, PhD
role: PRINCIPAL_INVESTIGATOR
References: