ClinRO Sedation Validation

Duke University

Status: Completed

Conditions: Pediatric Sedation

Study type: Observational

Funder types: Other

Identifiers

NCT03956342

Pro00102030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 2 patient groups

Pediatric Clinicians - Group 1

Description:

Pediatric clinical care clinicians who work with patients who are sedated for diagnostic or therapeutic procedures. May included, MDs, DOs, PharmDs, Nurse Practitioners, or nurses with a BSN or higher level nursing degree. This cohort will complete a first round of interviews to assess measure content.

Pediatric Clinicians - Group 2

Description:

Pediatric clinical care clinicians who work with patients who are sedated for diagnostic or therapeutic procedures. May included, MDs, DOs, PharmDs, Nurse Practitioners, or nurses with a BSN or higher level nursing degree. This smaller cohort will be a randomized subset of the original cohort and will complete interviews to assess changes made based on the feedback from the first cohort.