ClinRO Sedation Validation

NCT03956342 | Completed

• 1 other identifier: Pro00102030
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Sedation

Outcome Measures

Primary Outcomes (4)

• 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

  A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.

  1 hour

• 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

  A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.

  1 hour

• 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

  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.

  1 hour

• 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

  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.

  1 hour

Study Arms (2)

Pediatric Clinicians - Group 1

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \. Lack of access to a telephone for interview

Sponsors & Collaborators

• Duke University: lead
• Duke Clinical Research Institute: collaborator

Study Sites (1)

Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space

Durham, North Carolina, 27701, United States

Location

Study Officials

• Christina Zigler, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Bryce B Reeve, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 20, 2019
• Study Start: April 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)