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Completed

NCT Number: NCT03956342

ClinRO Sedation Validation

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.

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Key information

Conditions

Pediatric Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Durham, North Carolina, 27701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Lack of access to a telephone for interview

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 1 hour

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

  2. 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

    Time frame: 1 hour

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

  3. 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

    Time frame: 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.

  4. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Clinical Research Institute

Registry information

Official study title

Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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