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ClinRO Sedation Validation

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ClinicalTrials.gov Identifier: NCT03956342
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
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.

Condition or disease
Pediatric Sedation

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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019

Group/Cohort
Pediatric Clinicians
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.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956342


Contacts
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Contact: Courtney M Mann, MA 1-919-613-7851 courtney.mann@duke.edu
Contact: Alexy Hernandez 1-919-668-6864 alexy.hernandez@duke.edu

Locations
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United States, North Carolina
Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space Recruiting
Durham, North Carolina, United States, 27701
Contact: Courtney M Mann, MA    919-613-7851    courtney.mann@duke.edu   
Contact: Alexy Hernandez    1-919-668-6864    alexy.hernandez@duke.edu   
Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
Investigators
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Principal Investigator: Christina Zigler, PhD Duke University
Principal Investigator: Bryce B Reeve, PhD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03956342     History of Changes
Other Study ID Numbers: Pro00102030
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared outside of the study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No