- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956342
ClinRO Sedation Validation
Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27701
- Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
1. Lack of access to a telephone for interview
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 hour
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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.
|
1 hour
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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.
|
1 hour
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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.
|
1 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christina Zigler, PhD, Duke University
- Principal Investigator: Bryce B Reeve, PhD, Duke University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00102030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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