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ClinRO Sedation Validation

NCT ID: NCT03956342

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2019-11-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric Sedation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke Clinical Research Institute

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Zigler, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Bryce B Reeve, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00102030

Identifier Type: -

Identifier Source: org_study_id