ClinRO Sedation Validation

December 26, 2019 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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
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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Christina Zigler, PhD, Duke University
  • Principal Investigator: Bryce B Reeve, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2019

Primary Completion (ACTUAL)

November 15, 2019

Study Completion (ACTUAL)

November 15, 2019

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 17, 2019

First Posted (ACTUAL)

May 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

April 1, 2019

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)?

NO

IPD Plan Description

Individual participant data will not be shared outside of the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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