ClinRO Sedation Validation

Pediatric Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956342
• Other study ID #: Pro00102030
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: April 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Sedation

Locations

Country	Name	City	State
United States	Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.	1 hour
Primary	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	A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.	1 hour
Primary	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	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
Primary	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	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