- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06370338
Cardiothoracic Critical Care as Subspecialty and Its Core Competencies
July 30, 2025 updated by: Rafal Kopanczyk, Ohio State University
Delphi Study for Evaluation of Cardiothoracic Critical Care as a Subspecialty and Its Core Competencies
The aim of this study is to develop a consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, based on a Delphi consensus among a panel of experts in this field.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will use the Delphi process to conduct this study.
This survey research involves Phase 1 and Phase 2 of questioning, each phase involves up to 3 rounds of questions to determine agreement or disagreement.
Each round will take approximately 20 minutes to complete, and responses will remain completely confidential.
For both phases, the questions will either be 7-point Likert or multiple choices.
For both phases, the group of questions will be sent up to three times until agreement (up to 80% of agreement consensus).
Questions that have obtained agreement will be removed in each round.
The questions will help the experts and the research team understand where there is current agreement on, or topic that may need to be discussed/studied further to unify trainings.
Study Type
Observational
Enrollment (Estimated)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alberto Uribe, MD
- Phone Number: 6142933559
- Email: alberto.uribe@osumc.edu
Study Contact Backup
- Name: Jeremy Reeves
- Phone Number: 6142933559
- Email: jeremy.reeves@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center
-
Contact:
- Alberto Uribe, MD
- Phone Number: 6142933559
- Email: alberto.uribe@osumc.edu
-
Contact:
- Jeremy Reeves, BA
- Phone Number: 6148067569
- Email: jeremy.reeves@osumc.edu
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
A team of experts in the field of cardiothoracic critical care anesthesia.
Description
Inclusion Criteria:
- The participants will be experts in the field of Cardiothoracic Surgery Critical Care Medicine to better understand the training needs of the field. Experts must have been in practice for a minimum of 5 years and have at least 50% of practice in cardiothoracic intensive care units.
- The participants will have graduated from a critical care fellowship in either an administration, education, or research role.
Exclusion Criteria:
- Participants who do not meet the exclusion criteria will be excluded due to their lack of experience in the field.
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 |
Intervention / Treatment |
|---|---|
|
Delphi Panel
Experts in the field of cardiothoracic critical care with administrative, educational, and research roles.
|
Experts will be approached to participate in the research via email.
If the experts agree to participate they will check 'yes' in the email with the informed consent and will be directed to the Qualtrics survey.
If the expert decides to decline consent they will check 'no' in the email and will not be enrolled.
Subjects who agree to participate will undergo 2 phases of questions with three rounds of the same questions in each phase.
This Delphi survey research involves Phase 1 and Phase 2 of questioning, each phase involves up to 3 rounds of questions to determine agreement or disagreement.
Each round will take approximately 20 minutes to complete, and your responses will remain completely confidential.
For both phases, the questions will either be 7-point Likert or multiple choices.
For both phases, the group of questions will be sent up to three times until we obtain agreement (up to 80% of agreement consensus).
Questions that have obtained agreement will be removed in each round.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field
Time Frame: 12 months
|
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of consensus on defining training core competencies, goals, and milestones.
Time Frame: 12 months
|
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating.
|
12 months
|
|
Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality"
Time Frame: 12 months
|
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 11, 2024
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
April 12, 2024
First Submitted That Met QC Criteria
April 12, 2024
First Posted (Actual)
April 17, 2024
Study Record Updates
Last Update Posted (Actual)
August 3, 2025
Last Update Submitted That Met QC Criteria
July 30, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024B0101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Consensus Development
-
University of Southern CaliforniaCompleted
-
University of Southern CaliforniaEnrolling by invitationConsensus DevelopmentUnited States
-
National University of Ireland, Galway, IrelandHealth Research Board, IrelandRecruiting
-
Istanbul Bilgi UniversityCompleted
-
Charite University, Berlin, GermanyCompleted
-
The University of Hong KongGerontechnology Platform, The Social Innovation and Entrepreneurship Development...CompletedConsensus DevelopmentHong Kong
-
University of Southern CaliforniaEnrolling by invitationConsensus DevelopmentUnited States
-
University of SheffieldSheffield Teaching Hospitals NHS Foundation Trust; South Yorkshire and Bassetlaw...UnknownNurse's Role | ACP | Development, ConsensusUnited Kingdom
-
University of British ColumbiaCompleted
-
ThinkWellCompletedDecisional Variability by Presentation Methods for ConsensusUnited Kingdom
Clinical Trials on Delphi Questionnaire
-
Medipol UniversityInternational Association of Non Invasive Ventilation; International Academy... and other collaboratorsNot yet recruitingCritical Illness | Critical Care | Mechanical Insufflation-exsufflation Session ( With Cough Assist) | Critical Care, Intensive Care | Delphi Study | Consensus | Mechanical Insufflation-exsufflation | Airway ClearanceSpain, Italy, Turkey (Türkiye)
-
University of Southern CaliforniaCompleted
-
University of Rome Tor VergataEnrolling by invitation
-
University of Southern CaliforniaEnrolling by invitationConsensus DevelopmentUnited States
-
One ClinicPoissy-Saint Germain Hospital; Versailles Saint-Quentin-en-Yvelines University and other collaboratorsCompletedEndometriosisFrance
-
Universidad de ZaragozaUniversidad Miguel Hernandez de ElcheNot yet recruitingPerioperative Care | Enhanced Recovery After Surgery | Surgical CareSpain
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
University of Southern CaliforniaEnrolling by invitationConsensus DevelopmentUnited States
-
University Hospital, GhentAstellas Pharma Inc; MedtronicCompleted
-
University Children's Hospital, ZurichCompleted