Consensus DevelopmentNCT06370338
Cardiothoracic Critical Care as Subspecialty and Its Core Competencies
An observational study of Consensus Development, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Consensus Development
- What is being tested?
- Delphi Questionnaire
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A team of experts in the field of cardiothoracic critical care anesthesia.
Who may be able to join
- 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.
Who cannot join
- Participants who do not meet the exclusion criteria will be excluded due to their lack of experience in the field.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Alberto Uribe, MD, 614-293-3559, alberto.uribe@osumc.edu
Jeremy Reeves, BA, 6148067569, jeremy.reeves@osumc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Consensus Development
- Being tested
- Delphi Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Delphi Panel | Experts in the field of cardiothoracic critical care with administrative, educational, and research roles. Receives: Other: Delphi Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating.
Measured: 12 months
Secondary outcomes (2)
Degree of consensus on defining training core competencies, goals, and milestones.
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating.
Measured: 12 months
Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality"
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start11 Apr 2024
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consensus DevelopmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafal Kopanczyk, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370338
- Sponsor's protocol ID
- 2024B0101
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delphi Study for Evaluation of Cardiothoracic Critical Care as a Subspecialty and Its Core Competencies
- ClinicalTrials.gov ID
- NCT06370338
- Acronym / sponsor ID
- 2024B0101
- Conditions
- Consensus Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delphi Panel | – | Other: Delphi QuestionnaireExperts in the field of cardiothoracic critical care with administrative, educational, and research roles. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A team of experts in the field of cardiothoracic critical care anesthesia.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who do not meet the exclusion criteria will be excluded due to their lack of experience in the field.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi QuestionnaireExperts 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. | Other | Delphi Panel |
Primary outcome
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.
2 secondary outcomes
Degree of consensus on defining training core competencies, goals, and milestones.
Time frame: 12 months
Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality"
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consensus Development, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Uribe, MD (6142933559, alberto.uribe@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.