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TrainingNCT05007704

Competencies Required by Anesthesiologists Managing Critically Ill Patients

An observational study of Training and Education, run by Prashant Nasa at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Critical Care Medicine (CCM) has emerged as an independent specialty over the last few decades. Anesthesiologists being perioperative physicians, often practice CCM full time or part-time. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Training, Education, Competence
What is being tested?
Global Experts Consensus opinion using Delphi Methodology
How many people
1,155 participants
Where
1 siteIndia
Study dates
11 Sep 2021to 21 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Preliminary survey: A cross-sectional will be circulated through snowball sampling technique among Anesthesiologists worldwide. Delphi Process: Global Experts in Anesthesiology and Critical Care Medicine.

Who may be able to join

  • Preliminary survey
  • Anesthesiologists who have completed their training within the last three years.
  • Selection of experts for the Delphi process:
  • Anesthesiologist (a medical graduate who has completed a nationally recognized Anesthesiology training programme)
  • Involved in the management of critically ill patients in ICU
  • More than ten years of experience in teaching and training in Critical Care.

Who cannot join

  • Preliminary survey
  • Anesthesiologists have started training in critical care medicine immediately after completion of their Anesthesia training
  • Anesthesiologists who refused to participate
  • Delphi Process selection of experts:
  • Non-Anesthesiologist intensivist
  • Anesthesiologist not involved in the management of critically ill patient
  • Pediatric Intensivist

Trial locations and contacts

1 site in 1 country.

India1 site
  • Tata Memorial Hospital

    Mumbai

Other trials in India

About this study

Official title: Competencies Required by Anesthesiologists Managing Critically Ill Medical and Surgical Patients in an Intensive Care Unit

Critical Care Medicine (CCM) has emerged as an independent specialty over the last few decades. Anesthesiologists being perioperative physicians, often practice CCM full time or part-time. Deficiencies have been noted by experts in the Anesthesiology training in certain competencies required for the management of critically ill medical and surgical patients in the Intensive care unit (ICU). This is often compounded by considerable variation in the training curriculum of the Anesthesiologists based on the geographical region and base specialty. The Intensive \& Critical Care Medicine Committee of the World Federation of Societies of Anesthesiologists (WFSA), has developed a preliminary survey of recently qualified Anesthesiologists, to review the existing competencies for CCM in the Anesthesiology curriculum across the globe. The results of this survey will be used to identify the gaps and additional competencies required for Anesthesiologists to practice Critical Care in ICU through expert consensus, using a Delphi process.

Read the detailed description

BACKGROUND:

CCM has emerged as an independent specialty over the last few decades. Anesthesiologists being perioperative physicians are an integral part of this progress, with many of them opting for CCM as a full-time career. The coronavirus disease 2019 (COVID-19) pandemic has brought unprecedented challenges to the health care system. Anesthesiologists working in the operating room (OR) and those working in the ICU have been the frontline workers along with other Critical Care professionals in the management of critically ill patients with COVID-19. Though a few countries have recognized CCM as a separate specialty of medicine, in most countries, it is considered as a sub-specialty of broad specialties like Anesthesiology, Pulmonary Medicine or Internal Medicine. Some professional bodies have developed a formal curriculum for training in CCM. The Competency-Based Training programme in Intensive Care Medicine (CoBaTrICE) from the European Society of Intensive Care Medicine (ESICM) is a widely accepted formal structured training curriculum in CCM. Most curricula are designed only for high-income, well-resourced training and practice environments and do not account for additional skills and competencies that may be required to practice in resource variable settings, something the COVID-19 pandemic has demonstrated needs to be universal. The transition of Anesthesiologists working in OR or managing critically ill surgical/ polytrauma patients into working in ICU has largely been smooth. Nevertheless, experts have noted deficiencies in the Anesthesiology training in certain competencies required for the management of critically ill medical and surgical patients in the ICU. This is often compounded by considerable variation in the training curriculum of the Anesthesiologists based on the geographical region and type of institution. There is a need to identify these competencies so that Anesthesiologists who wish to practice full time or part-time Critical Care can acquire these competencies to improve their ability to manage critically ill patients in ICU in different World Health Organization defined healthcare facilities levels. This may also help provide guidance to educators worldwide regarding the competencies to be included in Anesthesiology training that may help Anesthesiologists work better with critically ill patients in ICU. These competencies have never been formally identified or published. The investigators plan to review the existing competencies for CCM in the Anesthesiology curriculum across the globe through a preliminary survey. Thereafter, the investigators plan to identify the additional competencies required through consensus among Experts, using a Delphi method. These additional competencies, classified as mandatory, desirable, and optional, may serve as a guide for Anesthesiologists to practice Critical Care in ICU in different levels of health care facilities worldwide.

OBJECTIVES

  1. The investigators aim to review/identify the existing competencies for CCM in the Anesthesiology curriculum across the globe.
  2. The investigators aim to generate expert consensus on the additional competencies (mandatory desirable and optional) required for Anesthesiologists to practice Critical Care in the ICU.
  3. Provide guidance to educators worldwide regarding the competencies to be included in the Anesthesiology curriculum that may help Anesthesiologists work better with critically ill patients in ICU.

METHODOLOGY

Steering Committee:

A Steering Committee comprising of Anesthesiologists with experience in CCM will be formed under the auspices of the Intensive and Critical Care Medicine Committee (ICCCM) of the World Federation of Societies of Anaesthesiologists (WFSA).

Preliminary survey:

The Steering Committee will develop a preliminary survey to assess the knowledge and skills of Anesthesiologists across the globe following Anesthesiology training, which is required to achieve the various Critical Care competencies. A literature review on the existing Critical Care competencies from various professional bodies will be conducted to develop a list of Critical Care competencies, using CoBaTrICE as a base. The preliminary survey will be sent to approximately 500 Anesthesiologists across the globe by the Experts. The competencies of participants in CCM will be assessed under six domains in the survey (Disease diagnosis and management, Procedures, Monitoring and therapeutic interventions, Resuscitation, Communication and End-of-life care, Patient safety and Crisis Resource Management) using a 5-point Likert scale (never seen, have observed, can manage under supervision, can manage with minimal assistance, and can manage independently).

The first section of this survey will include the participant demographics, country of origin and training, year of completing training, and a few training characteristics. The results of the survey will be used to draft competencies for inclusion in Round one of the Delphi.

Delphi process:

The Delphi process is a well-established methodology to generate consensus on a particular topic using the "collective intelligence" of panel members. The steering committee members will perform a literature search on the available evidence, draft the initial statements and conduct iterative Delphi rounds to generate consensus among the experts. The Steering Committee members will not participate in the Delphi surveys themselves.

Steps of the Delphi process

Step 1: Establishing a preliminary list of competencies:

A literature review on the existing Critical Care competencies from various professional bodies will be conducted to develop a list of Critical Care competencies, using CoBaTrICE as a base and categorized under the six core domains (disease diagnosis and management, procedures, monitoring and therapeutic interventions, resuscitation, communication and end-of-life care, patient safety and crisis resource management). The results of the preliminary survey will be used to draft statements for Round one of Delphi.

Step 2: Preparation of the Delphi Round one survey:

The list of the competencies will be sent to the Experts as a Delphi questionnaire. The anonymity of the participating experts will be maintained during the Delphi rounds. The participant will be asked to score each of the competencies listed on a 5-point Likert scale (non-essential, optional, optional but desirable, desirable, and mandatory). The participating expert will be invited to provide feedback regarding omission, addition, or modification of the items on the questionnaire. The response and feedback of experts will be collated during the analysis of results and shared in the following survey as controlled feedback.

Step 3: Subsequent Delphi Rounds:

The steering committee will review the results of round one. The competencies listed will be modified, deleted, or added if found ambiguous based on the feedback and comments of the results. Competencies deemed "non-essential" by more than 50% of the respondents will be eliminated. The remaining competencies will be continued in the subsequent rounds until consensus is achieved (>80% of respondents). Lower-rated items identified for removal may be retained in the second round if more than 20% of participating experts considered them "mandatory". The summary results of Round two will be presented to Experts, and the survey process will be repeated with the modified questionnaire. The Delphi rounds will be continued till desired consensus and stability is achieved for competencies.

Step 4: Final Consensus on Competencies to be included:

The summary results of the last stable round will be used to issue the consensus on the additional competencies to be included. These competencies will also be classified as those mandatory, desirable, and optional, which may serve as a guide to decide which competencies are required for working in different levels of health care facilities worldwide. The results of the final survey, consensus competencies, and the manuscript will be circulated among the experts for approval before submission for publication.

Being tested
Global Experts Consensus opinion using Delphi Methodology
Keywords
Training of Anesthesiologists, Training in Intensive care medicine, Anesthesiologists intensivist, Curriculum of training for Anesthesiologists

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Global Experts Consensus opinion using Delphi MethodologyBehavioural

    The Investigators will conduct iterative Delphi Rounds with Global experts to achieve consensus on Competencies required for Anesthesiologists to manage critically ill medical and surgical patients in ICU

Study groups in NCT05007704
Study groupRoleWhat they receive
Anesthesiologists for preliminary surveyAnesthesiologists who have completed their training within the last three years to identify preliminary competencies for Delphi round one survey.
Global Experts in Anesthesiology and Critical Care MedicineAnesthesiologist (a medical graduate who has completed a nationally recognized Anesthesiology training programme) involved in the management of critically ill patients in ICU and have more than ten years of experience in teaching and training in Critical Care. They will be involved in the Delphi process to generate expert consensus on the additional competencies (mandatory desirable and optional) required for Anesthesiologists to practice Critical Care in the Intensive Care Unit (ICU).
Receives: Behavioral: Global Experts Consensus opinion using Delphi Methodology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of Preliminary Competencies

    Using a 5-point likert scale (never seen, have observed, can manage under supervision, can manage with minimal assistance, and can manage independently) through a cross-sectional survey with 500 recently (less than three years) trained Anesthesiologists.

    Measured: 30 days

  2. Consensus among participating experts

    The participating experts will be asked to score each of the competencies listed on a 5-point Likert scale (nonessential, optional, optional but desirable, desirable, and mandatory).The Delphi rounds will be continued till desired consensus and stability is achieved for competencies.

    Measured: 45 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start11 Sep 2021
  3. Primary completion30 Sep 2021
  4. Study completion21 Mar 2022

Resources

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
Cross-sectional
Enrolment
1,155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007704
Sponsor's protocol ID
WFSA-CCM
Status last verified
Apr 2022
First submitted
11 Aug 2021
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The study protocol and statistical analysis of preliminary survey and Delphi process

Publications

  • Hastie J. Anesthesiologists as perioperative leaders. Int Anesthesiol Clin. 2020 Fall;58(4):58-63. doi: 10.1097/AIA.0000000000000296. No abstract available.

    PubMed 32889956
  • Barrett H, Bion JF. An international survey of training in adult intensive care medicine. Intensive Care Med. 2005 Apr;31(4):553-61. doi: 10.1007/s00134-005-2583-7. Epub 2005 Mar 5.

    PubMed 15750798
  • CoBaTrICE Collaboration. The educational environment for training in intensive care medicine: structures, processes, outcomes and challenges in the European region. Intensive Care Med. 2009 Sep;35(9):1575-83. doi: 10.1007/s00134-009-1514-4. Epub 2009 Jun 23.

    PubMed 19547957
  • Kain ZN, Fitch JC, Kirsch JR, Mets B, Pearl RG. Future of anesthesiology is perioperative medicine: a call for action. Anesthesiology. 2015 Jun;122(6):1192-5. doi: 10.1097/ALN.0000000000000680. No abstract available.

    PubMed 25886775
  • Gelb AW, Morriss WW, Johnson W, Merry AF, Abayadeera A, Belii N, Brull SJ, Chibana A, Evans F, Goddia C, Haylock-Loor C, Khan F, Leal S, Lin N, Merchant R, Newton MW, Rowles JS, Sanusi A, Wilson I, Velazquez Berumen A; International Standards for a Safe Practice of Anesthesia Workgroup. World Health Organization-World Federation of Societies of Anaesthesiologists (WHO-WFSA) International Standards for a Safe Practice of Anesthesia. Anesth Analg. 2018 Jun;126(6):2047-2055. doi: 10.1213/ANE.0000000000002927.

    PubMed 29734240
  • Diamond IR, Grant RC, Feldman BM, Pencharz PB, Ling SC, Moore AM, Wales PW. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. J Clin Epidemiol. 2014 Apr;67(4):401-9. doi: 10.1016/j.jclinepi.2013.12.002.

    PubMed 24581294
  • Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.

    PubMed 34322364
  • Junger S, Payne SA, Brine J, Radbruch L, Brearley SG. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review. Palliat Med. 2017 Sep;31(8):684-706. doi: 10.1177/0269216317690685. Epub 2017 Feb 13.

    PubMed 28190381

Questions about this trial

What is this clinical trial studying?

An observational study of Training and Education, run by Prashant Nasa at 1 site in India.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 20 Apr 2022. 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 India. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of Preliminary Competencies (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007704, which also lists 8 linked publications.

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 20 Apr 2022.

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