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CTRI Number  CTRI/2024/05/066591 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes 
Study Design  Other 
Public Title of Study   Effect of informed consent training on anaesthesia trainee doctors 
Scientific Title of Study   IMpact of sImulation-based Training of Anaesthesia residenTs on Informed cONsent process (IMITATION study) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4318_Version 2.0 dated 03.03.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai

Mumbai (Suburban)
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reshma Ambulkar 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhinav Chetri 
Designation  Junior Resident 2 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Tata Memorial Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9123315871  
Fax    
Email  c.abhinav03@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia Critical care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai, MAHARASHTRA 410210 India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshma Ambulkar  Tata Memorial Centre  Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9821790448

rambulkar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  MD Anesthesia Trainees/Senior Residents 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NA 
Intervention  Training of Anaesthesia residents  Anesthesia residents both Trainees and senior residents from the Institute will be assessed, after obtaining their consent for the same. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. MD Anesthesia Trainees/Senior Residents working and training in the department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Mumbai
2. Research staff willing to be a part of the study
 
 
ExclusionCriteria 
Details  1. Anesthesia Trainees /Senior Residents who refuse to give consent
2. Anesthesia Trainees / Senior Residents whose tenure is likely to end before the completion of all three phases of the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in consent process as defined by 3-point improvement in the consent taking checklist assessed by the research nurse  Until 4 weeks post training 
 
Secondary Outcome  
Outcome  TimePoints 
1. Quantum of checklist score improvement after training
2. Predictors of significant improvement in change as per the baseline demographics
3. Assessment of improvement in compliance to AAGBI guidelines after training
4. Assessment of self-perceived improvement in consent taking after the training, assessed on a 5-point Likert scale
 		 Until 4 weeks post training 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background :

Informed consent is a fundamental principal in the health care context which includes the patient’s capacity to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Hence, the informed consent refers both to the health professional’s obligation of information disclosure to the patient and to the quality of the patient’s understanding and decision making

Informed consent is composed of three components: preconditions, information, and consent.

“Preconditions” in this context means that a patient is competent as well as willing to grant consent for the proposed medical treatment. To exercise this right, the patient should possess the capacity to make such decisions and must be able to decide without being influenced by other individuals, which includes medical personnel.

The second component of informed consent is “information”. As per the World Health Organisation (WHO) resolution on the promotion of patients’ rights, patients have the right to receive full knowledge regarding the status of their health. This includes their current medical condition, information about the suggested medical procedure, any risks and benefits associated with the said procedure, and any possible alternatives to the planned procedure. The patient should also be educated about the possible effects on their health should they refuse to proceed with the proposed treatment. The process of informed consent should also include a definite care plan including the physician’s advice, and it must be ensured that the patient has successfully comprehended the information shared with them.

Taking informed consent is a fundamental skill expected to be mastered by anaesthesia residents during their training period. Informed consent forms a component of the anaesthesia patient care competency within the pre-anaesthetic evaluation, assessment, and preparation. Studies have shown that consent discussions are usually incomplete. These shortcomings of insufficient consent discussion are often responsible for increased litigation.


Aim : To assess the impact of training in the process of consent taking for anaesthesia

Objectives:

  1. Assessment of impact of consent training on practices regarding anaesthesia consent process of the whole study population
  2. Assessment of impact of consent training on practices regarding anaesthesia consent process of the individual study participants
  3. Assessment of existent practices regarding anaesthesia consent process
  4. Correlation between clinical experience and quality of anaesthesia consent process

Correlation between clinical experience and degree of improvement in quality of anaesthesia consent process.


We aim to assess the residents on their baseline level of consent taking for Anaesthesia, train them and evaluate the impact of the training given to them.



 
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