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CTRI Number  CTRI/2023/12/060473 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   educational study 
Study Design  Other 
Public Title of Study   Implementation of Directly observed procedural skills as formative assessment for post graduate anesthesia students 
Scientific Title of Study   Implementation of Directly observed procedural skills (DOPS) as a tool for formative assessment among anesthesia residents- perception of faculties and students” 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhara Tanna 
Designation  associate professor 
Affiliation  GMERS medical college, Vadodara 
Address  6th floor, Department of Anesthesia, hospital building, GMERS medical college and hospital, Gotri main road, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  09979877486  
Fax    
Email  dr.dharatushar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhara Tanna 
Designation  associate professor 
Affiliation  GMERS medical college 
Address  6th floor, department of anesthesia, hospital building, GMERS Medical College and hospital, Gotri main road, Vadodara
GMERS Medical College and hospital, Gotri main road, Vadodara
Vadodara
GUJARAT
390021
India 
Phone  9979877486  
Fax    
Email  dr.dharatushar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dhara Tanna 
Designation  associate professor 
Affiliation  GMERS medical college 
Address  6th floor, department of anesthesia, hospital building, GMERS Medical College and hospital, Gotri main road, Vadodara
GMERS Medical College and hospital, Gotri main road, Vadodara
Vadodara
GUJARAT
390021
India 
Phone  9979877486  
Fax    
Email  dr.dharatushar@gmail.com  
 
Source of Monetary or Material Support  
GMERS medical college and hospital, Gotri, Vadodara 
 
Primary Sponsor  
Name  Dr Dhara Tanna 
Address  Department of Anesthesia, GMERS hospital, Gotri, Vadodara 
Type of Sponsor  Other [self] 
 
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 Dhara Tanna  GMERS medical college and hospital  6th floor, department of anesthesia, GMERS Medical College and hospital, Gotri main road, Vadodara
Vadodara
GUJARAT 
9979877486

dr.dharatushar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional human ethics committee, GMERS medical college and hospital, Gotri, Vadodara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post graduate students of Anesthesia department 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  all post graduate students of anesthesia department will be included 
 
ExclusionCriteria 
Details  unwilling to participate, and students with outside the hospital posting will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To get qualitative feedback regarding feasibility of DOPS from faculties and students by focused group discussions  at the end of all DOPS assessments of all students 
 
Secondary Outcome  
Outcome  TimePoints 
To assess improvement in post graduate students’ skills  after each DOPS session 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   11/12/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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

Skill development is very important part of anesthesia training. During conventional anesthesia post graduate training, the procedures are usually done under faculty’s supervision and real time guidance is provided. However, focus is on technical aspects of the procedures, and other aspects like preparation, communication with the patient, identifying difficulty and timely seeking help are usually overlooked. Assessment drives learning. Traditional assessment methods do not judge students’ skills.

In post graduate training, students become focused on knowledge gain so as to pass in summative assessment and get the post graduate degree.  The skills and confidence of the students can be enhanced if formative assessments and feedback are done regularly during their training. Workplace based assessment (WPBA) tools like DOPS, mini-CEX, case-based discussions can very well help the students to understand their fallacies and enhance their skills, as constructive feedback is integral part of such assessments. 

Purpose/ Aim:

With this project, we would like to start WPBA in the form of DOPS in regular practice, along with its entry in particular student’s logbook.

 Objectives: 

·      To plan and implement DOPS as a routine formative assessment

·      To assess improvement in post graduate students’ skills

·      To get qualitative feedback regarding feasibility of DOPS from faculties and students by focused group discussions

·      Change in practice from routine assessments to formative assessments

 

Methodology

 Study design- mixed method observational study 

Study participants and setting- The project will be conducted in department of anesthesia among the residents and faculties, after ethical approval from institutional ethics committee. Faculties who wish to participate and anesthesia residents in their first and second year of training will be included, after taking written and informed consent. The residents who have other peripheral postings will be excluded.  

 Study procedure- The residents and faculties will be trained about DOPS before commencement of the project, by sharing literature, videos, and power point presentation by a faculty from MEU of our institute. One day workshop will be organized at the MEU center for methods of WPBA, inviting a prominent faculty from this field. The faculties will also be trained on how to give constructive feedback to the students. 

Study tool: DOPS checklists for anesthesia skills are available online from Australian and New Zealand College of Anaesthetists (ANZCA). They will be modified as per the procedures if needed, and will be validated by subject experts as well as member of MEU. After modification, final checklists will be prepared. DOPS checklist includes 11 points, each point is given score from 1 to 5, very satisfied, Satisfied, neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied. 

We plan to conduct DOPS assessments monthly during resident’s OT postings, on elective patients. The students will be assessed for skills as per their level of training. As for example, first year residents will be assessed for spinal anesthesia and supraglottic airway insertion. Second year residents will be assessed for peripheral nerve blocks and laryngoscopy and intubation. The faculty assessing the student will score the performance from 1 to 5 on each of the 11 points of DOPS checklist. At the end, faculties will also give score as per global assessment scores, as per their confidence on students to leave the procedures on themselves without supervision. The students will be given constructive feedback post assessment. Mainly, the points on which student performed well, and area where there is a scope of improvement. Time taken for DOPS and feedback will be recorded. Each such interaction will be entered in their logbooks. We plan for minimum 3 interactions per student, per procedure. 

At the end of this project, focused group discussion will be planned for faculties as well students, separately, to know their feedback on DOPS. Discussion will be conducted by a faculty who is not directly involved in this project, and with whom faculties as well students can share their opinions without hesitancy. Opinions regarding feasibility, problems, student and faculty interest, their approach, communication, satisfaction, etc. will be discussed. The discussion will be audio recorded after their consents, and will be transcribed. Transcripts will be reviewed by two members involved in this project. Potential problems and scope of improvements will be identified, if any. Themes of the qualitative feedback will be identified and analysed accordingly.  

Quantitative feedback will also be taken from faculties and students regarding usefulness of such assessments. Feedback from the faculties regarding feasibility, limitations, time constrain, etc will also be taken 
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