| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post graduate students of Anesthesia department |
|
|
Intervention / Comparator Agent
|
|
|
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 |