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CTRI Number  CTRI/2024/04/066477 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Use of Direct Observation of Procedural skills for Formative Assessment of residents working in ICU 
Scientific Title of Study   Introduction of Direct Observation of Procedural Skills as a Work Place Based Assessment Tool among Residents working in ICU. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nazia Nazir 
Designation  Professor 
Affiliation  GIMS 
Address  Department of Anaesthesiology & Intensive Care, First Floor, Main OT Complex, Government Institute of Medical sciences, 201310

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9560102957  
Fax    
Email  nazunazir@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nazia Nazir 
Designation  Professor 
Affiliation  GIMS 
Address  Department of Anaesthesiology & Intensive Care, First Floor, Main OT Complex, Government Institute of Medical sciences, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9560102957  
Fax    
Email  nazunazir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nazia Nazir 
Designation  Professor 
Affiliation  GIMS 
Address  Department of Anaesthesiology & Intensive Care, First Floor, Main OT Complex, Government Institute of Medical sciences, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9560102957  
Fax    
Email  nazunazir@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology & Intensive Care, First Floor, Main OT Complex, Government Institute of Medical sciences, India, 201310 
 
Primary Sponsor  
Name  GIMS 
Address  Department of Anaesthesiology & Intensive Care, First Floor, Main OT Complex, Government Institute of Medical sciences, Greater Noida, India, 201310 
Type of Sponsor  Government medical college 
 
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 Nazia Nazir  Government Institute of Medical Sciences   Department of Anaesthesiology and Intensive Care, First Floor, Main OT Complex, Government Institute of Medical Sciences, Greater Noida, 201310
Gautam Buddha Nagar
UTTAR PRADESH 
9560102957

nazunazir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIMS Institutional Ethics Committee, Greater Noida.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Residents working in ICU who consent to be part of the study will be directly observed for formative assessment of their ultrasound guided central venous catheter insertion skill in ICU 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Use Of Direct Observation of Procedural Skills as a Work Place Based Assessment Tool Among Residents Working In ICU.  Day 1- first session of DOPS Day 15- second session of DOPS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All the residents working in the Intensive Care Unit from the second year of residency onwards

All patients between 18-60 years of age of either gender for CVC insertion in ICU 
 
ExclusionCriteria 
Details  first year anesthesia residents
pregnant patients
children lees than 18 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Direct Observation of Procedural Skills as a tool for providing constructive feedback to improve competence of residents.  Day 1- first DOPS session
Day 15- second DOPS session 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the perception of the faculty & residents with Direct Observation of Procedural Skills as Work Place Based Assessment tool.  day 1- first session of DOPS
day 15- second session of DOPS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   08/05/2024 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nazunazir@gmail.com].

  6. For how long will this data be available start date provided 16-03-2025 and end date provided 02-02-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The core team of faculty members (n~6) will be formed. A faculty orientation seminar will be organized in the Department of Anaesthesiology regarding DOPS assessment and the method of giving feedback. The orientation of the residents working in ICU (n~30) to DOPS assessment will be done and informed consent will be obtained. Consent from the patients will be obtained. Patients in the vulnerable group (e.g. pediatric patients, pregnant patients, patients requiring emergency central venous catheter insertion) will be excluded.

Assessment using a pre-validated structured proforma (DOPS Checklist form) for central venous catheter insertion (ultrasound guided) by NHS Mastery Skills Pathway. [2] Each parameter is rated on a five‑point scale of 1 to 5. Every student will be directly observed while performing the procedure by the faculty members in the ICU. Observations will be documented on the DOPS checklist and the final score will be noted down as D1‑Score. During the first DOPS assessment, constructive feedback using the checklist as the basis will be given to residents by the observer to encourage self-directed learning and reflective practice

The second DOPS assessment (D2 score) will be done after 15 days of the first DOPS to assess the improvement in procedural skills and to check the retention of knowledge. Further constructive feedback will be given.

The perception of the faculty and residents regarding the conduct of DOPS and as an assessment tool will be taken in the form of feedback from all the faculty and residents at the end of the second DOPS assessment using a 5-point Likert scale ranging from 1-5 (Strongly Agree=5, Agree=4, Neutral=3, Disagree=2, Strongly disagree=1) and some open-ended questions. (Table 1,2) Data will be collected using Google form and the questionnaire will be circulated through WhatsApp to faculty. The feedback will be collected anonymously and confidentiality of responses will be maintained. The patient demographics will also be recorded.

The data will be analyzed using appropriate statistical tests.

 

 
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