| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nazunazir@gmail.com].
- 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.
- 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.
|