| CTRI Number |
CTRI/2025/02/080169 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Simulation based teaching of crisis Resource Management (CRM) among Pediatric Residents |
|
Scientific Title of Study
|
Impact of teaching simulation based crisis resource management (CRM) A prospective randomized pilot study among pediatric residents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivansh Raj Sharma |
| Designation |
Junior resident |
| Affiliation |
Department of Pediatrics |
| Address |
Department of Pediatrics
3rd floor, Himalayan Institute of Medical Sciences SRHU, Jolly Grant, Swami Ram Nagar Dehradun UTTARANCHAL 248016 India |
| Phone |
8171134300 |
| Fax |
|
| Email |
shivanshraj123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ashok K Deorari |
| Designation |
Principal |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Principal Office, University Building, 1st Floor
SRHU, Jolly Grant, Swami Ram Nagar
Dehradun UTTARANCHAL 248016 India |
| Phone |
9818131391 |
| Fax |
|
| Email |
ashokdeorari@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shivansh Raj Sharma |
| Designation |
Junior resident |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Pediatrics
Library Building, 3rd Floor,
SRHU, Jolly Grant, Swami Ram Nagar
Dehradun UTTARANCHAL 248016 India |
| Phone |
8171134300 |
| Fax |
|
| Email |
shivanshraj123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences, SRHU, Jolly Grant, Swami Ram Nagar, Dehradun 248016, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Himalayan Institute of Medical Sciences |
| Address |
Jolly Grant, Dehradun, Uttarakhand 248140 |
| Type of Sponsor |
Private 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 Shivansh Raj Sharma |
Himalayan Institute of Medical Sciences |
Department of Pediatrics, 3rd Floor, SRHU, Jolly Grant, Swami Ram Nagar Dehradun UTTARANCHAL |
8171134300
shivanshraj123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Himalayan Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Simulation-based CRM Principles teaching |
Structured debriefing on CRM principles one time for seven minutes |
| Comparator Agent |
Unstructured Feedback |
Feedback on CRM Principles one time for five minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Pediatric residents with minimum exposure to Paediatric emergency for at least 8 weeks.
2. Residents who have had at least 8weeks of PICU posting.
3. Emergency room and PICU staff nurses.
|
|
| ExclusionCriteria |
| Details |
1. 2nd year residents who have had their PICU posting in last 8 weeks.
2. Those who refuse to give consent
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome will be measured by time to intervention and scenario outcome |
At baseline immediately after the scenario |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Team Leader performance, team performance using ottawa Global rating score & MAYO high perfmance score |
8 weeks after the initial assessment |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
17/02/2025 |
| 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="3" 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
|
Around 27% of medical errors occur due to communication errors in medical field. Simulation based training allows users at all levels, from novice to expert, to practice and develop skills with their knowledge, and provides a safe, supportive educational environment where mistakes carry no penalties or fear of harm to patients or learners. Crisis resource management, in simple terms are non-technical skills needed for effective teamwork in crisis, ability to translate medical knowledge to real world actions and predicting what all things could happen in immediate future in the setting of an emergency. Though there are multiple studies looking into effects of teaching crisis resource management skills in medical field, there is a paucity of literature in India. Also there are very few studies examining the retention ability of these skills in healthcare professional. Hence, we would like to conduct this first of its kind experimental study in the country. to determine if including crisis resource management principles during training followed by reflective debriefing would better prepare pediatric residents in managing various crisis situation. |