| CTRI Number |
CTRI/2024/03/063671 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving point of care ultrasound documentation among emergency medicine residents |
|
Scientific Title of Study
|
Improving point of care ultrasound documentation among emergency medicine residents (i-POCUS):an implementation research |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. M. Gaayathri |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
M.Gaayathri
Junior Resident
Emergency Medicine and Trauma
JIPMER
Pondicherry PONDICHERRY 605006 India |
| Phone |
7997251745 |
| Fax |
|
| Email |
gaayathrimiriyala@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
First Floor EMSD Office room,
EMSD Building
Department of Emergency Medicine and Trauma
JIPMER
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9846556133 |
| Fax |
|
| Email |
jd1292@jipmer.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
First Floor EMSD Office room,
EMSD Building
Department of Emergency Medicine and Trauma
JIPMER
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9846556133 |
| Fax |
|
| Email |
jd1292@jipmer.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute Of Postgraduate Medical Education And Research,Dhanvantri Nagar,Gorimeedu Pondicherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute Of Postgraduate Medical Education And Research |
| Address |
Jawaharlal Institute Of Postgraduate Medical Education And Research,Dhanvantri Nagar,Gorimeedu Pondicherry
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manu Ayyan |
Jawaharlal Institute of Postgraduate and Medical Research |
EMSD Office room,First Floor EMSD Building
Department of Emergency Medicine and trauma care
Jawaharlal Institute of Postgraduate and Medical Research
Pondicherry,605006 Pondicherry PONDICHERRY |
9846556133
jd1292@jipmer.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Observational studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Point of care ultrasound documentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Emergency medicine residents in the residency program at JIPMER. |
|
| ExclusionCriteria |
| Details |
Emergency medicine residents who have not completed a point of care ultrasound training.
Missing Reporting Forms or documentation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the change in proportion of ultrasound examinations done by emergency residents that has 80% compliance with the standard reporting guidelines for point of care ultrasound in emergency department |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the emergency medicine residents confidence and proficiency in using the ACEP standard reporting guidelines for point of care ultrasound |
12 months |
| To identify the factors that facilitate or hinder the adoption and implementation of the standard reporting guidelines for point of care ultrasound documentation among emergency medicine residents |
3 months |
| To estimate the impact of the implementation of the ACEP standard reporting guidelines on image archiving and the retrieval of point of care ultrasound images in the emergency department |
9 months |
| To determine the impact of the implementation of the ACEP standard reporting guidelines on credentialing or attaining expected competencies in using POCUS for clinical decision-making |
6 months |
|
|
Target Sample Size
|
Total Sample Size="272" Sample Size from India="272"
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)
|
16/03/2024 |
| 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="2" Months="0" 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
|
Point-of-care ultrasound is routinely performed in the emergency department, which helps in diagnostic accuracy, providing timely care , and procedural safety.It is rapid and has high diagnostic accuracy in detecting potentially life threatening pathologies so that fast and timely intervention can save the lives of patients.Emergency Medicine residents should be competent enough to perform POCUS and reach correct diagnoses which requires POCUS documentation adhering to standard reporting guidelines.Improving documentation and image archiving will lead on to quality improvement of POCUS.It also helps in enhancing residents confidence and proficiency in performing POCUS.we are conducting an implementation research study with a mixed method approach in which we measure the current quality of point-of-care ultrasound documentation in our emergency department and implement the ACEP guidelines standard reporting format, and we estimate the change in proportion of scans compliant with standard reporting guidelines. We conduct focused group discussions to identify the factors that hinder the adoption and implementation of standard reporting guidelines; based on the feedback collected, we modify the implementation strategy and implement it in different iterative cycles. By the end of our study we aim to increase the number of scans properly documented according to ACEP standard reporting format. |