| CTRI Number |
CTRI/2024/07/070280 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Pre Hospital Emergency Service Use And Healthcare Seeking Behaviour Of Patients In Emergency Department Of A Tertiary Care Hospital In Southern India |
|
Scientific Title of Study
|
Evaluating the Pre-Hospital Emergency Services Healthcare-Seeking Behaviour Amongst the Patients Reporting to The Emergency Medicine Department Of A Tertiary Care Hospital In Southern India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devika J L |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
LH 9 6th floor Department of Emergency Medical Technology MCHP MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9740583374 |
| Fax |
|
| Email |
devika1.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Nayak Sujir |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Emergency Medicine Kasturba Medical College and Kasturba Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449111397 |
| Fax |
|
| Email |
sachin.sujir@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Nayak Sujir |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Emergency Medicine Kasturba Medical College and Kasturba Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449111397 |
| Fax |
|
| Email |
sachin.sujir@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education, Udupi - 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education |
| Address |
Kasturba Medical College and Hospital Tiger Circle Road Madhava Nagar Manipal Udupi Karnataka PIN- 576104 |
| 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 Sachin Nayak Sujir |
Kasturba Hospital Manipal |
Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education
Udupi
KARNATAKA |
9449111397
sachin.sujir@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients who come in Ambulance or Private Vehicles and are Categorized into P1 P2 P3 based on the Emergency Severity Index Triage system |
|
| ExclusionCriteria |
| Details |
All patients who have been admitted in another hospital and subsequently transferred to Kasturba Hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Factors contributing to the use of Ambulance/ EMS
Public Awareness about Emergency Medical Services in India
Development and Validation of questionnaire about EMS awareness |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recommendations for positioning an ambulance in an areas where ambulance access is challenging thereby reducing EMS dispatch time |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
07/08/2024 |
| 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="1"
Months="0"
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
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. After IRC, IEC and CTRI registration, following the addressal of patients primary complaint and the delivery of emergency care, patient (if possible), bystander/ family members will be explained about the study and informed consent will be obtained and they will be given with the questionnaire. Acquired data will be analyzed by JAMOVI statistics software version 2.4.11. The questionnaire validation will be done by administering to the subject matter experts and specializing in questionnaire development and validation. |