NCT04577924

Brief Summary

Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala. This study aimed to describe the prehospital care of RTI victims presenting to the emergency department in Jubilee Mission Medical College and Research Institute, Thrissur.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
978

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

September 29, 2020

Last Update Submit

February 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pre-hospital care profile of RTI Victims presenting to the emergency department in a tertiary care center in Kerala as measured by a questionnaire.

    Pre-hospital care received by RTI Victims presenting to the emergency department in a tertiary care center in Kerala

    Hospital admission days through discharge; up to 30 days

Study Arms (1)

Road traffic injury victims

All RTI patients presenting to ED within 24 hours of injury is included in the study.. Individual's not consenting to be part of the study or withdrawing consent later on would be excluded. We also would exclude cases where pre-hospital care provider could not be traced or where reliable data patient could not be collected even after repeated interview.

Other: Interview

Interventions

Trained research assistants would abstract the data as per a preset proforma. The data would be collected from the patient (if coherent), pre-hospital care provider or primary care provider. Data would was also obtained from patient records and the proforma filled by the attending doctors on duty. Follow up of cases would be done until discharge from the hospital.

Road traffic injury victims

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All RTI patients presenting to ED within 24 hours of injury irrespective of gender, race or comorbidities involved in an RTI would be approached to be recruited for the study.

You may qualify if:

  • All Road traffic injury (RTI) patients presenting to ED within 24 hours of injury

You may not qualify if:

  • Individual's not consenting to be part of the study or withdrawing consent later on
  • Cases where pre-hospital care provider could not be traced or where reliable patient data could not be collected even after repeated interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Salish Varghese, MD

    salishvarghese@gmail.com

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 8, 2020

Study Start

January 1, 2019

Primary Completion

April 30, 2019

Study Completion

July 31, 2019

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Individual participant data would be shared once published in a peer reviewed journal.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
from 2025 for a period of 1 year

Locations