Home » Trials » SLCTR/2025/004
A cluster randomized controlled trial on the short- and long-term impact of a brief educational intervention aimed at optimizing paediatric medical officers’ management of snake bite envenomations compared to standard practice in selected resource-limited paediatric treatment facilities in rural Sri Lanka
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SLCTR Registration Number
SLCTR/2025/004
Date of Registration
The date of last modification
Feb 14, 2025
Scientific Title of Trial
A cluster randomized controlled trial on the short- and long-term impact of a brief educational intervention aimed at optimizing paediatric medical officers’ management of snake bite envenomations compared to standard practice in selected resource-limited paediatric treatment facilities in rural Sri Lanka
Public Title of Trial
A cluster randomised controlled trial on the short- and long-term impact of a brief educational intervention aimed at optimizing paediatric medical officers’ management of snake bite envenomations compared to standard practice in selected resource-limited paediatric treatment facilities in rural Sri Lanka
Disease or Health Condition(s) Studied
Snake envenomation in children
Scientific Acronym
RCT-BEISME (Randomized Controlled Trial - Brief Educational Intervention Study for Medical Education)
Public Acronym
RCT-BEISME (Randomized Controlled Trial - Brief Educational Intervention Study for Medical Education)
Brief title
A Randomized Controlled Trial on the Impact of an Educational Intervention to Optimize Paediatric Snakebite Management in Rural Sri Lanka
Universal Trial Number
U1111-1316-8460
Any other number(s) assigned to the trial and issuing authority
P/128/09/2024 (ERC, Faculty of Medicine, Kelaniya)
What is the research question being addressed?
What is the short- and long-term impact of brief educational interventions aimed at optimizing paediatric medical officers’ management of snake bite envenomations compared to standard practice in selected resource-limited paediatric treatment facilities in rural Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Study settings: eight referral hospitals of the districts Ampara, Batticaloa, Monaragala, Anuradhapura, Polonnaruwa, Kurunegala, Kegalle, and Trincomalee. Resource limited paediatric treatment facility is defined for the study as a setting with previously reported shortage in antivenom in the hospital.
All medical officers currently providing care to children in the above hospitals and are willing share the newly acquired knowledge and training with fellow medical officers in the same treatment unit will be included in the study.
Randomisation will be done at the hospital level to prevent contamination (in quasi-experimental design) . Four hospitals will be offered the intervention and the others four will continue standard practice.
Participant Medical officers in the control arm will have access the all-national resources including guidelines and services of National Snakebite Hotline and Poison Information Centers; however, they will not be exposed to the proposed intervention.
Participant Medical officers in the intervention arm will join a half-day interactive workshop conducted by the Sri Lanka College of Paediatricians and members of the National Snake Bite Expert committee, Sri Lanka Medical Association.
Workshop contents will include: management of paediatric snake bites based on the SLMA guidelines, management of antivenom induced anaphylaxis in children, clinical and syndromic identification of snakebites, delivery of effective first aid and avoiding harmful first aid in children.
Intervention will be conducted as a training of trainers (TOT) workshop and participants will be encouraged share the knowledge and skills they achieve with colleagues in their respective paediatric care settings (i.e. wards, paediatric emergency department or ICU). The units will have access the all-national resources including guidelines and services of National Snakebite Hotline and Poison Information Centers (standard practice).
Both groups will be blinded for the process of hospital-based monitoring of mortality and morbidity data and guideline adherence (verified by medical records)
Inclusion criteria
All medical officers currently employed in paediatric wards of the eight referral hospitals of the districts Ampara, Badulla, Monaragala, Anuradhapura, Polonnaruwa, Kurunegala, Kegalle, and Trincomalee, who are willing share the newly acquired knowledge and training with fellow medical officers in the same treatment unit will be included in the study.
Exclusion criteria
Medical officers who primarily work in non-paediatric treatment facilities in the same hospitals will be excluded.
Primary outcome(s)
|
1.
Level of adherence to SLMA Expert Committee on Snakebites based national guideline while managing children with venomous snake bites by the participating hospitals in the intervention-arm and the control-arm |
[ Immediately before and after the intervention. Long term impact will be assessed 1-year after the intervention. ] |
Secondary outcome(s)
|
1.
Change in the participant medical officers’ knowledge regarding pictorial identification of snakes, evidence of envenoming, indication for antivenom therapy, regimen and dose of antivenom therapy, and management of antivenom adverse reactions, assessed using a questionnaire. |
[ Immediately before and after the intervention. Long term impact will be assessed 1-year after the intervention. ] |
|
2.
Improvement in mortality following venomous snake bites in children. Records will be individually verified and morbidity and mortality data be presented as descriptive data. |
[ During the period of 1-year before and for 1-year after the educational intervention is concluded ] |
Target number/sample size
122 (61 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-02-21
Anticipated end date
2026-04-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Ethical Review Committee, Faculty of Medicine, University of Kelaniya
Status
Approved
Date of Approval
2024-11-12
Approval number
P/128/09/2024
Details of Ethics Review Committee
| Name: | Ethical Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 06, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Kavinda Dayasiri
Professor in Paediatrics
PO Box 06, Thalagolla Road, Ragama, Sri Lanka
0718460130
0718460130
kavindad@kln.ac.lk
Contact Person for Public Queries
Kavinda Dayasiri
Professor in Paediatrics
PO Box 06, Thalagolla Road, Ragama, Sri Lanka
0718460130
kavindad@kln.ac.lk
Primary study sponsor/organization
Department of Paediatrics, Faculty of Medicine, University of Kelaniya
PO Box 06, Thalagolla Road, Ragama, Sri Lanka
Tel: 0718460130
Email: kavindad@kln.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Not applicable
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
