Home » Trials » SLCTR/2013/023
A cluster randomised controlled trial of educational intervention on management of snakebite in the North Western Province of Sri Lanka
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SLCTR Registration Number
SLCTR/2013/023
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A cluster randomised controlled trial of educational intervention on management of snakebite in the North Western Province of Sri Lanka
Public Title of Trial
Education on treating snakebite
Disease or Health Condition(s) Studied
Snakebite
Scientific Acronym
EIMS (Educational Intervention in the Management of Snakebite)
Public Acronym
None
Brief title
Educational Intervention in Snakebite
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
2013/EC/19 (Ethics Review Committee, Faculty of Medicine, University of Peradeniya)
What is the research question being addressed?
Will a systematic educational program to improve the knowledge of the first contact doctor and nurse in the management of snakebite reduce snakebite related morbidity, mortality and direct costs involved in government hospitals in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
A doctor and a nurse involved in management of snake bite from each hospital in the North Western Province (NWP) will be invited to participate based on their availability, interest and willingness. Provincial director of NWP will provide the participants’ list.Participating hospitals will be randomized into a test group and a control group.
A workshop will be held for the test group at the beginning of the study, and will include • Lectures from a panel of experts • Provision of the SLMA Snakebite management guideline • A poster: snakebite management algorithm
At the end of six months, an identical workshop will be held for participants of the control group
Inclusion criteria
• All hospitals in NWP including Base Hospitals, District Hospitals and Peripheral Units. • Doctors and nurses involved in management of snake bite
Exclusion criteria
Teaching Hospital, Kurunegala as it is the tertiary referral centre for all other hospitals in the NWP
Primary outcome(s)
|
1.
Improvement of documentation in BHT (using a pre-determined checklist of 20 key items of information) |
[ At the completion of one year following the educational intervention ] |
|
2.
Improvement of management (as determined by an expert group who will compare the management with the SLMA guideline) |
[ At the completion of one year following the educational intervention ] |
|
3.
Reduced transfers for specialized care (using hospital records) |
[ At the completion of one year following the educational intervention ] |
Secondary outcome(s)
|
1.
Reduction in the number of complications 1.1. Number needing ICU care 1.2. Number experiencing ADR following antivenom 1.3. Number experiencing severe anaphylaxis following antivenom 1.4. Duration of hospital stay 1.5. Case fatality rate |
[ At the completion of one year following the educational intervention ] |
Target number/sample size
Test group has 24 hospitals and control group has 20 hospitals based on randomisation
Countries of recruitment
Sri Lanka
Anticipated start date
2013-07-30
Anticipated end date
2014-07-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
SACTRC-South Asian Clinical Toxicology Research Collaboration
Regulatory approvals
Status
Approved
Date of Approval
2013-05-13
Approval number
2013/EC/19
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
SAM Kularatne
Professor
Department of Medicine, Faculty of Medicine, University of Peradeniya
Sri Lanka
0773420771
samkul@sltnet.lk
Contact Person for Public Queries
SAM Kularatne
Professor
Department of Medicine, Faculty of Medicine, University of Peradeniya
Sri Lanka
0773420771
samkul@sltnet.lk
Primary study sponsor/organization
SACTRC-South Asian Clinical Toxicology Research Collaboration
Faculty of Medicine,
University of Peradeniya
0814479822
0814479822
enquiry@sactrc.org
www.sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
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
