Contact information
Type
Scientific
Primary contact
Dr Indika Gawarramana
ORCID ID
Contact details
SACTRC
Faculty of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka
+94 (0)81 447 9822
indika@sactrc.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
071669
Study information
Scientific title
A hospital based cluster randomised controlled trial to evaluate treatment behaviour following educational interventions and essential antidote stocking in the treatment of acute poisoning patients
Acronym
Study hypothesis
That the provision of an education program on management of self-poisoning with supply of essential antidote stock will improve management of self-poisoning when compared with the provision of guidelines alone.
Ethics approval
University of Peradeniya, Sri Lanka gave approval on the 13th December 2007
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Clinical guidelines of the treatment of acutely poisoned patients
Intervention
A half-day interactive teaching session using a lecture/workshop format delivered by an expert (consultant physician) in the primary hospital to medical and other hospital staff. The distribution of posters describing treatment algorithms derived from National Poison Treatment Guidelines Book plus distribution of promotional items with reminder messages (folders for patient's inpatient notes, whiteboards for the wards and pens; all with prompts to look-up the National Poison Guidelines).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Use of forced emesis
2. Use of activated charcoal
3. Use of pralidoxime
4. Use of antidotes for paracetamol
Collected continuously and analysed at 6 and 12 months post-intervention.
Secondary outcome measures
1. Cost of treatment
2. Deaths from poisoning
3. Extent of irreversible acetylcholinesterase inhibition following organophosphate ingestion
4. Improvement in antidote stocking
Analysed at 12 months.
Overall trial start date
01/10/2008
Overall trial end date
01/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All primary rural hospitals in North Central Province with inpatient facilities
Participant type
Patient
Age group
Other
Gender
Not Specified
Target number of participants
42 hospitals
Participant exclusion criteria
Primary hospitals without inpatient facilities
Recruitment start date
01/10/2008
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Sri Lanka
Trial participating centre
SACTRC
Peradeniya
20400
Sri Lanka
Sponsor information
Organisation
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Sponsor details
c/o Professor Andrew Hamilton Dawson
Program Director
Visiting Professor of Medicine
University of Peradeniya
Peradeniya
20400
Sri Lanka
+94 (0)81 447 9822
adawson@sactrc.org
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
International Collaborative Research Grant:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 071669)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Health and Medical Research Council (NHMRC) (Australia)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23990989
Publication citations
-
Results
Senarathna L, Buckley NA, Dibley MJ, Kelly PJ, Jayamanna SF, Gawarammana IB, Dawson AH, Effect of a brief outreach educational intervention on the translation of acute poisoning treatment guidelines to practice in rural Sri Lankan hospitals: a cluster randomized controlled trial., PLoS ONE, 2013, 8, 8, e71787, doi: 10.1371/journal.pone.0071787.