Condition category
Not Applicable
Date applied
24/03/2009
Date assigned
06/05/2009
Last edited
02/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.sactrc.org

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23990989

Publication citations

  1. 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.

Additional files

Editorial Notes