Home » Trials » SLCTR/2010/008


A clustered RCT of educational interventions on treatment of patients with acute poisoning in rural Asian hospitals

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SLCTR Registration Number

SLCTR/2010/008


Date of Registration

06 Oct 2010

The date of last modification

Mar 03, 2019


Trial Status



Application Summary


Scientific Title of Trial

A clustered RCT of educational interventions on treatment of patients with acute poisoning in rural Asian hospitals


Public Title of Trial

Effect of educational interventions on the treatment of patients with poisoning


Disease or Health Condition(s) Studied

Poisoning


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

The Australian National Health and Medical research Council grant number for this project is 630650.


Trial Details


What is the research question being addressed?

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. Specifically in patients presenting with poisoning to primary hospitals there will be: 1. Reduction of forced emesis 2. Reduction of gastric lavage 3. An increased use of activated charcoal 4. An increased use of pralidoxime in organophosphate poisoning 5. An increased use of oral methionine or n-acetylcysteine for paracetamol poisoning which will result in reduced inter-hospital transfers 6. A decrease in mortality


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Available


Intervention(s) planned

We will do a three arm clustered randomised trial of educational interventions in 106 primary rural hospitals in three non-contiguous provinces in Sri Lanka (North Western Province, North Central and Southern Province) The primary hospitals will be randomised (in a 1:1:1 ratio) to receive one of the following interventions: Control: Supply of new copies of National Poison Treatment Guidelines Book (Management of Poisoning, Prof Ravindra Fernando, published by the National Poisons Information Centre) only. Primary Intervention 1- Direct Primary Hospital Practice 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). This would be followed up one year later with a refresher session in a similar format. Primary Intervention 2 - Centralised Further Education & Training Intervention: The delivery of a full day educational intervention to available primary care doctors and nursing staff from a number of health institutions in a central location. This will include a component of ‘training the trainer’ to provide them with teaching materials so they could run a small session to train other staff at their institution. To assist them with becoming local ‘clinical champions’ of change, additional distance learning material will be supplied to these participants. The distance learning material will consist of a short course comprising case vignettes and case-based reading material. This will come from the distance learning course in Clinical Toxicology from the Post-Graduate Medical Institute of Sri Lanka & Colombo University. Completion of the material will be recognised as part of continuing medical education where appropriate. The promotional items described in Primary Intervention 1 will also be distributed to these hospitals.


Inclusion criteria

All primary rural hospitals with inpatient treatment facilitie


Exclusion criteria

None



Primary outcome(s)

1.

Use of forced emesis and/or gastric lavage : a. Documentation of primary hospital charts b. Validation by history of intervention in the subset transferred to referral hospital

[

6, 12, 18 & 24 months

]
2.

Use of activated charcoal: a. Documentation of primary hospital charts b. Validation by history of intervention and examination (for evidence of charcoal ingestion) in a subset transferred to referral hospital

[

6, 12, 18 & 24 months

]
3.

Use of pralidoxime: a. Documentation of primary hospital charts b. Validation by hospital pharmacy records and central pharmacy ordering. c. Detection of pralidoxime in blood samples in the subset transferred to referral hospital

[

6, 12, 18 & 24 months

]
4.

Use of oral methionine or n-acetylcysteine: a. Documentation of primary hospital charts b. Validation by hospital pharmacy records and central pharmacy ordering

[

6, 12, 18 & 24 months

]
5.

Rate of inter-hospital transfer for paracetamol poisoning

[

6, 12, 18 & 24 months

]

Secondary outcome(s)

1.

Deaths from poisoning a. Documented in primary and referral hospital charts and from interhospital ambulance transfer records

[

6, 12, 18 & 24 months

]
2.

Extent of irreversible red cell acetylcholinesterase inhibition at admission

[

6, 12, 18 & 24 months

]
3.

Economic Analysis: a. Hospital based direct costs of antidote maintenance and patient related costs such as transport would be estimated.

[

6, 12, 18 & 24 months

]
4.

Persistence of behavioural change. a. The magnitude of effect would be measured over time in each intervention group and in the control to determine if the behavioural change is maintained.

[

6, 12, 18 & 24 months

]
5.

Factors that may influence the extent and persistence of behavioral change. a. We will (post hoc) examine how variable the effect is and whether factors such as hospital size, staffing, patient load and proximity to referral centres correlate with the extent of behavioural change. b. We will also (at the end of the intervention and at the end of data collection) undertake focus group discussions in hospitals with high and low rates of change from each arm of the trial. These discussions will involve standard qualitative research analysis techniques to bring out the main thematic elements in the perceptions of the participants in terms of the success or failure of particular interventions.

[

6, 12, 18 & 24 months

]

Target number/sample size

106 primary rural hospitals


Countries of recruitment

Sri Lanka


Anticipated start date

2010-12-01


Anticipated end date

2013-08-26


Date of first enrollment


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

Australian NHMRC


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2010-03-23


Approval number

EC/2007/98


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 & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Andrew Dawson
Professor, Clinical School, UNSW
Randwick, NSW Australia
+61 401915196


ahdawson@gmail.com

Contact Person for Public Queries

Andrew Dawson
Professor, Clinical School, UNSW
Randwick, NSW Australia
+61 401915196


ahdawson@gmail.com


Primary study sponsor/organization

South Asia Clinical Research

Faculty of Medicine, University of Peradeniya
0814479822

enquiry@sactrc.org
www.sactrc.org

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


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