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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2010/008
Date of registration: 06/10/2010
Primary sponsor: South Asia Clinical Research
Public title: Effect of educational interventions on the treatment of patients with poisoning
Scientific title: A clustered RCT of educational interventions on treatment of patients with acute poisoning in rural Asian hospitals
Date of first enrolment: 1/12/2010
Target sample size: 106 primary rural hospitals
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={DBFF6C03-9F5B-4A42-9DEE-D362BBEC7C91}
Study type:  Interventional
Study design:  Clustered randomised clinical trial with 3 arms  
Countries of recruitment
Sri Lanka
Contacts
Name: Andrew Dawson 
Address:  Clinical School, UNSW, Randwick, NSW Australia
Telephone: +61 401915196
Email: ahdawson@gmail.com
Affiliation:  Professor
Name: Andrew Dawson 
Address:  Clinical School, UNSW, Randwick, NSW Australia
Telephone: +61 401915196
Email: ahdawson@gmail.com
Affiliation:  Professor
Key inclusion & exclusion criteria
Inclusion criteria: All primary rural hospitals with inpatient treatment facilities
Exclusion criteria: None

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Poisoning
Intervention(s)
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 and 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 Insti
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

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

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

4. Use of oral methionine or n-acetylcysteine:

a. Documentation of primary hospital charts

b. Validation by hospital pharmacy records and central pharmacy ordering

5. Rate of inter-hospital transfer for paracetamol poisoning
Secondary Outcome(s)
1. Deaths from poisoning

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

2. Extent of irreversible red cell acetylcholinesterase inhibition at admission

3. Economic Analysis:

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

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.


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.
Secondary ID(s)
The Australian National Health and Medical research Council grant number for this project is 630650. There is no other sponsor or registry
Source(s) of Monetary Support
Australian NHMRC
Secondary Sponsor(s)
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