ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12608000074392

Ethics application status

Approved

Date submitted

7/02/2008

Date registered

8/02/2008

Date last updated

30/08/2019

Date data sharing statement initially provided

30/08/2019

Date results provided

30/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The Despatch Trial: DElivering Stroke Prevention for patients with ATrial fibrillation: a Cluster randomised controlled trial in a primary Health care setting.

Scientific title

Does a multifaceted educational intervention targetting general practitioners increase anticoagulant prescribing in patients over the age of 65 with atrial fibrillation compared with evidence-based guidelines? A cluster randomised controlled trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Despatch

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atrial Fibrillation

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Despatch is a multifaceted, tailored educational intervention to redress noted barriers to the translation of best evidence into clinical practice relevant to the management of atrial fibrillation. Despatch will consist of the following components:
a) decisional support through a specifically created “Stop Stroke” specialist tele-service. b) Academic detailing: The “Stop-Stroke” members will include nurses with training in stroke medicine who will be employed as academic detailers. Academic detailing sessions will be delivered via three telephone sessions.
c) GP, patient and practice decision tools

The intervention will be delivered over a 12-month period after GP randomisation.

Outcomes will be assessed using data collected from patient medical records.

Intervention code [1]

Behaviour

Comparator / control treatment

GPs randomised to a the Control will receive evidence-based guidelines by mail

Outcomes will be assessed using data collected from patient medical records.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of patients over the age of 65 with a diagnosis of atrial fibrillation who have been prescribed warfarin.

Timepoint [1]

1) Note of a prescription at any time during the 12-months after GP randomisation.
2) Note of a prescription current at 12-months post-randomisation

Secondary outcome [1]

Proportion of patients prescribed antithrombotic treatment judged as "appropriate" according to stroke risk using a validated evidence-based risk stratification scheme and evidence-based guidelines

Timepoint [1]

1) Note of an "appropriate" prescription at any time from time of GP randomisation up to 12-months after GP randomisation.
2) Appropriate antithrombotic treatment current at 12-months post-randomisation

Secondary outcome [2]

Percentage of time patients are on warfarin.

Timepoint [2]

From time of GP randomisation up to 12-months post-randomisation.

Secondary outcome [3]

Time on warfarin: (survival analysis) Time from "initiation" of warfarin until ceasation (or end of follow-up period) will be calculated.

Timepoint [3]

Measured over 12-months from GP randomisation.

Secondary outcome [4]

Proportion of patients over the age of 65 who are receiving appropriate antithrombotic treatment. The appropriateness of warfarin will be judged according to the "quality control" of anticoagulation as assessed using standardised criteria and definitions.

Timepoint [4]

12-months

Secondary outcome [5]

Proportion of patients with a record of having experienced an ischaemic Stroke

Timepoint [5]

12 months

Secondary outcome [6]

Proportion of patients with a record of having experienced a Haemorrhagic stroke

Timepoint [6]

12 months

Secondary outcome [7]

Proportion of patients with a record of having experienced a stroke, (type not otherwise specified)

Timepoint [7]

12 months

Secondary outcome [8]

Proportion of patients with a record of having experienced "minor" bleeding. Classification of bleeding using standardised definitions applied in previous clinical trials.

Timepoint [8]

12 months

Secondary outcome [9]

Proportion of patients with a record of having experienced "major bleeding".
Classification of bleeding using standardised definitions applied in previous clinical trials.

Timepoint [9]

12 months

Secondary outcome [10]

Proportion of patients with a record of having experienced any cerebrovascular event (ischaemic stroke, haemorrhagic stroke, stroke not otherwise specified)

Timepoint [10]

12 months

Eligibility

Key inclusion criteria

This is a cluster randomised controlled trial with general practices designated the unit of randomisation. Outcome measures will be assessed using patient data derived from medical records.

Inclusion criteria:
1) GPs with a practice location within Sydney Metropolitan Area.
2) GPs must utilise an electronic data-base for issuing prescriptions and recording patient information (sex, age, contact details).

Inclusion criteria for patients:
1) Aged older than 65 years
2) Ability to provide consent for medical record audit.

Minimum age

N/A

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria for GPs:

GPs engaged primarily in "special interest practice" with limited contact of elderly patients (> 65 years of age) will be considerd ineligible to participate.

GPs in part-time practice (2 days a week or less) will initially be considered ineligible. However, this ineligibility criterion will be reviewed depending on the rate of recruitment of GPs and feasibility of recruitment.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation was performed by a senior statistician , from the Clinical Epidemiology Program at the Ottawa Hospital Research Institute, Canada. The statistican was not .otherwise involved in the study and therefore had not been involved in study design or participant recruitment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The exact sequence of randomisation will be determined by the biostatistician. At a minimum, permuted block randomisation will be performed using random block sizes. Randomisation will be stratified by practice size (that is, by the number of GPs per cluster)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/12/2008

Actual

22/10/2008

Date of last participant enrolment

Anticipated

Actual

8/10/2009

Date of last data collection

Anticipated

Actual

13/10/2010

Sample size

Target

2000

Accrual to date

Final

1116

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2000

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health & Medical Research Council, Level 5, 20 Allara Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Government body

Name

NHMRC

Address

National Health & Medical Research Council, Level 5, 20 Allara Street
Canberra ACT 2601

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of New South Wales, Human Research Ethics Committee

Ethics committee address [1]

The University of New South Wales
KENSINGTON UNSW NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/05/2007

Ethics approval number [1]

HREC 07068

Summary

Brief summary

Non-valvular atrial fibrillation (NVAF) is a common heart condition associated with a major risk of fatal and disabling stroke. Inexpensive anticoagulant medication has been proven to reduce all-cases of death and stroke in people with NVAF.  

Anticoagulant treatment for NVAF is substantially underused resulting in avoidable patient deaths and disabling stroke. This study seeks to optimise the management of NVAF in general practice.  

We are developing an educational program for general practitioners which we hypothesis will increase the number of people with NVAF over the age of 65 who are prescribed anticoagulant medication.

Trial website

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

Dr Melina Gattellari

Address

Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170

Country

Australia

Phone

61 2 8738 9281

Fax

02 87389281

[email protected]

Contact person for public queries

Name

Dr Melina Gattellari

Address

Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170

Country

Australia

Phone

61 2 8738 9281

Fax

None

[email protected]

Contact person for scientific queries

Name

Dr Melina Gattellari

Address

Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170

Country

Australia

Phone

61 2 8738 9281

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4450	Study protocol	Gattellari M, Leung DY, Ukoumunne OC, Zwar N, Grimshaw J, Worthington JM. Study Protocol. The DESPATCH study: Delivering Stroke Prevention for patients with atrial fibrillation. A cluster randomised controlled trial in primary health care. Implementation Science 2011 http://www.implementationscience.com/content/6/1/48

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Study protocol: the DESPATCH study: delivering stroke prevention for patients with atrial fibrillation - a cluster randomised controlled trial in primary healthcare.	2011

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically