Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000259943
Ethics application status
Approved
Date submitted
9/03/2011
Date registered
9/03/2011
Date last updated
20/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Two colours pale: a randomised trial to test the differential effectiveness of sending mail printed on white or yellow paper to promote GP interest in participating in research.
Scientific title
Two colours pale: a randomised trial to test the differential effectiveness of sending mail printed on white or yellow paper on the proportion of GPs registering interest in participating in research.
Secondary ID [1] 259759 0
NA
Universal Trial Number (UTN)
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General Practitioner response to register interest in participating in research 261339 0
Condition category
Condition code
Other 259488 259488 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to test and evaluate a response-aiding strategy to facilitate recruitment for a randomised evaluation of an on-going education program (ACTRN12611000076976).

A cover letter advising GPs of an opportunity to participate in an education program and a form allowing GPs to register their interest in receiving further information about the program will be printed on either white or pale yellow paper. The cover letter and form will be otherwise identical and will be sent to GPs via standard post, enclosed in an envelope identifying the sender as the University of New South Wales.

It is anticipated that all letters will be mailed on the same day. We will assess outcomes eight weeks' from the date of the mail-out.
Intervention code [1] 264186 0
Behaviour
Comparator / control treatment
Mail sent on white paper will be considered the comparator.
Control group
Active

Outcomes
Primary outcome [1] 262297 0
The proportion of GPs returning the form, either via reply paid mail or, will be compared between groups. The numerator will be the number of forms returned. The denominator will be the number of GPs per group initially randomised into one of the two groups.
Timepoint [1] 262297 0
Eight weeks from the date of the mailout.
Secondary outcome [1] 273480 0
The proportion of GPs returning the form registering their interest to receive further information about the program will be compared between groups. GPs whose mail was "returned to sender" will be removed from the denominator.
Timepoint [1] 273480 0
Eight weeks from the date of the mailout.
Secondary outcome [2] 273481 0
The proportion of GPs enrolling in the education program will be compared between groups calculated by dividing the number of GPs randomised per group by the number of GPs returning a signed consent form to participate in the study.
Timepoint [2] 273481 0
Eight weeks from the date of the mailout.
Secondary outcome [3] 273482 0
The proportion of GPs returning the form registering their interest to receive further information or who have contacted research staff to indicate they have "retired", or are "to be retired within the next 9 months", or are currently or due to be on extended leave (ie maternity or sick leave or recreation leave for more than two months) or whose relatives/practice staff notify research staff of a GP's retirment, extended leave or death.
Timepoint [3] 273482 0
Eight weeks from the date of the mailout

Eligibility
Key inclusion criteria
GPs known to be in active practice, as indicated on a national data-base of GP contact details held by AMPCO (www.ampco.com.au) who have been randomly selected by AMPCO on behalf of the researchers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GPs who have previously been contacted to take part in the educational program will not form the "study base" from which the 2,500 GPs will be randomly selected.

Contact details of up 92 GPs currently participating in another education program will be removed if they appear in the list of the 2,500 randomly selected GPs.

GPs whose mail is "returned to sender" for the purposes of secondary outcome 1.

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)
Contact details of GPs, known to be in active practice, will be randomly selected from a national data-base of clinicians. These GPs will be contacted by mail and will be invited to register their interest in receiving further information for an ongoing study evaluating an education program (ACTRN12611000076976). This study is therefore a trial of a response-aiding strategy to increase GP registrations to receive further information about the education program, registered as (ACTRN12611000076976).

Contact details of GPs have been forwarded to a statistician, not otherwise part of the research team, to randomly allocate GPs to receive the cover letter and registration form printed on either white or yellow paper.

This file will then be forwarded to AMPCO who will be outsourcing the mail-out on behalf of the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each randomly selected GP will be randomly assigned a unique ID code and ordered by this random ID number. Simple randomisation, whereby each GP has a 50/50 probability of being allocated into one of two groups will be carried out using SAS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264630 0
Charities/Societies/Foundations
Name [1] 264630 0
BUPA Foundation
Country [1] 264630 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
BUPA Foundation
Address
50 Bridge Street
SYDNEY NSW 2000
Country
Australia
Secondary sponsor category [1] 263769 0
Government body
Name [1] 263769 0
Commonwealth Department of Health and Ageing (Research Fellowship Awarded to Chief Investigator)
Address [1] 263769 0
Address: GPO Box 9848,
Canberra ACT 2601, Australia
Canberra
Country [1] 263769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266633 0
UNSW HREC
Ethics committee address [1] 266633 0
Ethics committee country [1] 266633 0
Australia
Date submitted for ethics approval [1] 266633 0
Approval date [1] 266633 0
08/03/2011
Ethics approval number [1] 266633 0
HREC 07067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32325 0
Address 32325 0
Country 32325 0
Phone 32325 0
Fax 32325 0
Email 32325 0
Contact person for public queries
Name 15572 0
Dr Melina Gattellari
Address 15572 0
Senior Research Fellow
School of Public Health and Community Medicine
Division of Population Health
Locked Bag 7008
LIVERPOOL NSW 1871
Country 15572 0
Australia
Phone 15572 0
61 2 9612 0656
Fax 15572 0
Email 15572 0
[email protected]
Contact person for scientific queries
Name 6500 0
Dr Melina Gattellari
Address 6500 0
Senior Research Fellow
School of Public Health and Community Medicine
Division of Population Health
Locked Bag 7008
LIVERPOOL NSW 1871
Country 6500 0
Australia
Phone 6500 0
61 2 9612 0656
Fax 6500 0
Email 6500 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.