Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000814077
Ethics application status
Approved
Date submitted
29/09/2010
Date registered
29/09/2010
Date last updated
11/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of an incentive on young people's willingness to complete a telephone survey after a consultation with their doctor or nurse in general practice.
Scientific title
The influence of a guaranteed movie ticket incentive, versus a 1/500 chance of winning an iPod, on the response rate of young people completing a telephone survey after a consultation with their doctor or nurse in general practice.
Secondary ID [1] 252788 0
The main trial in which the incentive trial is nested is "Health risk screening and counselling of adolescents and youth friendly practice: a cluster randomised controlled trial in primary care" (ISRCTN16059206).
Universal Trial Number (UTN)
U1111-1117-1778
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effectiveness of incentives on telephone survey response rates following a doctor or nurse's consultation in general practice. 258289 0
Condition category
Condition code
Public Health 258400 258400 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: participants will be offered one movie ticket which will be posted upon completion of a telephone interview*.

Arm 2: participants will be offered a 1/500 chance of winning an iPod (valued at A$200 as of September 2010) upon completion of a telephone interview*. Once 500 interviews are completed, across the whole project, the iPod winner is randomly drawn and the winner is notified by telephone.

*The one-off telephone interview, conducted by research staff interviewers, is of 40-50 minutes and is completed as soon after the general practice consultation as possible. The content includes the young person's experience of the practice and the consultation, questions on their lifestyle and psycho-social health risks plus their use of other health services. Young people's interest in participation is registered at the general practices by research assistants prior to the consultation.
Intervention code [1] 257242 0
Lifestyle
Intervention code [2] 257307 0
Prevention
Intervention code [3] 257308 0
Early detection / Screening
Comparator / control treatment
In a prior phase of this work (2007-2010), young people interviewed after their general practice consultations were offered entry into a prize draw for an iPod. In order to increase completion rates, in the next phase of our work, we are now conducting a nested randomised control trial of incentives within the overall trial by comparing the completion rates for those who now receive the iPod draw incentive versus the guaranteed movie ticket incentive. The incentive resulting in the better completion rate will then be used in the remainder of the overall trial.
Control group
Active

Outcomes
Primary outcome [1] 259318 0
Interview completion rates to increase by 20% to 75% of all young people who were registered as interested in hearing about participation in the interview.
Timepoint [1] 259318 0
Interviews completed by one month after registration.
Secondary outcome [1] 265766 0
Nil
Timepoint [1] 265766 0
Nil

Eligibility
Key inclusion criteria
Aged 14-24 years; had a consultation, during the recruitment period, with a doctor or nurse at a practice participating in the main trial.
Minimum age
14 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Factors compromising ability to consent such as non-English speaking; cognitive disability; psychosis or severe emotional distress; extremely physically unwell such as febrile and vomiting; or, extreme immaturity (if under 18 years of age and not a mature minor as judged by the GP and unable to obtain parental/guardian consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research assistants (RAs) approach young people (YP) in the clinic waiting room and ask if they would be willing to provide their first name and telephone number in order to be contacted about the Project. RAs will be blinded to the randomisation of each YP until they have selected the YP they are to approach (e.g. if more than one in the waiting room at the same time) thus preventing any subconscious judgement about individual YPs and their potential incentive preference. According to a pre-randomised schedule the YP would be offered either the iPod draw or the movie ticket as an incentive upon completion of the telephone survey. A clear record of YP who agree, refuse or turn out to be ineligible will be kept by the RA. Also, the time of the day, date and randomisation allocation revealed to the RA will be recorded by the RA for later cross-checking of the fidelity of the allocation.
To eliminate the bias that might arise from the diversity between clinicians and practices (e.g. patients within one practice are more likely to be more similar to each other than to patients in other practices) we will randomise all patients within each practice.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order for the allocation of subjects is generated using simple randomisation by using a randomisation table, that is created by computer software (i.e. computerised sequence generation in Microsoft Excel). The software ensures a balanced allocation between two arms (i.e. Intervention arm and Control arm). No stratified allocation is to be employed in the study.]
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/09/2010
Actual
9/09/2010
Date of last participant enrolment
Anticipated
29/11/2011
Actual
23/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
326
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257684 0
Government body
Name [1] 257684 0
National Health & Medical Research Council
Country [1] 257684 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lena Sanci
Address
General Practice & Primary Health Care Academic Centre
University of Melbourne
200 Berkeley Street
Carlton, Victoria, 3053
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 256956 0
None
Name [1] 256956 0
Address [1] 256956 0
Country [1] 256956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259797 0
Human Research Ethics Committee, University of Melbourne
Ethics committee address [1] 259797 0
Melbourne Research Office, University of Melbourne, VIC, 3010, Australia
Ethics committee country [1] 259797 0
Australia
Date submitted for ethics approval [1] 259797 0
Approval date [1] 259797 0
21/04/2010
Ethics approval number [1] 259797 0
0931083

Summary
Brief summary
We are conducting a trial to systematically evaluate if 14-24 year old young people are more likely to complete a telephone interview if they receive a guaranteed movie ticket upon completion compared with a 1/500 chance of winning a bigger prize ie an iPod. This trial is nested within a larger randomised controlled trial (RCT) ("Health risk screening and counselling of adolescents and youth friendly practice: a cluster randomised controlled trial in primary care" - ISRCTN16059206) which is exploring the effects of a systems level intervention encouraging youth friendly practice in primary care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31345 0
A/Prof Lena Sanci
Address 31345 0
Department of General Practice and Primary Health Care, University of Melbourne
200 Berkeley St Carlton 3053, Victoria
Country 31345 0
Australia
Phone 31345 0
+61 3 8344 6152
Fax 31345 0
Email 31345 0
l.sanci@unimelb.edu.au
Contact person for public queries
Name 14592 0
Dr Ann-Maree Duncan
Address 14592 0
General Practice & Primary Health Care Academic Centre
University of Melbourne
200 Berkeley Street
Carlton, Victoria, 3053
AUSTRALIA
Country 14592 0
Australia
Phone 14592 0
+61 3 8344 7196
Fax 14592 0
+61 3 9347 6136
Email 14592 0
ann-maree.duncan@unimelb.edu.au
Contact person for scientific queries
Name 5520 0
A/Prof Lena Sanci
Address 5520 0
General Practice & Primary Health Care Academic Centre
University of Melbourne
200 Berkeley Street
Carlton, Victoria, 3053
AUSTRALIA
Country 5520 0
Australia
Phone 5520 0
+61 3 8344 6152
Fax 5520 0
+61 3 9347 6136
Email 5520 0
l.sanci@unimelb.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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