Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000421932
Ethics application status
Not yet submitted
Date submitted
14/04/2011
Date registered
21/04/2011
Date last updated
3/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-consultation prevention summaries and reminders in general practice: cluster randomised controlled trial of effects on performance of preventive activities
Scientific title
A cluster randomised trial to examine whether giving pre-consultation prevention summaries and reminders to patients attending general practices increases the performance of preventive activities, compared with usual care.
Secondary ID [1] 259991 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Conditions for which primary or secondary prevention is available and recommended in the RACGP Guidelines for Preventive Activities in General Practice 7th edition. This includes health problems in the following categories:


Cardiovascular
Infection
Injuries and accidents
Metabolic and endocrine
Renal and urogenital
Reproductive health and childbirth
Cancer 265673 0
Condition category
Condition code
Other 265806 265806 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Cancer 265810 265810 0 0
Any cancer
Cardiovascular 265925 265925 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a sheet of paper, generated and printed automatically, given to the patient when he or she arrives for a consultation at a general practice. Each patient will receive a sheet no more often than every six months, during the one year trial period. The sheet will contain information about preventive activities that are indicated for the patient, why they are important, when each activity has last been performed, the result, finding or action at that time, and when the activity was or is due to be performed next. The sheet will encourage the patient to discuss the information on the sheet with their doctor or nurse in the imminent consultation.
Intervention code [1] 264423 0
Early detection / Screening
Intervention code [2] 264424 0
Prevention
Comparator / control treatment
Usual care: this will be whatever care the general practitioner would normally provide for that particular patient at that particular consultation. This will differ between patients, based on each patient's age, gender and known medical history, and may differ between visits made by the same patient, depending on whether any indicated preventive activities have become due and/or been performed at or since the previous consultation.
Control group
Active

Outcomes
Primary outcome [1] 266551 0
Performance of indicated preventive activities, This will be measured by automated extraction and analysis of de-identified data from each patient's electronic medical record.
Timepoint [1] 266551 0
The data will accumulate throughout the one year trial period, and will be extracted at the end of the trial period.
Secondary outcome [1] 276019 0
Numbers of consultations and fees billed during the trial. This will be measured by automated extraction and analysis of de-identified data from each patient's electronic medical and billing record.
Timepoint [1] 276019 0
The data will accumulate throughout the one year trial period, and will be extracted at the end of the trial period.

Eligibility
Key inclusion criteria
Patient attends the practice during the trial
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

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)
Subjects are enrolled automatically at their first attendance during the trial.
General practices are randomly allocated to intervention or control group.
The nature of the intervention means that allocation cannot be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices in each Division of General Practice will be ranked on their baseline performance of preventive activities, and allocated alternately to intervention or control group. Divisions of General Practice will be ranked according to the aggregate preventive performance of participating practices in them.

A random number provided by statistician will determine whether the the highest-ranked practice in the highest-ranked Division of General Practice is allocated to intervention or control group, and allocation of practices will alternate down the list of practices thereafter.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 264894 0
Self funded/Unfunded
Name [1] 264894 0
Country [1] 264894 0
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 263994 0
None
Name [1] 263994 0
None
Address [1] 263994 0
None
Country [1] 263994 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266851 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 266851 0
University of Adelaide
Adelaide
South Australia 5005
Ethics committee country [1] 266851 0
Australia
Date submitted for ethics approval [1] 266851 0
01/05/2011
Approval date [1] 266851 0
Ethics approval number [1] 266851 0

Summary
Brief summary
This trial seeks to discover whether giving patients arriving for consultations at general practices a summary of their preventive care status, that encourages them to discuss this with the GP or nurse that they are about to see, results in increased performance of preventive activities that are recommended and due to be performed for that patient. The study is aimed at improving the performance of a wide range of preventive activities, including all routine child and adult immunisations, screening for common chronic conditions including high blood pressure (hypertension), high cholesterol (hyperlipidaemia), diabetes and kidney disease, and prevention and early detection of a range of cancers. Who is it for? All patients attending a participating practice during the trial will be enrolled automatically in this study. Trial Details: The intervention will consist of a sheet of paper, generated and printed automatically, given to you when you arrive for a consultation at a general practice. You will receive no more than two information sheets, one every six months, over the one year trial period. The sheet will contain information about preventive activities that are recommended for you based on your age, gender and known medical history, why they are important, when each activity has last been performed, the result, finding or action at that time, and when the activity was or is due to be performed next. The sheet will encourage you to discuss the information on the sheet with your doctor or nurse in the imminent consultation. You will not be required to re-attend the practice for the purposes of this study, but can attend as and when you feel it is necessary or as agreed between you and your GP or nurse. If your general practice is randomly allocated to be in the ‘usual care’ control group, all care will occur as it normally would.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32481 0
Address 32481 0
Country 32481 0
Phone 32481 0
Fax 32481 0
Email 32481 0
Contact person for public queries
Name 15728 0
Dr. Oliver Frank
Address 15728 0
Discipline of General Practice
University of Adelaide
South Australia 5005
Country 15728 0
Australia
Phone 15728 0
+61 407 181 683
Fax 15728 0
+61 8 8313 3511
Email 15728 0
oliver.frank@adelaide.edu.au
Contact person for scientific queries
Name 6656 0
Dr. Oliver Frank
Address 6656 0
Discipline of General Practice
University of Adelaide
South Australia 5005
Country 6656 0
Australia
Phone 6656 0
+61 407 181 683
Fax 6656 0
+61 8 8313 3511
Email 6656 0
oliver.frank@adelaide.edu.au

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.