Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000553976
Ethics application status
Approved
Date submitted
30/05/2011
Date registered
31/05/2011
Date last updated
6/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of continuing medical education and feedback to altering diabetes at a population level. A randomised controlled trial.
Scientific title
Rural General Practitioners. Can a rural GP focussed intervention involving continuing medical education, reminders and feedback improve the clinical indicators related to management of Type 2 diabetes when compared to rural GPs who do not receive the intervention.
Secondary ID [1] 262264 0
Nil
Universal Trial Number (UTN)
1111-1121-8252
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 267962 0
Condition category
Condition code
Public Health 268099 268099 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GPs in the intervention group will receive a multi-component intervention involving continuing medical education, reminders and feedback over two years. An online module that provides continuing medical education on best practice diabetes care will be available to GPs during the two year intervention period. This module will take approximately six hours to complete and can be completed at any time over the intervention period. GPs will have access to targeted and specialist advice through the use of the Website consultant enquiry forms. Questions submitted with these forms will be answered by a endocrinologist. GPs will receive regular (at baseline and six monthly over the two year intervention) feedback on their individual perfomance and town-based comparative feedback. This feedback, based upon objective clinical measures obtained from pathology records, will be emailed to GPs.
Intervention code [1] 256337 0
Treatment: Other
Comparator / control treatment
Intervention towns will be compared with towns allocated to usual care that have been matched on population, remoteness, indigenous population, and socio economic index.
Control group
Active

Outcomes
Primary outcome [1] 266854 0
Glycaemic control. Using the most recent HbA1c for each case within each 24 month time frame, the mean HbA1c across the town, and the proportion of all cases whose most recent HbA1c value is 7.0%, will be determined.
Timepoint [1] 266854 0
24 months
Secondary outcome [1] 276504 0
Blood lipids and urinary albumin control. Clinical practice guidelines recommend that blood lipids, and urinary albumin levels are tested once every 12 months as part of an annual cycle of care. Using the most recent results for each case within each 24 month time frame, the mean values of blood lipids and urinary albumin, and the proportion of all cases whose most recent values are within the relevant target ranges will be determined
Timepoint [1] 276504 0
24 months
Secondary outcome [2] 276505 0
Frequency of HbA1c testing.The data from the laboratory will provide the dates on which each patient had an HbA1c test. Therefore, over each 24 month period, the mean number of HbA1c tests will be determined for each patient. The proportion of cases that have had 1, 2, 3 and 4 or more HbA1c tests will also be determined for each 24 month period.
Timepoint [2] 276505 0
24 months
Secondary outcome [3] 276506 0
Frequency of blood lipid and urinary albumin testing. For each 24 month period (pre and post test), the mean number of blood lipid and urinary albumin excretion tests will be determined for each patient. The proportion of cases that have had 1, 2, 3 and 4 or more of each type of test will also be determined for each 24 month period.
Timepoint [3] 276506 0
24 months
Secondary outcome [4] 276518 0
Be cost-effective in terms of cost per Quality Adjusted Life Year (QALY) gained as a result of improved clinical outcomes
Timepoint [4] 276518 0
24 months

Eligibility
Key inclusion criteria
Towns defined by Postal Areas (POAs are Australia Bureau of statistics approximations of postcodes) that are: i) regional or remote according to ARIA plus classification ii) have a population of 10,000 to 30,000; iii) are in Victoria, New South Wales, Queensland or South Australia
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Towns that have fewer than 5 fulltime GPs

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)
Towns that were eligible for inclusion were paired according to relative remoteness, Indigenous population, and total population. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Paired towns were allocated to intervention or control group by a coin flip
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
Recruiting
Date of first participant enrolment
Anticipated
25/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4052 0
2330
Recruitment postcode(s) [2] 4048 0
2429
Recruitment postcode(s) [3] 4051 0
2446
Recruitment postcode(s) [4] 4049 0
2460
Recruitment postcode(s) [5] 4050 0
2794
Recruitment postcode(s) [6] 4056 0
4352
Recruitment postcode(s) [7] 4053 0
4405
Recruitment postcode(s) [8] 4058 0
4610
Recruitment postcode(s) [9] 4054 0
4700
Recruitment postcode(s) [10] 4055 0
4807
Recruitment postcode(s) [11] 4057 0
4860

Funding & Sponsors
Funding source category [1] 267155 0
Government body
Name [1] 267155 0
National Health and Medical Research Council
Country [1] 267155 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Notting Hill Campus
Department of General Practice
Building 1, 270 Ferntree Gully Road
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 266228 0
University
Name [1] 266228 0
University of Newcastle
Address [1] 266228 0
University of Newcastle
Medicine and Public Health,
Rm 262 David Maddison Building,
Cnr King and Watt Sts
Newcastle NSW 2300
Country [1] 266228 0
Australia
Secondary sponsor category [2] 266229 0
Charities/Societies/Foundations
Name [2] 266229 0
Baker IDI
Address [2] 266229 0
PO Box 6492
St Kilda Rd Central
Victoria 8008
Country [2] 266229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269147 0
Monash University. Standing committee on ethics in research involving humans (SCERH)
Ethics committee address [1] 269147 0
Monash University,
Building 3E, Room 111, Clayton Campus, Wellington Road, Clayton Vic 3800
Ethics committee country [1] 269147 0
Australia
Date submitted for ethics approval [1] 269147 0
Approval date [1] 269147 0
06/01/2009
Ethics approval number [1] 269147 0
CF08/3467 - 2008001712
Ethics committee name [2] 269148 0
The University of Newcastle, Human Research Ethics Committee
Ethics committee address [2] 269148 0
Research Services
Research Offices
University Drive
Callaghan NSW 2308
Ethics committee country [2] 269148 0
Australia
Date submitted for ethics approval [2] 269148 0
Approval date [2] 269148 0
18/06/2009
Ethics approval number [2] 269148 0
H-2009-0157

Summary
Brief summary
To test whether population-level effects can be achieved by implementing best-evidence practice change strategies for the care and management of diabetes. The study will test whether a rural GP-focused intervention involving Continuing Medical Education (CME), reminders & feedback can:
i. Improve patterns of diabetes care as measured by frequency of testing for blood lipids, haemoglobin A1c (HbA1c) and urinary albumin
ii. Improve clinical outcomes as measured by glycaemic control, blood lipid control and urinary albumin control.
iii. Be cost-effective in terms of cost per Quality Adjusted Life Year (QALY) gained as a result of improved clinical outcomes
Trial website
www.diabetesedforgps.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31072 0
Address 31072 0
Country 31072 0
Phone 31072 0
Fax 31072 0
Email 31072 0
Contact person for public queries
Name 14319 0
Dr Chris Paul
Address 14319 0
The University of Newcastle
Room 268
David Maddison Building
Cnr King & Watt St
Newcastle NSW 2300
Country 14319 0
Australia
Phone 14319 0
+61 2 49138472
Fax 14319 0
+61 2 49138779
Email 14319 0
Chris.Paul@newcastle.edu.au
Contact person for scientific queries
Name 5247 0
Dr Leon Piterman
Address 5247 0
Department of General Practice
School of Primary Health Care
Bldg 1, 270 Ferntree Gully Rd
Notting Hill Victora 3168
Country 5247 0
Australia
Phone 5247 0
+61 3 9902 4465
Fax 5247 0
+61 3 8575 2233
Email 5247 0
Leon.Piterman@monash.edu

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
SourceTitleYear of PublicationDOI
EmbasePoor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners.2017https://dx.doi.org/10.1186/s13063-017-1869-8
N.B. These documents automatically identified may not have been verified by the study sponsor.