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Trial registered on ANZCTR


Registration number
ACTRN12612000747820
Ethics application status
Approved
Date submitted
9/07/2012
Date registered
13/07/2012
Date last updated
13/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial to test an educational innovation of diabetes care in general practice
Scientific title
A Randomised Controlled Trial to identify whether any difference exists in the management and control of metabolic targets in type 2 diabetic patients, when managed by GPs, compared with management by GPs who have completed an online education program, Spaced Education Diabetes
Secondary ID [1] 280803 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 286866 0
Condition category
Condition code
Metabolic and Endocrine 287190 287190 0 0
Diabetes
Public Health 287236 287236 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to assess the effectiveness of a tailored, adaptive, online spaced education program, Spaced Education Diabetes (SED), on improving the provision of evidence based management of type 2 diabetic patients by GPs. The researchers will be collecting two main data sets to evaluate the effectiveness of SED; data on GPs management of standardised type 2 diabetic patients (presented in video vignettes), and data on GPs management of real patients under their care. These data will be measured at baseline and then post-intervention. Upon recruitment, all participants will receive a copy of the NHMRC/ RACGP Handbook in Diabetes Care.

Phase 1:
Standardised patients - all participating GPs will view six video vignettes (2-4 minutes each) featuring an actor portraying patients with type 2 diabetes presenting to a GP. Vignettes will be accessible via a secure website, and the software used will allow GPs to view them at their own pace, and in their own time - GPs will have a maximum of 3 months to complete the fist six vignette scenarios. The vignettes will be adapted from the Spaced Education Diabetes (SED) program and will present patients who would benefit from a change in their current management. After viewing the videos, GPs will answer questions on whether they would prescribe (new drug or change therapy), investigate (order a test) or write a referral for the patient represented in the video. Participating practitioners will answer questions related to the further management of each ‘patient’ in the vignette, and this survey will demonstrate a baseline level of their knowledge of type 2 diabetes management.
Real Patients - Upon recruitment, GPs will provide de-identified data on 30 type 2 diabetic patients under their care. Each patient will have three data values recorded over the study, for Body Mass Index (BMI), Blood Pressure (BP), glycated haemoglobin concentration (HbA1c), Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), triglycerides and total cholesterol results. Information on the patient’s current prescribed medication for the management of lipids, blood pressure and diabetes will also be recorded. This information will be used by the research team to generate comparisons between the baseline data and post-intervention data.
It is envisaged that phase 1 will take 3 months.

Phase 2:
Standardised patients - GPs will be randomised in to two groups. GPs randomised to the control group will receive no further intervention and will be advised to continue with usual care. GPs randomised to the intervention group will receive the SED program, focusing on the implementation of guidelines for the management of blood pressure, lipids and glucose control in type 2 diabetes. SED will be delivered to GPs via email and will involve distribution of case studies with six multiple choice questions on the management of hyperglycaemia, hyperlipidaemia and hypertension in diabetes. Questions will be repeated after 14 days or 21 days depending on participant responses. The intervention known as ‘Spaced Education’ (SE) is built around clinicians answering small numbers of case-based multiple choice questions that are emailed to them over a number of days. These questions are repeated using an evidence-based adaptive algorithm which personalizes the spacing and content of a course to the demonstrated knowledge level of each learner. The program will be completed when each GP answers each question correctly twice, and is expected to take 6 to 8 weeks. Following completion of the SED program, all GPs will view a further six video vignettes (2-4 minutes each), with scenarios similar to those presented in phase 1 of the study, featuring an actor portraying a patient with diabetes presenting to a GP. GPs will be able to access and complete vignette scenarios in their own time, and will have approximately 3 months to complete the final six scenarios. Participants are again invited to answer questions on whether they would prescribe a drug, investigate or write a referral for the patients in the videos.
Real Patients - GPs will again be asked for de-identified data on the same 30 type 2 diabetic patients under their care, at 6 months and 9 months after randomisation to measure the change in GP management of type 2 diabetes from baseline to post-SED intervention.
It is envisaged that phase 2 will take 9 months.
Intervention code [1] 285237 0
Other interventions
Comparator / control treatment
To determine whether any difference exists in the management and control of metabolic targets of type 2 diabetes, between patients under standard GP care (control) and patients under the care of GPs who have completed online diabetes spaced education (SED). GPs allocated to the control group will not have access to the educational program (SED) and patients are managed as per standard procedure. This means that the GPs are free to access the NHMRC/ RACGP Handbook in Diabetes Care (provided to all participants upon recruitment to the study) and/ or alternative diabetes care guidelines if they deem this necessary to manage real and simulated patients.
Control group
Active

Outcomes
Primary outcome [1] 287482 0
The proportion of subjects with parameters within NHMRC guidelines (Phase 2) will be compared using multivariable logistic regression, taking into account cluster randomisation and after adjusting for possible confounders such as demographic variables. The effect of the SED intervention as compared to Standard Practice will be presented as odds-ratio and associated 95% confidence interval. Multivariable linear and logistic regressions will also be used to determine if any identifiable subgroups of patients have a high chance of poor control of hyperglycaemia, hyperlipidaemia and hypertension, taking into account cluster randomisation and possible confounders. These identifiable subgroups will be determined for each arm and compared. Prior to randomisation, all 50 GPs will be operating under Standard Practice (Phase 1), the data from which will be instrumental to establish the baseline and determine identifiable subgroups of patients with poor control. P-values less than 0.05 will be considered as statistically significant. SAS (Version 9.2) and Stata (Version 11) will be used to perform the analyses of all data in this study.
Timepoint [1] 287482 0
At nine months after randomisation
Secondary outcome [1] 298262 0
GPs will be purposively sampled and interviewed regarding their thoughts on the acceptability and appropriateness of the SED program. Purposive sampling will be based on changes (positive or negative) to patient's blood pressure, lipid profile and HbA1c, but also the age, gender and location of the GP (rural vs. metropolitan). A thematic framework analysis will be used to classify or 'code' the data. There is transparency with this method which allows other members of the team not involved in the analysis to easily follow the process. This phase of the study will give valuable GP feedback regarding the usability and practicalities of the SED program. Strengthening the relevance of the study's results to general practice in the Australian community and how they could impact future type 2 diabetes care.
Timepoint [1] 298262 0
At nine months after randomisation

Eligibility
Key inclusion criteria
Participants will be general practitioners (GPs) registered with the appropriate state authority and working in community-based practices across Australia.

Actors to take part in the simulated consultations will be recruited from an existing pool of actors the research team has used previously.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GP participants will be excluded from the study if they are unable to provide informed consent.

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)
GPs will be recruited by email from the Curtin Health Innovation Research Network (CHIReN), using purposive sampling methods (snowball, volunteer, convenience sampling). CHIReN is a network of 100+ GPs who have already agreed to participate in projects for Curtin Health Innovation Research Institute. The GPs are based across Australia, including rural areas. Allocation is not concealed. A flyer will be emailed to the GPs with information on the study asking for their reply if they are interested in participating.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Phase 2 of the study will involve randomisation of GP participants in to two arms - the SED arm and the standard care (control) arm. Simple randomisation will occur in Phase 2 using a randomisation table created by computer software (ie. computer sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285601 0
Self funded/Unfunded
Name [1] 285601 0
Country [1] 285601 0
Australia
Primary sponsor type
Individual
Name
Professor Moyez Jiwa
Address
Curtin Health Innovation Research Institute (CHIRI)
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 284434 0
None
Name [1] 284434 0
Address [1] 284434 0
Country [1] 284434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287601 0
Curtin University Human Research Ethics Comittee
Ethics committee address [1] 287601 0
Ethics committee country [1] 287601 0
Australia
Date submitted for ethics approval [1] 287601 0
Approval date [1] 287601 0
03/07/2012
Ethics approval number [1] 287601 0
HR 59/2011

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

Contacts
Principal investigator
Name 34414 0
Address 34414 0
Country 34414 0
Phone 34414 0
Fax 34414 0
Email 34414 0
Contact person for public queries
Name 17661 0
Professor Moyez Jiwa
Address 17661 0
Curtin Health Innovation Research Institute (CHIRI)
GPO Box U1987
Perth, WA 6845
Country 17661 0
Australia
Phone 17661 0
+61 8 9266 1768
Fax 17661 0
+61 8 9266 2508
Email 17661 0
[email protected]
Contact person for scientific queries
Name 8589 0
Professor Moyez Jiwa
Address 8589 0
Curtin Health Innovation Research Institute (CHIRI)
GPO Box U1987
Perth, WA 6845
Country 8589 0
Australia
Phone 8589 0
+61 8 9266 1768
Fax 8589 0
+61 8 9266 2508
Email 8589 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

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