Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001140842
Ethics application status
Approved
Date submitted
15/10/2012
Date registered
26/10/2012
Date last updated
26/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
General practitioner documentation of dementia diagnosis: a randomized controlled trial using the interventions of education and audit feedback
Scientific title
General practitioner documentation of dementia diagnosis: a randomized controlled trial using the interventions of education and audit feedback
Secondary ID [1] 281385 0
Lilly Study Number: H6L-AY-S001 (IIT)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 287619 0
Condition category
Condition code
Neurological 287947 287947 0 0
Dementias
Public Health 287948 287948 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Educational workshop with pre- reading and reflection using the Royal Australian College of General Practitioner's (RACGP) learning module 'General Practitioners caring for people with dementia' based on RACGP dementia guidelines 'Care of patients with dementia in general practice'. Each geographic 'cluster' is offered the workshop at a time and date convenient to researcher and participants. The 2 hour workshop is delivered by the researcher, a GP Fellow of RACGP, using a powerpoint presentation supplied by RACGP as part of their learning module.
2. Audit feedback: An audit is conducted for each participating GP at 0 and 6 months using the built in search engine in their electronic medical records. The researcher (a GP), undertakes the audit or supports a member of staff to to do the task. GPs randomized to audit feedback can conduct their own audit if they wish. Each GP has their own chart in which data is recorded, consisting of the number of patients >65 years consulting in 2x6month periods before and after the trial commences and the number of dementia diagnoses documented in each of these 2 patient samples. This data provides both an intervention and the outcome measure. The results are shared at the beginning of the trial with GPs randomized to audit intervention and at the workshop for GPs randomized to education plus audit.
Intervention code [1] 285863 0
Diagnosis / Prognosis
Intervention code [2] 285868 0
Early detection / Screening
Intervention code [3] 285869 0
Behaviour
Comparator / control treatment
Usual general practice with no intervention other than enrollment in the trial
Control group
Active

Outcomes
Primary outcome [1] 288157 0
The number of dementia diagnoses documented in the GP's computerized medical records in the patient population aged over 65 years seen 6 months before commencement of the trial
Timepoint [1] 288157 0
Audit at commencement of trial
Primary outcome [2] 288170 0
The number of dementia diagnoses documented in computerized medical records in the patient population aged over 65 years seen in the six month period after commencement of the trial
Timepoint [2] 288170 0
Audit 6 months after trial commences
Primary outcome [3] 288171 0
The change in audited dementia diagnoses in computerized medical records in the active 6 month patient population aged over 65 years at the end of the trial compared with the beginning of the trial
Timepoint [3] 288171 0
Calculated at the end of the trial when the second audit is conducted, 6 months after trial commences
Secondary outcome [1] 299524 0
Learning outcomes and met learning needs in dementia knowledge for GPs
Timepoint [1] 299524 0
Evaluation questionnaires completed by participants at the end of each workshop. The evaluation questionnaires have been prepared by a project officer at the Mackay Division of General Practice, accredited to evaluate RACGP learning modules, to meet requirements for reporting outcomes of GP professional Development activities.
Secondary outcome [2] 299525 0
Feasibility and acceptability of audit of dementia diagnoses in general practice
Timepoint [2] 299525 0
A reflective description of the audit process and interactions of participants to data collection and feedback, recorded during the trial and prepared as a document in the months following the trial.

Eligibility
Key inclusion criteria
1. Practicing general practitioner consulting with patients aged over 65 years
2. Consent to provide audit data of number of patients aged over 65 years consulting during trial periods and the number of documented dementia diagnoses in these active patients
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. General practitioners with changing patient populations. eg, moving practice during the trial

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)
Enrollment: General practices were invited to participate, firstly through a phone call to the principal GP and/or practice manager and then through a visit supplying trial information.

Consent: GPs signed a consent form to participate and were aware that the trial would involve an educational workshop and audit feedback. The trial was approved as an active learning module by the RACGP, entitling them to 40 category 1 accreditation points for professional development. At the end of the trial all GPs received their audit data and the workshop was offered to those who were not randomized to receive this at the beginning of the trial.

The researcher, a GP, recruited participants, all of whom met the criteria for inclusion, ie: actively practicing GPs with patients >65 years in their practice population. Following recruitment, the researcher randomized participants to one of 4 groups using Excel software. Allocation was not concealed for the researcher, and GPs were notified of their audit results and workshop times in relation to the intervention they had been randomized to.

Interventions: arrangements were made with the practices for audit data collection and dates and venues set for educational workshops relevant to the intervention allocated. Audit data was supplied to relevant GPs at the beginning of the trail either through a practice visit or at the workshop for those with the combined intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomization: Stratified randomization was achieved by listing the participating GPs in an Excel column in geographic clusters. A second column applied the Excel randomizing formula to assign each cluster to one of 4 groups. A third column recorded the randomized group number before it randomly changed again. One group was a control of usual practice and the remaining 3 were intervention groups. The interventions were: educational workshop, audit feedback, and both education and audit. Cluster randomization was chosen to minimize leakage and facilitate delivery of interventions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Audit data was to be collected by the researcher or a member of practice staff other than the GP to avoid leakage of this data to GPs who were allocated to non audit-feedback intervention groups. Ethics required trial information be supplied as part of informed consent to participate. Therefore all participants were aware of the interventions that they would receive by the end of the trial, but they were not formerly advised which group they had been randomized to during the trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5824 0
4737
Recruitment postcode(s) [2] 5825 0
4740
Recruitment postcode(s) [3] 5826 0
4754
Recruitment postcode(s) [4] 5827 0
4800
Recruitment postcode(s) [5] 5828 0
4802
Recruitment postcode(s) [6] 5829 0
4804
Recruitment postcode(s) [7] 5830 0
4805
Recruitment postcode(s) [8] 5831 0
4807
Recruitment postcode(s) [9] 5832 0
4810
Recruitment postcode(s) [10] 5833 0
4814
Recruitment postcode(s) [11] 5834 0
4820
Recruitment postcode(s) [12] 5835 0
4824
Recruitment postcode(s) [13] 5842 0
4880
Recruitment postcode(s) [14] 5845 0
4811

Funding & Sponsors
Funding source category [1] 286142 0
Charities/Societies/Foundations
Name [1] 286142 0
Alzheimer's Australia Research (AAR) Entirely Post Graduate Research Scholarship in Social Research and Dementia
Country [1] 286142 0
Australia
Funding source category [2] 286143 0
Commercial sector/Industry
Name [2] 286143 0
Eli Lilly Research
Country [2] 286143 0
Australia
Funding source category [3] 286144 0
University
Name [3] 286144 0
James Cook University Post Grad Research School
Country [3] 286144 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
School of Medicine
Angus Smith Drive
Townsville
QLD 4811
Country
Australia
Secondary sponsor category [1] 284953 0
Charities/Societies/Foundations
Name [1] 284953 0
Alzheimer's Australia Research (AAR) Entirely Post Graduate Research Scholarship in Social Research and Dementia
Address [1] 284953 0
PO Box 4808
Higgins
ACT 2615
Country [1] 284953 0
Australia
Other collaborator category [1] 277121 0
Charities/Societies/Foundations
Name [1] 277121 0
Royal Australian College of General Practitioners
Address [1] 277121 0
100 Wellington Parade
EAST MELBOURNE VIC 3002
Country [1] 277121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288196 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 288196 0
Ethics committee country [1] 288196 0
Australia
Date submitted for ethics approval [1] 288196 0
Approval date [1] 288196 0
30/07/2008
Ethics approval number [1] 288196 0
H3067

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

Contacts
Principal investigator
Name 34823 0
Address 34823 0
Country 34823 0
Phone 34823 0
Fax 34823 0
Email 34823 0
Contact person for public queries
Name 18070 0
Dr Fiona Millard
Address 18070 0
Aurora Medical Centre
39 Old Prospect Rd
South Wentworthville
NSW 2145
Country 18070 0
Australia
Phone 18070 0
+61408879473
Fax 18070 0
+61296313245
Email 18070 0
[email protected]
Contact person for scientific queries
Name 8998 0
Dr Fiona Millard
Address 8998 0
Aurora Medical Centre
39 Old Prospect Rd
South Wentworthville
NSW 2145
Country 8998 0
Australia
Phone 8998 0
+61408879473
Fax 8998 0
+61296313245
Email 8998 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.