Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000010998
Ethics application status
Approved
Date submitted
10/12/2019
Date registered
9/01/2020
Date last updated
9/01/2020
Date data sharing statement initially provided
9/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical and Healthcare Improvement through My Health Record usage and Education in General Practice – The CHIME-GP Study
Scientific title
Clinical and Healthcare Improvement through My Health Record usage and Education in General Practice – The CHIME-GP Study
Secondary ID [1] 300013 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHIME-GP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prescription rates 315500 0
Pathology referral rates 315512 0
Radiology referral rates 315513 0
Condition category
Condition code
Public Health 313788 313788 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The education intervention is multi-faceted and includes participation in online webinars, online seminars, self-paced online learning modules, reflection activities, guided online forums and clinical audit.

The study has three arms. A prescribing education arm, a pathology test ordering education arm and a diagnostic imaging ordering education arm. The Choosing Wisely Australia recommendations form the basis of the specific medications and tests targetted in the intervention.

The specific medication, pathology and imaging tests addressed for each of the topic streams are:

Prescribing

Proton pump inhibitors
Diuretics
Inhaled corticosteroids
Benzodiazepmnes
Opiates
NSAIDS

Pathology Ordering

FBC
Urea, creatinine and electrolytes
LFT
TFT
Vitamin D
MSU

Diagnostic Imaging

Low back pain imaging - lumbosacral spine xray and CT scanning

The modes of the training delivery and schedule are summarised below:

Month 1 Initial engagement webinar (45-60 mins)
Evening webinar meeting facilitated by expert GPs.
Study information to be presented to participants including key timelines.
Opportunity for Q+A about the study process.
Short didactic presentation introducing the topic (safe use of medicines, pathology or radiology)
Introduction to MHR, benefits and application.
Case studies where the theory is applied in practice, plus case study examples.

Month 2 Online learning module (60 mins)
To include data of national, current trends in inappropriate prescribing and testing ordering.
Information about MHR, the future of MHR and current uptake.
Tips and tricks for engagement, barriers, algorithms that can be used.
Information about where MHR can fit into practice - checking the record, look for duplicates, identifying medications prescribed or test results from elsewhere.
A case study scenario demonstrating using MHR.
Case studies will be incorporated to apply the information delivered in the module.

Month 2 Online Forum - Community of Practice (30 mins)
Online forum for participants to reflect on learning and to discuss with peers the best approach in managing cases.
The forum will be monitored by a GP Medical Educator who will seed topical content and cases for discussion.
This forum will be available to participants for the duration of the study.

Month 2 Clinical Audit - Quality Improvement (30-60 mins)
Study participants will be required to complete a clinical audit (quality improvement) activity related to the study arm that they are in.
The clinical audit activity will involve the collection and analysis of patient data with the intention to implement changes to clinical practice to improve patient outcomes.
No identifying patient information will be collected or reported as part of the audit. The information will only be used by the GP for quality improvement activities.
The information collected as part of the audit will be each participant’s reflection on the changes to clinical practice as a result of the study and audit activity.

Month 3 Two (2) Case-based learning webinars / podcast (45-60 mins each)
Two webinars will be held concurrently with the participants conducting the patient audits.
The webinars will be facilitated by expert GPs and will provide participants with a virtual network to learn from via case-based learning.
Short case presentations will be delivered during the study period and the participants will discuss the management.
Participants will be encouraged to bring a case presentation from their clinical practice for discussion with the group.
The webinars will be recorded and made available online or as a podcast.
Webinar will be run during lunch time and evening to maximise the options for participation.

Months 3-4 Post-intervention quiz and case scenarios (30 mins)
Post intervention case scenarios to assess intention to treat and use of MHR.

Length of education intervention

The education intervention will be delivered over three to four months with an anticipated six hours invlovement for participants.

Intervention adherence monitoring

Adherence to the educational activies will be monitored by electronic records of participants' logging in to sesssions and repsonses to online activities.
Intervention code [1] 316282 0
Behaviour
Intervention code [2] 316367 0
Treatment: Other
Comparator / control treatment
'Usual care' describes the medication prescribing, pathology or imaging test ordering behaviour of physicians in the trial who had not been exposed to the relevant education intervention (i.e. regarding prescribing, pathology or test imaging respectively). Outcomes will be measured as between group changes between the 6 months prior to the intervention compared with 6 months following the intervention. Thus, changes in the prescribing arm prescription rates will be compared with changes in the prescription rates in the imaging and pathology arms; changes in the pathology ordering rates in the pathology arm will be compared with changes in the pathology ordering rates in the prescribing and imaging education arms; and changes in the imaging ordering rates in the imaging arm will be compared with changes in the imaging ordering rates in the prescribing and pathology arms.
Control group
Active

Outcomes
Primary outcome [1] 322197 0
Composite primary outcome measure:
• Differences between intervention and control groups in changes in the cost per 100 consultations of selected prescriptions, pathology and radiology test ordering in the six months prior to the intervention compared with six months following the intervention. Prescribing, pathology and imaging test ordering will be assessed by using an automated data extract from patients' electronic health records.

The specific medication, pathology and imaging tests addressed are:

Proton pump inhibitors
Diuretics
Inhaled corticosteroids
Benzodiazepmnes
Opiates
NSAIDS
FBC
ESR
Urea, creatinine and electrolytes
LFT
TFT
Vitamin D
MSU
Lumbosacral spine xray
Lumbosacral spine CT scanning
Timepoint [1] 322197 0
Six months prior to the intervention compared with six months following the intervention.
Secondary outcome [1] 377679 0
Differences between intervention and control groups in changes in the rate per 100 consultations of selected prescriptions in the six months prior to the intervention compared with six months following the intervention, as assessed by automated data extract from patients' electronic health records

The specific medications addressed are:

Proton pump inhibitors
Diuretics
Inhaled corticosteroids
Benzodiazepmnes
Opiates
NSAIDS
Timepoint [1] 377679 0
Six months prior to the intervention compared with six months following the intervention.
Secondary outcome [2] 377680 0
Differences between intervention and control groups in changes in the rate per 100 consultations of selected pathology test ordered in the six months prior to the intervention compared with six months following the intervention, as assessed by automated data extract from patients' electronic health records.

The, specific pathology tests addressed are:

FBC/ESR
Urea, creatinine and electrolytes
LFT
TFT
Vitamin D
MSU
Timepoint [2] 377680 0
Six months prior to the intervention compared with six months following the intervention.
Secondary outcome [3] 377681 0
Differences between intervention and control groups in changes in the rate per 100 consultations of selected diagnostic imaging in the six months prior to the intervention compared with six months following the intervention, as assessed by automated data extract from patient electronic health records.

a. The specific imaging tests addressed are::

Low back pain imaging - lumbosacral spine xray and CT scanning
Timepoint [3] 377681 0
Six months prior to the intervention compared with six months following the intervention.
Secondary outcome [4] 377682 0
Differences between intervention and control groups in changes in knowledge assessment tests conducted prior to the intervention compared with following the intervention. The knowedge tests are specifically designed for this study.
Timepoint [4] 377682 0
Prior to the intervention compared with following the intervention.
Secondary outcome [5] 378112 0
Qualitative analysis
Perceptions and attitudes concerning the education intervention, attitudes and behaviours toward rational prescribing and testing (as defined by the Choosing Wisely recommendaitons), as well as engagement with MHR.
Timepoint [5] 378112 0
Prior to the intervention compared with the six months following the intervention
Secondary outcome [6] 378113 0
Health economic evaluation
Total cost of the intervention.
Timepoint [6] 378113 0
The intervention time period
Secondary outcome [7] 378114 0
Health economic evaluation
Between group changes in targetted prescription costs over time, measured by electronic health record data and PBS costs
Timepoint [7] 378114 0
Six months prior to the intervention compared with six months following the intervention
Secondary outcome [8] 378115 0
Health economic evaluation
Between group changes in targetted pathology test costs over time, measured by electronic health record data and MBS costs
Timepoint [8] 378115 0
Six months prior to the intervention compared with six months following the intervention
Secondary outcome [9] 378116 0
Health economic evaluation
Between group changes in targetted diagnostic imaging costs over time, measured by electronic health record data and MBS costs
Timepoint [9] 378116 0
Six months prior to the intervention compared with six months following the intervention

Eligibility
Key inclusion criteria
As a pragmatic trial, the inclusion criteria for the study are as broad as possible to replicate real-world conditions. The target research population is the Australian primary care medical workforce.
Inclusion criteria:
• Participants must hold an Australian Pharmaceutical Benefits Scheme (PBS) prescriber number and Medicare provider number
• Participants must undertake clinical work at least one day per week in a clinical practice having compatible electronic health records with PenCS data extraction tools installed and MHR access
• Participants must reside in a jurisdiction where pathology and imaging results are included in MHR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are aimed to minimise the inclusion of participants who would not be able to provide meaningful data.
• Absence from clinical work for more than 8 weeks over the study period

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)
While the study will be analysed at the level of individual participants, in order to minimize contamination of control groups, the education intervention will be randomised at a practice level. Following consent to participate, participants and their practices will be randomised to one of the three topic streams (intervention arms) on a 1:1:1 basis. A stratified randomisation approach will be used to ensure a balance of practice sizes (less than or equal to 5 GPs vs greater than or equal to 6 GPs), remoteness area of the practice (RA1 or RA2-5) and number of GPs from the practices participating). Randomisation will be carried out by the study’s statisticians (Batterham and Kobel) (e.g. to group A, B or C) but the statisticians will remain blinded as to the education intervention assigned to each group. As no clinical treatments will be undertaken, the researchers do not believe there is a situation in which breaking the study codes will be required.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) within strata
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The evaluation design is a pragmatic cluster-randomised three arm parallel trial and a prospective qualitative enquiry. The effect of the intervention in each education arm will be assessed, using the other two arms as controls.

Data will be collected from participants’ participation in the online educational program and assessments, the electronic health records generated by the participants and from telephone interviews with selected participants.

Sample size, sample size calculation or justification of numbers
The study is conservatively powered for testing significance in sub-group analyses (e.g. change in prescribing rates or change in pathology test ordering) with a 1:1 intervention: control allocation. As this is a three arm trial, the final number of control cases in sub-group analyses will be twice those assumed in these calculations. A medium intervention effect (f2 = 0.15) is detectable at 80% power and a = 0.05 with 55 participants, in a two arm trial (27.5 in each arm), analysed using linear multiple regression with a single regression coefficient. The generally accepted practice level intra-cluster correlation coefficient (ICC) of GP behavior is 0.05 and an average of three participating GPs per practice will be assumed. This results in a conservatively estimated design effect of 1.1. Thus the target recruitment is a minimum of 31 participants in each of the three arms of the trial (n=93). To allow for 25% attrition, the study will aim to recruit 40 participants in each of the three arms (n=120). With the above assumptions, the study will achieve 99% power with a = 0.05 for the composite primary outcome.

The evaluation will synthesise the results in a mixed-methods analysis embedding qualitative pre/post interviews in the quantitative results to investigate behaviour change and mechanisms.

While the mixed-methods study will address the objectives using a combination of quantitative and qualitative methods, we will use resource utilisation as a composite primary quantitative outcome measure for hypothesis testing:
• The study will test the primary hypothesis that the education intervention will result in a difference between intervention and control groups in changes in the cost per 100 consultations of selected prescriptions, pathology and radiology test ordering in the six months following the intervention compared with six months prior to the intervention.

Quantitative data analysis
The use of a randomised recruitment design and stratified randomisation of the intervention will reduce the potential for sampling bias. The statisticians will be blinded as to participant randomisation allocation. Each of the data elements described will be statistically analysed using multi-level modelling methods to test for between-group (intervention vs. control) differences in the change in variables over the course of the study period. Where appropriate, analyses will control for demographic (age and sex) and practice environment (size, area-level socioeconomic disadvantage and rurality) variables and include MHR access rates as a covariate.

Health economic evaluation
Economic evaluation of the educational intervention will consider the joint cost and effects of strategies aimed at reducing inappropriate prescribing, pathology and imaging, as well as report on intervention costs per session and individuals trained. Quantitative practice change evidence from MHR and GP data audit pre-post intervention will be triangulated with GP self-reported assessment of the impact of training by Medcast. Within study cost effectiveness analysis will focus on observed intervention cost and cost offsets and where appropriate net incremental cost per reduction in prescribing, pathology and imaging.
Conservative modelling of changes in health system effects and costs for appropriate deprescribing (e.g. reduced inappropriate use of benzodiazepines, proton pump inhibitors, inhalable corticosteroids and opiates) will be undertaken where effects within study have been shown.

Qualitative analysis
It is planned to interview 30 participants prior to and following the trial, 10 from each of the three education intervention arms. The final number of participants will be determined by whether data saturation has been reached in the interviews. Data saturation will be assessed as occurring when no new information has been collected over two subsequent interviews. The pre- and post-intervention interviews will be conducted as individual 30-minute telephone interviews with practice GPs. The interview questions will be used to elicit their perceptions and attitudes about the education session intervention, their attitudes and behaviours toward rational prescribing and testing, as well as their engagement with MHR.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2020
Actual
Date of last participant enrolment
Anticipated
31/03/2020
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304466 0
Government body
Name [1] 304466 0
Australian Digital Health Agency (ADHA)
Country [1] 304466 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medcast
Address
12/92 Pitt St,
Sydney
NSW 2000
Country
Australia
Secondary sponsor category [1] 304737 0
University
Name [1] 304737 0
University of Wollongong
Address [1] 304737 0
University of Wollongong
Northfields Ave
Wollongong
NSW 2522
Country [1] 304737 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304899 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 304899 0
Ethics committee country [1] 304899 0
Australia
Date submitted for ethics approval [1] 304899 0
Approval date [1] 304899 0
03/12/2019
Ethics approval number [1] 304899 0
2019/367

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

Contacts
Principal investigator
Name 98578 0
Prof Andrew Bonney
Address 98578 0
School of Medicine
Level 1, Building 28
Northfields Ave
University of Wollongong
Wollongong
NSW 2522
Country 98578 0
Australia
Phone 98578 0
+61 2 42215473
Fax 98578 0
Email 98578 0
[email protected]
Contact person for public queries
Name 98579 0
Christine Metusela
Address 98579 0
School of Medicine
Level 1, Building 28
Northfields Ave
University of Wollongong
Wollongong
NSW 2522
Country 98579 0
Australia
Phone 98579 0
+61 2 42215246
Fax 98579 0
Email 98579 0
[email protected]
Contact person for scientific queries
Name 98580 0
Andrew Bonney
Address 98580 0
School of Medicine
Level 1, Building 28
Northfields Ave
University of Wollongong
Wollongong
NSW 2522
Country 98580 0
Australia
Phone 98580 0
+61 2 42215473
Fax 98580 0
Email 98580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant level data will not be available, however practice level data will be made available on request with permission of the primary sponsors. Due to the relatively small sample size and geographic stratification of participant doctors there is a risk of inadvertant identification of participants.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomised trial of general practitioner online education for prescribing and test ordering.2023https://dx.doi.org/10.1136/bmjoq-2023-002351
N.B. These documents automatically identified may not have been verified by the study sponsor.