Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000566730
Ethics application status
Approved
Date submitted
31/03/2022
Date registered
13/04/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
13/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feedback for reducing overuse of pathology test requesting by Australian general practitioners
Scientific title
Evaluating a feedback intervention for reducing overuse of pathology test requesting by Australian general practitioners: a factorial cluster randomised controlled trial
Secondary ID [1] 306790 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General practitioner test ordering 325838 0
Condition category
Condition code
Public Health 323160 323160 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General practitioners (GPs) allocated to the control group will not receive any active intervention during the trial.

GPs allocated to one of eight intervention groups will receive individualised written performance feedback on their pathology test combination requesting rates from the Chief Medical Officer of Australia. The feedback provided to all intervention groups will be consistent in content and length other than three potential effect modifiers to be evaluated in the trial: (1) opportunity of Continuing Professional Development (CPD)-accredited online educational webinar and self-audit activity aimed at improving pathology requesting (no vs. yes); (2) provision of pathology test cost information (no vs. yes); and (3) feedback format (letter vs. pamphlet). The feedback will be delivered by mail and present the recipients’ rate of requesting of targeted combinations of pathology tests compared with the median request rate of their GP peers in the same geographic stratum. The targeted test pathology combinations are:
1. Iron studies (66596), Thyroid Stimulating Hormone (TSH) (66716) and Vitamin D (66833);
2. Iron studies (66596), Vitamin D (66833) and Vitamin B12 (66838/66839);
3. Iron studies (66596), TSH (66716) and Vitamin B12 (66838/66839);
4. Iron studies (66596), Thyroid Function Tests (TFT) (66719) and Vitamin B12 (66838/66839);
5. Iron studies (66596), TFT (66719) and Vitamin D (66833);
6. TSH (66716) and Vitamin D (66833) and Vitamin B12 (66838/66839);
7. Iron studies (66596) and Vitamin D (66833);
8. Iron studies (66596) and Vitamin B12 (66838/66839);
9. Iron studies (66596) and TFT (66719);
10. TSH (66716) and Vitamin D (66833).
Performance feedback will be provided for up to three pathology test combinations where the recipient’s requesting rate is higher than 90% of their GP peers practicing in a similar geographic region.

Purpose of the intervention: To reduce overuse of pathology test combination requests by high-requesting GPs

Materials: 4-page feedback report and CPD-accredited educational activities (1 hour online webinar and self-directed audit activity)

Provider: Australian Government Department of Health

Mode of delivery: Feedback letter mailed to participants at their nominated mailing address. Educational activities to be accessed online.

Tailoring: Feedback on pathology test combination request rate will be individualised to the recipient. Educational activities will be standard for all recipients.

Fidelity: Return to sender to be documented for mailed feedback. Participation in educational activities to be documented.
Intervention code [1] 323248 0
Behaviour
Comparator / control treatment
GPs in the control group will not receive any written feedback on their pathology test requesting behaviour during the trial nor invited to participate in the CPD-accredited online educational webinar and self-audit activity aimed at improving pathology test requesting.
Control group
Active

Outcomes
Primary outcome [1] 330915 0
Overall rate of requesting of any of the displayed combinations of pathology tests (listed below) by each recipient per 1000 Category 1 patient consultations over the 6 months following intervention delivery, assessed using Medicare Benefits Schedule (MBS) data. Targeted test pathology combinations are: 1. Iron studies (66596), TSH (66716) and Vitamin D (66833); 2. Iron studies (66596), Vitamin D (66833) and Vitamin B12 (66838/66839); 3. Iron studies (66596), TSH (66716) and Vitamin B12 (66838/66839); 4. Iron studies (66596), TFT (66719) and Vitamin B12 (66838/66839); 5. Iron studies (66596), TFT (66719) and Vitamin D (66833); 6. TSH (66716) and Vitamin D (66833) and Vitamin B12 (66838/66839); 7. Iron studies (66596) and Vitamin D (66833); 8. Iron studies (66596) and Vitamin B12 (66838/66839); 9. Iron studies (66596) and TFT (66719); 10. TSH (66716) and Vitamin D (66833).
Timepoint [1] 330915 0
0 to 6 months after intervention delivery (where time 0 is date of intervention delivery)
Secondary outcome [1] 408064 0
Overall rate of requesting of any of the displayed combinations of pathology tests by each recipient per 1000 Category 1 consultations over >6 to 12 months, and 0 to 12 months following intervention delivery (where time 0 is date of intervention delivery), assessed using MBS data.
Timepoint [1] 408064 0
Baseline, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [2] 408065 0
Rate of requesting of the displayed combination of Iron studies, TSH and Vitamin D pathology tests by recipient per 1000 category 1 consultations over 0 to 6 months, >6 to 12 months, and 0 to 12 months post intervention delivery (where time 0 is date of intervention delivery), assessed using MBS data.
Timepoint [2] 408065 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [3] 408066 0
Rate of requesting of the displayed combination of Iron studies, Vitamin D and Vitamin B12 pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [3] 408066 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [4] 408067 0
Rate of requesting of the displayed combination of Iron studies, TSH and Vitamin B12 pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [4] 408067 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [5] 408068 0
Rate of requesting of the displayed combination of Iron studies, TFT and Vitamin B12 pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [5] 408068 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [6] 408069 0
Rate of requesting of the displayed combination of Iron studies, TFT and Vitamin D pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [6] 408069 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [7] 408070 0
Rate of requesting of the displayed combination of TSH, Vitamin D and Vitamin B12 pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [7] 408070 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [8] 408071 0
Rate of requesting of the displayed combination of Iron studies and Vitamin D pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [8] 408071 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [9] 408072 0
Rate of requesting of the displayed combination of Iron studies and Vitamin B12 pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [9] 408072 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [10] 408073 0
Rate of requesting of the displayed combination of Iron studies and TFT pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [10] 408073 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [11] 408074 0
Rate of requesting of the displayed combination of TSH and Vitamin D pathology tests by recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [11] 408074 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [12] 408075 0
Rate of requesting of Iron studies by each recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [12] 408075 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [13] 408076 0
Rate of requesting of TSH by each recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [13] 408076 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [14] 408077 0
Rate of requesting of Vitamin D by each recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [14] 408077 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [15] 408078 0
Rate of requesting of Vitamin B12 by each recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [15] 408078 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [16] 408079 0
Rate of requesting of TFT by each recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [16] 408079 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [17] 417505 0
Rate of requesting of Ferritin by each recipient per 1000 Category 1 consultations over the following periods: 0 to 6 months, >6 to 12 months, 0 to 12 months post intervention delivery, assessed using MBS data.
Timepoint [17] 417505 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [18] 417506 0
Overall rate of requesting of any of the 10 targeted pathology test combinations by each GP per 1,000 category 1 consultations over 0 to 6 months, >6 to 12 months, and 0 to 12 months after intervention delivery, assessed using MBS data.
Timepoint [18] 417506 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [19] 417507 0
Rate of requesting of any of the pathology test combinations that are not displayed in recipients individualised feedback by each GP per 1,000 category 1 consultations over 0 to 6 months, >6 to 12 months, and 0 to 12 months after intervention delivery, assessed using MBS data.
Timepoint [19] 417507 0
Baseline, 0 to 6 months, >6 to 12 months, 0 to 12 months after intervention delivery
Secondary outcome [20] 417508 0
Estimated number of requests for the targeted pathology test combinations saved as a result of any audit and feedback intervention compared with control over 6 and 12 months, using MBS data.
Timepoint [20] 417508 0
0 to 6 months, 0 to 12 months after intervention delivery

Eligibility
Key inclusion criteria
General practitioners (GPs) practising in Australia, who are in the top 10% of GP referrers overall for 10 targeted combinations of pathology tests and in the top 10% of referrers for at least 2 individual test combinations. Targeted combinations of pathology tests are:
1. Iron studies (66596), TSH (66716) and Vitamin D (66833);
2. Iron studies (66596), Vitamin D (66833) and Vitamin B12 (66838/66839);
3. Iron studies (66596), Thyroid Stimulating Hormone (TSH) (66716) and Vitamin B12 (66838/66839);
4. Iron studies (66596), Thyroid Function Tests (TFT) (66719) and Vitamin B12 (66838/66839);
5. Iron studies (66596), TFT (66719) and Vitamin D (66833);
6. TSH (66716) and Vitamin D (66833) and Vitamin B12 (66838/66839);
7. Iron studies (66596) and Vitamin D (66833);
8. Iron studies (66596) and Vitamin B12 (66838/66839);
9. Iron studies (66596) and TFT (66719);
10. TSH (66716) and Vitamin D (66833).
Only pathology tests requests that lead to a service being rendered by a pathologist and for which a Medicare Benefits Schedule (MBS) claim is made are in scope.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. GPs with <1000 Category 1 services between 1 July 2019 and 30 June 2020, and/or <1000 Category 1 services between 1 July 2020 and 30 June 2021.
2. GPs who did not make any in-scope pathology test requests within the nominated 24-month period (1 July 2019 to 30 June 2021).
3. GPs who participated in user testing of the intervention.
4. GPs who are currently or have been involved in a Department of Health compliance activity commencing on or after 1 May 2021.
5. GPs with a hospital as their primary practice address.
6. GPs with a primary practice address in remote or very remote geographical areas (MM6-7).

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)
Eligible GPs will be clustered in area-specific clusters, based on practice location and in accordance with SA1 classification, and these will be randomised into one of the nine study arms using stratified block randomisation. All clusters will be randomised at once so concealment of allocation sequence is not an issue.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using a computer-generated randomisation algorithm in the statistical program R. Clusters will be stratified by geographic region using MMM classification (urban, regional/rural-remote: MMM1, MMM2-5).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
This is a 9-arm partial 2 x 2 x 2 factorial cluster randomised trial conducted in Australian general practice. A cluster design will be used to minimise cross-contamination between GPs within the same general practices. A no intervention control group will be included to test the effectiveness of any form of performance feedback. A 2 x 2 x 2 factorial design will be used to simultaneously assess the effect of three factors: (1) opportunity of Continuing Professional Development (CPD)-accredited online educational webinar and self-audit activity aimed at improving pathology requesting (no vs. yes); (2) provision of pathology test cost information (no vs. yes); and (3) feedback format (letter vs. pamphlet).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All baseline characteristics of study cohort will be summarised and reported as N (%) for categorical variables and mean ± standard deviation or median (Q1-Q3) for continuous variables, subject to distribution assessment, and the differences between groups will be assessed using Chi2/Fisher’s exact test for categorical data and either T-test or Wilcoxon U-test for normal and skewed continuous data, respectively.
The main analysis will be conducted based on modified intention-to-treat (ITT) basis and a set of sensitivity analyses (including Per protocol analysis) will be used to confirm the robustness of study findings. Type and reason for sensitivity analysis will be reported.
The primary analysis will consist of comparing the mean rate of pathology requests between the intervention arms, considered as one group, and the control arm.
Multilevel mixed effect regression analysis (with random intercept for clustering by SA1) will be used to assess the impact of the intervention on changes in pathology requests, while controlling for potential key confounders (e.g., GPs years of practice or other factors identified during the baseline comparison), baseline rate of pathology requests and remoteness.
Similarly, multilevel mixed effect modeling will be used to examine the impact of effect modifiers (i.e. opportunity of CPD-accredited educational activities, provision of pathology test cost information, feedback format) on changes in pathology requests.
Type of regression model will be determined after careful data examination. The rate of pathology test requests is anticipated to be positively skewed and potentially heteroscedastic. To overcome these issues the data will be either log transformed and analysed using mixed effect linear regression or if assumptions for linear regression are not met, original data will be modeled using generalized mixed effect linear model with gamma family distribution and appropriate link function will be considered.
Level of significance for the study is set at alpha level of 0.05 and Bonferroni correction will be used to account for multiple comparisons.
Detailed statistical methods will be pre-specified in a separate statistical analysis plan.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2022
Actual
12/05/2022
Date of last participant enrolment
Anticipated
2/05/2022
Actual
12/05/2022
Date of last data collection
Anticipated
12/08/2023
Actual
12/08/2023
Sample size
Target
5841
Accrual to date
Final
5964
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311127 0
Government body
Name [1] 311127 0
Australian Government Department of Health
Country [1] 311127 0
Australia
Primary sponsor type
Government body
Name
Australian Government Department of Health
Address
PO Box 9848, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 312464 0
None
Name [1] 312464 0
Address [1] 312464 0
Country [1] 312464 0
Other collaborator category [1] 282231 0
Other Collaborative groups
Name [1] 282231 0
Wiser Healthcare Collaboration
Address [1] 282231 0
c/o Denise O’Connor, Monash University and Cabrini Health, Malvern VIC 3144
Country [1] 282231 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310656 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 310656 0
Ethics committee country [1] 310656 0
Australia
Date submitted for ethics approval [1] 310656 0
08/10/2021
Approval date [1] 310656 0
30/11/2021
Ethics approval number [1] 310656 0
JH03507

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

Contacts
Principal investigator
Name 118414 0
Ms Dina Schram
Address 118414 0
Co-principal investigator - Denise O'Connor
Australian Government Department of Health
PO Box 9848, Canberra ACT 2601
Country 118414 0
Australia
Phone 118414 0
+61 02 6289 5631
Fax 118414 0
Email 118414 0
pathology.requesting@health.gov.au
Contact person for public queries
Name 118415 0
Dina Schram
Address 118415 0
Australian Government Department of Health
PO Box 9848, Canberra ACT 2601
Country 118415 0
Australia
Phone 118415 0
+61 02 6289 5631
Fax 118415 0
Email 118415 0
pathology.requesting@health.gov.au
Contact person for scientific queries
Name 118416 0
Denise O’Connor
Address 118416 0
Monash-Cabrini Department of Musculoskeletal Health and Clinical Epidemiology,
Monash University and Cabrini Health
154 Wattletree Road, Malvern VIC 3144
Country 118416 0
Australia
Phone 118416 0
+61 03 9508 3428
Fax 118416 0
Email 118416 0
denise.oconnor@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is not available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15599Statistical analysis planGorelik A, Schram D, Elwick A, Glasziou P, Buchbinder R, McCaffery K, Thomas R, O'Connor DA. Statistical analysis plan: Evaluating a feedback intervention for reducing overuse of pathology test requesting by Australian general practitioners: A 2x2x2 factorial cluster randomised controlled trial. OSF Preprints; 2023.   To make available in open access journal or open s... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating an audit and feedback intervention for reducing overuse of pathology test requesting by Australian general practitioners: Protocol for a factorial cluster randomised controlled trial.2023https://dx.doi.org/10.1136/bmjopen-2023-072248
N.B. These documents automatically identified may not have been verified by the study sponsor.