Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000658617
Ethics application status
Approved
Date submitted
16/05/2023
Date registered
19/06/2023
Date last updated
14/06/2024
Date data sharing statement initially provided
19/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Making the first osteoporotic fracture the last: Evaluating a new integrated model of osteoporosis management in primary care. The INTERCEPT study.
Scientific title
Making the first osteoporotic fracture the last: Evaluating the effectiveness of a new integrated model of osteoporosis management targeting GP behaviours of patient investigation and management of potential osteoporotic fractures.
Secondary ID [1] 309532 0
Nil known
Universal Trial Number (UTN)
Trial acronym
INTERCEPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 329876 0
Osteoporotic fracture 329877 0
Secondary fracture 329880 0
Condition category
Condition code
Musculoskeletal 326782 326782 0 0
Osteoporosis
Metabolic and Endocrine 326785 326785 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves administering the Model.

The Model has been designed to integrate secondary osteoporotic fracture prevention and have primary care as the hub of osteoporosis management and investigation. Hospital-based Fracture Liaison Services (FLS) and community-based private radiology practices are mechanisms of identification and referral to and from primary care. Within this Model, the majority of cases are seen and managed by their General Practitioner (GP). Only complex cases that require specialist management (e.g., those with secondary osteoporosis) will be referred to, and managed by a hospital-based FLS.

The basic premise of this Model is that the GP is made aware of a patient’s potential osteoporotic fracture and then encouraged to investigate and manage it in accordance with best-practice guidelines. This applies for patients identified with a potential osteoporotic fracture by private radiology and the hospital-based FLS. The intervention process with the GP is described below:

1. The referring GP receives a diagnostic report from Spectrum Medical Imaging (SMI) or a discharge report from Westmead Hospital. These reports are generated and delivered to the referring GP independent of the study, following established communication pathways between the GP and service provider.

2. By the end of the following week, the Community and Radiology Coordinator (CRC) or Fracture Liaison Service Co-ordinator (FLS-C) will send the referring GP an alert letter via fax and/or, if applicable, via Medical Objects (a commercial medical document messaging service to which about 80% of practices in Sydney are subscribed). This letter will simply alert the GP to the fact that a patient of theirs has been diagnosed with a fracture that may or may not be due to osteoporosis. The letter also encourages the GP to review the case using a management flowchart based upon the Royal Australian College of General Practitioners (RACGP) guidelines. The letter is sent with the intent that it will prompt the GP to initiate investigations and, if osteoporosis is confirmed, commence the patient on treatment as appropriate. The summary of RACGP guidelines document is faxed along with the alert letter or may be accessed through a link via the Medical Objects letter. The alert letter provides a link (https://www.sosfracturealliance.org.au/sfppc) that allows the GP to review the Best Practice Guidelines and GP management plans.

3. After 4 weeks, the GP will receive a Fracture Management Survey via fax to assess what measures the GP has or has not taken in relation to the patient’s potential osteoporotic fracture. The Form will be pre-populated with patient and GP details, information about the radiological finding that triggered the contact, and a request to return the form within four weeks.

4. Where the Survey has not been returned, the CRC/ FLS-C will resend the questionnaire after four weeks as a Reminder letter reminding the GP of the purpose of the project and why it is important to complete the questionnaire and return it as soon as possible. If there is no response to this after a further round of reminders no further action will be taken.

5. The CRC/ FLS-C will review the returned Fracture Management Survey. Where the returned Survey states that the patient has been investigated and found to have osteoporosis, the CRC/FLS-C will review the action taken and whether it was in accordance with RACGP guidelines for the management of osteoporosis. If the response was NOT in accordance with these guidelines, the CRC/FLS-C will contact the GP in writing seeking further clarification. Where the returned Survey states that the patient has been referred to a specialist and the results are not yet available, this will be flagged, and a follow-up questionnaire will be sent to the GP after a further four weeks.

6. For GPs who had diagnosed their patient with osteoporosis and commenced them on appropriate treatment, the CRC/FLS-C will contact the GP via follow-up survey to gather information from them on adherence to the treatment after six months using a follow-up survey.

In summary, in addition to the baseline diagnostic report provided with standard care (as per the RACGP guidelines), the intervention (or the Model) will involve the GP receiving alert letters and surveys to offer them an additional opportunity (on top of the diagnostic report) to review the patient and commence investigations and/or treatment for osteoporosis.

To clarify, no individuals presenting to a participating GP practice (intervention or usual care group) during the study duration will be restricted in any way in terms of the care and treatment they receive from their GP.

The overall duration of the trial is from January 2023 to January 2026 (36 months) and will involve the following stages: 1) preparation and establishment (January - June 2023; 6 months); 2) study implementation (July 2023 - October 2024; 16 months) and follow-up of all cases (October 2024 - July 2025; 10 months); 3) finalisation, analysis and dissemination of findings (August 2025 - January 2023).
Intervention code [1] 326003 0
Behaviour
Comparator / control treatment
The usual care for osteoporosis will be the active control in this study, whereby GPs receive a diagnostic report from private radiology practices or hospitals where their patients have had a scan. As detailed in the RACGP guidelines, best practice of a patient following a fracture may include history taking, assessing diagnosis, fracture risk assessment, osteoporosis-directed investigations, education on falls prevention and lifestyle modifications, initiation of supplementation and/or osteo-protective pharmacotherapy, and referral to a medical specialist. If patients are commenced on pharmacotherapy, it would also be expected that the GP reviews the patient at some point by the 6-month mark to discuss treatment, review adherence and provide repeat scripts. Best practice, however, is not always undertaken by GPs due to various factors, and it is the purpose of the intervention to promote this.
Control group
Active

Outcomes
Primary outcome [1] 334638 0
The primary outcome is the proportion of patients with a potential osteoporotic fracture referred by their GP for a bone density scan and/or the proportion of patients prescribed osteo-protective pharmacotherapy within three months of an initial diagnostic report.

For this study, the definition of bone density scan is a DEXA scan and osteo-protective pharmacotherapy includes the following:
• bisphosphonates (alendronate, risedronate, zoledronic acid)
• denosumab
• raloxifene
• hormone replacement therapy (including oestrogen replacement in females and testosterone replacement in males)
• osteo-anabolic therapies such as teriparatide or romosozumab.

Osteo-protective pharmacotherapy does not include cholecalciferol, calcium, vitamin K2 or other dietary supplements.

To assess this outcome, this study will analyse difference in outcomes between intervention and usual care groups using linked de-identified individual Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data as a proxy for GP behaviour change. This data will be provided by the Australian Institute of Health and Welfare (AIHW). Specific data items that we will request to enable measurement of change in our primary and secondary outcomes are:
• DEXA scan MBS items: 12306, 12312, 12315, 12320, 12321, 12322.
Timepoint [1] 334638 0
At the conclusion of the study.
Secondary outcome [1] 421488 0
Proportion of patients with a potential osteoporotic fracture referred by their GP who have a blood test related to bone health within three months of the initial diagnostic report. For this study, a blood test related to bone health refers to vitamin D and creatinine or calcium/magnesium/phosphate.

To assess this outcome, this study will analyse difference in outcomes between intervention and usual care groups using linked de-identified individual Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data as a proxy for GP behaviour change. This data will be provided by the Australian Institute of Health and Welfare (AIHW). Specific data items that we will request to enable measurement of change in our primary and secondary outcomes are:
• Bone health MBS items: 66833, 66500
Timepoint [1] 421488 0
At the conclusion of the study.
Secondary outcome [2] 421489 0
Proportion of GPs who initiate a chronic disease management plan within three months of the initial diagnostic report.

To assess this outcome, this study will analyse difference in outcomes between intervention and usual care groups using linked de-identified individual Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data as a proxy for GP behaviour change. This data will be provided by the Australian Institute of Health and Welfare (AIHW). Specific data items that we will request to enable measurement of change in our primary and secondary outcomes are:
• Chronic disease management plan MBS items: 721, 723, 732
Timepoint [2] 421489 0
At the conclusion of the study.
Secondary outcome [3] 421490 0
Proportion of patients with a potential osteoporotic fracture prescribed osteoprotective pharmacotherapy by their GP at 10 months post initial diagnostic report.

To assess this outcome, this study will analyse difference in outcomes between intervention and usual care groups using linked de-identified individual Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data as a proxy for GP behaviour change. This data will be provided by the Australian Institute of Health and Welfare (AIHW).
Timepoint [3] 421490 0
At the conclusion of the study.

Eligibility
Key inclusion criteria
The inclusion criteria for patients includes:
• Age 50 years or older.
• Confirmed fracture on X-ray, CT or MRI.
• Referred by a GP.

The CRC/FLS-C will use this list of potential osteoporotic fracture cases to generate a list of GPs and GP practices. From this, the inclusion criteria for GPs includes:
- GPs who practice in Primary Care as their main occupational activity, and who have referred a patient to the private radiology practice SMI for an imaging study for any indication; or
- GPs who manage patients who have had an imaging study for any indication at Westmead Hospital, whether or not they are the referring provider.
- GP practices with a residential address within the Central and Eastern Sydney PHN, South Western or Western Sydney PHNs.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age less than 50 years.
• Any fracture due to significant trauma, metastatic bone disease or haematological malignancy, metabolic bone disease (e.g. Paget’s disease of bone; severe primary. hyperparathyroidism, end-stage renal failure)
• A fracture not clearly described in the report.
• Fractures of the toes, fingers and face.
• Ankle fractures in women.
• Complex or major fractures, and intermediate complexity fractures in those aged over 75 years (FLS cases only).
• Patients who are identified as already being managed for osteoporosis.
• Women who are pregnant or who are planning on becoming pregnant.
• Patients referred by a medical specialist other than GP (SMI cases only).
All remaining fractures will be considered potential osteoporotic fractures.

There is no exclusion criteria for GPs.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A web-based randomisation sequence with web-based data entry will be used. The relevant stratification will be programmed into the web-based sequence and allocation will be concealed from the Community and Radiology Coordinator (CRC). The CRC is employed by a private radiology practice, Spectrum Medical Imaging (SMI), and will have several main tasks:

1. To triage cases diagnosed radiologically with a potential osteoporotic fracture
2. To alert the patient’s GP of the potential osteoporotic fracture if the GP practice has been randomised to the intervention arm
3. To monitor GP response rate to the model and follow-up with reminders
4. To keep record of cases and GPs randomised to the control arm but not offer further communication with the GP.

Therefore, allocation will be concealed from GPs and their cases, where they will be unaware of their participation in the study (a consent waiver has been requested).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Model will be evaluated using a Cluster Randomised Controlled Trial (cRCT) with randomisation at the GP practice level, to compare outcomes amongst practices allocated to the Model versus usual care.

Randomisation will be by the GP practice, stratified by source of referral (FLS vs. private radiology practice), and within private radiology practice by location of practice (Western Sydney vs. Eastern Sydney) and size of practice of referring GP (1 GP, 2-5 GPs, 6+ GPs) – a total of seven strata.

GP practices will be randomised as patients with a potential osteoporotic fracture are identified; all subsequent patients of a GP practice previously randomised will be automatically included in the same randomised group.

The GP practice of a case will either be randomised into the intervention arm (receiving the Model) or the control (usual care) arm (and receive no communication from the CRC or FLS-C).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will compare outcomes between usual care and intervention groups post intervention, using a mixed effects logistic regression model to adjust for correlation of outcomes within GP/GP practice. The model will include intervention group (intervention or usual care), stratification variables (FLS versus private radiology practice and location and size of GP practice), as well as sex and age group of patients. Separate analyses will be undertaken for each outcome. Results will be presented as the odds ratios (odds of the outcome in the intervention versus usual care group), with 95% confidence intervals.

Assuming at least 100 GP practices per arm, with an average of 3-5 patients per practice, an intra-class correlation coefficient (ICC) of 0.1, a coefficient of variation for cluster size of 0.9, 80% power and a 5% significance level, the study will be able to detect:
· an increase of 10-15% in the proportion of patients with a potential osteoporotic fracture who have a bone density scan and/or fill a script for osteo-protective pharmacotherapy within three months of the initial diagnostic report
· an increase of 10-15% in the proportion of patients with a potential osteoporotic fracture who have a blood test related to bone health e.g. vitamin D within 3 months of the initial diagnostic report.
· an increase of 10-15% in the proportion of patients with a potential osteoporotic fracture where the GP initiated a chronic disease management plan within 3 months of the initial diagnostic report.
· an increase of 10-15% in the proportion of patients with a potential osteoporotic fracture who fill a second prescription of osteo-protective pharmacotherapy at 10 months after the initial diagnostic report.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
1/09/2023
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
1000
Accrual to date
690
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24665 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 40278 0
2015 - Alexandria
Recruitment postcode(s) [2] 40280 0
2022 - Bondi Junction
Recruitment postcode(s) [3] 40284 0
2031 - Randwick
Recruitment postcode(s) [4] 40283 0
2035 - Maroubra
Recruitment postcode(s) [5] 40276 0
2145 - Westmead
Recruitment postcode(s) [6] 40281 0
2170 - Casula
Recruitment postcode(s) [7] 40282 0
2170 - Liverpool
Recruitment postcode(s) [8] 40279 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 313724 0
Government body
Name [1] 313724 0
NHMRC (Investigator Grant - APP1196062)
Country [1] 313724 0
Australia
Primary sponsor type
Other Collaborative groups
Name
ANZAC Research Institute
Address
The ANZAC Research Institute
Concord Repatriation General Hospital
Gate 3, Hospital Road
Concord NSW 2139
Australia
Country
Australia
Secondary sponsor category [1] 315538 0
University
Name [1] 315538 0
University of Sydney
Address [1] 315538 0
The University of Sydney
CAMPERDOWN NSW 2050
Australia
Country [1] 315538 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312895 0
The Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 312895 0
Hospital Rd, Concord NSW 2139
Ethics committee country [1] 312895 0
Australia
Date submitted for ethics approval [1] 312895 0
01/05/2023
Approval date [1] 312895 0
06/07/2023
Ethics approval number [1] 312895 0
2023/ETH00731

Summary
Brief summary
The overarching aim of this quality improvement project is to assess whether an Integrated Model of Osteoporosis Management (the Model) improves GP investigation and management of patients determined from radiology reports or a hospital-based Fracture Liaison Service to have a potential osteoporotic fracture. The study design is a Cluster Randomised Controlled Trial (cRCT) with randomisation at the GP practice level, to compare outcomes amongst practices allocated to the Model versus usual care. Specifically, this study hypothesises that GP practices randomised to the model (intervention group), compared to GP practices randomised to the control (usual care) group, will:
• Refer a greater proportion of patients with a potential osteoporotic fracture for a bone density scan and/or prescribe a greater proportion of patients with osteo-protective pharmacotherapy within three months of an initial diagnostic report.
• Refer a greater proportion of patients with a potential osteoporotic fracture for a blood test related to bone health within three months of the initial diagnostic report.
• Initiate a chronic disease management plan for a greater proportion of patients should investigations confirm the fracture being due to osteoporosis.
• Prescribe osteo-protective pharmacotherapy for a greater proportion of patients with a potential osteoporotic fracture at 10 months post initial diagnostic report.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126254 0
Prof Markus Seibel
Address 126254 0
Bone Research Program, ANZAC Research Institute, Gate 3, Concord Hospital, Concord, NSW 2139
Country 126254 0
Australia
Phone 126254 0
+61 425 242 084
Fax 126254 0
Email 126254 0
Markus.Seibel@sydney.edu.au
Contact person for public queries
Name 126255 0
Prof Markus Seibel
Address 126255 0
Bone Research Program, ANZAC Research Institute, Gate 3, Concord Hospital, Concord, NSW 2139
Country 126255 0
Australia
Phone 126255 0
+61 425 242 084
Fax 126255 0
Email 126255 0
Markus.Seibel@sydney.edu.au
Contact person for scientific queries
Name 126256 0
Prof Markus Seibel
Address 126256 0
Bone Research Program, ANZAC Research Institute, Gate 3, Concord Hospital, Concord, NSW 2139
Country 126256 0
Australia
Phone 126256 0
+61 425 242 084
Fax 126256 0
Email 126256 0
Markus.Seibel@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing is not possible due to potential for participant identification. Therefore, due to privacy concerns and to address ethical guidelines, individual participant data will not be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19066Study protocol    Has been submitted, waiting for reply.
19170Statistical analysis plan    Will be submitted for peer-reviewed publication on... [More Details]
19171Clinical study report    Will be submitted for peer-reviewed publication on... [More Details]



Results publications and other study-related documents

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