None listed
Conditions
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.
Interventions
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).
Sponsors
Study design
Eligibility
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.
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.