Osteoporosis New Zealand (ONZ) case finding activity

Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

Best practice fragility fracture care and prevention in New Zealand.

Development of a national systematic approach – from BoneCare 2020 Background.

In 2012, Osteoporosis New Zealand published BoneCare 2020: A systematic approach to hip fracture care and prevention for New Zealand. At the time of publication, New Zealand lacked a coordinated, nationwide strategy and systems to optimally manage individuals who sustained fragility fractures. Publication of BoneCare 2020 in late 2012 proved helpful to maintain a focus for quality improvement initiatives during the last decade.

A key element of BoneCare 2020 is the strategic pyramid which follows a stepwise top-down approach based on the size of impact on both the patient and the health system.

Intro to the continuous quality improvement programme toward best practice fragility fracture care and prevention in NZ – progress to date As New Zealand enters a new demographic era, the burden imposed by fragility fractures is set to escalate substantially. A national quality improvement initiative being led by the ACC, ONZ and other partners in the Live Stronger for Longer Program has followed a systematic nationally consistent approach to ensure that every patient in New Zealand with a fragility fracture receives appropriate equitable care, management, support, information and falls assessment to improve patient outcomes and reduce health sector costs.

Commencing at the end of 2020 Osteoporosis New Zealand (ONZ) and The Accident Compensation Corporation (ACC) have been working in partnership on a quality improvement programme to support best practice fragility fracture care and prevention in New Zealand. This national quality improvement initiative has National Clinical Networks, National Clinical Standards, and Registries to benchmark performance to ensure equitable care, consistent delivery and improved patient outcomes.

Individuals who sustain fragility fractures are the most readily identifiable group that are at high risk of sustaining secondary fractures in the future.

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

The Fracture Liaison Service (FLS) model of care is advocated by leading global organisations in the bone health arena as the most clinically effective and cost-effective mechanism to deliver secondary fracture prevention in a reliable and consistent fashion for people who sustain fragility fractures.

The Australia and New Zealand Fragility Fracture Registry (ANZFFR) To enable FLS clinicians to in real time to benchmark the care they provide against the “Clinical Standards for FLS in NZ”, identify variation in service delivery and continuously improve secondary fragility fracture prevention the Australia and New Zealand Fragility Fracture Registry (ANZFFR) was developed.

This ANZFFR is the collection of information about the care of people aged 50 years and over, who have had a fragility fracture (a broken bone caused by a low impact injury such as a fall from a standing height).

The ANZFFR is also configured as a patient management system so that the FLS clinicians can complete the identification, assessment, investigation, and recommendation functions within the Registry. This informs the Key Performance Indicators (KPI’s) of the “Clinical Standards for FLS in NZ”. The Registry therefore performs a quality improvement function at a national level.

The ultimate goal of the ANZFFR is to use data to improve health system performance and maximise outcomes for people with fragility fractures by improving secondary fracture prevention, reducing rates of further fragility fractures and their associated morbidity and mortality.

This will be achieved by: •

Evaluating FLS performance against the Clinical Standards for Fracture Liaison Services in New Zealand.

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Identifying variation in FLS service delivery and patient care across healthcare systems and allow respective FLS services to use quarterly summary data to drive service level improvement, as well as benchmark with other services through a community of practice framework and peer-peer / peer-mentor support.

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Preventing future fragility fractures by monitoring secondary prevention interventions.

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Standardising care across Australia and New Zealand by addressing barriers to the use of the best available evidence.

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Provide publicly available information so that patients can be reassured they receive the standard of care they need after a fragility fracture.

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Provide data for research questions or projects, nationally and internationally, as required.

Because this involves collecting patient identified information and that 10-15% of the fragility fracture population will be “vulnerable” with respect to making treatment decisions, formal approval was sought from the National Ethics Committee. This was granted on 28 January 2022 and is reviewed annually. This is a very robust review of all aspects of the Registry and “opt out” consent was approved. This means that patients are informed verbally and by written Patient and Relative Information Sheets about the Registry. Their information is recorded in the Registry unless they request not to be included.

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

Each site also appointed a local Principal Investigator and registered with the National Ethics Committee project to gain local site approval prior to any patient level data being entered.

Appendix A provides a summary of the data management plan for the FFR which has been approved by HDEC. This covers additional information relating to data governance, security, data storage, data management etc.

FLS teams are trained not only in the practical aspect of using the Registry but also in their ethical responsibilities.

The Bay of Plenty Fracture Liaison Service A fracture liaison service was estblished in the BOP region in 2017 however at this time the FTE was significantly below the international benchmark.

In the current business case the BOP FLS has been fully resourced to levels based on international benchmarking and include an FLS clinical lead, corodinator and administrator as follows.

Current BOP FLS

As a consequence of the reduced FTE we are aware that during the last 5 years there will be patients that did not receive evidence based care at the time of their fracture. Additionally, patients whom presented to an after-hours environment other than the hospital, may have missed intervention by the FLS team and may not have come to the attention of their primary care provider either.

Nationally there are an estimated up to 200,000 older Kiwis that have broken a bone since their 50th birthday prior to the implementation of FLS who may not have undergone a bone health assessment, and evidence-based care at the time of their fracture.

Continuation of Secondary Fracture Prevention – the BOP Proof of Concept Project – Intro and Objectives To provide appropriate care to cohort of patients in the BOP that did not receive evidencebased care at the time of their fracture we propose a proof of concept (POC) be undertaken in the BOP region. The POC will develop, define, and refine reliable processes that ensure these individuals receive appropriate care with a view to a national rollout. It is assumed that this process may take up to 12 months to ensure that processes are robust and can be expanded to a national rollout. Additional FTE will be available to conduct this Proof of Concept.

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

Why this region?

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Highly effective FLS in place for ~5yrs with varying FTE throughout (Silver IOF accreditation).

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Combination of Urban and Rural communities with wide geographic spread.

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Strong support for Strength & Balance education in the region.

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Effectively functioning Primary Care networks.

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Highly functional access to primary diagnostic tool of DXA scanning.

Patient Identification in the POC As fragility fractures cluster in time (see figure 1), In this Project we will undertake a one-off retrospective case finding of all patients that have fractured in the last 5 years who did not receive evidence-based care at the time of their fracture and are not on bone protection medication.

Identification will be done by applying an electronic data management (EDM) solution, Conporto/DrInfo, to a practice population. This will identify patients over 50yrs with history of fragility fracture (as per identified fracture coding). The EDM will then undertake a FRAX risk assessment of each patient based on other available information within the patient record (eg smoking status, disease coding etc). Patients with a 10yr hip fracture FRAX score of ≥3% will be included on the referral list to FLS for full assessment (may include referral to DXA scan, recommendation for initiation of bone-protection treatment etc).

We estimate ~740 patients fit the above criteria in the BOP region.

The model of care for these patients will use the same processes and standards as new fracture patients. The 5iQ structure of the Clinical Standards for Fracture Liaison in New Zealand (i.e. clinical standards relating to identification, investigation, information, intervention, integration and quality) enables FLS teams to benchmark their provision of care for individuals with fragility fractures.

This process of care is then measured by entering patient data into the Fragility Fracture Registry.

To enable the first step in the FLS patient management process ‘identification’ consent is required from the patient’s practice.

Ideally, each Practice will give consent for Patient referral to FLS via agreement with PHO for ‘bulk referral’. If Patient is indicated for bone-protection medication and is suitable for zoledronic acid infusion, this can be administered either in the primary or secondary care setting with ACC providing funding for first infusion. Patient’s Primary Care provider then will manage ongoing infusions as indicated.

DRAFT timeline 2023/2024 July/August:

engage/educate/consent Primary Care.

August:

Primary Care to communicate (method TBC) with patient cohort to advise of their identification as part of the POC and advised of next steps; POC patient cohort referral list created to send to FLS.

September:

FLS receives patient cohort list and commences patient contact for FLS initial assessment via phone.

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

Appendix A

Australia and New Zealand Fragility Fracture Registry (ANZFFR) Summary of Data Management Plan As Approved by the Health and Disability Ethics Committee Organisational Data Governance Oversight The overall governance of the Australia and New Zealand Fragility Fracture Registry is provided by the bi-national Steering Committee. This consists of researchers and clinicians representing the multidisciplinary nature of fragility fracture management and prevention.

New Zealand has an Implementation and Management committee. This has representatives from government health agencies, special societies, clinicians, and researchers. There is Māori representation and consumer representation is planned.

There will be a bi-national data governance sub-committee to address issues of data access and management, which will make recommendations to the Steering Committee.

Data management will be supervised by a Data Governance Sub-Committee of the ANZFFR Steering committee. The following policies have been developed and approved by the Health and Disability Ethics Committee (HDEC) as above.

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ANZFFR Steering Committee Terms of Reference

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ANZFFR Data Governance Sub-Committee Terms of Reference

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ANZFFR Data Access Policy

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ANZFFR Data Request Form

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ANZFFR Variable Checklist

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ANZFFR Confidentiality Agreement

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ANZFFR Outlier Management Policy

Registry Purpose Function and Overview The purpose of the Australia and New Zealand Fragility Fracture Registry is to use data to improve health system performance and maximise outcomes for people with fragility fractures by improving secondary fracture prevention, reducing rates of further fragility fractures and their associated morbidity and mortality.

The data will primarily be used to provide feedback on performance of Fracture Liaison Services (FLS), and their performance against the Clinical Care Standards for FLS in New Zealand. This feedback will be at several levels: local service, New Zealand, and benchmarking with Australian services. This will be made public in an Annual Report.

www.fragilityfracture.co.nz ANZFFR Summary of Data Management Plan NZ V1.0 9 February 2022

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

The de-identified data will also be available for approved, future, currently unspecified research projects if they have Ethics committee approval. The data governance sub-committee of the Registry will review each application and deem that it aligns with the aims of the Registry and will lead to improvement in the care of people with falls, osteoporosis, and fragility fractures.

See below for more details.

Patients’ privacy will be protected and controlled by the security systems of the data management and, also the level of detail (i.e., small numbers) in reports, which could potentially lead to identification.

If patients put restrictions on future research, a separate data field can be developed to acknowledge this, so their data can be excluded and that this can be audited.

The study coordinator in collaboration with the Principal Investigator will manage access to all study data. Only recognised FLS coordinators and site clinical leads or principal investigators will be provided logon access to the Registry. As this is a multi-site study, the software functionality will be used to ensure the coordinators at each site will only have access to data from their own sites.

Participants may withdraw consent at any time by informing their clinical team, emailing the Registry, completing the opt out form or using a link on the Registry website. On this notice, their record will be marked as Opted Out, but their identifiers will remain to prevent re-addition.

It will be possible for participants to request corrections and omissions to their data. All enquiries and complaints should initially be raised with the clinical team at their site. If this is unsatisfactory, they can contact the coordinating investigator for New Zealand, either directly or via the Registry website.

There will be no facility for returning results to participants. This is usual care, therefore all results and issues arising from usual care can be discussed with their clinical team. It will also be communicated to their GP. Annual Reports will be available on the Registry website, but individual participants will not be informed.

Participatory engagement with patient groups will be facilitated by having a Māori adviser, Pacifica adviser, and patient representatives on the New Zealand Implementation and Management committee.

The Registry function will be made transparent by publicly publishing annual reports. Quarterly updated data can be provided for public websites such as the Live Stronger for Longer website.

Security details As part of the clinical work, Registry specific source documents will be maintained. The source data is from the clinical record and by patient interview. The data required for the Registry may be recorded initially on a paper form which will be stored in locked filing cabinet in locked rooms until they are completed and entered into the web-based Registry. Once the data has been entered on the Registry the paper form will be securely destroyed.

The private information held in the database is encrypted using the specific service credentials and all data is transferred over encrypted connections. Users will only ever have 3 access to specific patient information derived from their own service. Any data used in reports is aggregated and contains no private information.

www.fragilityfracture.co.nz ANZFFR Summary of Data Management Plan NZ V1.0 9 February 2022

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

It is unlikely that any individual or organisation would receive any benefit from identifications of the individuals in the dataset however the possibility of identity theft is present. The risk of reidentification is reduced by using a secure server which is encrypted and only accessible to those authorised to do so.

The web-based Registry is accessed by password protected computers to the Registry application which is password protected with a two-step authentication protocol.

Storage details The data storage and management for this project will adhere to best practice guidelines, which is a secure web-based data management tool in line with current standards for medical registries. This will include: •

real-time user level reporting

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an integrated calendar for tracking patient-related tasks

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Excel import and export facilities

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API functions for pushing and pulling data from other systems

The Registry is to be hosted on secure Azure servers, located in University of New South Wales, Medical Information Technology facility where other bi-national registries are housed.

This storage arrangement is approved by the Ministry of Health. When secure Azure servers are available in New Zealand the Registry data will be transferred to New Zealand sovereign servers. This is likely before the end of 2022.

The registry is written in the current version of .Net and uses Microsoft SQL as the database.

Data Management in More Detail Consent for Data Collection and Use Opt-out consent is approved for this project. The participant is informed about the Registry at the time of initial clinical contact. This is done verbally, and the participant is provided with written information (Patient and / or Relative’s Information Sheet). Unless the participant declines, it is assumed that they have given consent for the data about their usual care for a fragility fracture to be collected into the Registry.

Data Collection Data will be collected from the following sources: •

Direct communication with the participant

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Participant medical records

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Communications with participant’s clinical care team (if indicated).

The data is collected by clinical staff as part of usual care and secondary prevention for a patient with a fragility fracture. All personnel involved in data collection will be trained in Good Clinical Practice for Research (GCP), study protocol, and collection requirements.

www.fragilityfracture.co.nz ANZFFR Summary of Data Management Plan NZ V1.0 9 February 2022

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

Privacy and Confidentiality Participants’ privacy and confidentiality will be respected through the protection of their data as outlined in this plan. The Registry will comply with legal and regulatory requirements regarding the privacy and confidentiality of participants’ data.

Participants will be able to access, and correct personal data held by the Registry. This process can occur via their clinical team. Because the Registry is collecting data about usual care, all aspects of their care will also be available via their GP. A process has been developed for action if participant privacy and confidentiality is breached.

Forms of Data Identifiable Data All data is collected in identifiable form.

De-identified Data De-identified data in this study includes but is not limited to •

All data items as outlined in the Data Dictionary apart from identifiers

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De-identified data will carry the participant’s Fragility Fracture Registry unique study number. The Investigator will retain a log linking participant code with identifiers. This log will not be made available to Contract Research Organisation (CRO) or Sponsor.

All data generated by the Registry will be in de-identified form. No attempt will be made to reidentify participants.

Anonymous / Anonymised Data De-identified data may be anonymised prior to being made available for future research Anonymised data will be irreversibly stripped of the unique participant code and any other identifiers.

Access to and Use of Data Identifiable Data •

Identifiable data can only be accessed by the data manager, HDEC and other government agencies to check compliance with legal and regulatory requirements.

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Researchers with appropriate ethics approval and comprehensive data management plans, subject to approval by Data Governance Sub-committee and Steering Committee, can request data for the purposes of research involving linked datasets. Identified data will not be provided directly, but via a data linkage centre. The researcher will receive linked but de-identified data.

De-identified Data De-identified data may be accessed and used by the following groups: •

The Investigator and suitably trained and experienced study staff, to conduct the study.

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The Health and Disability Ethics Committee and other government agencies only to check compliance with legal and regulatory requirements.

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Researchers with appropriate ethics approval and comprehensive data management plans, subject to approval by Data Governance Committee and Steering Committee.

www.fragilityfracture.co.nz ANZFFR Summary of Data Management Plan NZ V1.0 9 February 2022

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Te Whatu Ora – Hauora a Toi Bay of Plenty

Continuation of secondary fracture prevention to include prior fragility fractures Proof of concept

De-identified data may be included in published study results including, but not limited to, peerreviewed publications, clinical trial registry websites, scientific meetings, and regulatory submission.

Anonymous / Anonymised Data Anonymised data may be accessed and used by the same groups described for de-identified data.

Sending Data Overseas Identifiable and de-identified data will be sent and stored overseas in Australia as explained above.

Participants will be informed of the potential risks and cultural issues associated with sending and storing data overseas, and that there will be New Zealand representation on the overseas (joint Australia and New Zealand) data governance committee.

Future Use of Data De-identified data will be used by the Registry for future medical or scientific research as specified below: •

Unspecified purposes which are directly related to the study questions

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Unspecified purposes which are related to the conditions under study

De-identified data will be made available to other researchers on request for future research as specified above and / or will be added to data from other sources to form larger datasets.

In all cases, the ANZFFR Data Governance Committee and ANZFFR Steering Committee must be satisfied that appropriate Data Management Plans are in place and that ethical approval for use has been obtained in accordance with local laws and regulations.

Data Linking HDEC has approved the linkage of the data in the ANZFFR with data contained in the Australia and New Zealand Hip Fracture Registry (ANZHFR) (New Zealand data set only) and the Ministry of Health Mortality Collection.

The Ministry of Health will perform the data linkage for the Mortality Collection.

Both the ANZHFR and the ANZFFR New Zealand data is stored on the same server and is managed by the same data manager who will perform data linkage under the supervision of the ANZFFR and ANZHFR Data Governance Sub-Committees.

The HDEC has approved developing interoperability between the ANZFFR and the ANZHFR. All patients in the ANZHFR will also be included in the ANZFFR because hip fractures are the most severe of the fragility fractures. This follows the Ministry of Health publication “Interoperability Roadmap – accelerating the shift to a fully interoperable digital health information ecosystem”. Health Information Standards Organisation (HISO) 10083:2020, September 2020. There are small number of identical fields in both Registries, and it makes sense to only enter them once. This is practical because both Registries are stored in the same location and managed by the same data manager. This will become available at a later stage.

www.fragilityfracture.co.nz ANZFFR Summary of Data Management Plan NZ V1.0 9 February 2022

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