Skip to content

Translation of best practice osteoporosis re-fracture prevention: stopping fragility fractures to keep Australians out of hospital

Implementing the Osteoporosis Re-fracture Prevention Model of Care for patients over 50 with minimal trauma fractures: A hybrid type 3 effectiveness-implementation trial (IORP trial)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001093976
Enrollment
172
Registered
2020-10-20
Start date
2020-11-16
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients who sustain a minimal trauma fracture benefit from co-ordinated secondary fracture prevention clinics - Osteoporosis Re-fracture Prevention (ORP) services. There is cumulative evidence that these services increase rates of identification, investigation and initiation of appropriate treatment as well as reduce the rate of re-fracture and mortality. Multiple models of ORPs exist, with increasing numbers being implemented worldwide. However, existing ORPs may vary considerably in quality and the contribution of these services in truly reducing the care gap and treatment burden must be critically evaluated. Successful implementation of ORPs into practice needs to be informed by implementation research, with trials of sustainable implementation strategies to support more rapid and effective translation of effective models of care into practice. The Implementing the Osteoporosis Re-fracture Prevention Model of Care effectiveness-implementation hybrid trial (IORP trial) will assess the effect of a facilitated implementation strategy using existing local implementation resources and supports on multiple implementation, effectiveness outcomes. This project is designed to improve the implementation of ideal ORP services into three different hospital settings across three local health districts in New South Wales, Australia. The IORP trial will use available implementation training and resources as well as improvement cycles and implementation stages. It is a type 3 hybrid study, with emphasis on testing the implementation strategy, whilst also gathering information on effectiveness. Each site will have pre-implementation formative assessments, two implementation cycles (initial implementation, full implementation) and post implementation summative assessments. The study will use a stepped wedge design, commencing at the three sites in a sequential fashion. The trial will report implementation and effectiveness outcomes including reporting of 3 monthly key performance indicators, capture the fracture assessments, linked re-fracture and mortality data and qualitative analysis, and will compare effectiveness outcomes to those of a fourth comparator site, currently operating as a model site.

Interventions

The trial is designed to improve the implementation of ideal Osteoporosis Re-fracture Prevention (ORP) services into three different hospital settings across three local health districts in New South Wales, Australia and will have two elements: improvement cycles and implementation stages. Different research methodologies will be used for this trial, including qualitative data collection from focus group discussions (FGD) and semi-structured interviews (formative and summative evaluation), routi

The trial is designed to improve the implementation of ideal Osteoporosis Re-fracture Prevention (ORP) services into three different hospital settings across three local health districts in New South Wales, Australia and will have two elements: improvement cycles and implementation stages. Different research methodologies will be used for this trial, including qualitative data collection from focus group discussions (FGD) and semi-structured interviews (formative and summative evaluation), routine quantitative data extraction (% bone mineral density (BMD)), linkage data analysis (refracture and mortality) and costing data. Formative evaluation and creation of an implementation strategy will occur based on data from Focus group discussions (FGDs) and interviews with: (1) patients and their caregivers, (2) key ORP staff, and (3) other stakeholders (e.g. geriatricians, orthopaedics, radiologists, pharmacists). FGDs and interviews will use semi-structured questions. The purpose of the FGDs and interviews will be to describe the context in which each ORP service innovation will be implemented, identify barriers and facilitators to implementation, and develop an ORP service adapted for the setting that takes into account the unique features of the context. FGDs and interviews will be conducted face-to-face or by telephone. They will include demographic information, be audio-recorded and transcribed verbatim, taking <30 minutes. Content analysis will be applied by the two Project Managers working independently for research rigor, using NVivo software. Formative evaluation data will inform the development of localised implementation strategies; planning communication and marketing, resourcing, any training and preparation required for implementation. FGDs and interviews will also be conducted at the comparator site, to illustrate barriers, facilitators and experiences of implementation in this context. Cycle 1: Initial implementation (6 months at each site): Led by each site Chief Investigator (CI); each site will identify key initial components of their ideal ORP to implement in this cycle. Two months allocated for practical preparation, four months for initial implementation. Post cycle evaluation and Cycle 2 planning (2 months at each site): After each cycle, FGDs with patients and key ORP staff will evaluate how each cycle worked, how the service functioned and any barriers and facilitators to the optimum ORP (3 weeks). This formative evaluation will feed into problem solving discussions (1 week), followed by practical preparation for Cycle 2 (1 month). Data collection will repeat formative evaluation methods with staff and patients. Project Managers will analyse site-specific data and present brief formative evaluation (lessons learnt) at Site Steering Group planning meetings. Cycle 2: Full implementation (5 months at each site): Cycle 2 will proceed as Cycle 1, with 1 month preparation for 4 months full implementation of the optimal ORP model at each site. Summative evaluation (Post implementation, 1 month at each site) will consist of a final round of qualitative data collection and analysis. Recruitment and sampling will repeat formative evaluation methods, capturing the final evaluation of the ORP service delivery and implementation of the service. Each study site will also submit 3 months’ of service process data pre-implementation and post-implementation to benchmark their services against the optimal ORP service, to demonstrate the fidelity of site services. Cost-effectiveness data will also be collected pre and 3 years post-ORP service implementation.

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged 50 years or more that have been diagnosed with osteoporosis with a minimal trauma fracture visiting the participating hospital sites. ORP staff working within the participating hospital sites; will be identified by the primary investigators at each site and may include the ORP clinical lead and the ORP co-ordinator. Stakeholders (e.g. geriatricians, orthopaedics, medical administration, radiologist, pharmacist).

Exclusion criteria

Patients who are deemed ineligible for the service by the ORP staff (e.g. palliative patients, patients with metastatic bony malignancy)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026