Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001093976
Ethics application status
Approved
Date submitted
12/08/2020
Date registered
20/10/2020
Date last updated
20/10/2020
Date data sharing statement initially provided
20/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Translation of best practice osteoporosis re-fracture prevention: stopping fragility fractures to keep Australians out of hospital
Scientific title
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)
Secondary ID [1] 301993 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoporosis 318556 0
Condition category
Condition code
Musculoskeletal 316567 316567 0 0
Osteoporosis
Public Health 317006 317006 0 0
Health service research
Injuries and Accidents 317007 317007 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318590 0
Rehabilitation
Comparator / control treatment
The trial 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 effectiveness outcomes of the three sites will be compared to a fourth comparator site (primary reference comparator), currently operating as a model site. The pre-implementation phase ( two months before initial implementation) of each site will also be compared with post-ORP service implementation phase.
Control group
Active

Outcomes
Primary outcome [1] 324701 0
Any change in re-fracture, hospitalization and mortality rates among patients presenting to one of the participating hospital sites as assessed by comparing mortality and hospital record data held by NSW Ministry of Health (composite outcome).
Timepoint [1] 324701 0
1 year before and after ORP service implementation
Secondary outcome [1] 385429 0
Cost-effectiveness of the new ORP service by assessing the linked data identified from the NSW Admitted Patient Data Collection (APDC) and Emergency Department Data Collection (EDDC) as well as linked data related to service and medication usage obtained by linkage to the Pharmaceutical Benefits Scheme and the Medicare Benefits Scheme. Moreover, cost per secondary fracture averted and cost per quality-adjusted life years (QALYs) will also be assessed. Quality of life will be determined using EQ-5D.
Timepoint [1] 385429 0
Pre and 3 years post-ORP service implementation

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are deemed ineligible for the service by the ORP staff (e.g. palliative patients, patients with metastatic bony malignancy)

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17227 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 17228 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 17229 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 17230 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 30939 0
2170 - Liverpool
Recruitment postcode(s) [2] 30940 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 30941 0
2031 - Randwick
Recruitment postcode(s) [4] 30942 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 306415 0
Government body
Name [1] 306415 0
National Health and Medical Research Council Medical Research Futures Fund grant MRF1176600
Country [1] 306415 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo, NSW, 2007
Country
Australia
Secondary sponsor category [1] 306925 0
None
Name [1] 306925 0
Address [1] 306925 0
Country [1] 306925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306612 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306612 0
Research Directorate, Locked Bag 7103,
LIVERPOOL BC NSW 1871
Ethics committee country [1] 306612 0
Australia
Date submitted for ethics approval [1] 306612 0
Approval date [1] 306612 0
12/02/2019
Ethics approval number [1] 306612 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Patient sample size: 60 patients

Key ORP staff may include the ORP clinical lead and the ORP co-ordinator (participants will be identified as eligible by the primary investigators; sample size: 72 staff members)

Stakeholders may include staff from the ortho-geriatrics, orthopaedics, medical administration, radiology, pharmacy, falls clinic, endocrinology, rheumatology, and physiotherapy (participants will be identified as eligible by the key ORP staff; sample size: 40 stakeholders)

Contacts
Principal investigator
Name 104462 0
Prof Lin Perry
Address 104462 0
School of Nursing & Midwifery, Faculty of Health University of Technology Sydney Broadway, NSW 2007
Country 104462 0
Australia
Phone 104462 0
+61 295145840
Fax 104462 0
Email 104462 0
[email protected]
Contact person for public queries
Name 104463 0
Lin Perry
Address 104463 0
School of Nursing & Midwifery, Faculty of Health University of Technology Sydney Broadway, NSW 2007
Country 104463 0
Australia
Phone 104463 0
+61 295145840
Fax 104463 0
Email 104463 0
[email protected]
Contact person for scientific queries
Name 104464 0
Lin Perry
Address 104464 0
School of Nursing & Midwifery, Faculty of Health University of Technology Sydney Broadway, NSW 2007
Country 104464 0
Australia
Phone 104464 0
+61 295145840
Fax 104464 0
Email 104464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8781Study protocol  [email protected]
8782Statistical analysis plan  [email protected]
8783Clinical study report  [email protected]
8784Analytic code  [email protected]



Results publications and other study-related documents

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