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Trial registered on ANZCTR


Registration number
ACTRN12619001420134
Ethics application status
Approved
Date submitted
3/09/2019
Date registered
15/10/2019
Date last updated
22/07/2022
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating Osteoporosis in Primary Care: The Osteoporosis Risk and Management (ORMA) Project
Scientific title
Integrating Osteoporosis in Primary Care: The Osteoporosis Risk and Management (ORMA) Project
Secondary ID [1] 299142 0
None
Universal Trial Number (UTN)
U1111-1239-4578
Trial acronym
ORMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 314208 0
Condition category
Condition code
Musculoskeletal 312568 312568 0 0
Osteoporosis
Public Health 312569 312569 0 0
Health service research
Public Health 312570 312570 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this stepped wedge design, general practices will be randomly allocated to start the intervention every 4 weeks.

Intervention: Use of CAT-Osteoporosis by clinicians.

CAT-Osteoporosis is a module, part of CAT (Clinical Audit Tool) software developed by PenCS which uses graphs and reports to identify patients in risk of osteoporosis (Primary prevention) or to identify patients who require an improved disease management (Secondary prevention) by general practitioners.

Graphs and reports contain variables such as date of birth, sex, life style factors, androgen deficiency, menopause status, osteoporosis diagnosis, minimal trauma fracture, date of last fracture and recurring fracture which help the general practitioner to visually determine the health status of the participant.

Once general practices are randomized to start the intervention, they will have continuous access to the hotline, website and printer materials and it could be used as their discretion.

The study is implemented as follow:

-Recruitment: This phase involves the initial contact with the general practices. The Study team will work with the local Primary Health Network (PHN) whenever possible to engage with general practices. A total of 16 general practices will be invited to participate in the study.

-Phase I Pre-implementation: Involves the installation/integration of the CAT-Osteoporosis tool in the general practice PenCS software (previous consent from GPs). During this phase, GPs will not be able to determine whether the CAT-Osteoporosis tool has been installed in their computers, they will not receive any additional information on the module and will not be allowed to generate any reports. This phase will have a duration of 4 weeks and it will involve the export of baseline data from the PenCS system and the collection of practice-based characteristics (overall number of patients registered, number of GPs employed, combined EFT of GP employed, gender distribution of doctors, additional services offered at the clinic)

-Phase II Implementation: This phase involves the progressive (stepped wedge) implementation of CAT-Osteoporosis into 2 general practices every 4 weeks. GPs will receive a Quick Reference Guide (supplied by PenCS) in using the CAT and will be provided with teaching materials on osteoporosis detection and treatment (provided by Osteoporosis Australia), along with copy of the current RACGP osteoporosis guidelines. In addition, GPs will have access to a hotline (run by the Clinical Research Coordinator and Clinical Research Fellow (CI Zanker)) which will provide them with guidance on using the system and on decision-making processes.

-Phase III Post Implementation: During this phase data will be collected from general practices using CAT-Osteoporosis. This phase will involve monthly data extracts and will have a duration of 4 months. Once the last data extract has been collected, general practitioners involved in the study will proceed to fill up the post-implementation survey.

As this study is considered a Quality Improvement activities. General practices involved will meet the requirements for the Quality Improvement Incentive (QI) part of the Practice Incentive Program (PIP).
Intervention code [1] 315416 0
Diagnosis / Prognosis
Intervention code [2] 315417 0
Prevention
Comparator / control treatment
This is a stepped wedge design meaning that each general practice will constitute its own control until they are randomized to start the intervention with two new general practices starting the implementation phase every 4 week.
Duration of the study is as follow:
Pre-implementation: 4 weeks
Implementation: 4 weeks
Post - implementation: 4 months.
Control group
Active

Outcomes
Primary outcome [1] 321216 0
Proportion of patients appropriately identified with osteoporosis risk factors following RACGP osteoporosis guidelines, as assessed by examination of participant medical records.
Timepoint [1] 321216 0
4 months after implementation
Secondary outcome [1] 374349 0
Proportion of patients appropriately tested for osteoporosis following RACGP guidelines as assessed by the evaluation of the general practitioner.
Timepoint [1] 374349 0
4 months after implementation
Secondary outcome [2] 374350 0
Proportion of patients with an adequate documented diagnosis of osteoporosis as assessed by general practitioner's update of participant medical records.
Timepoint [2] 374350 0
4 months after implementation
Secondary outcome [3] 374770 0
Proportion of patients meeting the recommended guidelines for disease treatment evaluated through the examination of participant's medical records.
Timepoint [3] 374770 0
4 months after implementation
Secondary outcome [4] 374771 0
Impact of the educational support provided to participating GPs on the earlier detection and management of osteoporosis and associated risk factors in patients evaluated using the GPs post-implementation survey
Timepoint [4] 374771 0
4 months after implementation
Secondary outcome [5] 374772 0
Cost-effectiveness of ORMA project using Quality-Adjusted Life Year (QALY) data
Timepoint [5] 374772 0
4 months after implementation

Eligibility
Key inclusion criteria
• General practices located in Victoria.
• General practices with PenCS software pre-installed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• General practices using a different medical software than PenCS.
• General practices that have adopted a quality improvement process for their patients with osteoporosis in the last 12 months.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At each time point (every 4 weeks) two general practices will be randomly selected (using simple randomisation created by a computer software) to start the intervention. To align with the study timelines, in a case of delayed recruitment additional clinics will be added to the randomisation schedule at the time of their recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped Wedge design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive characteristics of all clinics will be presented. Changes in primary and secondary outcomes over time will be presented as number and proportion of overall sample. The effectiveness of the tool on primary outcome will be evaluated using mixed effects logistic regression with time being fixed effect allowing for the clustering of the outcome within the participant and within the clinic. Same analysis approach will be used for all secondary outcomes. Descriptive statistics will be used for evaluating the effectiveness of the education component. Cost-effectiveness of the tool will be evaluated using QALY. The incidence rate of osteoporotic fractures will be obtained from the extracted clinical data as well as by literature review. QALY measures associated with osteoporotic fractures in Australian setting will be obtained from the literature. Number of QALYs gained by using the CAT tool to improve the treatment of osteoporosis will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2019
Actual
24/07/2020
Date of last participant enrolment
Anticipated
30/03/2020
Actual
11/01/2022
Date of last data collection
Anticipated
31/07/2022
Actual
30/06/2022
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303682 0
Government body
Name [1] 303682 0
Melbourne Academic Center for Health
Country [1] 303682 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
176 Furlong Road, St Albans, VIC, 3021, Australia
Country
Australia
Secondary sponsor category [1] 303787 0
Hospital
Name [1] 303787 0
Western Health
Address [1] 303787 0
176 Furlong Road, St Albans, VIC, 3021, Australia
Country [1] 303787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304207 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 304207 0
Ethics committee country [1] 304207 0
Australia
Date submitted for ethics approval [1] 304207 0
28/08/2019
Approval date [1] 304207 0
08/10/2019
Ethics approval number [1] 304207 0
HREC/55360/MH-2019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96138 0
Prof Gustavo Duque
Address 96138 0
The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
Country 96138 0
Australia
Phone 96138 0
+61 3 83958212
Fax 96138 0
Email 96138 0
gustavo.duque@unimelb.edu.au
Contact person for public queries
Name 96139 0
Diana Navarro-Perez
Address 96139 0
The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
Country 96139 0
Australia
Phone 96139 0
+61 383958233
Fax 96139 0
Email 96139 0
diana.navarroperez@unimelb.edu.au
Contact person for scientific queries
Name 96140 0
Gustavo Duque
Address 96140 0
The University of Melbourne
176 Furlong Road, St Albans, VIC, 3021, Australia
Country 96140 0
Australia
Phone 96140 0
+61 3 83958212
Fax 96140 0
Email 96140 0
gustavo.duque@unimelb.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 collected will be non-identifiable


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4430Study protocol  diana.navarroperez@unimelb.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.