Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001132831
Ethics application status
Approved
Date submitted
23/10/2012
Date registered
24/10/2012
Date last updated
27/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing prevention, detection and treatment of osteoporosis through automated opportunistic reminders to patients, general practitioners and practice nurses.
Scientific title
In patients over 50 years old attending general practices, do automated opportunistic reminders issued to patients on arrival for consultations increase performance of indicated osteoporosis related care, compared to usual care?
Secondary ID [1] 281428 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 287681 0
Condition category
Condition code
Musculoskeletal 288022 288022 0 0
Osteoporosis
Public Health 288026 288026 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sheets with bone health related education, information based on the patients' electronic clinical record, and advice about possible desirable activities, that are generated and printed automatically when the patient is marked in the practice's electronic appointments system as 'arrived'. The education will be a few brief sentences about what osteoporosis is, and the risks that it poses to health and well-being. The information will tell the patient, depending on data in his or her electronic clinical record, that he or she either may be at high risk of osteoporosis, and why, or that they have been diagnosed with osteoporosis, what appropriate treatment(s) he or she is currently receiving, and what other treatments may be indicated. The advice will be to ask the doctor in the consultation to review the patient's bone health and treatments for it. Each eligible patient will be able to receive a sheet only once during the three month trial.
Intervention code [1] 285927 0
Early detection / Screening
Intervention code [2] 285928 0
Prevention
Comparator / control treatment
Care that the general practice usually provides to its patients
Control group
Active

Outcomes
Primary outcome [1] 288227 0
Proportions of patients who receive selected indicated osteoporosis-related services (bone mineral density, vitamin D level, advice or prescription of vitamin D and calcium supplement, prescription of treatment for osteoporosis (e.g . bisphosponates).

These outcomes will be measured by automated extraction of data from each patient's electronic clinical record.
Timepoint [1] 288227 0
3 months
Secondary outcome [1] 299659 0
Proportions of opportunities taken in each group during consultations to perform the services listed above.

These outcomes will be measured by automated extraction of data from each patient's electronic clinical record.
Timepoint [1] 299659 0
3 months
Secondary outcome [2] 299660 0
Numbers of consultations, Medicare item numbers and Medicare benefits claimed in each group.

These outcomes will be meausured by automated extraction of data from each patient's electronic clinical and administrative record.
Timepoint [2] 299660 0
3 months

Eligibility
Key inclusion criteria
Attend a participating general practice during the trial
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
General practices will be invited to participate.
The nature of the study prevents concealment of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices that are enrolled will be ranked by baseline performance of osteoporosis-related care. Starting with the two practices with the best performance, each pair of practices will be allocated to a usual care control group or to the intervention group by using randomised permuted blocks, which will ensure that equal numbers of practices in each stratum are allocated to each group.

An independent statistician will provide the table of random numbers to be used for the allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2012
Actual
4/10/2013
Date of last participant enrolment
Anticipated
Actual
3/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
13000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 286191 0
Charities/Societies/Foundations
Name [1] 286191 0
RACGP Foundation
Country [1] 286191 0
Australia
Primary sponsor type
Individual
Name
Dr. Oliver Frank
Address
Discipline of General Practice
University of Adelaide
North Terrace
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 285001 0
None
Name [1] 285001 0
None
Address [1] 285001 0
None
Country [1] 285001 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288266 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 288266 0
University of Adelaide
North Terrace
Adelaide
South Australia 5005
Ethics committee country [1] 288266 0
Australia
Date submitted for ethics approval [1] 288266 0
Approval date [1] 288266 0
17/07/2012
Ethics approval number [1] 288266 0
H-2012-093

Summary
Brief summary
Aims
This study aims to test the effect of informing and reminding patients, GPs and practice nurses opportunistically about care aimed at preventing, detecting and treating osteoporosis.

Research design
Cluster randomised controlled trial

Methods
Existing opportunistic reminder software used in general practices will be enhanced to provide reminders about osteoporosis-related care. Ten general practices will be randomised to a ‘usual care’ control group or to the intervention group, in which patients attending for consultations for whom osteoporosis-related care is due will receive an automatically-printed sheet of information and advice when they arrive for their consultation. The sheet will advise them to ask their GP or nurse about the care that is due. GPs and practice nurses will receive on-screen reminders during those consultations about the osteoporosis-related care that is due to be performed for the patient.

Likely outcomes and benefits
Performance of osteoporosis-related care will be significantly improved by the intervention. Widespread implementation of this strategy is expected to reduce the prevalence of osteoporosis and the loss of healthy life years resulting from preventable fractures. This will improve population health and reduce costs of health care.
Trial website
Trial related presentations / publications
Pre-consultation bone health information sheets increase care to prevent, detect and treat osteoporosis
Oliver Frank and Nigel Stocks
RACGP GP14 Conference, 10/10/2014, Adelaide
Public notes

Contacts
Principal investigator
Name 34863 0
Dr Dr. Oliver Frank
Address 34863 0
Discipline of General Practice
School of Population Health
University of Adelaide
Level 11, 178 North Terrace
Adelaide
South Australia 5005
Country 34863 0
Australia
Phone 34863 0
+61 407 181 683
Fax 34863 0
Email 34863 0
[email protected]
Contact person for public queries
Name 18110 0
Dr Dr. Oliver Frank
Address 18110 0
Discipline of General Practice
University of Adelaide
North Terrace
Adelaide
South Australia 5005
Country 18110 0
Australia
Phone 18110 0
+61 407 181 683
Fax 18110 0
+61 8 8313 3511
Email 18110 0
[email protected]
Contact person for scientific queries
Name 9038 0
Dr Oliver Frank
Address 9038 0
Discipline of General Practice
University of Adelaide
North Terrace
Adelaide
South Australia 5005
Country 9038 0
Australia
Phone 9038 0
+61 407 181 683
Fax 9038 0
+61 8 8313 3511
Email 9038 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.