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Trial registered on ANZCTR


Registration number
ACTRN12616000782437
Ethics application status
Approved
Date submitted
15/12/2015
Date registered
15/06/2016
Date last updated
27/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of vitamin D supplements in Australian residential aged care facilities (ViDAus Study)
Scientific title
Implementation of vitamin D supplements in Australian residential aged care facilities (ViDAus Study)
Secondary ID [1] 288153 0
Nil known
Universal Trial Number (UTN)
U1111-1177-6725
Trial acronym
ViDAus Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls Prevention 297065 0
Vitamin D deficiency 297066 0
Implementation Science 297067 0
Condition category
Condition code
Diet and Nutrition 297294 297294 0 0
Other diet and nutrition disorders
Injuries and Accidents 297295 297295 0 0
Fractures
Public Health 297300 297300 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The below described intervention will occur over 12 months for each participating residential aged care facility, The first group of participating sites began in December 2015 and the second group of participating sites will be beginning in June 2016. The study intervention will therefore be completed by June 2017.

Intervention: Multifaceted interdisciplinary education to increase vitamin D supplementation and reduce falls for older people in residential aged care facilities.

Educational information will be provided to all stakeholder groups in various formats. GPs, pharmacists and allied health staff will receive 4-5 newsletters throughout the duration of the intervention to report audit outcomes, provide education and to provide links to online materials. Each participating site will also receive these newsletters in addition to printed educational materials. This will include brochures and posters suitable for residents and their families and more detailed written information for nursing staff. A short educational film will also be made available to all sites who will be encouraged to show this to their residents and their families. Site management, nursing and care staff will also be encouraged to attend a 1 hour face-to-face group seminar delivered by the study officer at each site focused on providing information on the role, sources and recommended use of vitamin D supplements. All of these resources will be made available to participating sites within the first 4 months of the intervention.

6 monthly feedback of vitamin D supplement use prevalence for each participating facility.

Identification of a local leader and use of an expert opinion leader to disseminate information to stakeholders of participating facilities.

Support for the identification and execution of quality improvement opportunities to increase best practice vitamin D supplement use by residents. This will occur through discussions with the nominated key contact/s of each site both face to face and over the phone. Initial discussions will take place over the first 6 months of the intervention, with a plan to decide on a course of action at the end of this period once prevalence data has been reviewed and potential barriers have been identified.

Anonymous staff surveys and online questionnaires to measure knowledge, confidence and satisfaction. Anonymous resident and family questionnaires

Adherence to the above mentioned interventions will be measured by recording what was scheduled (E.g. face-to-face education), by taking attendance at sessions and via check in calls with key contacts to ascertain what has been achieved onsite (e.g. are educational posters and brochures on display, has the video been shown to residents and family members, have quality improvement plans been devised and has action been taken).
Intervention code [1] 293464 0
Behaviour
Intervention code [2] 294559 0
Lifestyle
Intervention code [3] 294560 0
Prevention
Comparator / control treatment
No intervention - standard care involving usual daily activities and care practices of each participating aged care facility without the influence of education, resources or facilitated quality improvement on vitamin D supplements..

This research encompasses a stepped wedge study design with the first half of participating facilities commencing the intervention at baseline and the second half of participating facilities commencing the intervention at six months. No intervention will be provided to the second half of facilities for the first six months and this will act as the comparator/control group.
Control group
Active

Outcomes
Primary outcome [1] 296871 0
Prevalence of adequate vitamin D supplement use, defined as equal to, or more than, 800IU/day. This will be assessed by collecting period prevalence data every six months from pharmacy databases that service participating sites. This will provide medication chart information for residents at participating sites throughout the duration of the intervention. All information collected will be de-identified.
Timepoint [1] 296871 0
Period prevalence points for data to be collected will be set for 1 week just before the start of the intervention, at the 6 month mark (baseline for the second wedge), 12 month mark (6 month mark for the second wedge) and the 18 month mark (to assess sustainability for the first wedge and prevalence at the end of the 12 month intervention for the second wedge sites). This equates to 4 separate collection points of the same information for all participating sites. This will assess rates prior to the intervention and allow for comparison between Wedge A and Wedge B participating facilities.
Secondary outcome [1] 319572 0
Rate of falls. This will be assessed by collecting the total number of falls that have occurred over each 6 month period in each participating site and dividing it by the number of occupied bed days to report as number of falls per 1000 occupied bed days.
Timepoint [1] 319572 0
Number of falls will be reported from pre-existing incident report databases routinely kept by each participating site. The number of falls will be collected for the previous 6 month period at baseline, 6 months (baseline for the second wedge), 12 months (6 months for the second wedge) and 18 months (12 months for the second wedge). This will total 4 collection points and data for 24 months.
Secondary outcome [2] 323142 0
Number of fallers, defined as the number of residents that have had at least 1 fall during each 6 month period. The number of new admissions during each period will be recorded to estimate the number of residents present in each facility during each 6 month period.
Timepoint [2] 323142 0
Number of fallers will also be reported from incident report databases routinely kept by each participating site. The number of fallers will be collected for the previous 6 month period at baseline, 6 months (baseline for the second wedge), 12 months (6 months for the second wedge) and 18 months (12 months for the second wedge). This will total 4 collection points and data for 24 months.
Secondary outcome [3] 323200 0
The prevalence of other medication use potentially related to falls and fracture prevention. This will be assessed by collecting period prevalence data from a nominated week in time every six months from pharmacy databases that service participating sites. This will provide medication chart information for residents at participating sites throughout the duration of the intervention. All information collected will be de-identified and variables collected will include:

- Calcium Supplement (yes/no and dosage)
- Osteoporosis Medication (yes/no)
- Total number of oral medications
Timepoint [3] 323200 0
Period prevalence points for data to be collected will be set for 1 week just before the start of the intervention, at the 6 months after intervention commencement (baseline for the second wedge), at 12 months (6 month mark for the second wedge) and at 18 months (to assess sustainability for the first wedge and prevalence at the end of the 12 month intervention for the second wedge sites). This equates to 4 separate collection points of the same information for all participating sites. This will assess rates prior to the intervention and allow for comparison between Wedge A and Wedge B participating facilities.
Secondary outcome [4] 323203 0
The feasibility of this multifaceted, interdisciplinary knowledge translation intervention will be determined by assessing the acceptability, fidelity and sustainability of the intervention.
Acceptability by stakeholder groups will be assessed through collected questionnaires, specifically designed for this intervention. Fidelity will be measured by recruitment and retention, collecting attendance at face-to-face educational sessions, recording whether a key contact or working group was identified and participated throughout the duration of the intervention, recording whether quality improvement activities were identified and implemented and also whether resources were made available to various target groups. Sustainability will be assessed by the same measures beyond the 12 month intervention.
Timepoint [4] 323203 0
Questionnaires will be provided to GPs, pharmacists, allied health and RACF staff at the beginning and again at the end of the 12 month intervention. Fidelity measures will be recorded throughout the duration of the intervention. Sustainability will be measured only for sites participating in the first wedge, at the 18 month mark (when the second wedge completes the 12 month intervention).

Secondary outcome [5] 324640 0
Effectiveness and perceived appropriateness of education and information provided. This will measured in three ways:
- Via pre and post education questionnaires provided to RACF staff during face-to-face education. These questionnaires have been specifically designed for this intervention.
- Via questionnaires provided to GPs, pharmacists and allied health professionals as well as RACF staff. These questionnaires have been specifically designed for this intervention.
- Via a short feedback questionnaire made available to residents and their family members.
Timepoint [5] 324640 0
Face-to-face education will be provided to each site during the first 4 months of the intervention. Pre and post education questionnaires will be provided during this time. Two questionnaires will be provided to GPs, pharmacists and allied health, with one at the beginning of the intervention and another at the end of the intervention (after 12 months). The short feedback questionnaire will be available for residents, their family members and RACF staff throughout the duration of the intervention.

Eligibility
Key inclusion criteria
Australian Residential Aged Care Facilities
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Australian residential aged care facilities with exclusively bed-bound, palliative or short term residents (<3months stay).
Australian residential aged care facilities with a baseline vitamin D supplement use prevalence of >80%.

Study design
Purpose of the study
Educational / counselling / training
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
Stepped wedge design, with the first half of participating facilities receiving the intervention from baseline and the second half of participating facilities receiving the intervention from 6 months. Both wedges receive a 12 month intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 292563 0
Other Collaborative groups
Name [1] 292563 0
Cognitive Decline Partnership Centre
Address [1] 292563 0
Level 3, Old Leighton Lodge (Building 8 via Gate 6)
Department of Rehabilitation and Aged Care (RACS)
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country [1] 292563 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Cognitive Decline Partnership Centre
Address
Level 3, Old Leighton Lodge (Building 8 via Gate 6)
Department of Rehabilitation and Aged Care (RACS)
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country
Australia
Secondary sponsor category [1] 291284 0
None
Name [1] 291284 0
Address [1] 291284 0
Country [1] 291284 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294039 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 294039 0
Level 13 Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 294039 0
Australia
Date submitted for ethics approval [1] 294039 0
30/03/2015
Approval date [1] 294039 0
09/06/2015
Ethics approval number [1] 294039 0
HREC/15/HAWKE/99

Summary
Brief summary
The purpose of this study is to promote widespread uptake of evidence based, best practice falls prevention in Australian residential aged care facilities. It is hypothesised that by employing implementation strategies such as education, conducting audits and facilitating system change to improve the timely identification of residents, we will see an increase in the use of vitamin D supplements by residents. It is anticipated that this will then assist with a reduction in falls over the long term in Australian residential aged care facilities.
Trial website
http://sydney.edu.au/medicine/cdpc/resources/vitamin-d-study.php
Trial related presentations / publications
Walker, P Miller Amberber, A Kurrle, S Kifley, A Cameron ID. 2017. Prevalence of vitamin D supplement use in Australian residential aged care facilities in November 2014. BMC Research Notes, 10:385.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5553921/
Public notes

Contacts
Principal investigator
Name 62010 0
Prof Ian D Cameron
Address 62010 0
John Walsh Centre for Rehabilitation Research
University of Sydney
Level 13 Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Country 62010 0
Australia
Phone 62010 0
+61 2 9926 4962
Fax 62010 0
+61 2 9926 4052
Email 62010 0
ian.cameron@sydney.edu.au
Contact person for public queries
Name 62011 0
Ms Pippy Walker
Address 62011 0
Menzies Centre for Health Policy, Charles Perkins Centre D17, The University of Sydney, NSW 2006
Country 62011 0
Australia
Phone 62011 0
+61 2 8627 5702
Fax 62011 0
+61 2 9926 4052
Email 62011 0
pippy.walker@sydney.edu.au
Contact person for scientific queries
Name 62012 0
Prof Ian D Cameron
Address 62012 0
John Walsh Centre for Rehabilitation Research
University of Sydney
Level 13 Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Country 62012 0
Australia
Phone 62012 0
+61 2 9926 4962
Fax 62012 0
+61 2 9926 4052
Email 62012 0
ian.cameron@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary