ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12623001141639

Ethics application status

Approved

Date submitted

20/09/2023

Date registered

6/11/2023

Date last updated

16/11/2023

Date data sharing statement initially provided

6/11/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE): Investigating the impact on quality use of medicines

Scientific title

Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE): Investigating the impact on quality use of medicines

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Polypharmacy

Dementia

Potentially inappropriate medications

Condition category

Condition code

Neurological

Dementias

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This trial will examine interventions to implement new Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (Guideline, https://app.magicapp.org/#/guideline/jMMeqj).

This is a RACF level intervention and each RACF will be randomised to one of three groups (Group A, B or C) . Each facility will receive all three levels of implementation strategies, one for each psychotropic medication class (antipsychotics, antidepressants, benzodiazepines). Each level of implementation strategy will be delivered simultaneously throughout the 12-month intervention period. The outcomes from RACFs delivering the level 3 or 2 intervention will be compared to the outcomes from RACFs delivering the level 1 intervention within each medication context. Each knowledge broker will be a registered pharmacist and will deliver each level of implementation strategy.

The possible implementation strategy to medication combinations include:
*Group A: Level 1 implementation strategy for antidepressants; Level 2 implementation strategy for benzodiazepines; Level 3 implementation strategy for antipsychotics.
*Group B: Level 1 implementation strategy for antipsychotics; Level 2 implementation strategy for antidepressants; Level 3 implementation strategy for benzodiazepines.
*Group C: Level 1 implementation strategy for benzodiazepines; Level 2 implementation strategy for antipsychotics; Level 3 implementation strategy for antidepressants.

Level 1 - Distribution of Guideline and supporting materials
The level 1 strategy will involve distribution of the Guideline and supporting materials in both hard copy and electronically to each RACF (including on-site staff and visiting healthcare professionals). Materials will be distributed by the knowledge broker at baseline as well as on request. Distributed materials will include the NHMRC-approved Guideline, a companion guide, medication factsheets on antipsychotics, benzodiazepines and antidepressants, and a curated inventory of existing resources. The level 1 resources will be standardised and no local tailoring of materials will be provided. The level 1 resources have been developed as part of the dissemination strategy for the new Guideline.

Level 2 - Current best practice
The level 2 strategy will involve provision of quality use of medicines (QUM) services and distribution of the Guideline and supporting materials. QUM services are an Australian government funded service. The QUM service will be a series of sessions focused on a medication class (antipsychotics, benzodiazepines or antidepressants). Each QUM session will run for up to 70-minutes. The sessions will be a face-to-face group education activity delivered by the knowledge broker to RACF registered nurses, enrolled nurses and aged care workers directly employed by the aged care provider organisation. Delivery of a session will occur once a every 3 months, with four QUM sessions delivered over the 12 months. The level 2 resources will be standardised and no local tailoring of materials will be provided. The level 2 resources have been developed as part of dissemination strategy for the new Guideline.

Level 3 - Knowledge broker service
The level 3 strategy will involve an onsite knowledge broker who will develop and lead local action plans, as well as provision of QUM services and distribution of the Guideline materials. The knowledge broker will be a registered pharmacist. Each knowledge broker will undergo a training program over a 4-5 week period prior to commencement of the trial. The training program consists of:
*3 x 1.5 hour workshops on knowledge translation delivered by implementation science experts
*1 x 1.5 hour webinar on the EMBRACE study design delivered by the chief investigators
*1 x 1.5 hour webinar on the Clinical Practice Guideline delivered by the chief investigators
* Residential Aged Care Pharmacist: Foundation Training Program (9 hours) developed and delivered by the Pharmaceutical Society of Australia

The knowledge brokers will work across each participating RACF for that organisation at 1-4 days a week (depending on the number of RACFs they oversee). The knowledge broker will assess local needs, tailor strategies and activities for each RACF. Local action plans will be updated at each study time point (baseline, 3, 6, 9 and 12). Ongoing fidelity of the intervention delivered by the knowledge brokers will be monitored using the discussion boards, local action plans and monthly meetings with the investigator team.

Monthly project meetings will be held with the knowledge brokers and the aged care provider organisation to monitor ongoing project progress and intervention fidelity for all three levels of intervention.

Intervention code [1]

Treatment: Other

Comparator / control treatment

This trial will use a counterbalanced randomized controlled trial design. This trial design involves three levels of intervention (Level 1, 2 and 3) evaluated across three medication context areas (antipsychotics, antidepressants and benzodiazepine).

Level 1 is considered to be usual care and involves minimal intervention. Level 2 and Level 3 are the additional higher levels of intervention.

The outcomes from RACFs delivering the level 3 or 2 intervention will be compared to the outcomes from RACFs delivering the level 1 intervention within each medication context (i.e. the RACFs will act as a comparison group for each).

Control group

Active

Outcomes

Primary outcome [1]

Proportion of RACF-level Guideline concordant use of antipsychotics, benzodiazepines and antidepressants with level 3 intervention compared level 1 and level 2.

The Guideline used in this study will be the Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (https://app.magicapp.org/#/guideline/jMMeqj).

Overall Guideline concordance will be measured as a dichotomous outcome (i.e. concordant vs. not concordant). This dichotomous outcome will be a composite outcome based on a series of indicators for each medication class that have been developed for this study. The Guideline composite outcome and indicators have been developed specifically for this study.

Timepoint [1]

6-months after intervention commencement.

Secondary outcome [1]

Timepoint [1]

3-, 9- and 12- months after intervention commencement.

Secondary outcome [2]

Proportion of RACFs concordant with each individual indicator of the Guideline concordance composite outcome for antipsychotic use with level 3 intervention compared level 1 and level 2.

Aggregate facility-level concordance will be assessed as the proportion of residents who are concordant with each of the below list of antipsychotic indicators.

*Residents using antipsychotics have documentation of experiencing distressing psychotic symptoms and/or aggression/agitation within the past 12 weeks that represents a direct threat to either the resident or other residents, staff or family for the resident's prescription of the antipsychotic.
*Residents using antipsychotics have documentation individually targeted non-pharmacological management strategies to manage distressing psychotic symptoms and/or aggression/agitation that are currently in place.
*Residents using antipsychotics are using a second-generation antipsychotic.
*Residents using antipsychotics have documentation of informed consent for use of the antipsychotic.
*Residents using antipsychotics have a documented date of next review for antipsychotic treatment effectiveness.
*Residents using antipsychotics have a current antipsychotic adverse event monitoring protocol in place.
*Residents using antipsychotics have used the current antipsychotic for less than 12 weeks.
*Residents using antipsychotics for more than 12 weeks are currently having the antipsychotic dose tapered.
*Residents using antipsychotics for more than 12 weeks and not currently tapering have documentation that the resident has been reviewed by either: a psychiatrist or geriatrician; a formal documented discussion between the prescriber and a psychiatrist or geriatrician in which both practitioners agree; or a documented clinical review involving the prescriber and at least one other medical practitioner in which both practitioners agree.

.

Timepoint [2]

3-, 6-, 9- and 12-month after intervention commencement.

Secondary outcome [3]

Proportion of RACFs concordant with each individual indicator of the Guideline concordance composite outcome for benzodiazepine use with level 3 intervention compared level 1 and level 2.

Aggregate facility-level concordance will be assessed as the proportion of residents who are concordant with each of the below list of benzodiazepine indicators.

*Residents using benzodiazepines have documentation of individually targeted non-pharmacological management strategies for sleep disturbance that were trialled for an adequate period of time prior to commencing the benzodiazepine.
*Residents using benzodiazepines have documentation of individually targeted non-pharmacological management strategies to manage sleep disturbance that are currently in place.
*Residents using benzodiazepines have documentation of informed consent for use of the benzodiazepine.
*Residents using benzodiazepines have a documented date of next review for benzodiazepine treatment effectiveness.
*Residents using benzodiazepines have a current benzodiazepine adverse event monitoring protocol in place.
*Residents using benzodiazepines have used the current benzodiazepine for less than 2 weeks.
*Residents using benzodiazepines for more than 2 weeks are currently having the benzodiazepine dose tapered.
*Residents using benzodiazepines for more than 2 weeks and not currently tapering have documentation of a review of the harms and benefits of benzodiazepine continuation.

Timepoint [3]

3-, 6-, 9- and 12-month after intervention commencement.

Secondary outcome [4]

Proportion of RACFs concordant with each individual indicator of the Guideline concordance composite outcome for antidepressant use with level 3 intervention compared level 1 and level 2.

Aggregate facility-level concordance will be assessed as the proportion of residents who are concordant with each of the below list of antidepressant indicators.

*Residents using antidepressants have documentation of moderate or severe major depressive disorder.
*Residents using antidepressants have documentation of individually targeted non-pharmacological management strategies that are currently in place.
*Residents using antidepressants have documentation of informed consent for use of the antidepressant.
*Residents using antidepressants have a documented date of next review for antidepressant treatment effectiveness.
*Residents using antidepressants have a current antidepressant adverse event monitoring protocol in place.
*Residents using antidepressants have used the current antidepressant for less than 6 months.
*Residents using antidepressants for more than 6 months are currently having the antidepressant dose tapered.
*Residents using antidepressants for more than 6 months and not currently tapering have documentation of a review of the harms and benefits of antidepressants continuation.

Timepoint [4]

3-, 6-, 9- and 12-month after intervention commencement.

Secondary outcome [5]

Proportion of RACFs concordant with the Guideline indicator for antipsychotic use with level 3 intervention compared level 1 and level 2.

The Guideline used in this study will be the Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (https://app.magicapp.org/#/guideline/jMMeqj).

Overall Guideline concordance will be measured as a dichotomous outcome (i.e. concordant vs. not concordant). This dichotomous outcome will be a composite outcome based on a series of indicators for each medication class that have been developed for this study. The Guideline composite outcome and indicators have been developed specifically for this study.

Timepoint [5]

3-, 6-, 9- and 12- months after intervention commencement.

Secondary outcome [6]

Proportion of RACFs concordant with the Guideline indicator for benzodiazepine use with level 3 intervention compared level 1 and level 2.

The Guideline used in this study will be the Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (https://app.magicapp.org/#/guideline/jMMeqj).

Overall Guideline concordance will be measured as a dichotomous outcome (i.e. concordant vs. not concordant). This dichotomous outcome will be a composite outcome based on a series of indicators for each medication class that have been developed for this study. The Guideline composite outcome and indicators have been developed specifically for this study.

Timepoint [6]

3-, 6-, 9- and 12- months after intervention commencement.

Secondary outcome [7]

Proportion of RACFs concordant with the Guideline indicator for antidepressant use with level 3 intervention compared level 1 and level 2.

The Guideline used in this study will be the Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (https://app.magicapp.org/#/guideline/jMMeqj).

Overall Guideline concordance will be measured as a dichotomous outcome (i.e. concordant vs. not concordant). This dichotomous outcome will be a composite outcome based on a series of indicators for each medication class that have been developed for this study. The Guideline composite outcome and indicators have been developed specifically for this study.

Timepoint [7]

3-, 6-, 9- and 12- months after intervention commencement.

Secondary outcome [8]

Proportion of RACF-level Guideline concordant use of antipsychotics, benzodiazepines and antidepressants with level 1 intervention compared to level 2 intervention.

The Guideline used in this study will be the Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (https://app.magicapp.org/#/guideline/jMMeqj).

Overall Guideline concordance will be measured as a dichotomous outcome (i.e. concordant vs. not concordant). This dichotomous outcome will be a composite outcome based on a series of indicators for each medication class that have been developed for this study. The Guideline composite outcome and indicators have been developed specifically for this study.

Timepoint [8]

3-, 6-, 9- and 12- months after intervention commencement.

Secondary outcome [9]

Change in RACF-level prevalence of antipsychotic use compared to baseline.

RACF-level prevalence will be calculated by number of residents administered an antipsychotic in the last 7 days (regular and PRN) divided by total number of residents assessed at the RACF.

This data will be extracted from audit reports of the medication records of each facility.

Timepoint [9]

Baseline, 3-, 6-, 9- and 12- months after intervention commencement.

Secondary outcome [10]

Change in RACF-level prevalence of benzodiazepine use compared to baseline.

RACF-level prevalence will be calculated by number of residents administered a benzodiazepine in the last 7 days (regular and PRN) divided by total number of residents assessed at the RACF.

This data will be extracted from audit reports of the medication records of each facility.

Timepoint [10]

Baseline, 3-, 6-, 9- and 12- months after intervention commencement.

Secondary outcome [11]

Change in RACF-level prevalence of antidepressant use compared to baseline.

RACF-level prevalence will be calculated by number of residents administered an antidepressant in the last 7 days (regular and PRN) divided by total number of residents assessed at the RACF.

This data will be extracted from audit reports of the medication records of each facility.

Timepoint [11]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [12]

Change in RACF-level prevalence of z-drug use compared to baseline.

Z-drugs are defined as: zopiclone, eszopiclone, zaleplon and zolpidem.

RACF-level prevalence will be calculated by number of residents administered a z-drug in the last 7 days (regular and PRN) divided by total number of residents assessed at the RACF.

This data will be extracted from audit reports of the medication records of each facility.

Timepoint [12]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [13]

Change in RACF-level prevalence of opioid use compared to baseline.

RACF-level prevalence will be calculated by number of residents administered an opioid in the last 7 days (regular and PRN) divided by total number of residents assessed at the RACF.

This data will be extracted from audit reports of the medication records of each facility.

Timepoint [13]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [14]

Change in RACF-level prevalence of anticonvulsant use compared to baseline.

RACF-level prevalence will be calculated by number of residents administered an anticonvulsant in the last 7 days (regular and PRN) divided by total number of residents assessed at the RACF.

This data will be extracted from audit reports of the medication records of each facility.

Timepoint [14]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [15]

Change in RACF-level proportion of residents hospitalisation compared to baseline. Hospitalisation will be assessed as residents who had one or more emergency department presentations or hospital admissions within the last 3 months.

This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each facility.

Timepoint [15]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [16]

Change in RACF-level proportion of residents falls compared to baseline.

A fall event (one or more) will be assessed as an event that results in a person coming to rest inadvertently on the ground or floor or other lower level within the last 3 months.

This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each facility.

Timepoint [16]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [17]

Change in RACF-level proportion of residents falls with major injury compared to baseline.

Falls with major injury will be assessed as a fall event (one or more) that resulted in a major injury, or injuries within the last 3 months.

This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each facility.

Timepoint [17]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [18]

Change in RACF-level proportion of residents polypharmacy compared to baseline.

Polypharmacy will be assessed as residents who were prescribed nine or more medications within the last 3 months.

This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each facility.

Timepoint [18]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [19]

Change in RACF-level proportion of residents who report good or excellent quality of life as assessed using The Quality of Life Aged Care Consumers (QOL-ACC) tool compared to baseline.

This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each facility.

Timepoint [19]

3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [20]

Change in RACF-level proportion of residents who experienced a decline in activities of daily living compared to baseline.

Activities of daily living will be assessed as residents who experience a decline in their activities of daily living assessment total score of 1 or more points within the last 3 months.

Activities of daily living will be measured using the Barthel Index of Activities of Daily Living.

This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each facility.

Timepoint [20]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [21]

Change in RACF-level prevalence of medication incidents compared to baseline.

Medication incidents will be assessed by reported incident events in the RACF electronic risk management system within the last 3-months.

Medication incidents will be categorised according to the severity and type (e.g. an administration error, adverse drug reaction, resident error, pharmacy dispensing error or prescribing error).

Timepoint [21]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Secondary outcome [22]

Change in RACF-level prevalence of behavioural incidents compared to baseline.

Behavioural incidents will be assessed as reported incident events in RACF electronic risk management system within the last 3-months.

Behaviour incidents will also be collected from the Serious Incident Response Scheme (SIRS) and will include unreasonable use of force (e.g. hitting, pushing, shoving, or rough handling a consumer), psychological or emotional abuse and inappropriate use of restrictive practice.

Timepoint [22]

Baseline, 3-, 6-, 9- and 12-months after intervention commencement.

Eligibility

Key inclusion criteria

This will be a RACF-level intervention. All RACFs operated by the four partnering aged care provider organisations will be eligible to participate.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

This study does not have a resident-level exclusion criteria. It is a facility-level intervention.

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)

An epidemiologist independent to the study will perform the random allocation using a computerised random number generator and will be the holder of the allocation schedule.

Each aged care provider organisation’s leadership team were responsible for identifying specific RACFs operated by that organisation to take part in the trial.

The independent epidemiologist will inform the investigator team of the RACF's group allocation. The investigator team will then inform the RACF management team and the knowledge broker.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The unit of randomisation will be each RACF.

Participating RACFs will be matched into blocks of three based on the aged care provider organisation and geographical location (e.g. metropolitan vs. regional).

A RACF within each block of three will be randomised to Group A, B or C.

Randomisation will be performed by an independent researcher using a computerised random number generator within SAS (SAS Institute, Cary, NC).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Other

Other design features

This trial will use a counterbalanced randomized controlled trial design. RACF’s will be randomly assigned to one of three groups (Group A, B or C). Each RACF will receive all three levels of implementation strategies, one for each psychotropic medication class. Each level runs concurrently and the RACF acts as it own control.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

SAMPLE SIZE

We will recruit up to 19 RACFs operated by four different aged care provider organisations in New South Wales, Queensland, Victoria and Western Australia.

ANALYSIS PLAN

Effectiveness analysis

All primary analyses will be conducted using the intention to treat (ITT) principle. Per protocol analysis will also be undertaken to provide a measure of reliability of the primary analysis. The per protocol set (PPS) will consist of all RACFs in the full analysis set without a major protocol deviation. Major protocol deviations include, but are not limited to: loss of knowledge broker or incomplete delivery of intervention (e.g. local action plans, QUM service)

The primary analysis will compare the proportion of RACF-level Guideline concordant use of antipsychotic, benzodiazepines and antidepressants at 6-months with level 3 intervention compared to level 1 and level 2, adjusted for the proportions of use of each medication class as measured at baseline. A linear mixed model will be employed treating facility as a random effect, with the intervention level and medication type contexts as fixed effects. Multiple imputation will be used to impute missing covariate values where necessary. Data will be analysed using SAS (SAS Institute, Cary, NC) and the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL).

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

26/09/2023

Date of last participant enrolment

Anticipated

Actual

16/10/2023

Date of last data collection

Anticipated

31/12/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council: Medical Research Future Fund

Address [1]

Research Administration Section National Health and Medical Research Council GPO Box 1421 Canberra City ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

381 Royal Parade, Parkville VIC 3052

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Queensland

Address [1]

St Lucia QLD 4072

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Sydney

Address [2]

Camperdown NSW 2006

Country [2]

Australia

Secondary sponsor category [3]

University

Name [3]

Flinders University

Address [3]

Sturt Rd, Bedford Park SA 5042

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research And Ethics Committee

Ethics committee address [1]

Wellington Rd, Clayton VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2023

Approval date [1]

21/04/2023

Ethics approval number [1]

35525

Summary

Brief summary

High and variable rates of psychotropic medication use persist in residential aged care facilities (RACFs) despite minimal evidence of benefit and increasing evidence of harm. Knowledge brokers are individuals or groups who facilitate the transfer of knowledge into practice.

This study will employ an onsite pharmacist to act as a knowledge broker to implement new Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care (the Guideline). 

The intervention will involve the delivery of three implementation strategies: Level 1 - passive distribution of the Guideline; Level 2 - current best practice; Level 3 - employment of a knowledge broker. Each RACF will receive each strategy for one of three psychotropics medication (antipsychotics, benzodiazepines and antidepressants). 

In the level 3 strategy, the knowledge broker will develop an action plan and will undertake a variety of ongoing local activities to facilitate implementation of the Guideline.

It is hypothesised that the level 3 intervention knowledge broker will lead to improvements in Guideline concordant use of antipsychotics, benzodiazepines and antidepressants in RACFs compared to the other two levels.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof J Simon Bell

Address

Monash University, 407 Royal Parade, Parkville VIC 3052

Country

Australia

Phone

+61 3 9903 9533

Fax

[email protected]

Contact person for public queries

Name

Amanda Cross

Address

Monash University, 407 Royal Parade, Parkville VIC 3052

Country

Australia

Phone

+61 3 9903 9035

Fax

[email protected]

Contact person for scientific queries

Name

Amanda Cross

Address

Monash University, 407 Royal Parade, Parkville VIC 3052

Country

Australia

Phone

+61 3 9903 9035

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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.

Trial Review

Documents added manually

Documents added automatically