Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000894594
Ethics application status
Approved
Date submitted
1/07/2024
Date registered
22/07/2024
Date last updated
22/07/2024
Date data sharing statement initially provided
22/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Maximising Embedded pharmacists in aGed cAre Medication Advisory Committees (MEGA-MAC): implementing Australia’s new Guiding Principles for Medication Management in Residential Aged Care Facilities using a knowledge broker and national quality improvement collaborative intervention.
Scientific title
Maximising Embedded pharmacists in aGed cAre Medication Advisory Committees (MEGA-MAC): implementing Australia’s new Guiding Principles for Medication Management in Residential Aged Care Facilities using a knowledge broker and national quality improvement collaborative intervention.
Secondary ID [1] 312244 0
Nil
Universal Trial Number (UTN)
Trial acronym
Maximising Embedded pharmacists in aGed cAre Medication Advisory Committees (MEGA-MAC).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 334030 0
Medication management 334254 0
Clinical governance 334255 0
Medication policy development 334256 0
Condition category
Condition code
Public Health 330794 330794 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will evaluate a multifactorial intervention to implement the Commonwealth of Australia (Department of Health and Aged Care) Guiding Principles for Medication Management in Residential Aged Care Facilities (Guiding Principles) in Australian residential aged care facilities (RACFs).

This is a RACF-level intervention. Each RACF will receive the intervention for nine months. The intervention involves a knowledge broker dyad (pharmacist and Medication Advisory Committee [MAC] representative) who will develop, implement and evaluate RACF-specific local action plans to implement the Guiding Principles. Knowledge brokers are individuals or groups that help to move knowledge from those who create the knowledge to those that use the knowledge. The knowledge broker dyad will be supported by a national quality improvement collaborative, called the MEGA-MAC collaborative.

The knowledge broker dyad will consist of:
* A registered pharmacist working on-site at the RACF. The pharmacist will be responsible for leading the knowledge broker dyad and will spend 4.5 hours per RACF per week on the intervention.
* A healthcare professional MAC representative (chair or member of the MAC) who provides services to the RACF. The MAC representative will spend 1.5 hours per RACF per week supporting the pharmacist to deliver the intervention.

The knowledge broker pharmacist may work at one participating RACF or multiple participating RACFs. In the latter case, the knowledge broker pharmacist may collaborate with a different MAC representative for each RACF, the same MAC representative for all the RACFs the MAC governs, or a mixture of both.

The knowledge broker dyads will be trained to deliver the intervention. Training will involve completing a series of self-paced education modules that will take approximately 4 hours in total. Training will be developed by the Project Management Team and will be made available to the knowledge broker dyads within 4 weeks of commencing the intervention. The education modules will cover topics on medication safety and the quality use of medicines in Australian residential aged care, the Guiding Principles, the MEGA-MAC study design and knowledge translation (e.g. local actions plans, how to be a knowledge broker).

The MEGA-MAC collaborative will act as a real-time clinical network to facilitate sharing of experience and expertise between the knowledge broker dyads at each RACF and support the knowledge broker dyads, RACFs, MACs and aged care provider organisations to implement the Guiding Principles into practice. The MEGA-MAC collaborative will be supported by a panel of clinical experts, implementation scientists and consumer representatives. The MEGA-MAC collaborative will conduct quarterly virtual ‘MEGA-MAC’ meetings (baseline, 3, 6 and 9 months), distribute quarterly ‘MEGA-MAC’ newsletters (baseline, 3, and 6 months), provide expert and peer review feedback on the knowledge broker dyads’ local action plans (baseline, 3 months and at 6 months), and offer ongoing ad-hoc expert and peer support via virtual meetings. ‘MEGA-MAC’ meetings will be approximately one hour in duration and all knowledge broker dyads participating in the intervention will be invited to attend.

Ongoing fidelity of the intervention delivered by the knowledge broker dyads will be monitored using the local action plans, the MEGA-MAC collaborative meetings and monthly meetings with the Project Management Team.
Intervention code [1] 328840 0
Treatment: Other
Comparator / control treatment
The trial will use an interrupted time series design. This design will involve retrospective (pre-intervention: - 6 months, -3 months, baseline) and prospective (post-intervention: 3 months, 6 months and 9 months) data collection. The outcomes from delivering the intervention post-intervention will be compared to pre-intervention.
Control group
Active

Outcomes
Primary outcome [1] 338559 0
Change in RACF-level concordance with the Guiding Principles post-intervention compared to pre-intervention.
Assessment method [1] 338559 0
Concordance with the Guiding Principles will be measured using a series of 28 indicators developed for this study. This score will be composed of indicators that measure a mixture of dichotomous and continuous outcomes. Total score will range from 0 to 28. Higher scores will indicate greater concordance with the Guiding Principles.
Timepoint [1] 338559 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [1] 436438 0
Change in RACF-level concordance with domain one study indicators post-intervention compared to pre-intervention.
Assessment method [1] 436438 0
Domain one study indicators assess the RACF’s MAC meeting concordance with the Guiding Principles using nine dichotomous (i.e. yes/no) indicators. The indicators have been developed specifically for this study. Aggregate RACF-level concordance will be assessed as the percentage of RACF concordance with the indicators. Higher scores will indicate greater concordance with the Guiding Principles. The nine domain one indicators are: *The RACF’s MAC met in the last quarter. *The RACF’s MAC meeting was multidisciplinary. *When a MAC governs more than one RACF, a representative of this RACF was in attendance. *The RACF’s report of residents’ experiences from RACF residents, their carers, family and/or substitute decision-makers regarding medication-related issues was presented. *The RACF’s report of RACF storage of medicines was presented. *The RACF’s report of medication incidents was presented. *The RACFs report of trends in the percentage (or numbers) of residents with polypharmacy was presented. *The RACF’s report of trends in the percentage (or numbers) of residents who received an antipsychotic medication was presented. *The RACF’s report of trends in the percentage (or numbers) of residents who received a comprehensive medication management review from an appropriately qualified pharmacist was presented.
Timepoint [1] 436438 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [2] 437011 0
Change in RACF-level concordance with domain two study indicators post-intervention compared to pre-intervention.
Assessment method [2] 437011 0
Domain two study indicators assess the RACF’s policies, procedures and guidelines using 10 dichotomous (i.e. yes/no) indicators. Half a point will be allocated if the policy, procedure or guideline is available at the RACF and half a point will be allocated if the policy, procedure or guideline is current (i.e. the policy, procedure or guideline is not expired or past the proposed review date). The indicators within this domain have been developed specifically for this study. Aggregate RACF-level concordance will be assessed as the percentage of RACF concordance with the indicators. Higher scores will indicate greater concordance with the Guiding Principles. The 10 domain two indicators are, the RACF has a policy, procedure or guideline regarding; *the collection and review of feedback from the resident, carers, family and/or substitute decision-makers regarding medicine use. *the provision of written medicines-related information to the resident, their carers, family and/or substitute decision-makers as part of any clinical consultation. *the residents’ use of complementary and self-selected non-prescription medicines. *a list of approved non-prescription nurse-initiated medications. *the documentation of medication incidents and management of potential or actual harm arising from the medication incidents. *obtaining a best possible medication history. *the roles and responsibilities of healthcare professionals regarding the use and review of medication charts. *the continuity of medicines supply for all residents receiving care. *the appropriate storage of all medications requiring refrigeration. *the appropriate storage of all Schedule Eight medications.
Timepoint [2] 437011 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [3] 437012 0
Change in RACF-level concordance with domain three study indicators post-intervention compared to pre-intervention.
Assessment method [3] 437012 0
Domain three study indicators assess the RACF’s admission processes using five continuous (i.e. proportion between 0 and 1) indicators. The indicators for this domain have been developed specifically for this study. Aggregate RACF-level concordance will be assessed as the percentage of residents who are concordant with each of the indicators. Higher scores will indicate greater concordance with the Guiding Principles. The five domain three indicators are: *Percentage of newly admitted residents who have their medicine needs, preferences and medicine-taking behaviours documented. *Percentage of newly admitted residents wishing to self-administer medicines who were assessed for their capability to self-administer medications. *Percentage of newly admitted residents with swallowing difficulties whose oral medications within their medication regimen were assessed for appropriateness. *Percentage of newly admitted residents whose vaccination status is documented. *Percentage of newly admitted residents who have nominated a person to assist with medicines-related decision-making.
Timepoint [3] 437012 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [4] 437013 0
Change in RACF-level concordance with domain four study indicators post-intervention compared to pre-intervention.
Assessment method [4] 437013 0
Domain four study indicators assess the RACF’s medication review processes using four continuous (i.e. proportion between 0 and 1) indicators. The indicators of this domain have been developed specifically for this study. Aggregate RACF-level concordance will be assessed as the percentage of residents who are concordant with the indicators. Higher scores will indicate greater concordance with the Guiding Principles. The four domain four indicators are: *Percentage of residents who have received a comprehensive medication review by an appropriately qualified pharmacist within the last year. *Percentage of newly admitted residents who have received a comprehensive medication review by an appropriately qualified pharmacist since their RACF admission. A newly admitted resident is defined as a resident who is admitted within the last three months of the audit date. *Percentage of residents with polypharmacy who have received a comprehensive medication review by an appropriately qualified pharmacist within the last year. Residents with polypharmacy will be identified from the National Aged Care Mandatory Quality Indicator Program reported by each RACF. *Percentage of residents receiving an antipsychotic medicine who have received a comprehensive medication review by an appropriately qualified pharmacist within the last year. Residents who have received an antipsychotic medicine will be identified from the National Aged Care Mandatory Quality Indicator Program reported by each RACF.
Timepoint [4] 437013 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [5] 437014 0
Change in RACF-level concordance with each of the 28 individual indicators post-intervention compared to pre-intervention.
Assessment method [5] 437014 0
Individual indicators have been developed for this study and listed in secondary outcomes 1, 2, 3 and 4. This will include indicators that measure a mixture of dichotomous and continuous outcomes. Higher scores will indicate greater concordance with the Guiding Principles.
Timepoint [5] 437014 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [6] 437015 0
Change in RACF-level proportion of residents hospitalised post intervention compared to pre-intervention. This outcome will include emergency department presentations and hospital admissions within the last 3 months.
Assessment method [6] 437015 0
This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each RACF.
Timepoint [6] 437015 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [7] 437016 0
Change in RACF-level proportion of residents who report ‘excellent’ or ‘good’ quality of life post intervention compared to pre-intervention.
Assessment method [7] 437016 0
This outcome will be assessed using the Quality of Life Aged Care Consumers (QOL-ACC). This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each RACF.
Timepoint [7] 437016 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [8] 437017 0
Change in RACF-level proportion of residents who report ‘excellent’, or ‘good’ consumer experience post intervention compared to pre-intervention.
Assessment method [8] 437017 0
This outcome will be assessed using using the Quality of Care Experience Aged Care Consumers (QCE-ACC). This outcome will be extracted from the National Aged Care Mandatory Quality Indicator Program reported by each RACF.
Timepoint [8] 437017 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [9] 437018 0
Change in RACF-level proportion of medication incidents post intervention compared to pre-intervention.
Assessment method [9] 437018 0
Medication incidents will be assessed by reported incident events in the RACF risk management system within the last 3 months.
Timepoint [9] 437018 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [10] 437019 0
Direct costs of the intervention: measurement and valuation of the direct costs of the intervention (e.g. salary costs of the knowledge broker dyad).
Assessment method [10] 437019 0
This will be examined by measuring costs related to the implementation of the intervention.
Timepoint [10] 437019 0
9 months post intervention commencement.
Secondary outcome [11] 437020 0
Downstream costs of the intervention: measurement and valuation of the downstream costs of the intervention (e.g. staff time preparing for MAC meetings) pre-intervention compared to post-intervention.
Assessment method [11] 437020 0
This will be assessed using a series of indicators and surveys developed for this study to examine differences in costs pre and post intervention. The indicators are listed in secondary outcomes 1, 2, 3 and 4 and the surveys will collect information on MAC meeting attendance, MAC meeting duration, who is typically responsible for intervention tasks involved in being concordant in the indicators, and how long it typically takes to complete them.
Timepoint [11] 437020 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.
Secondary outcome [12] 437021 0
Cost benefits: measurement of the monetised impact of medication incidents and hospitalisations pre-intervention compared to post-intervention.
Assessment method [12] 437021 0
This outcome will be examined by valuing medication incidents and hospitalisation during the pre and post intervention periods of this study (please refer to secondary outcomes 6 and 9).
Timepoint [12] 437021 0
Pre-intervention: -6 months, -3 months, baseline and post-intervention: 3 months, 6 months and 9 months.

Eligibility
Key inclusion criteria
This will be a system-level intervention delivered at the RACF-level. RACFs will be eligible if they have a MAC or commit to establishing a MAC by the commencement of the intervention.

Pharmacists will be eligible if they hold general registration with the Australian Health Practitioner Regulation Agency (AHPRA) as a pharmacist and are willing to commit to the delivery of the intervention.

The health care professional MAC representative will be eligible if they are a MAC chair or another suitable current MAC member, have a health professional background and are willing to commit to the delivery of the intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
This is a RACF-level intervention. This study does not have resident-level exclusion criteria.

RACFs will be ineligible if they don’t have a MAC or don’t commit to establishing a MAC by the commencement of the intervention.

Pharmacists will be ineligible if they do not hold general registration with the AHPRA or are not available to commit to the delivery of the intervention.

The health care professional MAC representative will be ineligible if they do not have a health professional background or are not willing and able to commit to the delivery of the intervention.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will involve interrupted time series design that will involve retrospective (pre-intervention) and prospective (post-intervention) data collection. Each RACF will act as its own control during the pre-intervention period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
Up to 15 RACFs will be recruited across Western Australia, South Australia, New South Wales and Victoria.

Effectiveness analysis
The primary analysis will employ a linear mixed model approach to investigate the effect of commencement of the intervention on the composite primary outcome. It will include treatment period (pre-intervention vs post-intervention) as a fixed, binary factor in the model; study month as a continuous, fixed factor; and individual site as a random effect nested within the random effect of a MAC.

An additional analysis will be presented that is the same as that described above but includes an interaction term between the treatment period and study month factors. We will follow recommendations for presentation of results of trials of this nature, and present both the models with and without the interaction term to allow comparison between the two.

Exploratory analyses to investigate the heterogeneity in treatment effects within sites and MACs will be undertaken by examining best linear unbiased predictions (BLUPs). Multiple imputation will be used to impute missing outcome values, where necessary.

All primary analyses will be conducted using the intention-to-treat (ITT) principle. Per protocol analysis will also be undertaken with the per protocol set including all RACFs without a major protocol deviation. Major protocol deviations may include, but are not limited to, the following:
*Loss of knowledge broker dyad (one or both members of the dyad)
*Incomplete delivery of the intervention (e.g. local action plans, attendance at MEGA-MAC meetings).

Data will be analysed using Stata (StataCorp, College Station, TX), SAS (SAS Institute, Cary, NC) and the Statistical Package for the Social Sciences (SPSS, Inc., Chicago, IL).

Economic evaluation
A net benefit analysis will be conducted to examine the relative costs and benefits of implementing the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 316621 0
Government body
Name [1] 316621 0
Commonwealth of Australia represented by the Department of Health and Aged Care
Country [1] 316621 0
Australia
Primary sponsor type
University
Name
Monash University
Country
Australia
Secondary sponsor category [1] 318807 0
University
Name [1] 318807 0
Univeristy of Sydney
Country [1] 318807 0
Australia
Secondary sponsor category [2] 319085 0
University
Name [2] 319085 0
Flinders University
Country [2] 319085 0
Australia
Secondary sponsor category [3] 319086 0
Other
Name [3] 319086 0
New South Wales Therapeutic Advisory Group Inc.
Country [3] 319086 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315406 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315406 0
Ethics committee country [1] 315406 0
Australia
Date submitted for ethics approval [1] 315406 0
18/03/2024
Approval date [1] 315406 0
03/05/2024
Ethics approval number [1] 315406 0
42018

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 134606 0
Prof John Simon Bell
Address 134606 0
Monash University, 381 Royal Parade, Parkville, VIC, 3052
Country 134606 0
Australia
Phone 134606 0
+61 03 9903 9533
Email 134606 0
Simon.Bell2@monash.edu
Contact person for public queries
Name 134607 0
Ms Brooke Blakeley
Address 134607 0
Monash University, 381 Royal Parade, Parkville, VIC, 3052
Country 134607 0
Australia
Phone 134607 0
+61 03 9903 9035
Email 134607 0
brooke.blakeley@monash.edu
Contact person for scientific queries
Name 134608 0
Dr Amanda Cross
Address 134608 0
Monash University, 381 Royal Parade, Parkville, VIC, 3052
Country 134608 0
Australia
Phone 134608 0
+61 03 9903 9471
Email 134608 0
amanda.cross@monash.edu

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is a RACF-level intervention and no individual participant data will be collected during the trial.



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.