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Trial registered on ANZCTR


Registration number
ACTRN12622000574741
Ethics application status
Approved
Date submitted
8/04/2022
Date registered
14/04/2022
Date last updated
7/08/2023
Date data sharing statement initially provided
14/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of Activating pharmacists to reduce medication related problems: The ACTMed stepped wedge randomised controlled trial
Scientific title
Investigating the effect of Activating pharmacists to reduce medication related problems: The ACTMed stepped wedge randomised controlled trial
Secondary ID [1] 306588 0
Medical Research Future Fund (MRFF) Grant MRFQ1000023
Universal Trial Number (UTN)
Trial acronym
ACTMed
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medication related problems 325976 0
Condition category
Condition code
Public Health 323290 323290 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To implement and evaluate, using a pragmatic stepped wedge randomized control trial, the use of an actionable and pharmacist-led medication safety dashboard with concurrent general practitioner feedback and economic incentives as a way of targeting serious medication related problems in the primary care setting. The intervention is called ACTMed.

The ACTMed intervention is being co-designed and piloted (subject to a separate ANZCTR registration). The intervention will be finalised and a decision made to progress to the trial phase made in conjunction with the ACTMed Steering Committee.

In this stepped wedge cluster RCT all practices will start without ACTMed. Each month 7 practices will be randomly assigned to have ACTMed introduced. After 7 months all practices will have ACTMed. Data collection will cease 6 months after the last practice has ACTMed.

Overview of ACTMed Intervention:
1. ACTMed dashboard collates a list of high risk patients identified by clinical indicators for pharmacist review. Only high-risk patients will be triaged by the pharmacist.
2. Trial Pharmacist triages patients flagged by indicators based on clinical review and creates an action plan to reduce risk. All actions of pharmacist or general practitioner are recorded in MedAdvisor for analysis by research team. Feedback to participating pharmacists and general practitioners of the current proportion of exposed individuals who have been identified as at risk of a serious medication related problem will occur. Additionally, the trial pharmacist will deliver feedback to the general practitioner through a variety of channels including face to face meetings, practice meetings and dissemination of the latest dashboard results.
3. Analysis of the primary outcome will be undertaken using individual-level data, with a supplementary practice-level analysis undertaken for robustness.

Details of the ACTMed intervention are highly dependent on the final list of clinical indicators chosen and the consumer/health practitioner co-design process. This includes the anticipated time taken for ACTMed triage and actioning, where and how any consumer contact occurs and when/how feedback to participating practices will occur. All details will be finalised during the co-design and pilot phase. The ANZCTR record will be updated accordingly.
Intervention code [1] 323335 0
Prevention
Comparator / control treatment
All practices will start without ACTMed. Each month 7 practices will be randomly assigned to have ACTMed introduced.
'Usual care' will be defined as consumers using any of the 'ad hoc' medicine review arrangements available to them in primary or tertiary care. This can include: medicines information provided at the point of dispensing by pharmacists; Home Medicines Reviews; MedsChecks and Diabetes MedsChecks; and usual care by hospital, and community pharmacists and general practitioners. No change to usual care will be initiated prior to the beginning of the ACTMed trial. Data on ad hoc interventions will be collected where possible.
Control group
Active

Outcomes
Primary outcome [1] 331022 0
Any change in the proportion of individuals from the exposed population with any serious medication-related problems will be compared between the intervention and pre-intervention periods. This will be determined within the Future Health Today software platform which will be able to determine: the exposed population and the proportion with a medication-related problem within a 24 hour time-period (software updates are run nightly).
Timepoint [1] 331022 0
One month post last-practice implementing the intervention
Secondary outcome [1] 408508 0
The rate of potentially preventable medication related hospital admissions in the pre-intervention period compared to the post-intervention period. This will be assessed by undertaking data linkage with data provided by Queensland Health to identify all hospitalisations related to the clinical indicators being measured (through a pre-specified list of ICD-10 codes).
Timepoint [1] 408508 0
12 months prior to intervention implementation to 12 months after intervention implementation.
Secondary outcome [2] 408509 0
Any change in the rate of medication-related deaths in the intervention compared to the pre-intervention period. This will be assessed by undertaking data linkage through Queensland Government (state death registry) for 12 months prior to the intervention compared to 12 months after the intervention.
Timepoint [2] 408509 0
12 months prior to intervention implementation to 12 months after intervention implementation.
Secondary outcome [3] 408510 0
Number and type of pharmacist actions to resolve medication related problems (composite outcome).
The extract process(es) to be measured will depend on the clinical indicators selected during the co-design and pilot phase. Pharmacist actions will be entered into the Future Health Today software platform. Summary data will be extracted from the software for analysis.
The ANZCTR trial registration will be updated once this measure has been finalised.
Timepoint [3] 408510 0
6 months post-last practice implementing the intervention
Secondary outcome [4] 408511 0
A client relevant experience measure ‘Consultation And Relational Empathy (CARE) Patient Feedback Measure’ will be used to measure aspects of the ACTMed service provision by pharmacists and GPs. In addition, a number of questions around care coordination (approximately three) as a patient Reported Outcome Measure (PREM) will be trialled through the trial.
Timepoint [4] 408511 0
6 months post-last practice implementing the intervention
Secondary outcome [5] 408512 0
Any change in health practitioner job satisfaction from baseline to 6 months post intervention implementation.
A previously validated measure will be used (Joyce C, et al 2011. Australian doctors’ satisfaction with their work: results from the MABEL longitudinal survey of doctors. MJA 194(1):30-33 doi: 10.5694/j.1326-5377.2011.tb04142.x).
Timepoint [5] 408512 0
Measured at baseline and 6 months post-last practice implementing the intervention.
Secondary outcome [6] 408513 0
False positive rate of each clinical indicator used in the ACTMed trial. The clinical indicator algorithm will be implemented using prescribing data, which can differ from dispense data. This discrepancy may lead to false positives of individuals identified as being at risk. Trial pharmacists will check dispense records (where possible) with My Health Record and record in the Future Health Today software platform any false positives.
Timepoint [6] 408513 0
1 month post last practice implementing the intervention
Secondary outcome [7] 425153 0
The persistence of any change in the proportion of individuals from the exposed population with any serious medication-related problems (primary outcome) once the intervention ceases. This will be determined within the Future Health Today software platform which will be able to determine: the exposed population and the proportion with a medication-related problem within a 24 hour time-period (software updates are run nightly).
Timepoint [7] 425153 0
7 months post last practice implementing the intervention

Eligibility
Key inclusion criteria
All adult consumers who are active at the general practitioner practice (based on the FHT definition of active, that is, not deceased and still attending the practice).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not able to provide full informed consent
Consumers who withdraw consent to be included in the Patron data repository.
Pregnant and breastfeeding women.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge cluster randomized controlled trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
An estimated sample size of N=42 practices is required for >90% power to detect a significant difference in the primary outcome, assuming a baseline medication-related problem rate of 0.08 in the ‘at risk’ population, a 10% relative difference in medication-related problems, an inter-cluster correlation (ICC) of 0.05, alpha=0.05 and that no data will be collected from 6 practices due to practice attrition. For the key secondary outcome, difference in medication-related problems at the practice level, we have 80% statistical power to detect a significant difference when the true pre-post intervention difference is at least a 19%. This estimate was informed by the use of Patron data which included 75 practices in Victoria to determine the proportion of ‘at-risk’ patients with a medication-related problem. We are anticipating an ‘at risk’ population of 35,238 individuals across 42 practices, based on an estimated 839 patients per practice across all indicators. This is comparable with estimates of the at-risk population and effect size of the intervention using key trials from the UK. While Dreishulte et al. showed a 40% reduction in high-risk prescribing using individual level time-series data, the PINCER national rollout showed an estimated 25% reduction at the more conservative practice level. Power calculations were undertaken using the ‘steppedwedge’ command in Stata statistical software v17 (StataCorp, College Station, TX, USA).

Outcomes will be analysed following the intention to treat (ITT) principle. The primary outcome will be analysed using a mixed-effects logistic regression model. Fixed effects will include ACTMed exposure (intervention/pre-intervention) and time, while random effects will account for the effect of clustering (at the practice level) and repeated measures for the same individual. The time fixed effect will account for time-dependent changes that may impact the primary outcome, such as a change in GP prescribing behaviour. A supplementary analysis, undertaken at the practice level, will use mixed effects models to account for the effect of clustering and repeated measures over time. The statistical analysis plan is included in the clinical trial registration.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/01/2023
Actual
22/05/2023
Date of last participant enrolment
Anticipated
2/10/2023
Actual
31/07/2023
Date of last data collection
Anticipated
29/03/2024
Actual
31/07/2023
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310919 0
Government body
Name [1] 310919 0
Australian Department of Health, Medical Research Future Fund (MRFF)
Country [1] 310919 0
Australia
Primary sponsor type
Individual
Name
Dr Jean Spinks
Address
Centre for the Business and Economics of Health
Level 5, Building 14
The University of Queensland
St Lucia, Brisbane
Queensland 4072
Country
Australia
Secondary sponsor category [1] 312213 0
Individual
Name [1] 312213 0
Professor Lisa Nissen
Address [1] 312213 0
Centre for the Business and Economics of Health
Level 5, Building 14
The University of Queensland
St Lucia, Brisbane
Queensland 4072
Country [1] 312213 0
Australia
Secondary sponsor category [2] 312557 0
Charities/Societies/Foundations
Name [2] 312557 0
National Aboriginal Community Controlled Health Organization
Address [2] 312557 0
Level 5 East Tower
2 Constitution Avenue
Canberra City
Australian Capital Territory 2601
Country [2] 312557 0
Australia
Secondary sponsor category [3] 312558 0
Other Collaborative groups
Name [3] 312558 0
Brisbane South Primary Health Network
Address [3] 312558 0
1st Floor Building 20
Garden City Office Park
2404 Logan Road, Eight Mile Plains
Queensland 4113
Country [3] 312558 0
Australia
Secondary sponsor category [4] 312559 0
Commercial sector/Industry
Name [4] 312559 0
MedAdvisor
Address [4] 312559 0
Level 2
971 Burke Road
Camberwell
Victoria 3124
Country [4] 312559 0
Australia
Secondary sponsor category [5] 312560 0
Charities/Societies/Foundations
Name [5] 312560 0
The Pharmaceutical Society of Australia
Address [5] 312560 0
Level 1, 17 Denison Street
Deakin
Australian Capital Territory 2600
Country [5] 312560 0
Australia
Secondary sponsor category [6] 312561 0
Government body
Name [6] 312561 0
The Australian Digital Health Agency
Address [6] 312561 0
Level 17, 1 Eagle Street
Brisbane
Queensland 4000
Country [6] 312561 0
Australia
Secondary sponsor category [7] 312562 0
Commercial sector/Industry
Name [7] 312562 0
The Pharmacy Guild of Australia
Address [7] 312562 0
Level 2, Pharmacy Guild House
15 National Circuit
Barton ACT 2600
Country [7] 312562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310478 0
The University Of Queensland Human Research Ethics Committee
Ethics committee address [1] 310478 0
Ethics committee country [1] 310478 0
Australia
Date submitted for ethics approval [1] 310478 0
05/12/2022
Approval date [1] 310478 0
26/04/2023
Ethics approval number [1] 310478 0
2022/HE002136

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

Contacts
Principal investigator
Name 117810 0
Dr Jean Spinks
Address 117810 0
Centre for the Business and Economics of Health
Level 5, Sir Liew Edwards Building (#14)
Corner of Campbell Rd and University Drive
The University of Queensland
Brisbane
Queensland 4072
Country 117810 0
Australia
Phone 117810 0
+61 7 33461167
Fax 117810 0
Email 117810 0
[email protected]
Contact person for public queries
Name 117811 0
Lisa Nissen
Address 117811 0
Centre for the Business and Economics of Health Level 5, Sir Liew Edwards Building (#14) Corner of Campbell Rd and University Drive The University of Queensland Brisbane Queensland 4072
Country 117811 0
Australia
Phone 117811 0
+61 7 3138 4404
Fax 117811 0
Email 117811 0
[email protected]
Contact person for scientific queries
Name 117812 0
Jean Spinks
Address 117812 0
Centre for the Business and Economics of Health
Level 5, Sir Liew Edwards Building (#14)
Corner of Campbell Rd and University Drive
The University of Queensland
Brisbane
Queensland 4072
Country 117812 0
Australia
Phone 117812 0
+61 7 33461167
Fax 117812 0
Email 117812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is sensitive health and clinical information, only summary data will be presented to protect patient privacy.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15722Study protocolSpinks J, Violette R, Boyle D, Petrie D, Fanning L, Hall K, Kelly F, Wheeler A, Ware R, Byrnes J, Chen E, Donald A, Ellis N, DelDot M, Nissen L. "Activating pharmacists to reduce medicine related problems: the ACTMed stepped wedge cluster randomized trial (SW-CRT) protocol". 2023, Medical Journal of Australia, forthcoming.    The study protocol will be published in a peer-rev... [More Details]
15725Informed consent form    The informed consent form can be requested from th... [More Details]
15726Ethical approval    Evidence of ethical approval can be requested from... [More Details]


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15722Study protocolSpinks J, Violette R, Boyle D, Petrie D, Fanning L, Hall K, Kelly F, Wheeler A, Ware R, Byrnes J, Chen E, Donald A, Ellis N, DelDot M, Nissen L. "Activating pharmacists to reduce medicine related problems: the ACTMed stepped wedge cluster randomized trial (SW-CRT) protocol". 2023, Medical Journal of Australia, forthcoming.  [email protected] The study protocol has been published in a peer-re... [More Details] 383688-(Uploaded-01-08-2024-20-42-10)-Medical Journal of Australia - 2023 - Spinks - Activating pharmacists to reduce the frequency of medication-related.pdf
15725Statistical analysis planSpinks J [email protected] The updated statistical analysis plan can be reque... [More Details] 383688-(Uploaded-01-08-2024-20-42-10)-SAP_ACTMed-V1.1.docx
15726Ethical approval    Evidence of ethical approval can be requested from... [More Details]

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseActivating pharmacists to reduce the frequency of medication-related problems (ACTMed): a stepped wedge cluster randomised trial.2023https://dx.doi.org/10.5694/mja2.52073
N.B. These documents automatically identified may not have been verified by the study sponsor.