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Trial registered on ANZCTR


Registration number
ACTRN12622000595718
Ethics application status
Approved
Date submitted
17/03/2022
Date registered
21/04/2022
Date last updated
7/08/2023
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-design of an intervention aimed to Activate pharmacists to review medication-related problems: The ACTMed co-design and pilot study
Scientific title
Co-design of an intervention aimed to Activate pharmacists to review medication-related problems: The ACTMed co-design and pilot study
Secondary ID [1] 306600 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 325824 0
Condition category
Condition code
Public Health 322973 322973 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To co-design and pilot 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.

Activities to be undertaken during the pilot phase include:

1. Selection of clinical indicators - preliminary epidemiological work will be undertaken using Patron data to develop a list of clinical indicators that will drive the recall selection within the dashboard. The Patron dataset is a deidentified dataset of clinical records from general practice, collected and governed by The University of Melbourne (https://medicine.unimelb.edu.au/school-structure/general-practice/engagement/data-for-decisions). Use of this data is subject a separate ethics application to The University of Melbourne.
2. Development of Future Health Today (FHT) module to identify ‘at risk’ individuals - a software platform for general practice that streamlines the identification and management of at-risk consumers to support recall, follow-up and to provide decision support according to clinical best practice standards
3. Development of the MedAdvisor recording platform to record all actions of pharmacists and General Practitioners when undertaking the ACTMed intervention for patients flagged as high risk of serious medication-related problems. The Future Health Today platform was co-designed with general practitioners and is now a fully-mature software platform. The ACTMed module and MedAdvisor module will be co-designed with input from pharmacists and general practitioners.
4. Co-design of the ACTMed intervention with consumers - activities will include ‘Kitchen Table Discussions' led by trained facilitators from Health Consumers Queensland (HCQ), and First Nation’s-led Yarning Circles in community to identify consumer priorities, preferences and informational needs when interacting with health practitioners around their medicines. Kitchen Table Discussions and Yarning Circles will occur face-to-face or via teleconference, taking into consideration the wishes of hosts and participants, their location, and any restrictions due to the global pandemic. It is anticipated that five Kitchen Table Events (which may be extended up to 10 Events) and 1-2 Yarning Circles will be undertaken until data saturation is reached. Each Kitchen Table Event and Yarning Circle is expected to last around 1.5 hours.

Five key questions will be asked of participants. Consumer participants will also be asked if they would like to audio record or video record a testimonial of their lived experience that they would like to share with the health practitioners co-designing the ACTMed intervention. Written consumer consent will be obtained. Yarning circles will be facilitated by a suitably qualified and respected Aboriginal and/or Torres Strait Islander person, in accordance with the preferences of the local governance group. Consumer interviews will be undertaken to gain a more nuanced understanding of consumers views on medicines safety, as well as the consumer experience of the intervention co-design process itself. These will be undertaken by an experienced pharmacist. Interviews will be undertaken either in person or via teleconference.
5. Co-design of the ACTMed intervention with health practitioners within a Primary Health Network (PHN) integrated care framework - Practitioners will be asked to work with researchers to design workflows and solutions that respect the consumer voice but acknowledge the resource contracts in which they practice. There are three components included in the health practitioner co-design process:
1. Design of revised workflow, following consultation with consumer participants
2. Design of the ACTMed dashboard and refinement of the clinical algorithm and
3. Practice-based workshops to refine the service and workflow to prepare for the pilot phase of the project.

The selection of clinical indicators and development of the Future Health Today and MedAdvisor modules will be undertaken concurrently with the initial consumer engagement work. This work is expected to last around 5 months. The consumer/health practitioner iterative co-design process will then occur over a period of 3 months.

Pilot Phase - to develop or adapt the aspects of the intervention to be trialled. The pilot phase expected to last 3 months.
Three General Practices will be recruited to participate in the pilot: one from Brisbane South Primary Healthcare Network, one in Melbourne and one Aboriginal and Community Controlled Health Organization (ACCHO) in Queensland. A pharmacist at each site will be recruited on a part-time basis to work in the General Practice or ACCHO for the pilot phase. It is anticipated that the service is piloted for a period of three months, which will be revised based on interim findings with input from the Steering Committee.
Results from the pilot study will be used to determine if the full trial will go ahead. This decision will be made in consultation with the Steering Committee. Data from the pilot study will not be included in the cluster randomised controlled trial.

Intervention code [1] 323125 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330747 0
Any change in the proportion of individuals from the exposed population with any serious medication-related problems at baseline compared to a 3 month follow-up (within the pilot phase). 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). The definition of 'exposed' and 'medicine-related problem' will be determined by the clinical indicators selected during the co-design phase.
Timepoint [1] 330747 0
3 months post pilot start date
Secondary outcome [1] 408753 0
To determine whether the ACTMed intervention is ready for evaluation in the stepped-wedge randomised controlled trial phase. This will be assessed as a composite of usability of the intervention as measured using the System Usability Scale, acceptability of the intervention determined by qualitative interviews with consumers and health practitioners, and effectiveness of the intervention determined by the primary outcome measure.
Timepoint [1] 408753 0
3 months post pilot start date.

Eligibility
Key inclusion criteria
a) Inclusion criteria: Consumer participants
• Aged 18 years or over
• Able to provide full informed consent
• Self-identified as / or a carer to an individual having a complicated or burdensome medicine regime OR having had a previous lived experience of a medicine problem

b) Inclusion criteria: General Practices
• use of Best Practice or Medical Director software (not cloud based);
• an available computer to install GRHANITE® data extraction software.

c) Inclusion criteria: Health practitioner participants
• Aged 18 years or over
• Able to provide full informed consent
• A registered health practitioner (GPs and pharmacists will be included at a minimum)
• Practice support staff such as practice managers will also be eligible to participate in practice workshops
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Exclusion criteria: Consumer participants
• Unable to provide fully informed consent

b) Exclusion criteria: General Practices
• do not use Best Practice or Medical Director software (not cloud based);
• no computer available to install GRHANITE® data extraction software.

c) Exclusion criteria: Health practitioner participants
• Unable to provide full informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Best practice qualitative data analysis techniques will be used to analyse the data from the various co-design activities. De-identified transcripts and notes will be managed and analysed using NVivo 12 software [QSR International, 2020]. Transcripts and notes will be read multiple times before being coded inductively for themes and content by two members of the research team. Themes and the coding framework will be iteratively refined, and coding will continue until no new codes emerge. Themes will be grouped into thematic clusters to highlight the connections between them, and to identify superordinate themes. Any disagreements between the coders will be resolved through discussion, or with a third coder if required. Codes will then be presented to the research team, and themes, clusters, and superordinates will be discussed. The coding framework will be adjusted, refined, and pruned as needed.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/04/2022
Actual
2/05/2022
Date of last participant enrolment
Anticipated
Actual
8/05/2023
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
3
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310937 0
Government body
Name [1] 310937 0
Australian Department of Health, Medical Research Future Fund (MRFF)
Country [1] 310937 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] 312230 0
Individual
Name [1] 312230 0
Professor Lisa Nissen
Address [1] 312230 0
Centre for the Business and Economics of Health
Level 5, Building 14
The University of Queensland
St Lucia, Brisbane
Queensland 4072
Country [1] 312230 0
Australia
Other collaborator category [1] 282206 0
Charities/Societies/Foundations
Name [1] 282206 0
National Aboriginal Community Controlled Health Organization
Address [1] 282206 0
Level 5 East Tower
2 Constitution Avenue
Canberra City
Australian Capital Territory 2601
Country [1] 282206 0
Australia
Other collaborator category [2] 282207 0
Government body
Name [2] 282207 0
Brisbane South Primary Health Network
Address [2] 282207 0
1st Floor Building 20
Garden City Office Park
2404 Logan Road, Eight Mile Plains
Queensland 4113
Country [2] 282207 0
Australia
Other collaborator category [3] 282208 0
Commercial sector/Industry
Name [3] 282208 0
MedAdvisor
Address [3] 282208 0
Level 2
971 Burke Road
Camberwell
Victoria 3124
Country [3] 282208 0
Australia
Other collaborator category [4] 282209 0
Commercial sector/Industry
Name [4] 282209 0
The Pharmacy Guild of Australia
Address [4] 282209 0
Level 2, Pharmacy Guild House
15 National Circuit
Barton ACT 2600
Country [4] 282209 0
Australia
Other collaborator category [5] 282210 0
Charities/Societies/Foundations
Name [5] 282210 0
The Pharmaceutical Society of Australia
Address [5] 282210 0
Level 1, 17 Denison Street
Deakin
Australian Capital Territory 2600
Country [5] 282210 0
Australia
Other collaborator category [6] 282211 0
Government body
Name [6] 282211 0
The Australian Digital Health Agency
Address [6] 282211 0
Level 17, 1 Eagle Street
Brisbane
Queensland 4000
Country [6] 282211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310491 0
The University Of Queensland Human Research Ethics Committee
Ethics committee address [1] 310491 0
Ethics committee country [1] 310491 0
Australia
Date submitted for ethics approval [1] 310491 0
10/03/2022
Approval date [1] 310491 0
28/04/2022
Ethics approval number [1] 310491 0
2021/HE002189

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

Contacts
Principal investigator
Name 117858 0
Dr Jean Spinks
Address 117858 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 117858 0
Australia
Phone 117858 0
+61 7 33461167
Fax 117858 0
Email 117858 0
[email protected]
Contact person for public queries
Name 117859 0
Lisa Nissen
Address 117859 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 117859 0
Australia
Phone 117859 0
+61 7 3138 4404
Fax 117859 0
Email 117859 0
[email protected]
Contact person for scientific queries
Name 117860 0
Jean Spinks
Address 117860 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 117860 0
Australia
Phone 117860 0
+61 7 33461167
Fax 117860 0
Email 117860 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15414Study protocol    The study protocol will be published in a peer-rev... [More Details]
15723Informed consent form    The informed consent form can be requested from th... [More Details]
15724Ethical approval    Evidence of ethical approval can be requested from... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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