ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001239954

Ethics application status

Approved

Date submitted

2/09/2020

Date registered

19/11/2020

Date last updated

28/02/2024

Date data sharing statement initially provided

19/11/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Providing therapy with dose administration aids and existing cardiovascular medicines - Pilot

Scientific title

Providing therapy with dose administration aids and existing cardiovascular medicines (PAX) - Pilot

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PAX Pilot

Linked study record

Health condition

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

Cardiovascular disease

Medication adherence

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

INTERVENTION: Letter to patients inviting them to receive a home-delivered dose administration aid.

This will be an 8 month pilot study designed as a “trial within cohort” (TwiC) randomised controlled trial (RCT). The TWiC design involves embedding a RCT within an established cohort (general practice in this case) to test the effectiveness of an intervention under pragmatic patient care environments, and to utilise information routinely collected in an existing cohort. The key difference compared to a standard RCT is that a patient subset is randomly selected to be offered the study intervention, with the outcomes of this subset compared to the remaining eligible patients in the cohort who receive usual care (i.e. control). In this way much more realistic and generalisable results are obtained, while maintaining randomisation. Patients on greater than equal to five medications will be identified in the medical records of participating GPs, at least one of which must be a cardiovascular medication. A GP and Study Coordinator will screen electronic medical records of potentially eligible participants using the inclusion and exclusion criteria. Eligible participants will be randomised to the intervention (i.e. a patient directed invitation letter from the GP) or control arms. Participants in the intervention arm (N is equal to 100 patients) will be sent a letter from the GP inviting them to try using a Dose Administration Aid (DAA), such as a Doseaid sachet. Those randomised to the control arm will not receive a letter and will form the standard care group.
Participants, who have received the letter and decide to take up the DoseAid offer, will contact the research team. A research team member will then contact them, providing further education, allowing them to seek clarification and obtaining verbal consent for the trial. The GP will prescribe the participants’ usual medications and provide the script to the local Pharmacy. The Pharmacy will then provide education to participants as required and consent them for a DoseAid as per usual care processes. DoseAid is a Queensland based company, licensed by the Therapeutic Goods Administration and is GMP-compliant. DoseAid will supply the medications and sort them into individually-labelled sachets with easy tear packaging by day, dose and time. These sachets are then rolled up in chronological date and time order. DoseAid will send the sachets to the Pharmacy and the latter will directly mail the sachets to participants in the intervention group. Participants will receive their DoseAid sachets monthly for 8 months.
Prescription Possession Ratio (PPR) will be measured at 8 months to monitor adherence. PPR is defined as the percentage of time that an individual has a valid prescription script according to practice prescription records in a given observation period.

Intervention code [1]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

Patients randomised to the control group will receive usual care which involves continuation of current care provided by their general practitioner and scheduled visits as per standard practice.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome will be difference between the intervention and usual care groups (intention to treat [ITT]) in prescription possession ratio at 8-months. Prescription Possession Ratio (PPR) is defined as the percentage of time that an individual has a valid prescription script according to practice prescription records in a given observation period. It will be assessing using the practice practice prescription records.

Timepoint [1]

End of study will occur after all patients in the intervention group finish 8 months follow-up in the intervention group.

Secondary outcome [1]

Systolic and diastolic blood pressure.

Timepoint [1]

At baseline when all eligible patients are randomised and at end of study after all patients in the intervention group finish 8 months follow-up in the intervention group. This data is not composite and will be extracted from the general practice electronic health records system.

Secondary outcome [2]

Number of GP Visits (including Telehealth appointments). This data will be extracted from the general practice electronic health records system.

Timepoint [2]

At end of study after all patients in the intervention group finish 8 months follow-up in the intervention group. This data will be extracted from the general practice electronic health records system.

Secondary outcome [3]

Intervention participant and prescriber acceptability of the DoseAid and study processes via end of study feedback. Semi-structured phone interviews will be conducted with trial participants and providers to understand their perspectives on the intervention and the use of DoseAids and to seek their views on how DoseAids could be more effectively implemented in practice.

Timepoint [3]

Data will be gathered following an interview guide at the end of the study i.e after all patients in the intervention group finish 8 months follow-up in the intervention group.

Secondary outcome [4]

Cholesterol

Timepoint [4]

Secondary outcome [5]

Blood sugar levels (HbA1c & fasting glucose)

Timepoint [5]

Eligibility

Key inclusion criteria

Participant inclusion criteria:
1. Community dwelling adults aged greater than equal to 18 years old
2. Prescribed at least 5 medicines, with at least 1 cardiovascular indication which includes medications for coronary artery disease, stroke, peripheral vascular disease, hypertension, hypercholesterolaemia, diabetes, arrhythmias, heart failure and valvular heart disease. Broadly this includes Pharmaceutical Benefits Scheme Anatomical Therapeutic Chemical Classifications A10, B01, B02, C01-C10.
3. Stable medical conditions and stable medications for at least 6 months prior to enrolment
4. Ability to give informed consent

Site selection criteria:
Primary care practices using electronic health records that have the ability to generate practice-level reports of the target population and have regular data extractions performed via MedicineInsight or network processes.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Participant exclusion criteria:
1. Responsible primary care or other responsible physician believes it is not appropriate for the patient to participate in the study.
2. A medical illness, which in the view of the treating physician, has an anticipated life expectancy of less than 8 months.
3. Patients using any other dose administration aid (e.g. webster pack, automated devices)
4. Patients with physical disabilities precluding use of the DoseAid (e.g. tearing the sachets) and without a carer to assist them.
5. Patients with significant cognitive or psychiatric conditions precluding informed consent and use of DoseAid

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)

The site coordinator and the GP will determine if a patient is eligible for inclusion in the trial. They will inform the staff at the central administration site where the randomisation of the list of eligible patients will occur.

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

The randomisation will be centrally computer generated.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The analysis for the primary outcome will be conducted according to the principle of intention-to-treat on aggregated de-identified data. The primary analysis will be a comparison between groups of Prescription Possession Ratio (PPR) at 8 months using Poisson regression model.
Secondary analyses will include comparison of means between groups for systolic and diastolic blood pressure, cholesterol; blood sugar levels (HbA1c & fasting glucose) at the end of study with adjustment for baseline values.

Reporting of process measures will be conducted to inform a larger trial:
• Proportion of those invited who participate
• Contamination of control sample by those who inadvertently crossover into the intervention e.g. participants who obtain a non-study dose administration aid.

There will be no pre-defined subgroup analyses. We will plan an exploratory analysis including by gender and age.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2020

Actual

12/12/2020

Date of last participant enrolment

Anticipated

8/01/2021

Actual

1/06/2021

Date of last data collection

Anticipated

30/09/2021

Actual

12/12/2021

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

National Heart Foundation

Address [1]

PO Box 2222
Strawberry Hills NSW 2012

Country [1]

Australia

Primary sponsor type

Other

Name

The George Institute for Global Health

Address

Level 5, 1 King St
Newtown NSW 2042
Australia

Postal Address:
PO Box M201
Missenden Rd
NSW 2050
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of New South Wales

Address [1]

The University of New South Wales
PO Box 259
Paddington, NSW 2021
Australia

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Westmead Applied Research Centre, University of Sydney

Address [2]

Westmead Applied Research Centre
REN Building Westmead Hospital
Darcy Road, Westmead NSW 2145

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District HREC

Ethics committee address [1]

Western Sydney Local Health District HREC
Westmead Applied Research Centre 
REN Building Westmead Hospital 
Darcy Road, Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2020

Approval date [1]

28/09/2020

Ethics approval number [1]

2020/PID01290

Summary

Brief summary

Dose administration aids (DAAs) facilitate ease of administration by packaging multiple tablets together by date and time, thereby reducing unintentional non-adherence and medication errors. Use of reminder packaging has been shown to improve adherence by 11% measured by pill count. However, barriers to DAA use remain including cost, limited GP involvement in the initiation process, lack of patient understanding and lack of randomised controlled trials of DAAs in Australia. 
The PAX Pilot study will determine if a coordinated strategy of delivering cardiovascular drug therapy via dose administration aids can effectively increase prescription possession ratio compared to usual care. The study will test the hypothesis that the use of dose administration aids will increase adherence and therefore, increase prescription possession ratio, among people with greater than equal to 5 medications compared to usual care.

Trial website

Trial related presentations / publications

Public notes

DAAs are accepted and widely available tools and the criteria in the planned study to characterise potentially eligible patients are the same as those currently operationalised under the Federally funded scheme to allow subsidised access to DAAs (with the addition of a requirement for one of the five or more medicines to be cardiovascular). Tens of thousands of Australian patients already receive this federally subsidised intervention and approximately 5 to 10% of elderly people use DAAs of some form in the community. The intervention is low-risk and does not involve the testing of any new or existing medicines or medical procedures. The trial is simply testing whether much expanded access of an existing intervention has any measurable impact on medication adherence.
There is therefore a unique opportunity to conduct a radically more cost-effective and rapidly implemented trial, while also improving generalisability of results.

Contacts

Principal investigator

Name

Dr Sonali Gnanenthiran

Address

The George Institute for Global Health AUSTRALIA
Level 5, 1 King St, Newtown NSW 2042 Australia

Country

Australia

Phone

+61 280524533

Fax

sgnanenthiran@georgeinstitute.org.au

Contact person for public queries

Name

Baldeep Kaur

Address

The George Institute for Global Health AUSTRALIA
Level 5, 1 King St, Newtown NSW 2042 Australia

Country

Australia

Phone

+61 280524533

Fax

bkaur@georgeinstitute.org.au

Contact person for scientific queries

Name

Sonali Gnanenthiran

Address

The George Institute for Global Health AUSTRALIA
Level 5, 1 King St, Newtown NSW 2042 Australia

Country

Australia

Phone

+61 280524533

Fax

sgnanenthiran@georgeinstitute.org.au

Data sharing statement

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

Yes

What data in particular will be shared?

All data is potentially available for sharing pending relevant ethics approvals and sign-off from the principle investigator.

When will data be available (start and end dates)?

Data will be available 3 years following closure of the study, estimated to be available from 31st March 2024.

Available to whom?

Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from pharmaceutical industry. Requesters must have demonstrated experience in medical research. Researchers must be able to demonstrate through their peer review publications in the area of interest and their ability to carry out the proposed use of requested data.

Available for what types of analyses?

The data sharing will only be for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.

How or where can data be obtained?

In the first instance, potential requesters are strongly encouraged to approach the relevant study investigators informally to discuss feasibility of data sharing. Study investigators can refer such requests to the Institute’s Data Access Coordinator (Director, Research Strategy and Services). Contact SGnanenthiran@georgeinstitute.org.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9399	Other			SGnanenthiran@georgeinstitute.org.au	Manual of operations by request from the PI - Dr S... [More Details]

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