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Trial registered on ANZCTR


Registration number
ACTRN12618000313235
Ethics application status
Approved
Date submitted
21/02/2018
Date registered
2/03/2018
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacy Trial Program (PTP)- Getting asthma under control using the skills of the community Pharmacist
Scientific title
'Pharmacy Trial Program (PTP)- Getting asthma under control using the skills of the community Pharmacist: Comparing the efficacy and cost effectiveness of a pharmacist-delivered service for people with uncontrolled asthma.
Secondary ID [1] 294110 0
None
Universal Trial Number (UTN)
Trial acronym
Pharmacy Trial Program - Asthma and Rhinitis Control (PTP-ARC)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 306703 0
Condition category
Condition code
Respiratory 305804 305804 0 0
Asthma
Public Health 305866 305866 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacy Trial Program (PTP) - Getting asthma under control using the skills of the community Pharmacist.
The proposed project addresses the need to improve clinical outcomes for the population at risk of uncontrolled asthma, by extending the role of pharmacists in the delivery of primary health care services through a community pharmacy. The trial will use a cluster randomised design to test the clinical and cost effectiveness of a pharmacy based service for asthma patients in the community. The cluster will be the community pharmacy and the unit of analysis the patient. It will comprise two groups (A & B).
Group A: Intervention Arm - The proposed intervention involves an evidence-based pharmacist-delivered service for patients with uncontrolled asthma, which can easily be integrated into pharmacists’ workflow. To deliver the intervention, the pharmacist will undertake three private consultations with the patient over a period of 12 months (at baseline, one month and 12 months), with a six-month telephone check-up mid-program. The consultations will focus on addressing three key factors associated with uncontrolled asthma:
1) Poor adherence characterised by underuse of preventer medication and/or over use of reliever medication,
2) Sub-optimal inhaler technique and/or
3) Uncontrolled allergic rhinitis.
The service will be delivered in 40 pharmacies in NSW, WA or TAS, each delivering the service to 7 patients. (280 participants in total)
*Group B: Low intervention - Pharmacy screening for uncontrolled asthma and referral to GP. The low intervention service will be delivered in 40 pharmacies in NSW, WA or TAS, each delivering the service to 7 patients. (280 participants in total)
Outcomes will be measured using the following validated tools:
*Asthma Control - Asthma Control Questionnaire (ACQ)
*The Impact of Asthma on Quality of Life Questionnaire (IAQLQ)
*Visual analogue scale to assess medication adherence.
*Inhaler technique score
*Rhinitis Control Assessment Test (RCAT)
*Short Form 12 (SF-12) a generic quality of life survey
In the intervention arm at the initial/ baseline visit (20 minutes) the pharmacist will:
*Assess Asthma related Quality of Life using IAQLQ
*Review short acting beta agonist (SABA) use.
*Assess asthma medication adherence with a visual analogue scale and using the dispensed medication history from the previous 12 months, then address any issues identified.
*Assess and correct inhaler technique.
*Assess allergic rhinitis control using the RCAT and recommend appropriate therapy/refer to the General Practitioner (GP) as appropriate.
*Use the SF-12 for economic evaluation
*Ask about Action Plan ownership and prompt to obtain an asthma action plan from their GP (if the individual does not already have one)
*Download preventer medication dispensing over the previous 12 months.
At the 1 month follow-up (15 minutes) the pharmacist will:
*Reassess asthma control using the ACQ.
*Remeasure Asthma related quality of life using IAQLQ
*Reassess Inhaler technique
*Review SABA use
*Assess allergic rhinitis control if appropriate using RCAT
At 6 months the pharmacist will contact the patient by phone (10 minutes) and will:
*Reassess asthma control using the ACQ
*Ask if there are any issues to address
At the 12 month (15 minutes) follow-up the pharmacist will:
*Reassess asthma control using the ACQ
*Reassess asthma medication adherence (VAS + dispensing history)
*Assess asthma-related quality of life using IAQLQ
*Reassess Inhaler technique
*Record action plan ownership
*Assess allergic rhinitis control if appropriate
*Use the SF-12 for economic evaluation
*Review short acing beta agonist use (SABA)
*Download preventer dispensing over the previous 12 months.
Pharmacists who take part in the trial will be required to undertake a continuing professional development (CPD) accredited online training course created by The Pharmaceutical Society of Australia and the National Asthma Council to enable consistent delivery of the intervention. The modules must be completed by each participating pharmacist prior to taking part in the trial and recruiting their first patient. As many pharmacies are located in rural and remote areas of Australia, this is the most appropriate way to deliver training to the trial participants (pharmacists). Trial participants will receive online accreditation once they demonstrate an understanding of their requirements under the trial. This online training course will familiarise the trial pharmacists with the materials and resources developed to facilitate the delivery of the service, including promotional material, training and management processes and templates. It will consist of 4 modules, each taking approximately 1-2 hours to complete.
The training will include:
*Service protocol
*Pharmacy eligibility and requirements
*Patient eligibility
*Clinical Pathway
*How to implement the service in the community pharmacy
*How to identify and recruit patients
*How to approach and engage with local GPs
A promotional resources kit will be distributed to all 40 participating pharmacies, and will include:
*Posters to promote the service
*Patient materials, including approved asthma resources and flyers/brochures about the service
*Local area marketing templates and process guides
The study materials pack will include:
*Patient invitation letters
*Patient referral letters for group B patients
*Patient follow-up material
*All participant plus patient information and consent documents, instruments and data recording materials
Pharmacies will be randomised to pharmacy asthma intervention (Group A) or screening and referral (Group B). Randomisation will be stratified by metro/urban/rural residential areas, matched to the distribution of the Australian population.
This project utilises evidence-based methods of utilising trained pharmacists to improve asthma patient’s inhaler use and medication adherence. These methods have been shown to improve asthma control in patients and improve their quality of life. The benefit to the health system is cost saving (better asthma control implies lower health care utilisation) and maximising asthma care capacity (using the privately funded infrastructure of pharmacy). Some of the costs of sub-optimally controlled asthma may stem from undermanaged rhinitis. By checking for rhinitis and providing treatment recommendations the quality of life of people with asthma may be incrementally improved as well.
Pharmacists will be audited by the research team after they complete the first 2 patients. Adherence to the trial protocol and data collected will be reviewed at this stage and help will be given if there are any problems.
Variations in service delivery will be minimised by:
*The inherent design of the intervention software which will provide structured support and data documentation for pharmacists.
*The training program for pharmacists will assess protocol competence prior to implementing the program in a given pharmacy.
*A project hotline will be maintained and will allow pharmacists to access project research staff at the lead site.
Intervention code [1] 300389 0
Behaviour
Comparator / control treatment
There will be one comparator group:

1. Group B - Asthma low intervention Pharmacy Group

A group of patients with asthma will have their asthma control assessed using the ACQ by the pharmacist and those identified as having poorly controlled asthma with an ACQ score greater than or equal to 1.5, will be invited to participate in the service. If the patient agrees, they will be given a Patient Information Sheet (PIS) and then asked to sign two consent forms (a study consent and a separate Medicare consent form). The pharmacist will:

*Assess Asthma related quality of life using the IAQLQ
*Review SABA use
*Ask about Action Plan ownership
*Assess allergic rhinitis control (RCAT)
*Use the SF-12 for QOL for economic evaluation
*Download preventer dispensing over the previous 12 months.

The patient will then be given a referral to their GP. They will be contacted by the research team at 1 month and 12 months to reassess the above points.
Control group
Active

Outcomes
Primary outcome [1] 304867 0
The change in proportion of patients in each group who have controlled asthma from baseline to 12 months measured using ACQ scores.
Timepoint [1] 304867 0
12 months post intervention commencement.
Secondary outcome [1] 343418 0
Mean change in ACQ score.
Timepoint [1] 343418 0
Between baseline and one month for Groups A and B, and between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [2] 343419 0
Mean change in asthma-related Quality of Life.
Timepoint [2] 343419 0
Between baseline and one month for Groups A and B, and between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [3] 343420 0
Mean change in visual analogue adherence score.
Timepoint [3] 343420 0
Between baseline and one month for Groups A and B, and between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [4] 343421 0
Mean change in inhaler technique scores. Standard score sheets already used in the literature and used by the National asthma council will be used. The pharmacists technique will be checked prior to starting the intervention (they will send a video demonstrating their technique and it will be checked by the research team) and pharmacists will check and correct patient technique.
Timepoint [4] 343421 0
Between baseline and one month for Groups A and B, and between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [5] 343422 0
Mean change in proportion of patients with an asthma action plan. Measured using a study specific questionnaire embedded in intervention software.
Timepoint [5] 343422 0
Between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [6] 343423 0
Mean change in RCAT score.
Timepoint [6] 343423 0
Between baseline and one month for Groups A and B, and between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [7] 343424 0
Patient satisfaction with the model in intervention arm via qualitative questionnaire upon completion. The qualitative questionnaire will be designed for the purpose of this study.
Timepoint [7] 343424 0
In Group A - 12 months post commencement of intervention.
Secondary outcome [8] 343425 0
Number of GP presentations for asthma over 12 months via study-specific questionnaire.
Timepoint [8] 343425 0
Assessed 12 months post commencement of intervention.
Secondary outcome [9] 343426 0
Change in proportion of patients using preventer therapy using study-specific questionnaire.
Timepoint [9] 343426 0
Between baseline and 12 months for Groups A, B post commencement of intervention.
Secondary outcome [10] 343427 0
Cost effectiveness and cost utility over trial period. Research group will determine the costs of providing the pharmacist asthma service (including set-up costs, training of pharmacists, educational manual, pharmacist’s time in providing consults/telephone follow-up) and costs of patients’ healthcare utilisation (doctor visits, medication use, hospitalizations and emergency presentations). This will then be compared to information on health care use (intervention and usual care) determined from linked Medicare (MBS and PBS) and hospitalisation data via the data linkage facilities in each of the participating states (Data Linkage Western Australia, the Centre for Health Records Linkage (CHEReL in NSW and the Tasmanian Data Linkage Unit). Using the SF-12 we will be able to calculate the quality adjusted life years (QALYS) of such a service.
Timepoint [10] 343427 0
Assessed 12 months post commencement of intervention.
Secondary outcome [11] 343590 0
Pharmacist satisfaction with the model in intervention arm via qualitative questionnaire upon completion. The qualitative questionnaire will be designed for the purpose of this study.
Timepoint [11] 343590 0
12 months post commencement of intervention.
Secondary outcome [12] 343591 0
GP satisfaction with the model in intervention arm via qualitative questionnaire upon completion. The qualitative questionnaire will be designed for the purpose of this study.
Timepoint [12] 343591 0
12 months post commencement of intervention.

Eligibility
Key inclusion criteria
Eligible patients will be 18 years or older, with a current diagnosis of asthma (symptoms of asthma plus use of asthma medication in the past 12 months), have an ACQ score of 1.5 or over, are able to communicate with the pharmacist in English, are regular clients of the pharmacy and have the ability to manage their own medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they:
*Have a high dependence on medical care
*Are unable to manage their own medication
*Have a confirmed diagnosis of COPD
*Have a terminal illness

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Clustered
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
1/09/2018
Date of last participant enrolment
Anticipated
30/09/2018
Actual
28/02/2019
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
840
Accrual to date
Final
377
Recruitment in Australia
Recruitment state(s)
NSW,TAS,WA

Funding & Sponsors
Funding source category [1] 298746 0
Government body
Name [1] 298746 0
Australian Federal Government - Department of Health
Country [1] 298746 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Woolcock Institute of Medical Research
Address
431 Glebe Point Road, Glebe, NSW 2037, Australia
Country
Australia
Secondary sponsor category [1] 297923 0
None
Name [1] 297923 0
Address [1] 297923 0
Country [1] 297923 0
Other collaborator category [1] 279944 0
University
Name [1] 279944 0
University of Sydney
Address [1] 279944 0
Camperdown, NSW 2006
Country [1] 279944 0
Australia
Other collaborator category [2] 279945 0
University
Name [2] 279945 0
Curtin University
Address [2] 279945 0
Kent St, Bentley, WA 6102
Country [2] 279945 0
Australia
Other collaborator category [3] 279946 0
University
Name [3] 279946 0
University of Tasmania
Address [3] 279946 0
Churchill Ave, Hobart, TAS 7005
Country [3] 279946 0
Australia
Other collaborator category [4] 279947 0
Commercial sector/Industry
Name [4] 279947 0
The Pharmacy Guild of Australia
Address [4] 279947 0
15 National Circuit. Barton ACT 2600.
Country [4] 279947 0
Australia
Other collaborator category [5] 279948 0
Other Collaborative groups
Name [5] 279948 0
The Pharmaceutical Society of Australia
Address [5] 279948 0
Level 1 25 Geils Court DEAKIN ACT 2600
Country [5] 279948 0
Australia
Other collaborator category [6] 279949 0
Other Collaborative groups
Name [6] 279949 0
National Asthma Council
Address [6] 279949 0
Suite 104, Level 1, 153-161 Park Street, South Melbourne, VIC 3205
Country [6] 279949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299685 0
University of Sydney Human Ethics
Ethics committee address [1] 299685 0
Ethics committee country [1] 299685 0
Australia
Date submitted for ethics approval [1] 299685 0
05/02/2018
Approval date [1] 299685 0
30/05/2018
Ethics approval number [1] 299685 0

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

Contacts
Principal investigator
Name 81290 0
Prof Carol Armour
Address 81290 0
Woolcock Institute
431 Glebe Point Road, Glebe, NSW 2037
Country 81290 0
Australia
Phone 81290 0
+61 2 9114 0000
Fax 81290 0
Email 81290 0
carol.armour@sydney.edu.au
Contact person for public queries
Name 81291 0
Carol Armour
Address 81291 0
Woolcock Institute
431 Glebe Point Road, Glebe, NSW 2037
Country 81291 0
Australia
Phone 81291 0
+61 2 9114 0000
Fax 81291 0
Email 81291 0
carol.armour@sydney.edu.au
Contact person for scientific queries
Name 81292 0
Carol Armour
Address 81292 0
Woolcock Institute
431 Glebe Point Road, Glebe, NSW 2037
Country 81292 0
Australia
Phone 81292 0
+61 2 9114 0000
Fax 81292 0
Email 81292 0
carol.armour@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.