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Trial registered on ANZCTR


Registration number
ACTRN12617000332325
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
3/03/2017
Date last updated
21/10/2019
Date data sharing statement initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to investigate the impact of a new pharmacy service on new medicine adherence
Scientific title
An evaluation to investigate the impact of the New Medicine Support Service on adherence to newly prescribed medicines
Secondary ID [1] 291049 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medicine adherence 301840 0
Condition category
Condition code
Public Health 301519 301519 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the delivery of the New Medicine Support Service by pharmacists. Intervention patients will receive up to two telephone or face-to-face consultations (determined by patient preference) with a pharmacist over 4 weeks who will assess patient adherence to their new medicine; identify any medicines related problems; establish any support the patient may need; and answer any questions the patient may have about their new medicine. In some cases a patient will only receive one consultation if at the first consultation the pharmacist deems it necessary to refer the patient back to their GP.

Consultations will generally take approximately 15 minutes and take place at approximately 2 and 4 weeks after dispensing of the patient's new medicine (study registration).
Intervention code [1] 297038 0
Behaviour
Comparator / control treatment
Control patients will not receive the New Medicine Support Service and only the usual medicine counseling from their pharmacist. Usual medicine counseling is the standard service a pharmacist provides to any patients they dispense newly prescribed medicines to.
Control group
Active

Outcomes
Primary outcome [1] 300930 0
The primary outcome of the study is patient adherence to their newly prescribed medicine at 2, 3 and 6 months following study registration.

This is assessed using the validated Morisky Medication Adherence Scale, pharmacy dispensing data and PBS data.
Timepoint [1] 300930 0
2, 3 and 6 months.
Secondary outcome [1] 331228 0
Proportion of patients referred back to their GP.
Timepoint [1] 331228 0
2 - 4 weeks

Eligibility
Key inclusion criteria
To be included in the study patients must meet the following criteria:
* Be aged 18 years or above;
* Be a Medicare and/or Department of Veterans affairs (DVA) card holder;
* Be living at home in a community setting;
* Be on a newly prescribed medicine for one of the following conditions:
– Asthma and other lung conditions such as COPD
– Conditions requiring antiplatelet / anticoagulant therapy
– Depression
– Dyslipidaemia
– Hypertension
– Type 2 diabetes
* Be able to understand and willing to consent to the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient cannot communicate sufficiently in English.
- Patients of public or private hospitals, day hospital facilities, transitional care facilities or to residents of an Aged Care facility.
- Patients who are collecting medicine where the only change from the previous medicine involves a dosage, strength, brand or formulation change(s).

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by
computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A minimum of 712 patients from at least 47 pharmacies will be required. Estimation of sample size was based on expecting an increase in adherence of 10%, based on a baseline adherence level of 60%, assuming 80% power, a two-sided test and alpha=0.05. It is expected that each pharmacy can recruit approximately 16 patients over 4-5 months, based on a previous pilot.

Descriptive Analysis
Continuous data will be explored using means and standard deviations if the data are approximately normally distributed and medians and inter-quartile ranges if the data are not normally distributed. Categorical data will be described using frequencies and percentages. The following patient characteristics will be described by treatment-arm: age, gender, geographic location and condition the new prescription is for.

Comparison between treatment arms
Intention-to-treat (ITT) analysis will be used for all outcomes. The ITT cohort is defined as all patients within a randomisation arm with measured outcomes or who are considered withdrawn from the study, without revoking consent. However, if a withdrawn patient also wishes to revoke their consent, they will not be included in the ITT analysis.
To compare medicines adherence between the current practice and intervention arm patients, differences in the categorised MMAS-4, MPR and PDC will be examined using the chi-squared test or Fisher’s exact test as appropriate. Simple logistic regression will be used to assess unadjusted effect of the NMSS associated with the outcome measure. Multilevel logistic regression will adjust for data clustering (patient and pharmacy) and confounding by age, sex, disease and number of medications. The significance of the variables in the model will be assessed using the Wald chi-squared test and determination of odds ratios with associated 95% confidence intervals. Goodness of fit to the model with be assessed using chi-squared, G-test and the Hosmer-Lemeshow statistics. Statistical significance will be assessed at the 5% level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2017
Actual
21/03/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
4/06/2018
Date of last data collection
Anticipated
31/12/2018
Actual
31/12/2018
Sample size
Target
712
Accrual to date
Final
847
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 295490 0
Government body
Name [1] 295490 0
Australian Government Department of Health
Country [1] 295490 0
Australia
Primary sponsor type
Other
Name
NPS MedicineWise
Address
PO Box 1147, Strawberry Hills, NSW 2012
Country
Australia
Secondary sponsor category [1] 294621 0
None
Name [1] 294621 0
Address [1] 294621 0
Country [1] 294621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296818 0
Bellberry Limited
Ethics committee address [1] 296818 0
Ethics committee country [1] 296818 0
Australia
Date submitted for ethics approval [1] 296818 0
Approval date [1] 296818 0
10/01/2017
Ethics approval number [1] 296818 0

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

Contacts
Principal investigator
Name 72122 0
Dr Isla Hains
Address 72122 0
NPS MedicineWise
PO Box 1147
Strawberry Hills
NSW 2012
Country 72122 0
Australia
Phone 72122 0
+61 2 82179235
Fax 72122 0
Email 72122 0
ihains@nps.org.au
Contact person for public queries
Name 72123 0
Isla Hains
Address 72123 0
NPS MedicineWise
PO Box 1147
Strawberry Hills
NSW 2012
Country 72123 0
Australia
Phone 72123 0
+61 2 82179235
Fax 72123 0
Email 72123 0
ihains@nps.org.au
Contact person for scientific queries
Name 72124 0
Isla Hains
Address 72124 0
NPS MedicineWise
PO Box 1147
Strawberry Hills
NSW 2012
Country 72124 0
Australia
Phone 72124 0
+61 2 82179235
Fax 72124 0
Email 72124 0
ihains@nps.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Under ethics data will only be reported in an aggregated format.


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.