Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000083897
Ethics application status
Approved
Date submitted
4/12/2020
Date registered
1/02/2021
Date last updated
1/02/2021
Date data sharing statement initially provided
1/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effectiveness of a patient-centred dispensing label on comprehension of medication dosing instructions
Scientific title
Effectiveness of a patient-centred dispensing label on patient comprehension of medication dosing instructions
Secondary ID [1] 302951 0
None
Universal Trial Number (UTN)
U1111-1262-3353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication Error 319984 0
Condition category
Condition code
Public Health 317916 317916 0 0
Health service research
Public Health 317917 317917 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The typical way of presenting information on labels of dispensed medicines can confuse some people. This randomised control trial aimed to evaluate the effectiveness of dispensing labels designed to be easier to read, these labels are called "patient-centred labels". The label was designed following international evidence and recommendations provided by the Australian Commission on Safety and Quality in Health Care that are yet to be implemented in Australian pharmacy practice. Compared with the standard dispensing label (70x30mm), the patient-centred label was double spaced (70x60mm) and contained more explicit instructions that were written in simple language using 12 point font size. A universal medication schedule was used to convey and simplify instructions for dosing for example ‘take 2 tablets in the morning, and take 2 tablets in the evening’ rather than ‘take TWO tablets TWICE a day’. Numbers rather than words were used to convey numeric information, for example ‘take 2 tablets...’ rather than ‘take TWO tablets...’. The trial was carried out using a structured interview approach with participants recruited from the waiting area of a tertiary-care hospital's pharmacy department. The intervention was administered face to face by a pharmacist researcher once-off during a 30 min interview. Participants were asked questions relating to how well they access and interpret health information and then randomly assigned to either a set of three standard dispensing labels or three patient-centred dispensing labels. They were asked to interpret their assigned dispensing labels and comprehend how they would take their medication. Participants were provided with inactive tablets or liquid and asked to demonstrate how they would take each medicine over a week on an A3 size grid sheet.
Intervention code [1] 319241 0
Prevention
Intervention code [2] 319438 0
Behaviour
Comparator / control treatment
Control group participants received a set of three standard dispensing labels. Compared with the patient-centred label, the standard dispensing label was smaller in size (70x30mm) and contained complex information in smaller fonts, for example 'take TWO tablets TWICE a day'. This label reflected the standard version of the dispensing label currently implemented in Australian pharmacy practice.
Control group
Active

Outcomes
Primary outcome [1] 325926 0
Comprehension of labels, measured using total number of weekly medicines correctly assigned on grid sheet specifically designed for this study.
Timepoint [1] 325926 0
Immediately following the intervention.
Secondary outcome [1] 389555 0
Nil
Timepoint [1] 389555 0
Nil

Eligibility
Key inclusion criteria
Participants waiting for prescription filling or a medical appointment were recruited from the waiting area of a pharmacy department in a 929-bed tertiary hospital in Brisbane, Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Refusal to provide written informed consent to participate.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/01/2020
Date of last participant enrolment
Anticipated
Actual
13/03/2020
Date of last data collection
Anticipated
Actual
13/03/2020
Sample size
Target
102
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307371 0
University
Name [1] 307371 0
The University of Queensland
Country [1] 307371 0
Australia
Primary sponsor type
Individual
Name
Dr Adam La Caze
Address
School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country
Australia
Secondary sponsor category [1] 308028 0
None
Name [1] 308028 0
Address [1] 308028 0
Country [1] 308028 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307459 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 307459 0
Ethics committee country [1] 307459 0
Australia
Date submitted for ethics approval [1] 307459 0
Approval date [1] 307459 0
28/08/2019
Ethics approval number [1] 307459 0

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

Contacts
Principal investigator
Name 107306 0
Dr Adam La Caze
Address 107306 0
School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country 107306 0
Australia
Phone 107306 0
+61 7 334 61985
Fax 107306 0
Email 107306 0
[email protected]
Contact person for public queries
Name 107307 0
Ahsan Saleem
Address 107307 0
School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country 107307 0
Australia
Phone 107307 0
+61 432 147 636
Fax 107307 0
Email 107307 0
[email protected]
Contact person for scientific queries
Name 107308 0
Adam La Caze
Address 107308 0
School of Pharmacy
The University of Queensland
Pharmacy Australia Centre of Excellence
Level 4, 20 Cornwall Street
Woolloongabba, QLD, 4102
Country 107308 0
Australia
Phone 107308 0
+61 7 334 61985
Fax 107308 0
Email 107308 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


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.