Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000574741
Ethics application status
Approved
Date submitted
14/05/2013
Date registered
21/05/2013
Date last updated
21/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A controlled trial of a health literacy education package for community pharmacists and pharmacy staff in Australia.
Scientific title
Are community pharmacists and pharmacy staff in Australia who undertake health literacy training more likely to use universal precautions with all pharmacy consumers compared to those who do not undergo the training?
Secondary ID [1] 281692 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Health Literacy in Pharmacy: The HeLP Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limited health literacy 287980 0
Inadequate health literacy awareness and education 287981 0
Condition category
Condition code
Public Health 288363 288363 0 0
Health service research
Public Health 289508 289508 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The education is based on an comprehensive literature review for current best evidence and identification of key resources and will cover topics surrounding health literacy, including definitions of health literacy, how it affects consumer healthcare and the healthcare system, why it is important for pharmacists and pharmacy staff to be aware of health literacy. The education will also cover methods to overcome health literacy problems with consumers, including particular communication techniques and strategies that allow for more effective information exchange to improve consumer understanding. Training will employ the use of computer based presentations and paper handouts which will be delivered in workshops run both on university premises and within the pharmacy premises. A select number of participants will receive computer-based training.
The initial training will occur once, with a duration of 4 to 5 hours.
For both Groups 1 and 2, the in-house pharmacy training will be delivered in six 30 minute sessions over a period of 12 weeks. This training will commence within 1-2 weeks after the initial training has occurred for the in-pharmacy trainers.
The pharmacist leading the training will be asked to keep a log of staff attending the training. The research assistants will also monitor the frequency of training sessions within the pharmacy.
Group 1 is the face-to-face group which will receive the initial health literacy training as a face-to-face class. Group 2 is the computer-based group which will receive the initial health literacy training in a computer based, self-directed format. Group 3 is the control group, and will have access to the education program following the completion of the trial
Intervention code [1] 286229 0
Behaviour
Comparator / control treatment
The control group (Group 3) will receive no intervention (ie the Health Literacy education program) during the study period. They will be offered the educational program after data collection for the intervention groups is complete.
Control group
Active

Outcomes
Primary outcome [1] 288532 0
The primary outcome is the extent of the application of universal precautions for pharmacy consumers by pharmacy staff. This will be assessed using both consumer entry and exit questionnaires assessing consumer understanding of the information supplied to them by the pharmacist or pharmacy assistant. The second method of assessment will use four simulated patient visits (mystery shoppers) to act out scripted case vignettes in the pharmacy, then completing an evaluation form at the conclusion of the interaction. Two visits will occur prior to training, and two following the completion of all training.
Timepoint [1] 288532 0
This will be assessed for 1 month before the intervention (May/June 2013)and for 1 month following the completion of the intervention (November 2013).
Secondary outcome [1] 300401 0
A secondary outcome is the measure of health literacy "friendliness" of the pharmacy as an organisation. This will be measured using an existing questionnaire developed by the United States Agency for Healthcare Research Quality that the pharmacists in charge or managing pharmacist will complete as a self-assessment. This will be conducted prior to receiving the training and following the completion of all training.
Timepoint [1] 300401 0
This will be assessed for 1 month before the intervention (May/June 2013)and for 1 month following the completion of the intervention (November 2013).
Secondary outcome [2] 301658 0
A further secondary outcome is the perception of the pharmacy as an organisation and its capacity to deliver services to people with limited health literacy. It will also gauge both knowledge and attitudes around health literacy. This will be measured using a questionnaire that the pharmacists in charge or managing pharmacist will complete as a self-assessment. All other pharmacy staff will also complete a similar questionnaire as a self-assessment. This will be conducted prior to receiving the training and following the completion of all training.
Timepoint [2] 301658 0
This will be assessed for 1 month before the intervention (May/June 2013)and for 1 month following the completion of the intervention (November 2013).

Eligibility
Key inclusion criteria
Community pharmacists and pharmacy staff working in pharmacies in Victoria, New South Wales and Western Australia.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 18 years old, consumers accessing emergency contraception or opioid replacement therapy (e.g. methadone).

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)
Block randomisation of pharmacies to one of three groups. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated blocks utilising the block randomisation method.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised (each pharmacy is cluster)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study has been powered to detect a 10% increase in the use of universal precautions (5% to 15% of interactions). With a power of 0.8 and alpha of 0.05, it has been calculated that the study will require 480 consumers across the three arms. The sample size will be increased by 10-20% to take into account attrition. Intra-pharmacy clustering will also be taken into account.Relative risk measures of behavioural change after educational package delivery.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
Date of last participant enrolment
Anticipated
3/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC

Funding & Sponsors
Funding source category [1] 286482 0
Government body
Name [1] 286482 0
Department Health and Ageing
Country [1] 286482 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 285272 0
Government body
Name [1] 285272 0
Pharmacy Guild of Australia
Address [1] 285272 0
Level 3, Computer Associates House
10 National Circuit
Barton ACT 2600
Country [1] 285272 0
Australia
Other collaborator category [1] 277397 0
University
Name [1] 277397 0
University of Technology Sydney
Address [1] 277397 0
15 Broadway
Ultimo NSW 2007
Country [1] 277397 0
Australia
Other collaborator category [2] 277398 0
University
Name [2] 277398 0
University of Queensland
Address [2] 277398 0
Brisbane QLD 4072 Australia
Country [2] 277398 0
Australia
Other collaborator category [3] 277399 0
University
Name [3] 277399 0
Curtin UNiversity
Address [3] 277399 0
GPO Box U1987 Perth,
Western Australia 6845
Country [3] 277399 0
Australia
Other collaborator category [4] 277400 0
University
Name [4] 277400 0
University of Sydney
Address [4] 277400 0
The University of Sydney
NSW 2006
Australia
Country [4] 277400 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288936 0
Monash University Human Ethics Research Committee
Ethics committee address [1] 288936 0
Monash University
Level 1, Building 3e, Clayton Campus
Wellington Rd
Clayton VIC 3800
Ethics committee country [1] 288936 0
Australia
Date submitted for ethics approval [1] 288936 0
Approval date [1] 288936 0
17/12/2012
Ethics approval number [1] 288936 0
2012001910
Ethics committee name [2] 288937 0
Monash University
Ethics committee address [2] 288937 0
Monash University
Level 1, Building 3e, Clayton Campus
Wellington Rd
Clayton VIC 3800
Ethics committee country [2] 288937 0
Australia
Date submitted for ethics approval [2] 288937 0
15/02/2013
Approval date [2] 288937 0
29/04/2013
Ethics approval number [2] 288937 0
CF13/479 - 2013000212

Summary
Brief summary
Pharmacists and pharmacy staff frequently deal with customers who have limited ability to understand information about their medicines and health care. This project aims to adjust the services and counselling provided by pharmacists and pharmacy staff to accommodate the needs of people with low levels of health literacy without necessarily detecting health literacy issues.

The hypothesis for the study is that Australian pharmacists lack the ability to effectively communication with consumers who have health literacy issues, and are unaware of particular communication techniques to overcome health literacy barriers when interacting with consumers
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36678 0
Mr Gregory Duncan
Address 36678 0
Eastern Health Clinical School
Faculty of Medicine Nursing and Health Sciences
Monash University
5 Arnold St, Box Hill VIC 3128
Country 36678 0
Australia
Phone 36678 0
+61412040320
Fax 36678 0
Email 36678 0
[email protected]
Contact person for public queries
Name 36679 0
Mr Gregory Duncan
Address 36679 0
Eastern Health Clinical School
Faculty of Medicine Nursing and Health Sciences
Monash University
5 Arnold St, Box Hill VIC 3128
Country 36679 0
Australia
Phone 36679 0
+61412040320
Fax 36679 0
Email 36679 0
[email protected]
Contact person for scientific queries
Name 36680 0
Mr Gregory Duncan
Address 36680 0
Eastern Health Clinical School
Faculty of Medicine Nursing and Health Sciences
Monash University
5 Arnold St, Box Hill VIC 3128
Country 36680 0
Australia
Phone 36680 0
+61412040320
Fax 36680 0
Email 36680 0
[email protected]

No information has been provided regarding IPD availability


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.