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
ACTRN12614001017617
Ethics application status
Approved
Date submitted
9/09/2014
Date registered
22/09/2014
Date last updated
22/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacist demonstration of EpiPen and Anapen autoinjectors to simulated patients: assessment of accuracy.
Scientific title
Pharmacist demonstration of EpiPen and Anapen autoinjectors to simulated patients: assessment of accuracy.
Secondary ID [1] 285311 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaphylaxis 293023 0
Condition category
Condition code
Inflammatory and Immune System 293293 293293 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of pharmacist practice and performance in demonstrating adrenaline autoinjectors (EpiPen and Anapen) to simulated anaphylaxis patients.
Pharmacists were observed during a single consultation where a simulated patient requested advice on how to use an adrenaline autoinjector. Consultations lasted 5-15 minutes.
Intervention code [1] 290218 0
Not applicable
Comparator / control treatment
No control group as this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293129 0
Accurate demonstration (overall, i.e. for all devices) of all steps required for correct adrenaline autoinjector administration according to the steps for administration published on the (device specific) ASCIA Action Plan for Anaphylaxis.
Timepoint [1] 293129 0
Upon request for demonstration by the simulated patient.
Secondary outcome [1] 310416 0
Demonstration accuracy by device (original EpiPen, new-look EpiPen, Anapen). Accurate demonstration was defined as one that fulfilled all steps listed on the relevant Australasian Society of Clinical Immunology and Allergy (ASCIA) Action Plan for Anaphylaxis. A custom designed data collection tool (which we validated before use) captured demographic variables (broadly: pharmacy environment, pharmacist age group and gender), and adrenaline autoinjector variables (broadly: materials used for demonstration, use of references, steps used in demonstration, errors or omissions in demonstration and other advice provided).
Timepoint [1] 310416 0
Upon request for demonstration
Secondary outcome [2] 310417 0
Predictors of accurate demonstration based on the consultation with the pharmacist.
Binary logistic regression was performed to identify consultation-specific predictors of accurate EpiPen and Anapen demonstration. Potential predictors in the model were device type, age, gender, use of references, and general anaphylaxis and device-specific information provided by the pharmacist. Recognising that consultations with pharmacists may vary from brief to extended interactions (and thus to assess the impact of predictor variables independently and collectively), we conducted both single variable and multi variable (adjusted) logistic regression analyses. Odds ratios and 95% confidence intervals for each predictor were obtained.
Timepoint [2] 310417 0
After data analysis - i.e. this will not be identified at the time of demonstration.

Eligibility
Key inclusion criteria
Australian pharmacists working in community pharmacies, located within a 20km radius of the Perth Central Business District, and listed on the Pharmacy Registration Board of Western Australia Premises Register.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pharmacists who are known to the researcher.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Accuracy to be analysed descriptively. Binary logistic regression will be used to identify predictors of accurate demonstration. There is no existing data upon which to estimate sample sizes, however we elected to sample the majority of pharmacies within the Perth metropolitan area (sample represented 96% of all pharmacies within a 20km radius of Perth CBD, and 73% of all Perth metropolitan pharmacies). No formal sample size calculations were performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289930 0
Charities/Societies/Foundations
Name [1] 289930 0
Pharmaceutical Society of Western Australia
Address [1] 289930 0
21 Hamilton Street
Subiaco WA 6008
Country [1] 289930 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Centre for Optimisation of Medicines
School of Medicine and Pharmacology
Division of Pharmacy
M315, The University of Western Australia
32 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 288622 0
None
Name [1] 288622 0
Address [1] 288622 0
Country [1] 288622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291647 0
UWA HREC
Ethics committee address [1] 291647 0
The University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Ethics committee country [1] 291647 0
Australia
Date submitted for ethics approval [1] 291647 0
Approval date [1] 291647 0
01/03/2012
Ethics approval number [1] 291647 0
RA/4/1/5440

Summary
Brief summary
Successful treatment of anaphylaxis in the community relies on early and correct use of epinephrine autoinjectors. Community pharmacists supply these devices with and without prescription and have a crucial role teaching patients how to use them. Supply of epinephrine autoinjectors in Australia increased 70-fold in the past decade. New EpiPen and Anapen autoinjectors were launched in Australia in 2011 and 2012, with the potential to cause confusion. However there is no information about how pharmacists demonstrate epinephrine autoinjectors to patients. Therefore the aim of this study was to assess real-world community pharmacist demonstrations of EpiPen and Anapen. We also sought to identify consultation-based predictors of accurate demonstration.
Trial website
Trial related presentations / publications
This work has been presented as follows:
1. Salter SM, Loh R, Sanfilippo FM, Clifford RM. Pharmacist demonstration of adrenaline autoinjectors is accurate, but there is room for improvement. ASCIA 2014 Annual Conference: Melbourne (AU); September 10-12, 2014.
2. Salter SM, Loh R, Sanfilippo FM, Clifford RM. Pharmacist demonstration of adrenaline autoinjectors is accurate, but there is room for improvement. Internal Medicine Journal 2014; 44 (S4): S1-29.
3. Salter SM, Loh R, Sanfilippo FM, Clifford RM. Demonstration of epinephrine autoinjectors (EpiPen and Anapen) by pharmacists in a randomised, simulated patient assessment: acceptable but room for improvement. Allergy, Asthma & Clinical Immunology 2014 (in press as at 18 September 2014).
Public notes

Contacts
Principal investigator
Name 51334 0
Ms Sandra Salter
Address 51334 0
Centre for Optimisation of Medicines
School of Medicine and Pharmacology
Division of Pharmacy
M315, The University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country 51334 0
Australia
Phone 51334 0
+61 416 003 808
Fax 51334 0
Email 51334 0
sandra.salter@uwa.edu.au
Contact person for public queries
Name 51335 0
Ms Sandra Salter
Address 51335 0
Centre for Optimisation of Medicines
School of Medicine and Pharmacology
Division of Pharmacy
M315, The University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country 51335 0
Australia
Phone 51335 0
+61 416 003 808
Fax 51335 0
Email 51335 0
sandra.salter@uwa.edu.au
Contact person for scientific queries
Name 51336 0
Ms Sandra Salter
Address 51336 0
Centre for Optimisation of Medicines
School of Medicine and Pharmacology
Division of Pharmacy
M315, The University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country 51336 0
Australia
Phone 51336 0
+61 416 003 808
Fax 51336 0
Email 51336 0
sandra.salter@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary