Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000119392
Ethics application status
Approved
Date submitted
26/02/2008
Date registered
5/03/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacy dispensing records to identify and
educate patients with suboptimal asthma
management
Scientific title
Pharmacy dispensing records to identify and
educate patients with suboptimal asthma
management
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 2876 0
Condition category
Condition code
Respiratory 3013 3013 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to utilise a computerised solution within community pharmacy to
identify patients whose asthma may not be optimally managed, and then
implement and evaluate multidisciplinary educational interventions. A software
application that extracts data from the market leading pharmacy dispensing
software system in Australia (WiniFRED Dispense; PCA/NU Systems) developed by
the Research Team will be refined. The intervention study will be conducted across
three states: Tasmania, Victoria and South Australia, and community pharmacists
using the WiniFRED Dispense System will be personally invited to participate by
letter. Participating pharmacies will install the software application that will
generate a list of patients who have received six or more canisters of short-acting beta-2 agonists in the preceding 12 months. This indicates that the patient may be using on average three or more inhalations per day of reliever medication, which is in excess of contemporary guidelines for optimal asthma control. Identified patients will be randomised to an intervention or control group.
Intervention patients will either receive a mailed personalised letter and
intervention pack or an ‘alert flag’ will be placed in their personal details within the
dispensing system so that the pharmacist can give them an intervention pack with
appropriate counselling on their next visit to the pharmacy. Each intervention will
involve encouragement of patients to seek a review of their asthma management
from their general practitioner (GP).
The intervention pack will consist of the following information:
- a computer-generated personalised letter
- an educational leaflet about asthma
- asthma control, quality of life, and medication adherence questionnaires
- a computer-generated letter (and medication history) to give to their GP
- a GP satisfaction/perception survey of the intervention to give to their GP.
Control patients will receive usual care until follow-up, 12 months later. At this
time they will receive an intervention pack and all intervention patients will receive
repeat asthma-related questionnaires. Changes in asthma medication usage and
questionnaire scores will be examined. We recently conducted a pilot study in
Tasmania which demonstrated major improvements in the use of preventer medication at follow-up.
Intervention code [1] 2606 0
Treatment: Other
Comparator / control treatment
Patients identified as having received six or more asthma reliver medications in the preceding 12 months, randomised to the control group. Community pharmacists will be blinded to the control patients' identities to ensure that they receive no active intervention other than usual care, for the 12-month post-intervention follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 3895 0
Ratio of dispensed asthma preventer medication to asthma reliever medication
Timepoint [1] 3895 0
12 months
Secondary outcome [1] 6560 0
Asthma-related quality of life score
Timepoint [1] 6560 0
12 months
Secondary outcome [2] 6561 0
Medication adherence score
Timepoint [2] 6561 0
12 months
Secondary outcome [3] 6562 0
Asthma control score
Timepoint [3] 6562 0
12 months

Eligibility
Key inclusion criteria
The program will identify patients who have received six or more relievers (inhaled short-acting beta-2-agonists) in the preceding 12 months (at least three in each six-month period) indicating that they may be using on average three or more inhalations per day of reliever medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The data-mining software application will automatically exclude patients receiving inhaled anticholinergic therapy (tiotropium or ipratropium) or methylxanthines, indicating the likely presence of chronic obstructive pulmonary disease, or leukotriene-receptor antagonists, indicating the probable diagnosis of severe asthma likely to be under the care of a respiratory specialist.
The community pharmacist will use they're knowledge of each patient to exlude those who:
- are a resident of an aged care facility;
- are under 18 years of age;
- are unlikely to understand the letter (e.g. history of dementia with limited carer support);
- are likley to be overly alarmed by receiving the intervention; or
- possess other extenuating factors, which will be documented by the pharmacist.

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)
The group allocation process will be concealed from the pharmacist and occurs automatically upon running the data-mining software application, with only the resulting list of intervention patients available for viewing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The list of identified patients will be ranked in order of greatest number of reliever canisters dispensed in the preceding 12 months. The patient receiving the greatest number of relievers was randomly assigned to the intervention or control group, with subsequent patients being alternately assigned to the control or intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3130 0
Other
Name [1] 3130 0
Pharmacy Guild of Australia
Country [1] 3130 0
Australia
Primary sponsor type
University
Name
Unit for Medication Outcomes Research and Education, School of Pharmacy, University of Tasmania
Address
University of Tasmania
Churchill Avenue
Sandy Bay TAS 7005
Country
Australia
Secondary sponsor category [1] 2813 0
University
Name [1] 2813 0
School of Pharmacy and Medical Sciences, University of South Australia
Address [1] 2813 0
Level 4-47
Playford Building
Frome Road
Adelaide SA 5000
Country [1] 2813 0
Australia
Secondary sponsor category [2] 2814 0
University
Name [2] 2814 0
Victorian College of Pharmacy, Monash University
Address [2] 2814 0
381 Royal Parade
Parkville VIC 3052
Country [2] 2814 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5102 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 5102 0
Ethics committee country [1] 5102 0
Australia
Date submitted for ethics approval [1] 5102 0
30/11/2007
Approval date [1] 5102 0
06/02/2008
Ethics approval number [1] 5102 0
H0009823

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

Contacts
Principal investigator
Name 28405 0
Address 28405 0
Country 28405 0
Phone 28405 0
Fax 28405 0
Email 28405 0
Contact person for public queries
Name 11562 0
Bonnie Bereznicki
Address 11562 0
University of Tasmania
Churchill Ave
Sandy Bay TAS 7005
Country 11562 0
Australia
Phone 11562 0
+61 3 62262191
Fax 11562 0
+61 3 62267627
Email 11562 0
[email protected]
Contact person for scientific queries
Name 2490 0
Bonnie Bereznicki
Address 2490 0
University of Tasmania
Churchill Ave
Sandy Bay TAS 7005
Country 2490 0
Australia
Phone 2490 0
+61 3 62262191
Fax 2490 0
+61 3 62267627
Email 2490 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.