Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12609000196246
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
20/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Building on success: the sustainability and national feasibility of a community pharmacy intervention to improve the management of asthma
Scientific title
Building on success: the sustainability and national feasibility of a community pharmacy intervention to improve the management of asthma
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 4304 0
Condition category
Condition code
Respiratory 4538 4538 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A previous intervention study (not registered on a trials registry) saw patients with potentially suboptimal management of their asthma identified from their dispensed medication history – in particular, a high rate of provision of reliever compared with preventer medication for asthma. These patients were sent educational material from their community pharmacists and advised to seek a review of their asthma management from their general practitioner. The intervention resulted in a three-fold improvement in the management of asthma, measured by a significant shift towards more patients using preventer medications and relying less heavily on their reliever medications. There were also significant improvements in self-reported asthma control and asthma-related quality of life.
This project is examining the long-term sustainability of the previously funded asthma intervention program by performing a 12-month follow-up and data analysis. If the effects of this low-cost, high-value intervention are sustained, it is envisaged that it will significantly impact on health policy in asthma management. If the effects are not sustained, further analysis of the data will be undertaken to determine frequency of the intervention required to gain sustained improvements. In addition, patients, community pharmacists and general practitioners will be invited to participate in qualitative face-to-face interviews to determine the perceived feasibility of the community pharmacy intervention on a national scale. Identification of key barriers and enables to the implementation of the intervention will lead to an improved process if necessary, with a higher level of satisfaction among the target population.
Intervention code [1] 4035 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5416 0
Feasiblity - Qualitative analysis of patients, community pharmacists and general practitioners to identify common themes regarding the barriers and enables of a national intervention program. Interviews will be conducted face-to-face, on a one-to-one basis, and will be semi-structured.
Timepoint [1] 5416 0
The interviews will take place in March 2009.
Primary outcome [2] 5417 0
Sustainability - Quantitative analysis of the patients' asthma medcations, in particular, the ratio of dispensed inhaled corticosteroids to dispensed short-acting beta-2-agonists. The data will be collected by retrospective interrogation of pharmacy dispensing data, in all previously participating pharmacies. All data was de-identified originally, but uniquely coded to enable paired data analysis in the future.
Timepoint [2] 5417 0
The quantitive data will be collected in November 2008.
Secondary outcome [1] 9109 0
N/A
Timepoint [1] 9109 0
N/A

Eligibility
Key inclusion criteria
Participants (patients with asthma, community pharmacusts and general practitioners) must have been involved in the previous intervention study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who are deceased, patients who do not have a curent diagnosis of asthma, community pharmacists and GPs who no longer practice at least half-time.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4482 0
Charities/Societies/Foundations
Name [1] 4482 0
Asthma Foundations Australia
Country [1] 4482 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 Private Bag 26 Hobart TAS 7001
Country
Australia
Secondary sponsor category [1] 4042 0
University
Name [1] 4042 0
Research Services, University of Tasmania
Address [1] 4042 0
University of Tasmania Churchill Avenue Sandy Bay Private Bag 1 Hobart TAS 7001
Country [1] 4042 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6543 0
Tasmania Social Sciences Human Research Ethics Committee
Ethics committee address [1] 6543 0
Office of Research Services
University of Tasmania
Private Bag 1 Hobart
Tasmania 7001
Ethics committee country [1] 6543 0
Australia
Date submitted for ethics approval [1] 6543 0
Approval date [1] 6543 0
03/12/2008
Ethics approval number [1] 6543 0
H10378
Ethics committee name [2] 6544 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [2] 6544 0
Office of Research Services
University of Tasmania
Private Bag 1 Hobart
Tasmania 7001
Ethics committee country [2] 6544 0
Date submitted for ethics approval [2] 6544 0
Approval date [2] 6544 0
03/03/2008
Ethics approval number [2] 6544 0
H9039

Summary
Brief summary
A previous intervention project saw patients with potentially suboptimal management of their asthma identified from their dispensed medication history – in particular, a high rate of provision of reliever compared with preventer medication for asthma. These patients were sent educational material from their community pharmacists and advised to seek a review of their asthma management from their general practitioner. The intervention resulted in a three-fold improvement in the management of asthma, measured by a significant shift towards more patients using preventer medications and relying less heavily on their reliever medications.1 There were also significant improvements in self-reported asthma control and asthma-related quality of life.
This project is examining the long-term sustainability of the previously funded asthma intervention program by performing a 12-month follow-up and data analysis. If the effects of this low-cost, high-value intervention are sustained, it is envisaged that it will significantly impact on health policy in asthma management. If the effects are not sustained, further analysis of the data will be undertaken to determine frequency of the intervention required to gain sustained improvements. In addition, patients, community pharmacists and general practitioners will be invited to participate in qualitative face-to-face interviews to determine the perceived feasibility of the community pharmacy intervention on a national scale. Identification of key barriers and enables to the implementation of the intervention will lead to an improved process if necessary, with a higher level of satisfaction among the target population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29270 0
Address 29270 0
Country 29270 0
Phone 29270 0
Fax 29270 0
Email 29270 0
Contact person for public queries
Name 12517 0
Bonnie Bereznicki
Address 12517 0
Unit for Medication Outcomes Research and Education
School of Pharmacy, University of Tasmania
Churchill Avenue Sandy Bay
Private Bag 26
Hobart TAS 7001
Country 12517 0
Australia
Phone 12517 0
+61 3 62262191
Fax 12517 0
+61 3 62267627
Email 12517 0
[email protected]
Contact person for scientific queries
Name 3445 0
Bonnie Bereznicki
Address 3445 0
Unit for Medication Outcomes Research and Education
School of Pharmacy, University of Tasmania
Churchill Avenue Sandy Bay
Private Bag 26
Hobart TAS 7001
Country 3445 0
Australia
Phone 3445 0
+61 3 62262191
Fax 3445 0
+61 3 62267627
Email 3445 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.