All included intervention patients were sent a satisfaction survey (Appendix 25) at the end of the post-intervention period. The questions assessed the perceived usefulness and appropriateness of the intervention, as well as the satisfaction with the level of asthma care usually received by doctors and community pharmacists.
3.2.9 Post-intervention follow-up
Twelve months after the intervention, the researchers in Victoria and South Australia were provided with instructions for the post-intervention site visits (Appendix 26). The control patients’ identities were revealed, and pharmacists examined their dispensing information to determine whether they were eligible to be included in the study (that is, they did not meet any of the exclusion criteria). For ethical reasons, all included control patients who had received six or more relievers in the post-intervention period were sent an intervention pack, the same as that sent to intervention patients 12 months earlier.
Control patients who received less than six relievers in the post-intervention period were not sent an intervention pack, but their dispensing data were still included in the analyses, because they were otherwise eligible to remain in the study.
Intervention patients received a follow-up letter (Appendix 27), and were again provided with the three questionnaires on asthma control, asthma-related QOL and medication adherence behaviour knowledge, as well as a satisfaction questionnaire. Figure 24 displays a summary of the project’s methodology.
Figure 24. Summary of the project’s methodology
Dispensed any asthma-related medication in the last 12 months and not
flagged as deceased
Report generated, patients randomised and ranked according to use of reliever
medications
Patients receiving six or more relievers in preceding 12 months (and 3 or more in the two preceding six-month periods)
Intervention group
Pharmacist deemed eligibility. Patients received (either mailed or in person) personalised letter, education materials and
letter to give to their GP, asthma control, QOL and adherence surveys. De-identified
dispensing information provided to Tasmanian School of Pharmacy
Intervention group
Patients mailed repeat asthma control, QOL and adherence surveys, as well as a
satisfaction survey. De-identified dispensing information provided to the
Tasmanian School of Pharmacy
Receiving any inhaled anticholinergics, oral LTRAs or
methyxanthines
Patients receiving less than six reliever medications in preceding
12 months
Control group
Information stored for 12 months, pharmacist blinded to control patients’ identities. No education or information provided at this stage. De-identified information provided to the Tasmanian
School of Pharmacy
Control group
Pharmacist deemed eligibility. Patients received personalised letter, education materials and letter to give to
their GP, asthma control, QOL and adherence surveys. De-identified dispensing information provided to the
Tasmanian School of Pharmacy 12 months
Excluded
Excluded
Randomisation Pharmacies randomised to perform mailed or face-to-face intervention, and
MedeMine-for-Asthma program installed
Key:
Program algorithm Project methods
3.2.10 Handling of data and statistical analysis
All surveys and dispensing data were de-identified. Patient and GP surveys were coded with unique identification numbers that could be linked to patients’ dispensing data, but could not be re-identified by the researchers.
The asthma medications included in the analyses were inhaled SABAs (relievers) and ICS (preventers). Prior to performing statistical analyses, the dispensed quantities of asthma medications were converted to a standard equivalent dose:
• Salbutamol equivalence: salbutamol 100 #g = terbutaline 250 #g;315 and
• Beclomethasone-HFA equivalence: beclomethasone-HFA 100 #g = fluticasone 100 #g = budesonide 200 #g = ciclesonide 80 #g.134-136
Because eformoterol can now be prescribed as a reliever, as part of the Symbicort® Maintenance And Reliever Therapy regimen, it was counted as a reliever (with 3 #g of eformoterol equivalent to 100 #g of salbutamol)349 if the dispensing instructions indicated it was being used in this manner.
The preventer-to-reliever (P : R) ratio was calculated for each patient as the average beclomethasone-equivalent usage per day divided by the average salbutamol-equivalent usage per day. The primary outcome measure was the P : R ratio of dispensed asthma medication, and secondary outcome measures were other patterns in dispensed asthma medication, asthma questionnaire scores and participant satisfaction.
All variables were collated and entered into a statistical software package, Statview 5.01 (Abacus Concepts Inc, Berkeley, California, USA). Parametric data are presented as means ± standard deviations, and nonparametric data are presented as medians (interquartile ranges). Within-group comparisons of dispensing data were conducted using the Wilcoxon signed-rank test, and between-group comparisons were conducted using the Kruskal-Wallis test. Post hoc testing was performed using the Mann Whitney test with Bonferroni correction. The Bonferroni adjusted critical value controlled for multiple comparison testing, and was obtained by dividing the original threshold P
uptake of the intervention by pharmacists, the dispensing data was also analysed using the intention-to-treat method, whereby all eligible patients were analysed for changes in dispensing data.
Within group comparisons of asthma questionnaire scores were conducted using the paired Student’s t-test, and each intervention group was compared to the control group using the unpaired Student’s t-test. Proportional data were analysed using the %2 test. A significance level of P < 0.05 was used for all statistical procedures, with the exception of the post hoc Mann Whitney test, in which a Bonferroni adjusted significance level of
P < 0.0167 was used.322,323
3.2.11 Ethical approval and trial registration
This project received ethical approval from the Tasmanian Health and Medical Human Research Ethics Committee (ethics reference number H9823), Monash University’s Human Research Ethics Committee (ethics reference number 2008000274) and the University of South Australia’s Human Research Ethics Committee (ethics reference number P056/08). The study was registered with the Australian New Zealand Clinical Trial Registry (registration number ACTRN12608000119392).