Study Design and Setting
This is a non-randomized, before- and after- study of individuals with asthma attending two community pharmacies in Auckland, New Zealand. This study design was chosen to prevent potential direct/indirect educational effects of the intervention carrying over to the control group. The aim of this study is to inform the design of a larger cluster randomized controlled trial.
Individuals presenting to one of the two enrolled community pharmacies will be eligible to participate in the study if they meet the following eligibility criteria:
- Aged 18 years or over
- Prescribed a SABA as a ‘reliever’ for their asthma symptoms.
Individuals will not be eligible to participate if they are using a SABA for a reason other than asthma (e.g. viral respiratory infection, exercise-induced asthma) or do not manage their own medicines.
Community pharmacy study sites will be selected based on an expression of interest process via advertisement through the NZ pharmacy professional body (the Pharmaceutical Society of NZ (PSNZ)) email newsletter. Interested pharmacies will be selected based the demographics of the population they serve, pharmacy location, rationale for being a study site, and number of SABA prescriptions in the last year. To be eligible to participate, community pharmacies must report a sufficiently high volume of SABA dispensing to ensure the sample size is likely to be recruited.
Participants will be a sample of patients who self-select to be involved through advertisement in one of the two enrolled community pharmacies. All participants will go into a prize draw to win 3 x $NZD100 and 2 x NZD200 grocery vouchers.
Figure 1 describes the study procedure, including the survey items used. Both pharmacies will begin in a control phase, recruiting 30 participants per pharmacy. Following this, the pharmacists will receive detailed training on the intervention and both pharmacies will enter the intervention phase to recruit a further 30 participants each. In total, we aim to recruit 120 participants into the study, split evenly between the two study sites.
All participants will be asked to complete a study questionnaire at enrolment, 30 days and 90 days after enrolment. Those receiving the intervention will also complete a questionnaire immediately after receiving the intervention.
Each enrolled site will advertise the study through flyers and posters inside the pharmacy. Patients attending each community pharmacy who are interested in the study can use the QR code or URL on the advertisements to reach the study survey online. There will be an option to fill out a paper questionnaire if a patient wishes to be involved and does not have access to (or does not wish to use) an internet enabled device.
Patients that meet the eligibility criteria and agree to the online consent form will enter the study and be able to complete the questionnaires on their personal device, while waiting at their pharmacy.
All participants will complete the following at enrolment:
1. Demographics and patient characteristics
2. SRQ (5-items)
3. Asthma Control Test (ACT)
4. Medication Adherence Report Scale (MARS) for ICS (if applicable, for patients on ICS treatment)
All participants will be asked to complete follow-up questionnaires at 30 days and 90 days after enrolment. The survey URL will be sent to participants via email or text message. All participants will complete the following questionnaires online at follow-up:
2. ACT (90 days only)
3. MARS for ICS (if applicable)
The SRQ assesses patient beliefs about SABA to identify patients at risk of SABA over-reliance and overuse.(12). The SRQ is a questionnaire with a series of statements about SABA; participants indicate their level of agreement with each statement using a 5-point Likert scale, where 1=strongly disagree, 2=disagree, 3=uncertain, 4=agree and 5=strongly agree. Higher scores indicate higher necessity beliefs for SABA, reflecting higher reliance on SABA. Item 5 of the SRQ is only applicable for patients who are on preventer treatment; for patients who score ‘not applicable’ for this item as they are not on any preventer treatment, they will receive a score of 5 for this question item, as users on SABA monotherapy are at the highest risk of SABA overreliance and overuse.
The ACT is a five item questionnaire to assess asthma symptom control over the previous four weeks, with scores from 5 to 25.(16) High scores indicate better asthma control. The ACT will be used as safety measure within the study to ensure the effect of the intervention, reducing reliever overuse, does not lead to worsened asthma symptom control. A score difference of three has been shown to be associated with a clinically significant increased risk of exacerbations and rescue medication use. (17)
For participants who self-report using a ICS, MARS will be used to assess adherence.(13) MARS consists of five statements regarding adherence-taking behaviours that are answered on a 5-point Likert scale, where 1=always, 2=often, 3=sometimes, 4=rarely and 5=never. For each participant, a summed MARS score will be calculated ranging from 5 to 25. A high MARS score indicates better adherence.
Data on SABA use will be obtained from Testsafe Care Connect. This is an electronic clinical information sharing service provided by the northern region district health boards in New Zealand containing diagnostic (e.g. laboratory, radiology) results and reports; clinic and community letters; discharge summaries; eReferrals; community pharmacy dispensed medicines; and hospital appointments. Dispensing information on number of SABA inhalers dispensed will be obtained for the 90 day period prior to enrolment, and compared with the dispensing rate in the 90 days after enrolment (i.e. during the study duration. Dispensing rates in the 90 days after study completion (i.e. at 180 days) will also be obtained to evaluate the long-term effect of the intervention on SABA use.
Following completion of the enrolment questionnaires, participants recruited during the control phase of the study will receive usual care from their community pharmacy. This may involve education on asthma inhaler technique and reliever overuse. Pharmacists will be blinded to participants’ answers to the questionnaire. Participants will complete 30 day and 90 day follow-up as per study procedure.
Once control participants have completed the 90 day follow up they will be provided the same standardised messages that the intervention participants received at enrolment. This ensures all participants have the opportunity to receive the SRQ standardised intervention (i.e. the RRT). Participants will be invited to complete the SRQ immediately after the standardised messages are provided at the end of the 90 day study period.
Participants recruited during the intervention phase of the study will receive usual care from their community pharmacy in addition to the intervention. The brief, pragmatic intervention aims to shift any misplaced beliefs identified from the questionnaire, with the aim of reducing SABA over-reliance and overuse and improve adherence to preventer medication.
The intervention will include three components:
1. Delivery of targeted, standardised information, based on responses to the SRQ(18);
2. Personalised discussion between the pharmacist and participant based on the specific responses to the study questionnaires and
3. Referral to general practitioner (GP) for those at risk of SABA overuse.
The standardised information helps patients understand what their SRQ responses might mean for them. The aim of this information is to raise awareness of the problem of SABA overuse and provide advice about the correct use of SABA inhalers. This information will be provided directly to the patient on their personal device.
To complement the standardised messages, the pharmacist will have a discussion with the participant regarding their responses to the SRQ. The SRQ will provide the participant with a score between 5 and 25. A score of 15 or more indicates the participant holds beliefs that may lead them to over rely on SABA. For these participants, the pharmacist will give behaviour-change messages verbally along with written information to shift beliefs, based on the specific responses to each statement in the SRQ. For participants with scores of less than 15 on the SRQ, the pharmacists will provide messages that reinforce their current behaviour and strengthen their current treatment and asthma beliefs.
Finally, all participants who indicate they are not using a preventer, or answer ‘not applicable’ for item 5 of the SRQ, or report they are using SABA more than twice a week will be categorised as at risk of SABA overuse and will be referred to their GP. Pharmacists will also discuss this with the participant to encourage the patient to have a discussion with their GP about their answers to the questionnaire and their appropriateness for preventer treatment.
Immediately following the intervention, participants will be asked to complete the SRQ, and again at 30 and 90 days post-intervention.
Feasibility and acceptability measures
Feasibility will be evaluated through participant recruitment and retention rates, intervention fidelity, the appropriateness and procedures of outcome measures pre- and post-intervention, and acceptability by obtaining feedback from participants (both patients and pharmacists) on the intervention.
Recruitment and retention rates will be estimated through recording the number of participants invited to participate in the intervention by the pharmacist, number of participants who view the study URL but do not enter the study, number of participants recruited online and via the pharmacist, and number of participants retained at the 30 days and 90 days follow-up. Reasons for exclusion will also be recorded.
Intervention fidelity will be assessed through a researcher shadowing a 10% sample of intervention participant consultations (with patient and the pharmacist consent) using a fidelity checklist of the most important components of the intervention.
Appropriateness and procedures of the outcome measures pre- and post-intervention will be determined by the number of completed questionnaires at baseline, 30 days and 90 days, and proportion of participants with complete inhaler dispensing data.
To determine acceptability of the intervention versus usual care, feedback from participants and pharmacists will be obtained. Participants in the intervention group will be invited to complete an acceptability questionnaire directly after their first pharmacist consultation at enrolment. This questionnaire was developed using the Theoretical Framework of Acceptability,(19) to assess the acceptability of the intervention’s content and pharmacist delivery of the intervention. Participants will rate their agreement with statements on a five-point Likert-type scale, with higher scores indicating higher levels of acceptability.
Pharmacists will be invited to provide feedback on intervention acceptability after they have enrolled their last patient through a structured feedback session with a researcher, covering the training to deliver the intervention, intervention content, research design issues, intervention delivery, barriers to recruitment and the potential for future implementation.