Where:
The approximate number of patients per group The standard deviation
The difference in mean response between the intervention and control groups
A function based on the study power of 80% (=7.849)
Therefore:
Therefore = 19 patients per group.
4.4 Study method
The study was designed as a pragmatic six-month, prospective, randomised, open trial in which patients were randomised to pharmacist intervention (PI), or usual care (UC). The study procedure is summarised in Figure 4.
The inclusion criteria included patients, aged 18 to 70 years, with a clinical diagnosis of asthma, and fulfil the criteria for difficult asthma, who were able to speak, read and write in English, and were eligible for a MUR. Patients were excluded if they were not responsible for taking their own medications, or failed to provide written informed consent.
Screening future clinic lists and past clinic letters at the Leeds difficult asthma clinic identified patients for inclusion in the study. This was performed by the
investigator and reviewed by the clinical supervisor to ensure that potential patients had a confirmed diagnosis of asthma and met the criteria for difficult asthma. At least 2 weeks prior to their scheduled Difficult Asthma clinic
appointment, a letter was posted to each patient who met these criteria inviting him or her to participate in the study. This letter was addressed from the Lead Consultant, introducing and describing the study and a copy of the patient information sheet was included with it (see Appendix 5).
On the scheduled date of each screen patient’s appointment at the difficult asthma clinic, their medical notes were reviewed and patient questioned to ensure that they met the full study inclusion criteria, and written informed consent (Appendix 6) was obtained if they agreed to enrol in the study.
Patients were randomly allocated to one of two intervention arms. The first was the UC group, where patients received the ‘usual’ standard asthma review in clinic from a consultant, specialist registrar, or specialist respiratory nurse in line with the ‘usual’ standard difficult asthma clinic procedures. The second was the PI group, where patients received an asthma review from an advanced clinical pharmacist in clinic, comprising education on asthma and medication, inhaler technique training in addition to the ‘usual’ standard asthma review.
4.4.1 Intervention group
A protocol for independent practice was developed to guide the investigator in managing patients with difficult asthma (see Appendix 7). This was based on observation of the methods used by senior clinicians, as well as on the content of other educational intervention studies identified in the literature review.
The intervention provided by the advanced clinical pharmacist, an autonomous independent prescriber, in the difficult asthma clinic comprised:
1. Patient education on asthma pathology and medication, and
self-management, including the use and provision of a peak flow meter and Asthma Action Plan where necessary. This has formed an integral
component of most pharmacist interventional studies, as described in the literature review (Chapter 3.3.1), and so formed an similarly essential
component of the intervention (Gibson et al., 2002b, British Thoracic Society
and Scottish Intercollegiate Guidelines Network, 2014, Global Initiative for Asthma, 2014, Armour et al., 2007, Charrois et al., 2006, Mangiapane et al., 2005, Mehuys et al., 2008).
2. Inhaler technique assessment and optimisation using a structured assessment, using a ‘‘show and tell’’ inhaler technique training method (Basheti et al., 2008), where inhaled technique is observed and assessed using a checklist (Appendix 8) up to a maximum of three times for each device. In addition, inspiratory flow for different devices was determined using an In-Check DIAL flow meter (Clement Clarke, UK) to ensure that patients used the correct inhalation speeds to use their inhaler devices optimally (Capstick and Clifton, 2012).
3. Asthma assessment and review, which was based on components described in asthma guidelines (British Thoracic Society and Scottish
Intercollegiate Guidelines Network, 2014, Global Initiative for Asthma, 2014) and SIMPLES approach for primary care physicians (Ryan et al., 2013):
a. Assessment of asthma control
b. Where appropriate, review of: past asthma history (e.g. exacerbation frequency requiring OCS use or hospital admission), associated medical conditions that may impact on asthma control (e.g. symptoms of gastro-oesophageal reflux disease, rhinitis), family history.
c. Adherence assessment, using on non-confrontation questioning of the patient (Gamble et al., 2011, Gamble et al., 2009).
d. Review of aggravating factors, such as allergies, lifestyle (e.g. weight, diet and nutrition, smoking status), and housing condition [e.g.
presence of mould or damp, pets, or dust).
e. Medication review, ensuring their prescription is in line with the BTS/SIGN 2012 Guidelines on the management of asthma (British Thoracic Society and Scottish Intercollegiate Guidelines Network, 2014).
All patients in the PI group were referred by telephone and in writing (see referral form, Appendix 9) for a t-MUR from their usual community pharmacist, to take place between weeks 4 to 8. All patients were followed up at 6 months.
4.4.2 Usual care group
Patients randomised to this group had routine management comprising a standard review from a Consultant Physician, Specialist Registrar or Asthma Nurse Specialist. Standard practice is to assess asthma control, compliance, inhaler technique, and aggravating factors, then step up or down therapy as appropriate. Patients in this group were excluded from having a t-MUR during the study. All patients were followed up at 6 months.
Figure 4. Study Procedure
Includes anticipated potential patient deviations from protocol.
T = 0 weeks Assessed for eligibility
Excluded
Not meeting inclusion criteria
Declined to participate
Other reasons
T= 0 weeks Allocated to Usual Care Group
Received allocated intervention
Did not receive allocated intervention T= 0 weeks
Allocated to Pharmacist Intervention Group
Received allocated intervention
Did not receive allocated intervention
T= 6 months
Potential patients identified from future Difficult Asthma Clinic lists Initial invitation letter and
Information Sheet posted to patients
Pharmacist review and assessment
Optional case review between Doctor and Pharmacist
Patient should not have targeted MUR
Did Not receive t-MUR
Received t-MUR (protocol deviation) T= 4 - 8 weeks
Patient requires targeted MUR
Received t-MUR
Did Not receive t-MUR (protocoldeviation)
Referral to Community Pharmacy