None listed
Conditions
Brief summary
This single cohort, open-label, non-randomised pilot study aims to assess the feasibility and logistics of undertaking a structured community-pharmacist led asthma review with a capacity to adjust treatment under primary care physician standing order. The primary hypothesis is that a community pharmacist-led asthma review will be acceptable and feasible from patient, pharmacist and primary care physician perspective. This will directly inform the viability of a national multi-center study, powered to detect the effect on asthma control over a 12-month period. In this pilot study the pharmacist will conduct asthma review of 25 asthmatics, currently prescribed anti-inflammatory reliever (AIR) therapy at step one, as recommended by the NZ Adolescent and Adult Asthma Guidelines. The AIR algorithm was chosen for the simplicity of using a single budesonide/formoterol Turbuhaler during the pilot phase. Enrolled asthmatic participants who are prescribed budesonide/formoterol 200µg/6µg (Symbicort® Turbuhaler) per AIR step 1 (one actuation as required) will attend two study visits at week 0 and week 12 for their asthma reviews, at a local pharmacy in Tauranga, NZ. They will undergo assessment of asthma control, inhaler technique, QoL and titration of AIR therapy under a primary care physician standing order if required. In between visits participants will complete the asthma control measure, QoL, report asthma medication usage and asthma exacerbations at weeks four and eight. If indicated for reasons of worsening asthma, an unscheduled visit with the community pharmacist will be recommended to the participant where treatment escalation under the standing order will be offered or direct referral for primary care physician review if indicated. At 12 weeks an asthma review will take place to assess asthma control, inhaler technique, QoL and titration of AIR therapy under a primary care physician standing order if required. Participants, pharmacists and primary care physicians involved in the study will answer study questionnaires to provide feedback on the pilot experience and to evaluate the overall acceptability of pharmacist-led asthma reviews and capacity to adjust treatment of mild asthma.
Interventions
This study will examine the feasibility and logistics of undertaking a community pharmacist-led review of mild asthma, with the capacity to adjust participant Anti-Inflammatory Reliever (AIR) algorithm guidelines, known as AIR Therapy steps under a primary care physician standing order.
Participants will attend two visits to a study pharmacy at baseline and week 12 post-intervention commencement. The study will be conducted via face-to-face interaction between participants and community-pharma
This study will examine the feasibility and logistics of undertaking a community pharmacist-led review of mild asthma, with the capacity to adjust participant Anti-Inflammatory Reliever (AIR) algorithm guidelines, known as AIR Therapy steps under a primary care physician standing order. Participants will attend two visits to a study pharmacy at baseline and week 12 post-intervention commencement. The study will be conducted via face-to-face interaction between participants and community-pharmacist investigators with remote participant-reported outcomes collected in between study visits in electronic diaries. Notes on Questionnaires: The Asthma Control Measure (ACM) is a validated questionnaire used to assess asthma control over the past four weeks (1,2). This is a self-reported questionnaire completed by the participant, consisting of 5 questions, with five possible answers, corresponding to ratings on a scale of 1 to 5. The total score of the scale is proportional to worsening asthma control (1,2). The DPI technique questionnaire involves the scoring of each step involved in the administration of a DPI (3) this is cored by the pharmacist. The Inhaler Technique Questionnaire (InTeQ) is a subjective participant-reported inhaler technique questionnaire. The questionnaire is designed to be a participant tool for reporting and training in inhaler techniques. InTeQ uses 5 questions, with a 5-point Likert scale (4). EuroQol-5D Questionnaire (EQ-5D-5L) is a validated health-related quality of life questionnaire for the assessment of asthma patients (5,6). The EQ-5D-5L is a patient-reported outcome measure that consists of 5 questions with Likert Responses and a visual analog scale. The descriptive system covers 5 aspects of the participant’s health; mobility, self-care, usual activities, pain or discomfort, and anxiety and depression, with 5 possible answers for each question. The visual analog scale is used to capture the participant’s total health on the day of completion. Participant-reported medication use and adherence will be tracked based a five-point-Likert question. “How often do you not take your medication as prescribed?” adapted from work by Mehuys et al (7). The below outline data collected at each time point; Week 1 – Study Visit 1 (Approx. 45 mins in Pharmacy) • Informed consent • Inclusion/Exclusion criteria determined • Contact and demographic information • Medical history (incl Medication history) • ACM • EQ-5D-5L • Inhaler technique scoring and review (DPI). • InTe Participant Reviewed inhaler technique. • Self-reported medication use • Assessment of AIR step (according to AIR algorithm) and adjustment under a standing order if required. • Book follow-up visit for 12 weeks Participants reported electronic remote diaries - at weeks 4 and 8 (Approx. 20 mins) • The participant will complete the diary via digital link (email). • AIR Steps questionnaire (according to AIR algorithm) • ACM • EQ-5D-5L • InTeQ Participant Reviewed inhaler technique • Self-reported medication use • New medical events and new therapies will be recorded. Week 12 – Study Visit 2 (Approx. 30 mins in Pharmacy) • ACM • EQ-5D-5L • Inhaler technique scoring and review (DPI) • InTeQ Participant Reviewed inhaler technique • New medical events and new therapies will be recorded. • Assessment of AIR step (according to AIR algorithm) and adjustment under a standing order if required. • Self-reported medication use • Assessment of participant reported value of community pharmacy-led asthma review (through Questionnaire developed for study) • Acceptability to participants of pharmacist-led review and capacity to adjust treatment of mild asthma (through Likert Scale Questionnaire developed for the study, End of the Study (Conducted by Pharmacists and Primary care physicians via electronic database approx. 30 mins) • Acceptability to pharmacist investigators (involved in the study) of pharmacist-led review and capacity to adjust treatment of mild asthma (through Narrative Questionnaire) developed for the study. • Acceptability to primary care physicians (involved in the study) of pharmacist-led review and capacity to adjust treatment of mild asthma (through Narrative Questionnaire) developed for the study. Pharmacist Training: Pharmacists participating in the trial will be trained in the study protocol, and execution of AIR therapy adjustments under the standing order, and all associated questionnaires. Note on Study Intervention: Doses may be titrated within the pre-defined AIR algorithm steps depending on reported medication use, and control as defined in the standing order. As part of the participants’ diary entries, they will complete the AIR Step questionnaire (AIR algorithm), if indicated that they should change from their current Step, the participant will receive an invitation recommending they seek an asthma review. This can be organized with the PRN investigator or alternatively with their Primary Care Physician, attendance will not be compulsory. All outcomes will be documented within the study database. References: 1. Lara, M., Edelen, M. O., Eberhart, N. K., Stucky, B. D. & Sherbourne, C. D. Development and validation of the RAND Asthma Control Measure. European Respiratory Journal 44, 1243–1252 (2014). 2. Rudin, R. S., Qureshi, N., Foer, D., Dalal, A. K. & Edelen, M. O. Toward an asthma patient-reported outcome measure for use in digital remote monitoring. Journal of Asthma 1–6 (2021). 3. Santos, D. de O. et al. Atenção farmacêutica ao portador de asma persistente: avaliação da aderência ao tratamento e da técnica de utilização dos medicamentos inalatórios. J. bras. pneumol. 36, 14–22 (2010). 4. Lizano-Barrantes, C. et al. The Inhaler Technique Questionnaire (InTeQ): Development and Validation of a Brief Patient-Reported Measure. International Journal of Environmental Research and Public Health 19, 2591 (2022). 5. Hernandez, G. et al. EuroQol (EQ-5D-5L) validity in assessing the quality of life in adults with asthma: cross-sectional study. Journal of medical Internet research 21, e10178 (2019). 6. Szentes, B. L., Schultz, K., Nowak, D., Schuler, M. & Schwarzkopf, L. How does the EQ-5D-5L perform in asthma patients compared with an asthma-specific quality of life questionnaire? BMC pulmonary medicine 20, 1–11 (2020). 7. Mehuys, E. et al. Effectiveness of pharmacist intervention for asthma control improvement. European Respiratory Journal 31, 790–799 (2008).
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply: 1. Willing and able to provide written informed consent 2. Adults aged 18 to 65 years. 3. Physician diagnosis of asthma. 4. Have a prescription for Budesonide/formoterol 200µg/6µg (Symbicort® Turbuhaler) taken as required, per AIR algorithm step 1. 5. Access to a mobile phone and/or device with internet connectivity to complete remote assessments. 6. Willingness and ability to return for a follow up visit at week 12. 7. Willing to attend the study pharmacy for their asthma reviews throughout the length of the study. 8. Willing and able to comply with the study instructions.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: 1. Other chronic respiratory disease, such as COPD, Interstitial lung disease, etc. 2. Any acute or chronic medical condition that the investigator considers may impact the validity and reliability of the study results. 3. Current use of Budesonide/formoterol 200µg/6µg (Symbicort® Turbuhaler) as maintenance therapy per AIR algorithm step 2 or 3 4. Current use of any other inhaled medication for asthma. 5. Current use of theophylline, leukotriene receptor antagonist, sodium cromoglycate, nedocromil sodium or monoclonal antibody therapy for asthma. 6. Current use or use within the preceding 6 weeks of oral steroids. 7. Cognitive impairment preventing the participant from understanding the trial instructions or requires assistance in management of medications, complete questionnaires, or provide informed consent. 8. Active involvement in any clinical trial, or recent involvement in an interventional trial in the past 12 weeks.
Outcome results
None listed