Better Outcomes for Everybody: A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a community pharmacist-led intervention for patients with asthma and COPD

Abstract

Objective: To evaluate the effectiveness and cost-effectiveness of a community pharmacist-led intervention in asthma and COPD patients Design: A parallel, two-arm, randomized controlled trial Setting: 100 community pharmacies in Sicily, Italy. Participants: In total, 836 adult patients with asthma or COPD who take prescription medications to manage their chronic respiratory conditions were assessed for eligibility, recruited, and randomized. Participants were recruited by their pharmacist, primary care physician, or specialist physician and allocated via computer-randomized sequence on a 2:1 basis to intervention and control groups. Of all those who enrolled, 746 (89%) participants completed the study (489 intervention and 257 control). Interventions: The intervention group received the Chronic Respiratory Condition Medicines Use Review (CRC-MUR) intervention, a bespoke pharmacist-led medicines use review consultation, at baseline and six months, while the control group received usual care. All patients visited their pharmacist every three months over the 12-month study period to collect their prescribed medications and complete a structured questionnaire. Main outcome measures: The primary outcome was disease control assessed at 12 months using the Asthma Control Test (ACT>=20) or the Clinical COPD Questionnaire (CCQ<2). The secondary outcomes were disease control assessed at intermediate 3-month time points and cost-effectiveness. Results: In the intervention group, the proportion of patients with their condition controlled increased by 6.5 percentage points (CI95%: 0.032 to 13) from baseline to the end of the study, compared to no statistically significant change (CI95%: -10. to 7.8) in the control group. The odds ratio of disease control at 12 months was 1.43 (CI95%: 1.02 to 2.02; p=0.040) for the intervention group compared to the control group, adjusting for sex, age, and disease control at baseline. Regressing longitudinally and controlling for mixed-effects, the intervention led to a higher likelihood of successful condition management at all time points after baseline with a 12-month adjusted odds ratio of 1.83 (CI95%: 1.01 to 3.34; p=0.049). Conducting a cost-effectiveness analysis with 727 patients with complete cost data, the intervention was found to have an incremental cost of -€375 (CI95%: -€924 to €175) and an incremental effect of 0.028 QALYs (CI95%: -0.003 to 0.059) per patient over a year. Thus, CRC-MUR shows strong dominance over usual care. No significant changes to the estimated health effects or cost-effectiveness results were found after multivariate imputation of missing data. Conclusions: Compared with usual care, the CRC-MUR intervention improved asthma and COPD control effectively and cost-effectively. These results support the expanded utilisation of community pharmacists within primary health care to assist with chronic respiratory condition management. Trial registration: ISRCTN 38734433