Adyam Tesfamariam Kebede1,2, Elin Trapnes3, Marianne Lea3,4, Bjørg Abrahamsen5, Liv Mathiesen3. 1. Department of Pharmacy, Section for Pharmacology and Pharmaceutical Biosciences, University of Oslo, Oslo, Norway. adyam.t.kebede@gmail.com. 2. Department of Pharmaceutical Services, Oslo Hospital Pharmacy, Hospital Pharmacies Enterprise, South-Eastern Norway, Oslo, Norway. adyam.t.kebede@gmail.com. 3. Department of Pharmacy, Section for Pharmacology and Pharmaceutical Biosciences, University of Oslo, Oslo, Norway. 4. Department of Pharmaceutical Services, Oslo Hospital Pharmacy, Hospital Pharmacies Enterprise, South-Eastern Norway, Oslo, Norway. 5. Chief Physician at the Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.
Abstract
OBJECTIVE: To investigate the effect of pharmacist-led inhaler technique assessment service on readmissions and CAT-score in hospitalized COPD patients. Furthermore, to provide an effect estimate for sample size calculations for future studies and to gain experience on the feasibility of such studies. METHODS: A randomized controlled pilot study. Patients were randomized 1:1 to intervention or standard care. The primary endpoint was the difference in time to first readmission after hospital discharge between the treatment groups. RESULTS: There was no statistically significant effect on the time to readmission (median 41 days in the intervention group (19 patients) and 95 days in the control group (20 patients), HR 1.74, 95% CI 0.81-3.75, p = 0.16). There was no statistically significant difference between the groups in CAT-score 2 months after discharge, median scores being 25.5 and 24 in the intervention and the control group, respectively (p = 0.29). There was, however, a reduction of 3.5 units in CAT-score from baseline to 2 months after discharge in the intervention group, compared to no change in the control group. CONCLUSION: Pharmacist-led inhaler technique training had no effect on time to readmission or CAT-score. Future studies in larger populations should consider focusing on patients with less severe COPD, exploring CAT-score as a primary endpoint, consider stratifying for important baseline variables and evaluate the acceptability of the intervention. TRIAL REGISTRATION: Date of registration 01/10/2018. CLINICALTRIALS: gov identifier: NCT03691324.
OBJECTIVE: To investigate the effect of pharmacist-led inhaler technique assessment service on readmissions and CAT-score in hospitalized COPD patients. Furthermore, to provide an effect estimate for sample size calculations for future studies and to gain experience on the feasibility of such studies. METHODS: A randomized controlled pilot study. Patients were randomized 1:1 to intervention or standard care. The primary endpoint was the difference in time to first readmission after hospital discharge between the treatment groups. RESULTS: There was no statistically significant effect on the time to readmission (median 41 days in the intervention group (19 patients) and 95 days in the control group (20 patients), HR 1.74, 95% CI 0.81-3.75, p = 0.16). There was no statistically significant difference between the groups in CAT-score 2 months after discharge, median scores being 25.5 and 24 in the intervention and the control group, respectively (p = 0.29). There was, however, a reduction of 3.5 units in CAT-score from baseline to 2 months after discharge in the intervention group, compared to no change in the control group. CONCLUSION: Pharmacist-led inhaler technique training had no effect on time to readmission or CAT-score. Future studies in larger populations should consider focusing on patients with less severe COPD, exploring CAT-score as a primary endpoint, consider stratifying for important baseline variables and evaluate the acceptability of the intervention. TRIAL REGISTRATION: Date of registration 01/10/2018. CLINICALTRIALS: gov identifier: NCT03691324.
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