Thomas G H Kempen1, Maria Bertilsson2, Karl-Johan Lindner3, Johanna Sulku4, Elisabet I Nielsen5, Angelica Högberg6, Tomas Vikerfors7, Håkan Melhus8, Ulrika Gillespie9. 1. Pharmacy Department, Uppsala University Hospital, Ing.13 2 tr, 751 85 Uppsala, Sweden. Electronic address: thomas.kempen@medsci.uu.se. 2. Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 3. Pharmacy Department, Västmanland County Council, Västerås, Sweden. 4. Centre for Research and Development, Uppsala University/Region Gävleborg, Gävle, Sweden; Department of Development, Region Gävleborg, Gävle, Sweden. 5. Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. 6. Department of Development, Region Gävleborg, Gävle, Sweden. 7. Department of Infectious Diseases, Västerås Hospital, Västerås, Sweden. 8. Department of Medical Sciences, Uppsala University, Uppsala, Sweden. 9. Pharmacy Department, Uppsala University Hospital, Ing.13 2 tr, 751 85 Uppsala, Sweden.
Abstract
BACKGROUND: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence. AIM: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews. DESIGN: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial. SETTING:8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties. PARTICIPANTS: Patients aged 65years or older, admitted to one of the study wards. EXCLUSION CRITERIA: Palliative stage; residing in other than the hospital's county; medication review within the last 30days; one-day admission. INTERVENTIONS: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care. PRIMARY OUTCOME MEASURE: Incidence of unplanned hospital visits during a 12-month follow-up period. DATA COLLECTION AND ANALYSES: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using hierarchical models. RELEVANCE: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.
RCT Entities:
BACKGROUND: Mismanaged prescribing and use of medication among elderly puts major pressure on current healthcare systems. Performing a medication review, a structured critical examination of a patient's medications, during hospital stay with active follow-up into primary care could optimise treatment benefit and minimise harm. However, a lack of high quality evidence inhibits widespread implementation. This manuscript describes the rationale and design of a pragmatic cluster-randomised, crossover trial to fulfil this need for evidence. AIM: To study the effects of hospital-initiated comprehensive medication reviews, including active follow-up, on elderly patients' healthcare utilisation compared to 1) usual care and 2) solely hospital based reviews. DESIGN: Multicentre, three-treatment, replicated, cluster-randomised, crossover trial. SETTING: 8 wards with a multidisciplinary team within 4 hospitals in 3 Swedish counties. PARTICIPANTS: Patients aged 65years or older, admitted to one of the study wards. EXCLUSION CRITERIA: Palliative stage; residing in other than the hospital's county; medication review within the last 30days; one-day admission. INTERVENTIONS: 1, comprehensive medication review during hospital stay; 2, same as 1 with the addition of active follow-up into primary care; 3, usual care. PRIMARY OUTCOME MEASURE: Incidence of unplanned hospital visits during a 12-month follow-up period. DATA COLLECTION AND ANALYSES: Extraction and collection from the counties' medical record system into a GCP compliant electronic data capture system. Intention-to-treat-analyses using hierarchical models. RELEVANCE: This study has a high potential to show a reduction in elderly patients' morbidity, contributing to more sustainable healthcare in the long run.
Authors: Thomas G H Kempen; Maria Bertilsson; Nermin Hadziosmanovic; Karl-Johan Lindner; Håkan Melhus; Elisabet I Nielsen; Johanna Sulku; Ulrika Gillespie Journal: JAMA Netw Open Date: 2021-04-01