Acute Admitted Multimorbid Patients Clinical Trial
Official title:
Oslo Pharmacist Intervention Study - Effect on Readmissions
Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs)
when they are a part of the multidisciplinary treatment-team at hospital wards. However, in
the Norwegian health care system, there is a lack of studies on the effect of pharmacist
intervention on clinically relevant outcomes. Hospital readmissions has both clinical and
economical negative effects, and time outside the hospital until an eventual readmission is
considered as a clinical relevant outcome measure. The investigators are conducting a
randomized controlled trial at an internal medicine ward at Oslo University Hospital. 400
acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups will be
enrolled in the study. Patients randomized to the Control group will receive standard care
(without a pharmacist involved) and patients randomized to the Intervention group will
receive a pharmacist in their treatment team during the hospital stay. The study hypothesis
is that including a pharmacist in the multidisciplinary treatment team at a hospital ward,
will improve the patients drug treatment, hence lead to an increased time outside the
hospital until an eventual readmission.
The inclusion of patients was completed March 17th 2016 With 399 patients randomised. The
last day of follow-up on readmission and mortality was December 31, 2017. The Application
process for outcome data to the Norwegian Patient Registry and the Norwegian Cause of Death
Registry started in June 2017 and lasted until May 2018. Huge workload at the Registers
entails a very long processing time for outcome data. On May 25, 2018 the statistical
analysis plan was finalized and signed, hereunder the analysis population defined and the
endpoint analyses detailed. Outcome datafiles from patient registries was prepared for
analysis May 29 to June 6, 2018. Blinded outcome analyses was conducted June 8, 2018.
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The investigators have obtained approval for a protocol amendment to use the data from the
study in further analyses togheter with data from 100 new patients admitted to the internal
medicine ward. The hypothesis is that a set of patient characteristics can identify patients
who are at high risk of drug-related readmissions and who would benefit most from the
pharmaceutical intervention.The investigators aim to identify these patients by building a
statistical model based on significant variables from the 399 patients collected in the
randomised controlled trial. The statistical model will be validated using data from 100 new
patients admitted to the internal medicine ward.
The inclusion of patients to this New sample was finalised July 6th 2018 (primary
completion). Data on hospital readmissions and death will be collected from the Norwegian
Patient Registry and the Norwegian Cause of Death Registry in June 2020.
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