PRIMA-eDS/MoMMs trial (Management of Multiple Medications)

Full title Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in elderly populations by electronic Decision Support
Research type Research study
IRAS ID 136959
Contact Name David Reeves
Contact Email david.reeves@manchester.ac.uk
Sponsor organisation The University of Manchester
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Clinicaltrials.gov identifier
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Research summary Patients taking many prescribed drugs (polypharmacy) have increased risk of adverse health effects e.g. side-effects and drug interactions. The PRIMA-eDS project has developed recommendations for multiple drug prescription based on current best evidence, built into electronic decision-support computer software (the eDS-tool) for use by GPs to help them improve prescription, minimising risks for patients taking multiple medications. The eDS-tool supports GPs’ clinical judgement when reviewing medications by alerting them to adjustments that may improve symptom control and reduce side effects so improving quality of life. The eDS-tool is being evaluated in a large cluster randomised controlled trial - the PRIMA-eDS trial - involving four different European countries (England, Germany, Italy, Austria), funded by the European Union. The MoMMs (Management of Multiple Medications) trial is the UK branch of PRIMA-eDS and will involve around 60 GP practices in NW England. At each practice we will recruit 11 patients aged 75 or over taking at least 8 different prescribed drugs. Patients on the practice’s palliative care register or with advanced cancer or undergoing chemotherapy or radiotherapy or unable to give informed consent will be excluded. Patients will also need to have regular face-to-face appointments with a GP from the practice. After patients have been invited into the trial, the practice will be randomly allocated to run GP-led medication reviews supported by CLRN nurses either using the eDS-tool (Intervention group) or not (Control group). Following informed consent, participants will complete baseline questionnaires, then have their medication review appointment with the GP. Follow-up reviews will be held after 8, 16 and 24 months with follow-up questionnaires at 8 and 24 months. The aim of the trial is to test whether the eDS-tool genuinely benefits patients, then to fine-tune the software. If the tool proves successful we will be encouraging its widespread use in general practice.
REC Name North West - Greater Manchester East Research Ethics Committee
REC Reference 14/NW/0197
REC Opinion

Favourable Opinion

Favourable Opinion

Date of REC Opinion 17 April 2014