OPERAM - A European multicenter randomised clinical trial

OPERAM is divided into 9 work packages (WP), integrating partners from Belgium, Germany, Greece, Italy, Ireland, Switzerland, and The Netherlands. The core part of the project is the conduct of a large-scale cluster randomized controlled trial (RCT) to examine the effect of pharmacotherapy optimisation on clinical outcomes (WP1-4). Specific WP goals are: 

WP1 Clinical Trial Coordination, lead: UBERN (University of Bern)
-  To establish a Trial Coordinating Centre and all required central trial infrastructure.
-  To coordinate recruitment and follow-up of 2000 multimorbid patients aged ≥70 years with polypharmacy in four countries.

WP2 Method and Software Tool for Optimising Medication,  lead: UMCU (Universitair Medisch Centrum Utrecht)
-  To improve the Dutch Systematic Tool to Reduce Inappropriate Prescribing (STRIP),  including supporting software (STRIP Assistant) and deliver a functional method to optimise drug therapy with integration of existing national prescribing standards and available drugs from the four trial sites.
-  Operationalise data mining techniques to explore the perspectives of the users.

WP3 Medication Review and Implementation, lead: UCC (University College Cork)
-  To develop the standard operation procedure (SOP) of the intervention for the OPERAM clinical trial.

WP4 Clinical Outcomes and Patient Preferences, lead: UCL (Université catholique de Louvain)
-  To develop a valid and reliable method to adjudicate drug-related hospital admissions (DRAs)
-  To develop a core outcome set (COS) for pharmacotherapy optimisation among multimorbid elderly
-  To assess patients' perspectives

WP5 Systematic Reviews, lead: Ud'A (University Gabriele d’Annuzio)
-  To conduct a series of systematic reviews (SRs), summarising the evidence-based data comparing pharmacological and non-pharmacological interventions to prevent avoidable hospital admissions and rank these interventions according to their effectiveness and safety using network meta-analyses (NMA).

WP6 Network meta-analyses (NMA), lead: UOI (University of Ioannina)
-  To conduct a series of NMAs for the outcomes of interest and provide a relative ranking of interventions with the aim to determine the most effective interventions in preventing common causes of avoidable hospital admissions in multimorbid elderly.

WP7 Health Economics, lead: UNIBAS (University of Basel)
-  To perform economic data collection alongside the OPERAM RCT. On this basis, to assess resource use and cost implications, and cost-effectiveness, of pharmacotherapy optimisation in participating countries.

WP8 Integration, Dissemination and Exploitation, lead: tp21 GmbH
-  To support broad dissemination and exploitation activities.

WP9 Project Management, lead: UBERN
-  To ensure a smooth lead and project coordination.