Polypharmacy in chronic diseases

Reduction of Inappropriate Medication and Adverse drug events in elderly populations by electronic Decision Support

Workpackages

The project is scheduled for 4 years and will contain 12 work packages (WP):

WP 1: Management/Coordination of the Project

Duration: 48 months; Lead: UWH

Main objective of this work package is to ensure that the project is managed effectively and efficiently, and delivers within budget timely, high quality research outputs. The project will be under the control of the coordinator (UWH) which will be composed of the project leader (A. Sönnichsen) and the project  management team (M. Flamm and others).

WP 2: Systematic Review

Duration: 12 months; Lead: UNIMAN

The main objective of this WP is the identification of current best evidence for the drug treatment of the most common chronic diseases of older polymorbid patients.

WP 3: Development of electronic Decision Support (eDS) tool for the reduction of polypharmacy, implementation in partner countries

Duration 15 months; Lead: DMP

Main objective of this WP is the development of an electronic Decision Support (eDS) tool to reduce polypharmacy.

WP 4: Development of eCRF (electronical case report form) for Multicenter Clinical Trial; eCRF Implementation in Partner Countries

Duration:15 months; Lead: DMP

The main objective of this WP is the development of an electronic Case Report Form (eCRF).

WP 5: Ethics approval, trial registration, recruitment of GP-surgeries and Patients, GP-training, randomisation

Duration: 14 months; Lead: UNIMAN

The principle objective of this WP is to fulfil all prerequisites for the randomized controlled trial and get the trial started.

WP 6: Multicenter Clinical Trial – Intervention and Follow up

Duration: 30 months; Lead: UWH

In this work package the international cluster-randomized multicenter clinical trial will be carried out.

WP 7: Multicenter Clinical Trial – Statistical Issues

Duration: 41 months; Lead: UWH

The main objectives of this WP are calculation of adequate sample size, establishment of safety committee and safety monitoring during the study.

WP 8: Technical Support eDS and eCRF

Duration: 33 months; Lead: DMP

The main objective of this WP is ensuring uninterrupted availability and proper functioning of the eCRF and eDS tools over the whole time span of the study.

WP 9: Monitoring and Quality Assurance

Duration: 33 months; Lead: UMR

Monitoring, quality assurance, and data protection oversight of the multicenter clinical trial & usability testing of the eDS tool.

WP 10: Analysis and Synthesis of Results; Final Reporting

Duration: 9 months; Lead: UWH

The main objectives of this WP are the analysis of the data gathered within the multicenter clinical trial, and the final reporting to the European Commission.

  • Final analysis of the results of the RCT
  • Final report of PRIMA-eDS

WP 11: Optimizing the eDS-tool

Duration: 9 months; Lead: DMP

The main objective of this WP is optimizing and finalizing the eDS-tool for clinical use and setting the stage for further research that may become necessary during or after the RCT.

  • updating the decision rules and recommendations according to trial results
  • updating the eDS-tool regarding changes and updates of guidelines used by the tool
  • optimizing technical functionality

WP 12: Dissemination and exploitation

Duration: 48 months; Lead: UWH

The main objective of this WP is the active dissemination of information and project outcomes by:

  • development and maintenance of a project web site
  • dissemination and publication of the systematic reviews for guideline development of evidence based treatment of elderly patients with multiple chronic diseases
  • dissemination and publication of the results of the RCT
  • dissemination and exploitation of the eDS-tool