Main trial on PRIoritising MUltimedication in Multimorbid patients

 Trial objective

Gauge the effectiveness of a measure to optimise medication prescriptions on the appropriateness of such prescriptions for elderly, multimorbid patients in general practice, and on quality of life and therapy adherence.

 Trial design

  • Trial design: 2-arm, pragmatic, cluster-randomised (randomisation and intervention on the family practice level, measurement of patient-level outcomes) parallel group study, evaluation and statistical analysis of primary outcomes will be blinded with regard to group
  • Trial population: N=490 patients (age >=60, >=3 chronic diseases, regularly takes >=5 medications, MMSE>=26, capable and able to participate in telephone interviews) from 70 family practices in the Rhine-Main region of Hessia, Germany
  • Experimental intervention: internet-based, optimisation of multimedication with the assistance of HCA (complex intervention) using recommended standard treatment vs. control intervention: usual care using recommended standard treatment; (recommended standard treatment = geriatric guideline)
  • Follow-up per patient: 9 months, duration of trial per patient: 9 months
  • Primary endpoint: Difference between Medication Appropriateness Index (MAI)-score 6 months after baseline minus baseline (MAI T1-T0).
  • Secondary endpoint: (amongst other measures) quality of life (EQ-5D), observed adherence (several scores) after 6 and 9 months.
  • Statistical analysis: primarily according to the intention-to-treat-principle, secondary analysis per protocol by taking the hierarchical structure of the data into consideration (patients at practices).
  • Flussdiagramm der Studie:

 Duration

Begin: 01.03.2010

End: 29.02.2012

 Ethics committee vote

Vote of approval E 46/10 (vom 20.05.2010)

 Entry of trial into register

ClinicalTrials.gov: NCT01171339

Controlled Trials: ISRCTN99526053