Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial

BMJ Open. 2019 Jun 3;9(6):e026769. doi: 10.1136/bmjopen-2018-026769.


Introduction: Multimorbidity and polypharmacy are important risk factors for drug-related hospital admissions (DRAs). DRAs are often linked to prescribing problems (overprescribing and underprescribing), as well as non-adherence with drug regimens for different reasons. In this trial, we aim to assess whether a structured medication review compared with standard care can reduce DRAs in multimorbid older patients with polypharmacy.

Methods and analysis: OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people is a European multicentre, cluster randomised, controlled trial. Hospitalised patients ≥70 years with ≥3 chronic medical conditions and concurrent use of ≥5 chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland). Patients treated by the same prescribing physician constitute a cluster, and clusters are randomised 1:1 to either standard care or Systematic Tool to Reduce Inappropriate Prescribing (STRIP) intervention with the help of a clinical decision support system, the STRIP Assistant. STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People's Prescriptions/Screening Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing. The primary endpoint is any DRA where the main reason or a contributory reason for the patient's admission is caused by overtreatment or undertreatment, and/or inappropriate treatment. Secondary endpoints include number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient's drug compliance, the number of significant drug-drug interactions, drug overuse and underuse and potentially inappropriate medication.

Ethics and dissemination: The local Ethics Committees in Switzerland, Ireland, The Netherlands and Belgium approved this trial protocol. We will publish the results of this trial in a peer-reviewed journal.

Main funding: European Union's Horizon 2020 programme.

Trial registration number: NCT02986425 , SNCTP000002183 , NTR6012, U1111-1181-9400.

Keywords: clinical pharmacology; general medicine (see internal medicine); geriatric medicine; internal medicine.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Chronic Disease / drug therapy
  • Chronic Disease / epidemiology*
  • Cluster Analysis
  • Decision Support Systems, Clinical
  • Drug-Related Side Effects and Adverse Reactions / prevention & control*
  • Female
  • Geriatrics*
  • Hospitalization / statistics & numerical data*
  • Humans
  • Inappropriate Prescribing / prevention & control*
  • Male
  • Multimorbidity
  • Polypharmacy
  • Potentially Inappropriate Medication List / statistics & numerical data*
  • Quality of Life

Associated data

  • ClinicalTrials.gov/NCT02986425
  • NTR/NTR6012