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Geriatric medicine
Protocol
Rationale and design of OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM): a cluster randomised controlled trial
  1. Luise Adam1,
  2. Elisavet Moutzouri1,2,
  3. Christine Baumgartner1,
  4. Axel Lennart Loewe1,2,
  5. Martin Feller1,2,
  6. Khadija M’Rabet-Bensalah1,
  7. Nathalie Schwab1,
  8. Stefanie Hossmann3,
  9. Claudio Schneider1,
  10. Sabrina Jegerlehner1,
  11. Carmen Floriani1,
  12. Andreas Limacher3,
  13. Katharina Tabea Jungo2,
  14. Corlina Johanna Alida Huibers4,
  15. Sven Streit2,
  16. Matthias Schwenkglenks5,
  17. Marco Spruit6,
  18. Anette Van Dorland1,
  19. Jacques Donzé1,7,
  20. Patricia M Kearney8,
  21. Peter Jüni3,9,
  22. Drahomir Aujesky1,
  23. Paul Jansen4,
  24. Benoit Boland10,
  25. Olivia Dalleur10,11,
  26. Stephen Byrne12,
  27. Wilma Knol4,
  28. Anne Spinewine11,
  29. Denis O’Mahony13,
  30. Sven Trelle3,
  31. Nicolas Rodondi1,2
  1. 1 Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
  2. 2 Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
  3. 3 Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
  4. 4 Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
  5. 5 Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland
  6. 6 Department of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands
  7. 7 General Medicine and Primary Care, Brigham and Women’s Hospital Department of Medicine, Boston, Massachusetts, USA
  8. 8 Department of Epidemiology and Public Health, University College Cork, Cork, Ireland
  9. 9 Department of Medicine, Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
  10. 10 Cliniques universitaires Saint-Luc, Université catholique de Louvain, Louvain, Belgium
  11. 11 Louvain Drug Research Institute – Clinical Pharmacy, Université catholique de Louvain, Louvain, Belgium
  12. 12 School of Pharmacy, University College Cork, Cork, Ireland
  13. 13 Department of Medicine (Geriatrics), University College Cork and Cork University Hospital, Cork, Ireland
  1. Correspondence to Professor Nicolas Rodondi; nicolas.rodondi{at}insel.ch

Abstract

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.

  • clinical pharmacology
  • general medicine (see internal medicine)
  • internal medicine
  • geriatric medicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-026769

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    Footnotes

    • Contributors Study concept and design: NR, ST, DO, AS, WK, SB, OD, BB, PJü, PJ, PMK, MSc, DA, CB and KM-B. Acquisition, analysis or interpretation of data: LA, EM, ALL, SJ, CS, CF, NS, SH, CJAH, SS, MSc, AVD, OD, SB, WK, AS, DO, ST and NR. Drafting of the manuscript: LA, EM and MF. Critical revision of the manuscript for important intellectual content: LA, EM, CB, ALL, MF, KM-B, NS, SH, CS, SJ, CF, AL, KTJ, CJAH, SS, MSc, MSp, AVD, JD, PMK, PJü, DA, PJ, BB, OD, SB, WK, AS, DO, ST and NR. Statistical analysis: ST and AL. Obtained funding: NR. Administrative, technical or material support: NS, KTJ, MSp, AVD and SH. Supervision: NR, ST, DO, AS and WK.

    • Funding This work is supported by the European Union’s Horizon 2020 research and innovation program under the grant agreement No. 6342388, and by the Swiss State Secretariat for Education, Research and Innovation (SERI) under contract number 15.0137.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Author note The trial protocol has been peer-reviewed for ethical and funding approval prior to submission.

    • Patient consent for publication Obtained.