Randomized Controlled Trial

. 2019 Jun 3;9(6):e026769.

doi: 10.1136/bmjopen-2018-026769.

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

Luise Adam¹, Elisavet Moutzouri^{1

2}, Christine Baumgartner¹, Axel Lennart Loewe^{1

2}, Martin Feller^{1

2}, Khadija M'Rabet-Bensalah¹, Nathalie Schwab¹, Stefanie Hossmann³, Claudio Schneider¹, Sabrina Jegerlehner¹, Carmen Floriani¹, Andreas Limacher³, Katharina Tabea Jungo², Corlina Johanna Alida Huibers⁴, Sven Streit², Matthias Schwenkglenks⁵, Marco Spruit⁶, Anette Van Dorland¹, Jacques Donzé^{1

7}, Patricia M Kearney⁸, Peter Jüni^{3

9}, Drahomir Aujesky¹, Paul Jansen⁴, Benoit Boland¹⁰, Olivia Dalleur^{10

11}, Stephen Byrne¹², Wilma Knol⁴, Anne Spinewine¹¹, Denis O'Mahony¹³, Sven Trelle³, Nicolas Rodondi^{1

2}

Affiliations

¹ Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
² Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
³ Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
⁴ Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
⁵ Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
⁶ Department of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands.
⁷ General Medicine and Primary Care, Brigham and Women's Hospital Department of Medicine, Boston, Massachusetts, USA.
⁸ Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.
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 Cliniques universitaires Saint-Luc, Université catholique de Louvain, Louvain, Belgium.
¹¹ Louvain Drug Research Institute - Clinical Pharmacy, Université catholique de Louvain, Louvain, Belgium.
¹² School of Pharmacy, University College Cork, Cork, Ireland.
¹³ Department of Medicine (Geriatrics), University College Cork and Cork University Hospital, Cork, Ireland.

PMID: 31164366
PMCID: PMC6561415
DOI: 10.1136/bmjopen-2018-026769

Randomized Controlled Trial

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

Luise Adam et al. BMJ Open. 2019.

. 2019 Jun 3;9(6):e026769.

doi: 10.1136/bmjopen-2018-026769.

Authors

Affiliations

¹ Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
² Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
³ Clinical Trial Unit Bern, Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.
⁴ Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
⁵ Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland.
⁶ Department of Information and Computing Sciences, Utrecht University, Utrecht, The Netherlands.
⁷ General Medicine and Primary Care, Brigham and Women's Hospital Department of Medicine, Boston, Massachusetts, USA.
⁸ Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.
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 Cliniques universitaires Saint-Luc, Université catholique de Louvain, Louvain, Belgium.
¹¹ Louvain Drug Research Institute - Clinical Pharmacy, Université catholique de Louvain, Louvain, Belgium.
¹² School of Pharmacy, University College Cork, Cork, Ireland.
¹³ Department of Medicine (Geriatrics), University College Cork and Cork University Hospital, Cork, Ireland.

PMID: 31164366
PMCID: PMC6561415
DOI: 10.1136/bmjopen-2018-026769

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.

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

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Study flowchart (*planned numbers).

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical