'Optimising PharmacoTherapy In the multimorbid elderly in primary CAre' (OPTICA) to improve medication appropriateness: study protocol of a cluster randomised controlled trial.

Jungo, Katharina Tabea; Rozsnyai, Zsofia; Mantelli, Sophie; Floriani, Carmen; Löwe, Axel Lennart; Lindemann, Fanny; Schwab, Nathalie Christa; Meier, Rahel; Elloumi, Lamia; Huibers, Corlina Johanna Alida; Sallevelt, Bastiaan Theodoor Gerard Marie; Meulendijk, Michiel C; Reeve, Emily; Feller, Martin; Schneider, Claudio; Bhend, Heinz; Bürki, Pius M; Trelle, Sven; Spruit, Marco; Schwenkglenks, Matthias; ... (2019). 'Optimising PharmacoTherapy In the multimorbid elderly in primary CAre' (OPTICA) to improve medication appropriateness: study protocol of a cluster randomised controlled trial. BMJ open, 9(9), e031080. BMJ Publishing Group 10.1136/bmjopen-2019-031080

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INTRODUCTION Multimorbidity and polypharmacy are major risk factors for potentially inappropriate prescribing (eg, overprescribing and underprescribing), and systematic medication reviews are complex and time consuming. In this trial, the investigators aim to determine if a systematic software-based medication review improves medication appropriateness more than standard care in older, multimorbid patients with polypharmacy. METHODS AND ANALYSIS Optimising PharmacoTherapy In the multimorbid elderly in primary CAre is a cluster randomised controlled trial that will include outpatients from the Swiss primary care setting, aged ≥65 years with ≥three chronic medical conditions and concurrent use of ≥five chronic medications. Patients treated by the same general practitioner (GP) constitute a cluster, and clusters are randomised 1:1 to either a standard care sham intervention, in which the GP discusses with the patient if the medication list is complete, or a systematic medication review intervention based on the use of the 'Systematic Tool to Reduce Inappropriate Prescribing'-Assistant (STRIPA). STRIPA is a web-based clinical decision support system that helps customise medication reviews. It is based on the validated 'Screening Tool of Older Person's Prescriptions' (STOPP) and 'Screening Tool to Alert doctors to Right Treatment' (START) criteria to detect potentially inappropriate prescribing. The trial's follow-up period is 12 months. Outcomes will be assessed at baseline, 6 and 12 months. The primary endpoint is medication appropriateness, as measured jointly by the change in the Medication Appropriateness Index (MAI) and Assessment of Underutilisation (AOU). Secondary endpoints include the degree of polypharmacy, overprescribing and underprescribing, the number of falls and fractures, quality of life, the amount of formal and informal care received by patients, survival, patients' quality adjusted life years, patients' medical costs, cost-effectiveness of the intervention, percentage of recommendations accepted by GPs, percentage of recommendation rejected by GPs and patients' willingness to have medications deprescribed. ETHICS AND DISSEMINATION The ethics committee of the canton of Bern in Switzerland approved the trial protocol. The results of this trial will be published in a peer-reviewed journal. MAIN FUNDING Swiss National Science Foundation, National Research Programme (NRP 74) 'Smarter Healthcare'. TRIAL REGISTRATION NUMBERS Clinicaltrials.gov (NCT03724539), KOFAM (Swiss national portal) (SNCTP000003060), Universal Trial Number (U1111-1226-8013).

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM)

UniBE Contributor:

Jungo, Katharina Tabea; Mantelli, Sophie; Floriani, Carmen; Löwe, Axel Lennart; Lindemann, Fanny Eliza; Schwab, Nathalie Christa; Feller, Martin; Schneider, Claudio; Trelle, Sven; Rodondi, Nicolas and Streit, Sven

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2044-6055

Publisher:

BMJ Publishing Group

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

18 Sep 2019 16:25

Last Modified:

23 Oct 2019 09:40

Publisher DOI:

10.1136/bmjopen-2019-031080

PubMed ID:

31481568

Uncontrolled Keywords:

multimorbidity polypharmacy primary care

BORIS DOI:

10.7892/boris.133356

URI:

https://boris.unibe.ch/id/eprint/133356

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