Importance Inappropriate prescribing and prescribing omissions are major drivers of healthcare-related harm. Medication review may help improve pharmacotherapy.

Objective To study the effects of a primary care medication review intervention centered around an electronic clinical decision support system (eCDSS) on medication appropriateness and the number of prescribing omissions in older adults with multimorbidity and polypharmacy compared to usual care.

Design and Setting The “Optimising PharmacoTherapy In the multimorbid elderly in primary Care” (OPTICA) trial is a cluster randomized clinical trial conducted with general practitioners (GPs) and older multimorbid patients with polypharmacy in Swiss primary care settings, between January 2019 and February 2020. The 12-month follow-up was completed in February 2021.

Participants Eligible patients had to be ≥65 years of age with ≥3 chronic conditions and ≥5 long-term medications.

Intervention The intervention to optimize pharmacotherapy centered around an eCDSS compared to usual care.

Main Outcomes and Measures The two primary outcomes were the improvement in the Medication Appropriateness Index (MAI) and the Assessment of Underutilization (AOU) at 12 months. Secondary outcomes included the number of medications, number of falls and fractures and quality of life.

Results In 43 GP clusters, 323 patients were recruited (median age: 77 years (IQR: 73-83), 45% were female). 21 GPs with 160 patients were assigned to the intervention group and 22 GPs with 163 patients to the control group. On average, 1 recommendation to stop or start a medication were reported to be implemented per patient. At 12 months, there were no group differences in the improvement of medication appropriateness (Odds ratio (OR): 1.05; 95% confidence interval (CI): 0.59 to 1.87) nor the number of prescribing omissions (OR: 0.90; 95% CI: 0.41 to 1.96) in the intention-to-treat analysis. The per-protocol analysis showed no statistically significant group difference and there were no group differences in the secondary outcomes either.

Conclusions and Relevance In this randomized trial of GPs and older adults, medication reviews based on the eCDSS reduced inappropriate prescriptions but did not lead to higher appropriateness of patients’ medications. The intervention could be safely delivered to patients without causing any detriment to their health.

Funding Swiss National Science Foundation (407440_167465)

Question What is the effect of a GP administered medication review intervention supported by an electronic clinical decision support system on medication appropriateness in older patients with multimorbidity and polypharmacy?

Findings This cluster randomized controlled trial included 43 general practitioners and 323 patients. At the end of the 12-month follow-up period, medication appropriateness and the number of prescribing omissions did not differ between patients who received the intervention and those who received usual care.

Meaning The intervention to optimize pharmacotherapy was feasible and safe to implement in primary care but did not improve overall medication appropriateness nor reduce the number of prescribing omissions.

Prof. Spruit reports a settlement agreement between Spru IT and Utrecht University, in which all IP related to the "Systematic Tool to Reduce Inappropriate Prescribing" Assistant (STRIPA) is transferred to Utrecht University, in exchange for obtaining a free but non-exclusive right to provide STRIP Assistant consultancy or support services, both on a commercial basis, and to update the STRIP Assistant until June 2023. The other authors do not have any conflicts of interest to declare.

Clinicaltrials.gov: NCT03724539 KOFAM (Swiss national portal): SNCTP000003060 Universal Trial Number: U1111-1226-8013

The OPTICA trial was supported by the Swiss National Science Foundation, within the framework of the National Research Programme 74 "Smarter Health Care" (NRP74) under contract number 407440_167465 (to Prof. Streit, Prof. Rodondi, and Prof. Schwenkglenks).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol of the OPTICA trial and other documentation was approved by the competent ethics committee of the canton of Bern (KEK), Switzerland, and the Swiss regulatory authority (Swissmedic) (BASEC ID: 2018-00914).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Trial registration numbers Clinicaltrials.gov: NCT03724539

KOFAM (Swiss national portal): SNCTP000003060

Universal Trial Number: U1111-1226-8013

We will make the data for this study available to other researchers upon request after publication. The data will be made available for scientific research purposes, after the proposed analysis plan has been approved. Data and documentation will be made available through a secure file exchange platform after approval of the proposal. In addition, a data transfer agreement has to be signed (which defines obligations that the data requester must adhere to with regard to privacy and data handling). Deidentified participant data limited to the data used for the proposed project will be made available, along with a data dictionary and annotated case report forms. For data access, please contact the corresponding author.