Optimising prescribing in older adults with multimorbidity and polypharmacy in primary care (OPTICA): cluster randomised clinical trial

Abstract

Objective To study the effects of a primary care medication review intervention centred around an electronic clinical decision support system (eCDSS) on appropriateness of medication and the number of prescribing omissions in older adults with multimorbidity and polypharmacy compared with a discussion about medication in line with usual care. Design Cluster randomised clinical trial. Setting Swiss primary care, between December 2018 and February 2021. Participants Eligible patients were ≥65 years of age with three or more chronic conditions and five or more long term medications. Intervention The intervention to optimise pharmacotherapy centred around an eCDSS was conducted by general practitioners, followed by shared decision making between general practitioners and patients, and was compared with a discussion about medication in line with usual care between patients and general practitioners. Main outcome measures Primary outcomes were improvement in the Medication Appropriateness Index (MAI) and the Assessment of Underutilisation (AOU) at 12 months. Secondary outcomes included number of medications, falls, fractures, and quality of life. Results In 43 general practitioner clusters, 323 patients were recruited (median age 77 (interquartile range 73-83) years; 45% (n=146) women). Twenty one general practitioners with 160 patients were assigned to the intervention group and 22 general practitioners with 163 patients to the control group. On average, one recommendation to stop or start a medication was reported to be implemented per patient. At 12 months, the results of the intention-to-treat analysis of the improvement in appropriateness of medication (odds ratio 1.05, 95% confidence interval 0.59 to 1.87) and the number of prescribing omissions (0.90, 0.41 to 1.96) were inconclusive. The same was the case for the per protocol analysis. No clear evidence was found for a difference in safety outcomes at the 12 month follow-up, but fewer safety events were reported in the intervention group than in the control group at six and 12 months. Conclusions In this randomised trial of general practitioners and older adults, the results were inconclusive as to whether the medication review intervention centred around the use of an eCDSS led to an improvement in appropriateness of medication or a reduction in prescribing omissions at 12 months compared with a discussion about medication in line with usual care. Nevertheless, the intervention could be safely delivered without causing any harm to patients. Trial registration NCT03724539Clinicaltrials.gov NCT03724539

A mixed methods analysis of the medication review intervention centered around the use of the ‘Systematic Tool to Reduce Inappropriate Prescribing’ Assistant (STRIPA) in Swiss primary care practices

“…For the 133 patients, a minimum of one prescribing recommendation had been generated for 130 patients (97.7%). A total of 704 prescribing recommendations had been generated for patients in the intervention group [ 26 ]. For the 133 patients, an average of 3.7 STOPP/START recommendations (SD 1.8, range: 0–11, median = 3, IQR = 2–5) was generated by STRIPA per patient.…”

“…This research was embedded in the OPTICA trial [ 26 ], a cluster randomized controlled trial in Swiss primary care practices conducted by an interdisciplinary and interprofessional team (e.g., GPs, epidemiologists, etc.). The main goal of this trial was to investigate whether the use of a structured medication review intervention centered around the use of an eCDSS, namely the ‘Systematic Tool to Reduce Inappropriate Prescribing’ Assistant (STRIPA), helps to improve the medication appropriateness and reduce prescribing omissions in older multimorbid adults with polypharmacy compared to a medication discussion between GPs and patients [ 24 – 26 ]. The details of the trial protocol and the baseline characteristics of study participants have previously been reported [ 24 , 25 ].…”

“…Trial results were inconclusive on whether the medication review intervention centered around the use of an eCDSS led to an improvement in medication appropriateness or a reduction in prescribing omissions at 12 months compared to a medication discussion in line with usual care (without medication review). Nevertheless, the intervention was safely delivered without causing any harm to patients and led to the implementation of several prescribing recommendations [ 26 ].…”

“…The STRIPA generates patient-specific recommendations, based on the STOPP and START criteria, by considering medication lists, diagnoses, and selected lab values [ 21 ]. It is thus a promising tool for optimizing pharmacotherapy in older adults and has been tested in two clinical trials to determine if its use can improve clinical outcomes (e.g., European multicenter hospital-based OPERAM trial in Switzerland, the Netherlands, Belgium and Ireland [ 22 , 23 ], OPTICA trial in Swiss primary care settings [ 24 – 26 ].…”

Older adults' adherence to medications and willingness to deprescribe: A substudy of a randomized clinical trial

“…The methods and results of the 'Optimising PharmacoTherapy In the multimorbid elderly in primary Care' (OPTICA) trial (clinicaltrials.gov identifier: NCT03724539) have been reported elsewhere. [17][18][19][20] From January 2019 to February 2020, a total of 323 patients from 43 GP practices were recruited into this cluster randomized clinical trial. The last patient completed the 12-month follow-up in February 2021.…”