Interdisciplinary collaboration across secondary and primary care to improve medication safety in the elderly (The IMMENSE study) – a randomized controlled trial

Abstract

Background Suboptimal medication use contributes to a substantial proportion of hospitalizations and emergency department visits in older adults. We designed a clinical pharmacist intervention to optimize medication therapy in older hospitalized patients. Based on the integrated medicine management (IMM) model, the 5-step IMMENSE intervention comprise medication reconciliation, medication review, reconciled medication list upon discharge, patient counselling, and post discharge communication with primary care. The objective of this study was to evaluate the effects of the intervention on healthcare use and mortality. Methods A non-blinded parallel group randomized controlled trial was conducted in two internal medicine wards at the University Hospital of North Norway. Acutely admitted patients ≥ 70 years were randomized 1:1 to intervention or standard care (control). The primary outcome was the rate of emergency medical visits (readmissions and emergency department visits) 12 months after discharge. Results Of the 1510 patients assessed for eligibility, 662 patients were asked to participate, and 516 were enrolled. After withdrawal of consent and deaths in hospital, the modified intention-to-treat population comprised 480 patients with a mean age of 83.1 years (SD: 6.3); 244 intervention patients and 236 control patients. The number of emergency medical visits in the intervention and control group was 497 and 499, respectively, and no statistically significant difference was observed in rate of the primary outcome between the groups [adjusted incidence rate ratio of 1.02 (95% CI: 0.82–1.27)]. No statistically significant differences between groups were observed for any of the secondary outcomes, neither in subgroups, nor for the per-protocol population. Conclusions We did not observe any statistical significant effects of the IMMENSE intervention on the rate of emergency medical visits or any other secondary outcomes after 12 months in hospitalized older adults included in this study. Trial registration The trial was registered in clinicaltrials.gov on 28/06/2016, before enrolment started (NCT02816086).

Effectiveness of pharmacist-led medication reconciliation on medication errors at hospital discharge and healthcare utilization in the next 30 days: a pragmatic clinical trial

“…As most of the research on medication reconciliation comes from countries with a long tradition of clinical pharmacy (Anderson et al, 2019), our findings should be very informative for many settings in Central-Eastern Europe. The pragmatic design of our trial with broad patient inclusion criteria ( Zwarenstein et al, 2008 ) allowed the inclusion of patients who are usually excluded from studies evaluating pharmacist-led interventions ( Ravn-Nielsen et al, 2018 ; Graabaek et al, 2019 ; Karapinar-Çarkıt et al, 2019 ; Kempen et al, 2021 ; Johansen, Halvorsen, Svendsen, et al, 2022 ), thus providing evidence of the benefits of medication reconciliation for the general population of hospitalized medical patients. Notably, outcome assessment was performed by independent observers who were not included in the service provision.…”

“…Indeed, medication reconciliation has been repeatedly shown to reduce medication errors at transitions of care, while its impact on more patient-centered outcomes has led to mixed results, also in several well-designed studies (Cebron Zerovnik, and Kos 2019; Cheema et al, 2018 ; Ensing et al, 2015 ; Michaelsen et al, 2015 ; Mueller et al, 2012 ). While some studies on medication reconciliation performed in isolation or as part of more complex interventions at transitions of care have shown that post-discharge all-cause and medication-related healthcare utilization were substantially reduced ( Gillespie et al, 2009 ; Marusic et al, 2013 ; Lenssen et al, 2018 ; Ravn-Nielsen et al, 2018 ; Snyder et al, 2020 ; Schnipper et al, 2022 ), others have not ( Phatak et al, 2016 ; Karapinar-Çarkıt et al, 2019 ; Lea et al, 2020 ; Ceschi et al, 2021 ; Gurwitz et al, 2021 ; Kempen et al, 2021 ; Johansen et al, 2022 ).…”

Clinical pharmacist intervention to improve medication safety for hip fracture patients through secondary and primary care settings: a nonrandomised controlled trial

“…This was a key difference from prior clinical pharmacy studies which have focused on a single context, such as ward specific inpatients [ 69 ], outpatients [ 70 ], transition points [ 71 ], or one diagnosis tied to one setting [ 72 ]. Although, there are examples of studies following the patient through hospital care with follow-up in primary care for a wider group of patients than hip fracture only [ 31 , 73 ]. An alternative profession that could have contributed with a similar intervention, are geriatricians which could have been a Patient Pathway Geriatrician.…”

A Trial-Based Cost-Utility Analysis of a Medication Optimization Intervention Versus Standard Care in Older Adults

“…We used an intention-to-treat approach employing data collected during the IMMENSE study and health register data for the included patients. Previous publications from the IMMENSE study include the study protocol [ 11 ], the effectiveness evaluation for the primary and secondary outcomes [ 9 ], and an intervention fidelity analysis [ 12 ].…”

“…The primary outcome was the rate of emergency medical visits (acute readmissions and visits to emergency departments) 12 months after the index hospitalization. Although the study did not demonstrate a statistically significant effect on the primary outcome of the study [ 9 ], a cost-utility analysis (CUA) was pre-planned before performing the main analysis of the study. No CUA alongside a clinical trial of an IMM intervention has been published to date, and such analyses can guide resource allocation in healthcare.…”