Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.

BACKGROUND: Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. METHODS: We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. RESULTS: For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). CONCLUSIONS: In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.

COVID-19 highlights the need for universal adoption of standards of medical care for physicians in nursing homes in Europe.

The nursing home sector has seen a disproportionately high number of deaths as part of the COVID-19 pandemic. This reflects, in part, the frailty and vulnerability of older people living in care homes but has also, in part, been a consequence of the failure to include care homes in the systematic planning of a response to COVID, as well as a measure of neglect of standards and quality improvement in the sector. In response, the EUGMS published a set of medical standards of care developed in consultation with experts across its member national societies in 2015. The standards consisted of seven core principles of medical care for physicians working in nursing homes as a first step in developing a programme of clinical, academic and policy engagement in improving medical care for older people who are living and frequently also dying as residents in nursing homes. The gravity of the concerns arising for nursing home care from the COVID-19 pandemic, as well as emerging insights on care improvement in nursing homes indicate that an update of these medical standards is timely. This was performed by the writing group from the original 2015 guidelines and is intended as an interim measure pending a more formal review incorporating a systematic review of emerging literature and a Delphi process.

The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort - Trial Protocol.

BACKGROUND: The aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients' current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium. METHODS: We will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants' medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant's clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial's primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/- 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization. This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT02097654 , 27 March 2014.

Who are the main medical care providers of European nursing home residents? An EuGMS survey.

INTRODUCTION: Nursing home residents are complex, vulnerable and have been historically neglected. The EuGMS is committed to improving their care, and is currently developing a curriculum of core competencies. Integral to these efforts is identifying the physicians, for whom, education in these competencies needs to be directed. METHOD: A survey was distributed to European national geriatrics societies, asking members their perceptions of proportions of nursing home medical care delivered by various physician specialties, and the main functions carried out in nursing homes. RESULTS: Responses were received from 22 of 32 national geriatrics societies. The vast majority of care (estimated at 69%), is delivered by general practitioners, rather than geriatricians or specialist nursing home physicians. Nursing homes have acquired important roles in rehabilitation, respite and palliative care. CONCLUSION: Education and training to achieve the highest standards of care must be designed for general practitioners who do not have specialist training. Education and infrastructure must be developed for the evolving roles of nursing homes.

Incident adverse drug reactions in geriatric inpatients: a multicentred observational study.

BACKGROUND: Adverse drug reactions (ADRs) are common in older adults and frequently have serious clinical and economic consequences. This study was conducted as a feasibility study for a randomized control trial (RCT) that will investigate the efficacy of a software engine to optimize medications and reduce incident (in-hospital) ADRs. This study's objectives were to (i) establish current incident ADR rates across the six sites participating in the forthcoming RCT and (ii) assess whether incident ADRs are predictable. METHODS: This was a multicentre, prospective observational study involving six European hospitals. Adults aged ⩾ 65 years, hospitalized with an acute illness and on pharmacological treatment for three or more conditions were eligible for inclusion. Adverse events (AEs) were captured using a trigger list of 12 common ADRs. An AE was deemed an ADR when its association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre causality assessment. The proportion of patients experiencing at least one, probable/certain, incident ADR within 14 days of enrolment/discharge was recorded. RESULTS: A total of 644 patients were recruited, evenly split by sex and overwhelmingly of White ethnicity. Over 80% of admissions were medical. The median number of chronic conditions was five (interquartile range 4-6), with eight or more conditions present in approximately 10%. The mean number of prescribed medications was 9.9 (standard deviation 3.8), which correlated strongly with the number of conditions (r = 0.54, p < 0.0001). A total of 732 AEs were recorded in 382 patients, of which 363 were incident. The majority of events were classified as probably or possibly drug related, with heterogeneity across sites (χ2 = 88.567, df = 20, p value < 0.001). Out of 644 patients, 139 (21.6%; 95% confidence interval 18.5-25.0%) experienced an ADR. Serum electrolyte abnormalities were the most common ADR. The ADRROP (ADR Risk in Older People) and GerontoNet ADR risk scales correctly predicted ADR occurrence in 61% and 60% of patients, respectively. CONCLUSION: This feasibility study established the rates of incident ADRs across the six study sites. The ADR predictive power of ADRROP and GerontoNet ADR risk scales were limited in this population.

Implementation of geriatric care models in Europe (imAGE.eu): a cross-sectional survey in eight countries.

PURPOSE: Despite the beneficial impact of comprehensive geriatric assessment (CGA) for older patients in the hospital, it is not clear to what extent these models have been implemented in European hospitals. This study aims to map the implementation status of CGA-based models of care in general hospitals in Europe. METHODS: A cross-sectional survey study was conducted in autumn 2017 to map the implementation status of CGA-based care models in general hospitals (n = 178) in Belgium, Denmark, Estonia, Greece, Iceland, Ireland, Malta, and Slovenia. RESULTS: Acute geriatric units are implemented in all of the Belgian and the majority of Danish hospitals, but are scarce in Malta, Estonia, Slovenia and Greece. Geriatric rehabilitation units are most common in Ireland (63.6%) and Iceland (75%). In-hospital multidisciplinary geriatric consultation teams are widely implemented in Belgium (100%), Ireland (72.7%) and Denmark (59.1%), but are rare in Malta, Iceland, Estonia and Greece. Transitional care programs to ensure continuity of care after discharge are present in 60.1% of all hospitals. The intention to implement any of these care models in the next 5 years ranges from 10.3 to 25.4% and is the highest for co-management (36.5%), systematic screening of ED patients (36.2%) and transitional care programs (29.6%). CONCLUSIONS: A great variety in the implementation of CGA-based care models was observed among the surveyed EU countries with the uptake being the highest in Belgium, Denmark and Ireland. A supportive legislative framework and a residency training in geriatrics favor the implementation of the geriatric care models.

[Prevalence of psychotropic drug use among elderly Icelanders living at home]. / Algengi gedlyfjanotkunar eldri Islendinga utan stofnana.

OBJECTIVE: To evaluate the prevalence of psychotropic drug use among home-dwelling elderly Icelanders in the year 2006. MATERIALS AND METHODS: A population-based drug utilization study using the Icelandic Medicines Registry. The study group consisted of Icelanders, seventy years and older living at home (8% of total population). Prevalence of antidepressant, neuroleptic, anxiolytic and hypnotic use (ATC-groups N06A, N05A, N05B, N05C) was defined as the dispension per 100 individuals of one or more prescriptions for these drugs within the year 2006. For cross-national comparison we used data for 70-74 year olds in the Danish Registry of Medicinal Product Statistics. RESULTS: One third of all dispensed prescriptions in Iceland in 2006 were for people aged 70 years and older, and one fourth were for psychotropics. Elderly women were more likely than men to use psychotropics (RR=1.40 95% CI: 1.37-1.43). The prevalence of psychotropic use was 65.5% for women and 46.8% for men. Anxiolytics and hypnotics (N05B or N05C) were the most frequently used psychotropics, with a prevalence of 58.5% for women and 40.3% for men. Antidepressants were used by 28.8 % of women and 18.4 % of men. Neuroleptics were used by 5%. By comparing 70-74 years old Icelanders and Danes, the Icelanders were 1.5 to 2.5 times more likely to receive any psychotropics drug in 2006. CONCLUSION: Use of psychotropics, especially anxiolytics and hypnotics, is common among elderly Icelanders. Comparing information for 70 to 74 year olds with Danes of same age, the prescribing of psychotropics is more frequent in Iceland.

[Comparison of MDS-AC registration and conventional medical records in Iceland and other Nordic countries. A part of a Nordic study]. / Samanburdur á MDS-AC skráningu og hefdbundinni sjúkraskrá á brádadeild á Islandi og ödrum Nordurlöndum. Hluti samnorraennar rannsóknar.

OBJECTIVE: Complex functional decline and comorbid state is an important indicator of outcome for hospital care of older adults. In today acute care it is important to quickly be able to target those who might benefit from geriatric assessment. The MDS-AC is an evaluation system for geriatric acute care patients that records functional impairment and co-morbid states. The object of this study was to compare the MDS-AC registration with the traditional nurses and doctors records for chosen variables important to older patient care in Iceland and other Nordic countries. METHODS: This was a randomised prospective Nordic study. The study took place in Reykjavík, Copenhagen, Umeå, Oslo and Helsinki. Participants in each country were chosen from 75 year old and older patients admitted to acute care medical wards, 160 patients from each country. The results presented here show data from selected variables collected with the MDS-AC instrument version 1,1 in the first 24 hours of admission, compared with hospital notes for the first 48 hours. RESULTS: For ADL and IADL impairments the medical record missed between 20 to 96% of items registered with the MDS-AC and between 33 to 100% when there is no impairment detected. This was true for all the participating Nordic countries but the Icelandic medical records were in comparison more often incomplete for the variables chosen. CONCLUSION: The MDS-AC documents better than traditional medical records several important variables relating to function among the elderly. It may be possible to improve documentation with a standardized instrument such as the MDS-AC.