Impact of a personalised care plan for the elderly calling emergency medical services after a fall at home: The RISING-DOM multi-centre randomised controlled trial protocol.

BACKGROUND: A growing number of emergency calls are made each year for elderly people who fall. Many of them are not taken to hospital or are rapidly discharged from the Emergency Department (ED). Evidence shows that, with no further support, this vulnerable population is particularly at risk of injuries, dependency and death. This study aims to determine the effectiveness of a comprehensive geriatric assessment and a tailored intervention in the elderly calling on an Emergency Medical Service (EMS) for a fall at home, but not conveyed to the ED or rapidly discharged from it (less than 24 h from hospitalisation), to the time to institutionalisation or death. METHODS: Rising-Dom is a two-arm randomised (ratio 1:1), interventional, multi-centre and open study. Community-dwelling elderly people (≥ 70 years) who call an EMS for a fall at home are recruited. The intervention group receives home visits by a nurse with a comprehensive fall risk assessment and a personalised intervention care plan with a planned follow-up (six nurse home visits and five nurse phone calls). Subjects enrolled in the usual care-control group continue to receive their routine care for the prevention or treatment of diseases. Primary (time to institutionalisation or death) and secondary (unscheduled hospitalisations, additional EMS calls relating to falls, functional decline and quality of life) outcome data will be collected for both groups through five phone calls made by Clinical Research Associates (CRA) blind to the participants' group during the follow-up period (24-months). Twelve hospital centres in the South-West of France are participating in the study as study sites. The inclusion period started in October 2019 and will end in March 2022. By the end of this period, 1,190 subjects are expected to be enrolled. DISCUSSION: Studies on elderly home falls have rarely concerned people who were not taken to hospital. The Rising-Dom intervention scheme should enhance understanding of features related to this vulnerable population and investigate the impact of a nurse care at home on delaying death and institutionalisation. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04132544. Registration date: 18/10/2019. SPONSOR: University Hospital, Toulouse. https://www.clinicaltrials.gov/ct2/show/NCT04132544?term=rising-dom&draw=2&rank=1.

[Assessment in the home of the elderly following a first fall with Samu intervention]. / Évaluation au domicile des personnes âgées dans les suites d'une première chute avec intervention du Samu.

The Rising-Dom study is a project to evaluate the impact of home intervention by an experienced geriatric nurse on mortality and institutionalization of older people who fall. It is a multicentre randomised interventional study. The two-year follow-up will compare the evolution of two groups: intervention (assessment by the nurse and proposal of a care plan) vs. usual care (simple information on ageing well and on the prevention of falls at home). First feedback from the field.

[Step 1 screening: experimentation in Occitania with nurses and pharmacists]. / Icope : pour aider les professionnels de santé à prévenir la dépendance chez les seniors.

The ICOPE program proposed by the WHO to reduce the number of dependent subjects is composed of 5 steps that can be carried out in primary care: screening, integrated assessment, personalized care plan, monitoring of the plan care, community involvement and support for caregivers. The target population is independent seniors aged 60 years and over. Digital tools have been developed to facilitate the assessment and follow-up of the subjects included in this care project.

[Identifying frailty and delaying dependency]. / Repérer la fragilité et retarder l'entrée dans la dependence.

As a person ages, frailty and chronic pathologies appear which can restrict their level of activity and gradually lead to dependency. Identifying and treating this frailty in people aged 65 and over is therefore essential for improving and/or maintaining their quality of life.

Exploring Predictive Factors for Potentially Avoidable Emergency Department Transfers: Findings From the FINE Study.

OBJECTIVES: To assess the prevalence of potentially avoidable transfers (PAT) and identify factors associated with these transfers to emergency departments (EDs) among nursing home (NH) residents. DESIGN: This is a secondary outcome analysis of the FINE study, a multicenter observational study collecting data on NH residents, NH settings, and contextual factors of ED transfers. SETTINGS AND PARTICIPANTS: NHs in the former Midi-Pyrénées region of the southwest of France (n = 312); a total of 1037 NH residents who experienced ED transfers (n = 1017) between January 2016 and December 2016. METHODS: The analysis included resident baseline characteristics and NH and transfer decision-making characteristics. An expert group categorized the transfer status as either PAT or unavoidable. Multivariable analysis using a mixed logistic model, accounting for intra-NH correlation, was conducted to assess factors independently associated with PAT. RESULTS: Among 1017 included transfers, 87.02% (n = 885) were identified as PAT and 12.98% (n = 132) unavoidable transfers. Multivariable analysis revealed that the following patient-related factors were associated with a likely high rate of PAT: usual behavior disturbances before transfer, including productive trouble (OR 2.04, 95% CI 1.25-3.33; P = .0044) and unusual symptom of falling during the week preceding the transfer (OR 4.55, 95% CI 1.76-11.82; P = .0019). On the other hand, distance between ED and NH (OR 0.98, 95% CI 0.97-0.998; P = .0231), NH staff trained in palliative care in the last 3 years (OR 0.52, 95% CI 0.29-0.95; P = .0324), the impossibility of direct hospitalization to an appropriate unit (OR 0.54, 95% CI 0.34-0.87; P = .0117), and the resident Charlson Comorbidity Index (OR 0.90, 95% CI 0.82-0.99; P = .0369) were associated with a lower probability of PAT. CONCLUSION AND IMPLICATIONS: Transfers from NHs to hospital EDs were frequently potentially avoidable, meaning that there are still significant opportunities to reduce PAT. Our findings may help to specifically identify interventions that should be targeted at both NH and resident levels.

Do not PIMP my nursing home ride! The impact of Potentially Inappropriate Medications Prescribing on residents' emergency care use.

Nursing home residents often are poly-medicated, which increases their risks of receiving potentially inappropriate medications. This problem has become a major public health issue in many countries, and in particular in France. Indeed, high uses of potentially inappropriate medication prescriptions can lead to adverse effects that are likely to increase emergency room (ER) visits. However, there is a lack of empirical evidence on the causal relationship between the amount of use of potentially inappropriate medications and ER visit risks among nursing homes residents. Indeed, this question is subject to endogeneity issues due to omitted variables that simultaneously affect inappropriate medications prescriptions and ER use. We take advantage of the IDEM Randomized Clinical Trial (Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers) to overcome that issue. Indeed, randomization in the IDEM intervention group created exogenous variations in potentially inappropriate prescriptions, and was thus used as an instrument. Using an instrumental variable model, we show that over a 12-month period, a 1% increase in the share of potentially inappropriate medications spending in total medication spending leads to a 5.7 percentage point increase in residents' ER use risks (p < 0.001). This effect is robust to various model specifications. Moreover, the intensity of this correlation persists over an 18-month period. While tackling wasteful spending has become a priority in most countries, our results have important policy implications. Indeed, reducing potentially inappropriate medication spending in nursing homes should be a key component of value-based aging policies, which objectives are to reduce inefficient care, and provide health care services centered in people's interest.

Associations between Vitality/Nutrition and the Other Domains of Intrinsic Capacity Based on Data from the INSPIRE ICOPE-Care Program.

BACKGROUND: The vitality domain of intrinsic capacity (IC) represents the synthesis of biological interactions and metabolism. As part of the Integrated Care for Older People (ICOPE) program developed by the World Health Organization (WHO), vitality focuses on the nutritional status of older adults. The objective of this work was to describe the vitality domain of IC in community-dwelling older people and to examine the associations of the vitality components (appetite loss and weight loss) with the other IC domains assessed within the framework of ICOPE. METHODS: Cross-sectional data were obtained between January 2020 and February 2022 through the INSPIRE-ICOPE-Care program, a real-life ICOPE implementation initiative developed in the Occitania region of France. Participants were men and women aged 60 and older, looking for primary care services within the French healthcare system. RESULTS: Appetite loss was reported by 14.0% (2013) of the participants, and weight loss by 12.4% (1788). A total of 863 participants (6.01%) declaring weight loss also suffered from appetite loss. In total, 2910 participants (20.27%) screened positive for the domain of vitality. Appetite loss was significantly associated with positive screenings for the domains of cognition (OR = 2.14 [1.84;2.48]), vision (OR = 1.51 [1.28;1.79]), hearing (OR = 1.18 [1.01;1.37]), psychology (OR = 3.95 [3.46;4.52]), and locomotion 'OR = 2.19 [1.91;2.51]). We found significant associations of weight loss with the IC domains of cognition (OR = 1.65 [1.42;1.93]), psychology (OR = 1.80 [1.56;2.07]), locomotion (OR = 1.64 [1.41;1.91]), vision (OR = 1.24 [1.04;1.47]), and hearing (OR = 1.32 [1.12;1.55]). People reporting simultaneous appetite and weight loss showed higher odds of screening positive for psychological (OR = 5.33 [4.53;6.27]) and locomotion impairments (OR = 3.38 [2.88;3.98]). CONCLUSIONS: Appetite and weight loss are common among older people and are related to other potential IC impairments, especially psychological and locomotion. Further studies are needed to explore the longitudinal associations of vitality with the incidence of clinically meaningful declines in the other IC domains.

Exploring Population Characteristics and Recruitment Challenges in Older People Experiencing Falls at Home without Hospitalization or with an Emergency Department Visit: Insights from the RISING-DOM Experience.

Background: An increasing number of falls among community-living older adults are reported in emergency calls. Data on evidence of appropriate fall prevention interventions are limited and challenges in recruiting this population in randomized trials are acknowledged. Purpose: The main aim of this study was to provide demographic data, circumstance and fall-related outcomes of the population in the RISING-DOM study [Impact d'une évaluation des facteurs de RISque de chute et d'une prise en charge personnalisée, sur la mortalité et l'institutionnalisation, après INtervention du SAMU chez la personne âGée à DOMicile], a multicenter, randomized interventional trial involving community-dwelling older adults who have experienced a fall at home and were not hospitalized. Additionally, the challenges of remote recruitment in this population were discussed. Patients and Methods: Participants were identified through the Occitania Emergency Observatory database. Participant recruitment and data collection were performed through telephone interviews (October 2019-March 2022). Additionally, a sample survey of Emergency Medical Services calls was carried out. Results: Out of the 1151 individuals screened, a total of 951 participants were included in the trial follow-up, resulting in an acceptance rate of 82.62%. The screening delay was extended due to the COVID-19 pandemic. Recruiting difficulties were mainly related to identifying potential participants, unavailable contact information and unreachability. Participants' mean age was 84.1 years, 65.8% were women, and 44.3% lived alone. Pain was the most frequent outcome (53%). In the previous year, 73.5% of participants reported experiencing a fall, with 66.7% of those falls requiring assistance from Emergency Medical Services (EMS). Nearly, 40% did not take proactive steps to prevent future falls and walking aids (79.8%) were the most common preventive action. Conclusion: Indicators of a high-risk group of falls have been identified underscoring the need for appropriate fall interventions in the target population. Challenges of large sampling for randomized fall prevention trials were provided. Trial Registration: Clinicaltrials.gov identifier: NCT04132544. Registration date: 18/10/2019. https://www.clinicaltrials.gov/ct2/show/NCT04132544?term=rising-dom&draw=2&rank=1.

Factors associated with Emergency Medical Dispatcher request and residents' inappropriate transfers from Nursing Homes to Emergency Department.

PURPOSE: In the last decades, the amount of emergency department (ED) transfers of nursing home (NH) residents has disproportionally increased in western countries. The main role of emergency medical dispatcher (EMD) among this population is to refer residents to EDs in the most appropriate way. The aim of this study was to assess risk factors of inappropriate transfers from NH to ED after EMD request. METHODS: This research was a secondary analysis of a prospective observational multicenter study carried out in 17 EDs entitled FINE aimed to assess potentially inappropriate transfer prevalence among this population. Inappropriate transfers were determined in the FINE study threw a standardized approach by a unique expert team. RESULTS: Overall, 572/1037 (55.2%) of residents were transferred to the ED after an EMD's decision. Among them, 92/572 (16.1%) transfers was defined as inappropriate. The average age was 87.3 years old (SD = 0.3). The main reason for ED transfer were falls (217/572, 37.9%). In multivariate analysis, the presence of a Special Care Unit in NH was significantly associated with a high rate of inappropriate transfer (OR 1.78; 95 CI [1.07-2.93]; p = 0.02) whereas a medical examination by a general practitioner before the transfer (OR 0.55; 95 CI [0.33-0.83]; p = 0.02) and a prompt access to psychiatric advice (OR 0.54; 95 CI [0.33-0.84]; p = 0.007) were associated with a low rate of potentially inappropriate transfer. CONCLUSION: Promoting onsite medical assessment and partnership thanks to available geriatrician's advice may help the emergency medical dispatcher to improve the appropriateness of residents' transfer from Nursing Home to the emergency department.

Implementation of the WHO integrated care for older people (ICOPE) programme in clinical practice: a prospective study.

BACKGROUND: The INSPIRE integrated care for older people (ICOPE)-CARE programme is a public health programme implementing the ICOPE health-care pathway in clinical practice. The primary objective of this study was to describe the large-scale implementation and feasibility of the INSPIRE ICOPE-CARE guidelines in clinical practice. The secondary aims were to describe the characteristics of patients who were identified as positive for abnormalities in intrinsic capacity (ie, locomotion, cognition, psychology, vitality, hearing, and vision) during step 1, and to describe the prevalence of these positive screenings. METHODS: In this prospective study, we evaluated a real-life population of users of primary care services in the Occitania region (France). Participants who were aged 60 years and older and lived in a community were eligible for inclusion in our study. Individuals aged ≥60 years were screened (step 1) by health-care providers or through self-assessments using digital tools (the ICOPE MONITOR app and the ICOPEBOT conversational robot). Our implementation strategy involved raising awareness among health-care professionals about the WHO ICOPE programme, training professionals in the ICOPE-CARE guidelines, and developing a digital infrastructure (ie, digital tools, a database, and a remote ICOPE monitoring platform). The feasibility of implementing the INSPIRE ICOPE-CARE guidelines was determined by the anticipated inclusion of ≥10 000 participants, and having a follow-up rate of over 50%. FINDINGS: Between Jan 1, 2020, and November 18, 2021, 10 903 older people (mean age 76·0, SD 10·5 years; 6627 [60·8%] of whom were women) had a baseline step 1 screening done, and 5185 (70·4%) of 7367 eligible participants had a 6-month follow-up of step 1 screening. 10 285 (94·3%) participants had a positive intrinsic capacity result during screening at baseline. 958 (9·3%) participants were evaluated with step 2 (in-depth assessments). Positive intrinsic capacity was confirmed in 865 (90·3%) participants. Most recommendations in step 3 (care plan) were related to locomotion, vitality, and cognition. INTERPRETATION: The high number of participants included in our study, as well as the high rates of follow-up, provides evidence to suggest that the large-scale implementation of ICOPE in clinical practice is feasible. The very high prevalence of positive screening for impaired intrinsic capacity during step 1, as well as the high rates of confirmed deficits in intrinsic capacity during step 2, suggest that the INSPIRE ICOPE-CARE programme is able to target individuals who are at increased risk for functional loss and disability. FUNDING: Occitania Regional Health Agency, Region Occitanie and Pyrénées-Méditerranée, European Regional Development Fund, and The Interreg Program V-A Spain-France-Andorra.

Reply to Inzitari et al. Comment on "Blancafort Alias et al. A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study. Int. J. Environ. Res. Public Health 2021, 18, 5979".

This is a reply to the comment by Inzitari et al [...].

A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study.

The World Health Organization has developed the Integrated Care of Older People (ICOPE) strategy, a program based on the measurement of intrinsic capacity (IC) as "the composite of all physical and mental attributes on which an individual can draw". Multicomponent interventions appear to be the most effective approach to enhance IC and to prevent frailty and disability since adapted physical activity is the preventive intervention that has shown the most evidence in the treatment of frailty and risk of falls. Our paper describes the development of a multi-domain group-based intervention addressed to older people living in the community, aimed at improving and/or maintaining intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in older people. The process of intervention development is described following the Guidance for reporting intervention development studies in health research (GUIDED). The result of this study is the AMICOPE intervention (Aptitude Multi-domain group-based intervention to improve and/or maintain IC in Older PEople) built upon the ICOPE framework and described following the Template for Intervention Description and Replication (TIDieR) guidelines. The intervention consists of 12 face-to-face sessions held weekly for 2.5 h over three months and facilitated by a pair of health and social care professionals. This study represents the first stage of the UK Medical Research Council framework for developing and evaluating a complex intervention. The next step should be carrying out a feasibility study for the AMICOPE intervention and, at a later stage, assessing the effectiveness in a randomized controlled trial.

Factors Associated with Potentially Inappropriate Transfer to the Emergency Department among Nursing Home Residents.

OBJECTIVES: To determine the factors associated with the potentially inappropriate transfer of nursing home (NH) residents to emergency departments (EDs) and to compare hospitalization costs before and after transfer of individuals addressed inappropriately vs those addressed appropriately. DESIGN: Multicenter, observational, case-control study. SETTING AND PARTICIPANTS: 17 hospitals in France, 1037 NH residents. MEASURES: All NH residents transferred to the 17 public hospitals' EDs in southern France were systematically included for 1 week per season. An expert panel composed of family physicians, emergency physicians, geriatricians, and pharmacists defined whether the transfer was potentially inappropriate or appropriate. Residents' and NHs' characteristics and contextual factors were entered into a mixed logistic regression to determine factors associated independently with potentially inappropriate transfers. Hospital costs were collected in the national health insurance claims database for the 6 months before and after the transfer. RESULTS: A total of 1037 NH residents (mean age 87.2 ± 7.1, 68% female) were transferred to the ED; 220 (21%) transfers were considered potentially inappropriate. After adjustment, anorexia [odds ratio (OR) 2.41, 95% confidence interval (CI) 1.57-3.71], high level of disability (OR 0.90, 95% CI 0.81-0.99), and inability to receive prompt medical advice (OR 1.67, 95% CI 1.20-2.32) were significantly associated with increased likelihood of potentially inappropriate transfers. The existence of an Alzheimer's disease special care unit in the NH (OR 0.66, 95% CI 0.48-0.92), NH staff trained on advance directives (OR 0.61, 95% CI 0.41-0.89), and calling the SAMU (mobile emergency medical unit) (OR 0.47, 95% CI 0.34-0.66) were significantly associated with a lower probability of potentially inappropriate transfer. Although the 6-month hospitalization costs prior to transfer were higher among potentially inappropriate transfers compared with appropriate transfers (€6694 and €4894, respectively), transfer appropriateness was not significantly associated with hospital costs. CONCLUSIONS AND IMPLICATIONS: Transfers from NHs to hospital EDs were frequently appropriate. Transfer appropriateness was conditioned by NH staff training, access to specialists' medical advice, and calling the SAMU before making transfer decisions. TRIAL REGISTRATION: clinicaltrials.gov, NCT02677272.

High maintenance dosage of clopidogrel is associated with a reduced risk of stent thrombosis in clopidogrel-resistant patients.

BACKGROUND: Stent thrombosis remains an important complication after stent implantation, despite the use of dual antiplatelet therapy with aspirin (acetylsalicylic acid) and clopidogrel. Several studies have shown an increased risk of thrombotic events in patients with resistance to clopidogrel. Some recent studies have suggested that a higher clopidogrel maintenance dosage could enhance ex vivo platelet inhibition and thereby overcome resistance to clopidogrel. OBJECTIVES: To investigate whether a higher clopidogrel maintenance dosage is associated with a reduced risk of stent thrombosis after percutaneous coronary intervention (PCI) in clopidogrel-resistant patients and to evaluate the frequency of hemorrhagic accidents that could be associated with a high clopidogrel maintenance dosage. METHODS: An observational study was performed in 52 consecutive clopidogrel-resistant patients (resistance defined according to adenosine diphosphate-induced platelet aggregation assessment) who underwent a PCI with stenting at a tertiary referral center (Toulouse University Hospital, France). All patients received a clopidogrel loading dose of 300 mg, then 32 patients received a clopidogrel maintenance dosage of 75 mg/day (patients admitted between 2004 and 2005) and 20 patients received 150 mg/day (patients admitted in 2006). We compared the occurrence of definite stent thrombosis and hemorrhagic accidents between these two groups, using a regression model. RESULTS: Among the patients treated with clopidogrel 75 mg/day, 26 (81.3%) had definite stent thrombosis versus seven (35.0%) treated with 150 mg/day (adjusted relative risk [RR] 2.46; 95% CI 1.63, 2.76; p = 0.002). The risk of major adverse cardiac events (MACE) was also significantly lower in patients treated with 150 mg/day (adjusted RR 2.63; 95% CI 1.82, 2.82; p = 0.001). There was no significant difference between the two groups regarding hemorrhagic accidents. CONCLUSION: Our data suggest that a high maintenance dosage of clopidogrel (150 mg/day) is associated with a reduced risk of definite stent thrombosis and MACE compared with a maintenance dosage of 75 mg/day. The frequency of hemorrhagic accidents was similar between the two groups, underlining a positive benefit-risk ratio of this strategy in clopidogrel-resistant patients. These findings deserve confirmation in a prospective, well conducted study.

[Not Available]. / Hyperglycémies d'origine médicamenteuse : étude dans la Base Nationale Française de PharmacoVigilance (BNPV).

OBJECTIVE: To analyse drugs inducing hyperglycemia by using data reported to the French spontaneous reporting system and recorded in the French PharmacoVigilance Database (FPVD). METHODS: All cases with a report of hyperglycemia and/or diabetes in the French database between 1985 and 2008 were included in the study. We estimated the risk of hyperglycemia linked to drugs by the case/non-case method. Cases were reports including hyperglycemia and non cases all other reports. This risk was estimated through calculation of reporting odds ratios (ROR). RESULTS: During this period, 1219 reports including the words "hyperglycemia and/or diabetes" were registered (0.34% of the database). This adverse drug reaction occurred 1 fold over 4 in diabetics or as a part of HIV infection. Effect was "serious" in approximatively 50% of cases.We found an increase of risk during exposition with methylprednisolone [ROR=43.5; 95% CI (37.3-50.8)], tacrolimus [ROR=25; 95% CI (17.9-34.8)], olanzapine [ROR=19.9; 95% CI (14.9-26.5)], prednisone [ROR=18.9; 95% CI (15.7-22.8)] or pentamidine [ROR=15.4; 95% CI (8.2-28.3)]. CONCLUSION: Drug classes most frequently found in FPVD linked to hyperglycemia are antiretroviral, steroidal anti-inflammatory, second generation neuroleptic, immunosuppressive and diuretic drugs.

[Drug-induced hyperglycemia: a study in the French pharmacovigilance database]. / Hyperglycémies d'origine médicamenteuse : étude dans la Base Nationale Française de PharmacoVigilance (BNPV).

OBJECTIVE: To analyse drugs inducing hyperglycemia by using data reported to the French spontaneous reporting system and recorded in the French PharmacoVigilance Database (FPVD). METHODS: All cases with a report of hyperglycemia and/or diabetes in the French database between 1985 and 2008 were included in the study. We estimated the risk of hyperglycemia linked to drugs by the case/non-case method. Cases were reports including hyperglycemia and non cases all other reports. This risk was estimated through calculation of reporting odds ratios (ROR). RESULTS: During this period, 1219 reports including the words "hyperglycemia and/or diabetes" were registered (0.34% of the database). This adverse drug reaction occurred 1 fold over 4 in diabetics or as a part of HIV infection. Effect was "serious" in approximatively 50% of cases. We found an increase of risk during exposition with methylprednisolone [ROR=43.5; 95% CI (37.3-50.8)], tacrolimus [ROR=25; 95% CI (17.9-34.8)], olanzapine [ROR=19.9; 95% CI (14.9-26.5)], prednisone [ROR=18.9; 95% CI (15.7-22.8)] or pentamidine [ROR=15.4; 95% CI (8.2-28.3)]. CONCLUSION: Drug classes most frequently found in FPVD linked to hyperglycemia are antiretroviral, steroidal anti-inflammatory, second generation neuroleptic, immunosuppressive and diuretic drugs.

Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial.

Importance: Dementia is often underdiagnosed in nursing homes (NHs). This potentially results in inappropriate care, and high rates of emergency department (ED) transfers in particular. Objective: To assess whether systematic dementia screening of NH residents combined with multidisciplinary team meetings resulted in a lower rate of ED transfer at 12 months compared with usual care. Design, Setting, and Participants: Multicenter, cluster randomized trial with NHs as the unit of randomization. The IDEM (Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units) trial took place at 64 public and private NHs in France. Recruitment started on May 1, 2010, and was completed on March 31, 2012. Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included. The residents were followed up for 18 months. The main study analyses were completed on October 14, 2016. Intervention: Two parallel groups were compared: an intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice. During the inclusion period of 23 months, all residents of participating NHs who met eligibility criteria were included in the study. Main Outcomes and Measures: The primary end point (ED transfer) was analyzed at 12 months, but the residents included were followed up for 18 months. Results: A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs). The final study visit was completed by 1042 residents (73.0%). The main reason for early discontinuation was death (318 residents [22.7%]). The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24). Conclusions and Relevance: This study failed to demonstrate that systematic screening for dementia in NHs resulted in fewer ED transfers. The findings do not support implementation of multidisciplinary team meetings for systematic dementia screening of all NH residents, beyond the national recommendations for dementia diagnosis, to reduce ED transfers. Trial Registration: ClinicalTrials.gov Identifier: NCT01569997.

Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol).

AIMS: Three 'weak' opioid analgesics in association with paracetamol are marketed in France as step 2 analgesics: dextropropoxyphene, tramadol and codeine. These combinations are involved in several adverse drug reactions (ADRs), but no data are available about their comparative reporting rate. The aim was to compare the reporting rate of ADRs between tramadol/paracetamol (TRM+P), codeine/paracetamol (COD+P) and dextropropoxyphene/paracetamol (DXP+P). METHODS: All spontaneous reports submitted to the French Pharmacovigilance Database from 1 January 1987 to 31 December 2006 suspected to be induced by one of the three step 2 analgesic combinations (DXP+P, TRM+P, COD+P) were extracted. Their consumption for the same period was obtained from the French Drug Agency. The number of ADRs, serious ADRs and different organ classes of ADRs were compared according to their consumption. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each variable using DXP+P as reference. RESULTS: The reporting rate of ADRs was calculated as 24.9/100 000 person-years for DXP+P, 44.5/100 000 person-years for TRM+P and 12.5/100 000 person-years for COD+P. The reporting rate (OR 0.56, 95% CI 0.50, 0.63) and 'seriousness>>' (OR 0.65, 95% CI 0.53, 0.80) of ADRs were significantly higher with TRM+P than with DXP+P. However, hepatobiliary ADRs were significantly more frequent with the DXP+P combination (OR 2.62, 95% CI 1.59, 4.37). In contrast, the reporting rate (OR 1.99, 95% CI 1.82, 2.18) and 'seriousness' (OR 2.64, 95% CI 2.24, 3.11) of ADRs were significantly higher with DXP+P than with COD+P. CONCLUSIONS: Among the three step 2 analgesic combinations, reporting rate and 'seriousness' of ADRs are the highest with TRM+P and the lowest with COD+P. Our study suggests that the safety profile of DXP+P is worst than that of COD+P.

Drug interactions with cholinesterase inhibitors: an analysis of the French pharmacovigilance database and a comparison of two national drug formularies (Vidal, British National Formulary).

BACKGROUND: Cholinesterase inhibitors (ChEIs) could be involved in several drug-drug interactions (DDIs) because of their complex pharmacodynamic and/or pharmacokinetic properties. AIM: To identify spontaneous reports in the French Pharmacovigilance Database containing DDIs with the three ChEIs marketed in France (donepezil, galantamine or rivastigmine) and to compare the informativity of two national drug references, the French national formulary (Vidal) and the British National Formulary (BNF), for their ability to identify ChEI-related DDIs. METHODS: Spontaneous reports submitted to the French Pharmacovigilance Database concerning donepezil, galantamine or rivastigmine were reviewed by two clinical pharmacologists from Toulouse Regional Pharmacovigilance Centre. Spontaneous reports containing DDIs were identified according to Vidal, BNF or their own judgement (and with use of the interaction supplement of the French independent drug information bulletin La Revue Prescrire). Then, the potential of DDIs to result in adverse drug reactions (ADRs) was evaluated. Finally, the presentations of the different ChEIs in the two references (Vidal, BNF) were compared for their DDI informativity. RESULTS: A total of 1058 spontaneous reports were identified that involved ChEIs in the French Pharmacovigilance Database up to 31 March 2006; of these 376 (35.5%) contained at least one DDI according to experts' judgement. In total, 118 DDIs (31.4%) were the cause of ADRs. Most of the DDIs were due to pharmacodynamic interactions (247 cases, 65.7%). The most frequently encountered drugs involved in DDIs were bradycardic (205 cases, 54.5%) and anticholinergic (118 cases, 31.4%) drugs. DDIs were found in 309 spontaneous reports (29.2%) according to Vidal and in 127 (12.0%) according to BNF. In total, 88 'serious' ADRs were related to DDIs (including seven deaths, mainly due to cardiovascular ADRs). The most frequently observed ADRs due to DDIs were cardiovascular (67 cases, mainly bradycardia, atrioventricular block and arterial hypotension) and neurological (33 cases, mainly mental confusion). Comparison of the different presentations of summary of product characteristics (SPC) showed that Vidal was more informative than BNF for all the ChEIs, and that galantamine had the most complete data in the two references. CONCLUSION: DDIs were present in more than one-third of spontaneous reports including ChEIs registered in the French Pharmacovigilance Database. Approximately, one-third of these DDIs were the cause of ADRs. The informativity of European drug dictionaries differs substantially and Vidal was found to be more informative than BNF for all the ChEIs.

Factors predisposing nursing home resident to inappropriate transfer to emergency department. The FINE study protocol.

BACKGROUND: Each year, around one out of two nursing home (NH) residents are hospitalized in France, and about half to the emergency department (ED). These transfers are frequently inappropriate. This paper describes the protocol of the FINE study. The first aim of this study is to identify the factors associated with inappropriate transfers to ED. METHODS/DESIGN: FINE is a case-control observational study. Sixteen hospitals participate. Inclusion period lasts 7 days per season in each center for a total period of inclusion of one year. All the NH residents admitted in ED during these periods are included. Data are collected in 4 times: before transfer in the NH, at the ED, in hospital wards in case of patient's hospitalization and at the patient's return to NH. The appropriateness of ED transfers (i.e. case versus control NH residents) is determined by a multidisciplinary team of experts. RESULTS: Our primary objective is to determine the factors predisposing NH residents to inappropriate transfer to ED. Our secondary objectives are to assess the cost of the transfers to ED; study the evolution of NH residents' functional status and the psychotropic and inappropriate drugs prescription between before and after the transfer; calculate the prevalence of potentially avoidable transfers to ED; and identify the factors predisposing NH residents to potentially avoidable transfer to ED. DISCUSSION: A better understanding of the determinant factors of inappropriate transfers to ED of NH residents may lead to proposals of recommendations of better practice in NH and would allow implementing quality improvement programs in the health organization.