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Background: Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients' hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied.Methods: This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and having given their consent to be called for a 30-day and 90-day follow-up can be enrolled. For each 14-day period, 15 patients will be recruited in each care unit to obtain a total of 630 patients enrolled in all centers. Patients with a hospital stay of more than 21 days will be excluded. During the control period, there will be no clinical pharmacist in the care unit, whereas during the experimental period a clinical pharmacist will perform medication reconciliation and review with the healthcare team. The primary outcome will assess the impact of collaborative pharmaceutical care on preventable medication error rate. The secondary outcomes will evaluate the clinical impact of the strategy, the acceptance rate of pharmaceutical interventions, the induced and avoided costs of the strategy (cost-consequence analysis), and the healthcare team's satisfaction.Discussion: This study will assess the impact of collaborative pharmaceutical care associating medication reconciliation and review at patient admission to hospital in terms of preventable medication error rate and costs. This activity will prevent and correct medication errors arising earlier in the hospitalization.Trial Registration: ClinicalTrials.gov, NCT02598115 . Registered on 4 November 2015. [ABSTRACT FROM AUTHOR]

Background: Pharmacotherapy is necessary for the management of many diseases which number increased with aging. However, potentially inappropriate prescriptions and polymedication increases iatrogenic risks and can lead to adverse events. To limit the consequences of potentially harmful prescriptions, optimization of drug prescribing is a major stake of improving quality and safety of care in the elderly. The purpose of the OPTIM study is to study the impact of the optimization of drug prescribing on the evolution of functional autonomy at 18 months of follow-up.Methods: A multicenter, open-label, Randomized Controlled Trial was designed to assess the impact of an optimization program of drug prescribing consisting in a clinical medication review by a pharmacist, in collaboration with specialist physician of the geriatric/memory center and the referent physician, on the evolution of functional autonomy level, measured during 18 months of follow-up. The study will include 302 elderly outpatients visiting geriatric and memory centers, randomly distributed in one of the two parallel groups. One group will benefit of the intervention, while the other will be considered as control group. The effect of the intervention on evolution of the level of autonomy function, defined with repeated measures, will be estimated in a generalized linear mixed model. The intervention will be considered significant if the interaction between time and the study group is significant. Secondary analysis will be conducted to assess the impact of the intervention on secondary clinical outcomes.Discussion: The "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to loss of functional autonomy. It should also help to strengthen collaboration between the hospital team of geriatric/neurologist, the pharmacist and the private practice who are all involved in caring for the patient's health. The benefits for the patient are thus optimizing its medical management by linking health professionals met during his care pathway. In addition, pharmaceutical recommendations sent to referent physicians should help raise awareness of the prescription of drugs in these patients.Trial Registration Number Clinicaltrials: NCT02740764. [ABSTRACT FROM AUTHOR]

Background: Drugs with anticholinergic properties may be associated with various adverse clinical effects. The relationship between the anticholinergic (AC) burden and functional, global cognitive performance and behavior disturbances was assessed among elderly patients. Methods: A cross-sectional study was conducted between January 2012 and June 2014 in a memory clinic among outpatients living at home and with subjective cognitive decline (SCD) or neurocognitive disorders (NCD). The AC burden was measured using the Anticholinergic Drug Scale (ADS), the Anticholinergic Risk Scale (ARS), the Anticholinergic Cognitive Burden (ACB), Chew's score, Han's score, and the number of drugs with AC activity. Functional, cognitive performance and behavior disturbances were assessed using the Instrumental Activities of Daily Living (IADL) scale (IADL), the Mini Mental State Examination (MMSE), and the Neuropsychiatric Inventory (NPI). Results: Among 473 included patients, 46.3% were at major NCD. Patients took on average 5.3 ± 2.6 drugs. MMSE was lower when Han's score (p = 0.04) and number of AC drugs were higher (p < 0.001). IADL was lower when AC burden was higher, whatever the AC measurement. NPI was higher when ACB, Han's score, and number of AC drugs were higher. After adjustment, all AC scores remained associated with IADL, while Han's score and number of drugs with AC remained associated with the MMSE. Conclusions: In patients with SCD or NCD, AC burden is associated with lower functional score, whereas the cross-sectional association between AC burden and cognitive performance or behavioral disturbance varies according to AC scores. Particular attention should be paid when prescribing drugs with AC properties, especially among patients with memory complaints. [ABSTRACT FROM AUTHOR]

Background: Evidence-based patient and consumer information (EBPI) is an indispensable component of the patients' decision making process in health care. Prevention of accidental falls in the elderly has gained a lot of public interest during preceding years. Several consumer information brochures on fall prevention have been published; however, none fulfilled the criteria of an EBPI. Little is known about the reception of EBPI by seniors. Therefore we aimed to evaluate a recently developed EBPI brochure on fall prevention with regard to seniors' acceptance and comprehensibility in focus groups and to explore whether the participants' judgements differed depending on the educational background of the study participants. Methods: Seven focus groups were conducted with 40 seniors, aged 60 years or older living independently in a community. Participants were recruited by two gatekeepers. A discussion guide was used and seniors were asked to judge the EBPI brochure on fall prevention using a Likert scale 1-6. The focus group discussions were tape recorded, transcribed verbatim, and analysed using content analysis. Results: The participants generally accepted the EBPI brochure on fall prevention. Several participants expressed a need for more practical advice. The comprehensibility of the brochure was influenced positively by brief chapter summaries. Participants dismissed the statistical illustrations such as confidence intervals or a Fagan nomogram and only half of them agreed with the meta-information presented in the first chapter. The detailed information about fall prevalence was criticised by some seniors. The use of a case story was well tolerated by the majority of participants. Conclusion: Our findings indicate that the recently developed EBPI brochure on fall prevention in old age was generally well accepted by seniors, but some statistical descriptions were difficult for them to understand. The brochure has to be updated. However, not all issues raised by the participants will be taken into account since some of them are contrary to the principles of EBPI. [ABSTRACT FROM AUTHOR]

Background: The symptoms related to neurocognitive disorders (NCD) may lead to caregiver burden increase. Involving caregivers in research may be an effective way of improving the practicalities and relevance of interventions. The aim of this study was to gather opinion and gain consensus on the caregivers 'priorities, using a Delphi method and including aspects of needs in pharmaceutical dimension.Methods: Observational study using a modified Delphi method. This study was conducted in the Clinical and Research Memory Center of the University Hospital of Lyon (France), between September 2015 and January 2016. The expert panel was composed of 68 informal caregivers of people with subjective cognitive decline or NCD living at home.Results: Caregivers assigned a very high importance to the dimension "information needs about their relative's disease", i.e. information on the disease, the treatment and the research; and to "coping skills", i.e. skills related to emotional support, communication, relationship evolution with the relative and skills to cope with behavioural crisis, behavioural and cognitive disorders. The aspect "coping with behavioural disorders" received a high selection rate (83%).Conclusions: The main needs selected can be used to design relevant interventions and give guidance to policy to support caregivers. To meet caregiver's needs, interventions should focus on information about disease and treatment and psychoeducational interventions. [ABSTRACT FROM AUTHOR]

Background: Three arguments are usually invoked in favour of stepped wedge cluster randomised controlled trials: the logistic convenience of implementing an intervention in phases, the ethical benefit of providing the intervention to all clusters, and the potential to enhance the social acceptability of cluster randomised controlled trials. Are these alleged benefits real? We explored the logistic, ethical, and political dimensions of stepped wedge trials using case studies of six recent evaluations., Methods: We identified completed or ongoing stepped wedge evaluations using two systematic reviews. We then purposively selected six with a focus on public health in high, middle, and low-income settings. We interviewed their authors about the logistic, ethical, and social issues faced by their teams. Two authors reviewed interview transcripts, identified emerging issues through qualitative thematic analysis, reflected upon them in the context of the literature, and invited all participants to co-author the manuscript., Results: Our analysis raises three main points. First, the phased implementation of interventions can alleviate problems linked to simultaneous roll-out, but also brings new challenges. Issues to consider include the feasibility of organising intervention activities according to a randomised sequence, estimating time lags in implementation and effects, and accommodating policy changes during the trial period. Second, stepped wedge trials, like parallel cluster trials, require equipoise: without it, randomising participants to a control condition, even for a short time, remains problematic. In stepped wedge trials, equipoise is likely to lie in the degree of effect, effectiveness in a specific operational milieu, and the balance of benefit and harm, including the social value of better evaluation. Third, the strongest arguments for a stepped wedge design are logistic and political rather than ethical. The design is advantageous when simultaneous roll-out is impractical and when it increases the acceptability of using counterfactuals., Conclusions: The logistic convenience of phased implementation is context-dependent, and may be vitiated by the additional requirements of phasing. The potential for stepped wedge trials to enhance the social acceptability of cluster randomised trials is real, but their ethical legitimacy still rests on demonstrating equipoise and its configuration for each research question and setting.