Implementation assessment of a patient personalized clinical pharmacy programme (5P project) into orthogeriatric care pathway.

WHAT IS KNOWN AND OBJECTIVE: The orthogeriatric path (hip-fractured elderly patients) is composed of several transition points (emergency surgery, orthopaedic, geriatric and rehabilitation units). The intervention of clinical pharmacists can ensure the continuity of patients' drug management during their hospital stay. The aim of the study was to assess the implementation of clinical pharmacy activities in an orthogeriatric pathway, regarding its impact on medication error prevention, the healthcare professionals' and patients' satisfaction, and the estimated associated pharmaceutical workload. METHODS: Participants were aged 75 or older and managed for proximal femoral fracture. Their admission prescription was reviewed. If they were evaluated at high risk of adverse event (AE), medication reconciliation (MedRec) and pharmaceutical interviews (admission, discharge, and targeted on oral anticoagulant) were added at different steps of their care pathway. The achievement and duration of each clinical pharmacy activity were recorded. The number of pharmaceutical interventions (PI) made during prescription review, and unintentional discrepancies (UID) identified during MedRec were collected. A satisfaction questionnaire was sent to patients and healthcare professionals. RESULTS AND DISCUSSION: Among 455 included patients, 284 patients were considered at high risk of AE. Clinical pharmacy activity achievement rates varied between 12% and 98%. A total of 622 PI and 333 UID were identified. The overall patients' and healthcare professionals' satisfaction was rated from 63% to 100%. The total workload was estimated at 376 h: on average 16 min per prescription review, 43 min per admission MedRec, 26 min per discharge MedRec and 17 to 25 minutes per interview. CONCLUSION: The implementation of the programme showed a high potential of drug management securing. To sustain it, additional pharmaceutical human resources and high-performance computing tools are needed.

Drug-related problems in older patients with advanced chronic kidney disease identified during pretransplant comprehensive geriatric assessment.

BACKGROUND: Older patients with advanced chronic kidney disease may be exposed to a higher risk of adverse drug events due to chronic kidney disease and aging. The integration of clinical pharmacist into pretransplant comprehensive geriatric assessment is an opportunity to perform medication optimization. OBJECTIVE: The aim was to describe drug-related problems in older patients with advanced chronic kidney disease. METHODS: Observational study was conducted with retrospective data from July 2017 to April 2019. Patients≥65 years with advanced chronic kidney disease, referred by nephrologists for pretransplant comprehensive geriatric assessment were included. During medication optimization, the pharmacist evaluated the appropriateness of each medication prescribed and identified drug-related problems. Any drug-related problem identified lead to a pharmaceutical intervention. RESULTS: In total, 103 patients were included (74.5±2.9 years, 26.2% female, 47.6% on dialysis). Overall, 394 drug-related problems were identified in 93.2% of patients (3.8±2.4 drug-related problems per patient) during the medication optimization. Cardiovascular medications (25.1%), antithrombotics (13.5%) and drugs for peptic ulcer and reflux disease (10.2%) were the most involved drugs in drug-related problems. Drug-related problems mainly concerned drugs without indication (27.1%), inappropriate method of administration (24.4%) and non-conformity to guidelines (20.1%). CONCLUSION: A high prevalence of drug-related problems in older patients with advanced chronic kidney disease was identified during medication optimization. The systematic integration of a clinical pharmacist in the multidisciplinary team performing pretransplant comprehensive geriatric assessment may be relevant to detect inappropriate prescriptions and to prevent from adverse drug events.

Exposure to Anticholinergic and Sedative Drugs and Healthcare Costs in Older Patients with Neurocognitive Disorders.

BACKGROUND: Literature supports an increasing number of older patients living with neurocognitive disorders alongside with their annual worldwide costs. Therapeutic management of behavioral and psychological symptoms includes the use of anticholinergic and sedative drugs for which significant exposure is negatively associated with clinical outcomes. OBJECTIVE: The aim of this study was to assess the healthcare costs differences related to an increase in the exposure to anticholinergic and sedative drugs in older patients with neurocognitive disorder. METHODS: A longitudinal study was conducted during 3 years on 1,604 participants of the MEMORA cohort linked with both regional public health insurance and hospital discharge databases between 2012 and 2017. Direct medical and non-medical costs were included. Exposure to anticholinergic and sedative drugs was measured by the drug burden index (DBI). RESULTS: Costs difference associated with a DBI≥0.5 were + 338€ (p < 0.001). After adjustment on comorbidities, NCD stage, cognitive impairment, functional limitation, polypharmacy, and sociodemographic characteristics, a DBI≥0.5 was found to be an independent predictor of an increase of total healthcare costs by 22%(p < 0.001). CONCLUSION: Anticholinergic and sedative drugs have a substantial economic burden among older patients with neurocognitive disorder. More studies are required to assess the clinical and economic impact of an efficient strategy based on the reduction of the exposure to anticholinergic and sedative drugs and the promotion of non-pharmacological interventions.

Clinical, economic, and organizational impact of pharmacists' interventions in a cognitive-behavioral unit in France.

Objective Evaluate the clinical, economic, and organizational impact of pharmaceutical interventions performed during medication review in a cognitive-behavioral unit. Setting Study conducted in a cognitive-behavioral unit with retrospective data from January 2011 to june 2017. Methods This study was conducted from retrospective data of medication review in a cognitive-behavioral unit. During medication review, pharmacists identified relevant drug related problems lead to a pharmaceutical intervention which is submitted to the physician. All pharmaceutical interventions carried out from January 2011 to june 2017 were retrospectively analyzed to evaluate their clinical, economic and organizational impact using a multidimensional tool. Main outcome measure CLinical, Economic and Organizational impact using the CLEO tool. Results During the study period, 543 drug related problems and pharmaceutical interventions were recorded for patients hospitalized in the cognitive-behavioral unit (79.0 ± 9.5 years, 59% female). The most common types of drug related problems identified were 'non conformity to guidelines / contra-indication' (28.7%), 'drug without indication' (21.7%), and 'improper administration' (15.1%). The majority of pharmaceutical interventions were considered to have at least a clinical significant impact from the pharmacist's perspective (74%). Regarding the economic and organizational dimensions, 55.2% of pharmaceutical interventions would decrease the costs of care and 35.9% of pharmaceutical interventions would be favorable on the quality of care process. Conclusions The present study shows that the pharmacist may detect a high number of drug related problems with significant clinical relevance during medication review in a cognitive-behavioral unit. Describing and identifying significant pharmaceutical interventions in cognitive-behavioral unit patients allow us to better understand and improve clinical practice in this population.

Medication exposure and frailty in older community-dwelling patients: a cross-sectional study.

Objective To investigate the association between the medication exposure, measured by the polypharmacy/excessive polypharmacy and the anticholinergic and/or sedative drug exposure, on frailty status among French older community-dwelling patients. Setting day-care unit in France (Lyon), with retrospective data from July, 2017 to March, 2018. Method This monocentric cross-sectional study included community-dwelling patients aged 65 years and over and admitted at the day-care unit for a geriatric evaluation. Frailty was assessed according to the frailty phenotype, described by Fried et al. Polypharmacy and excessive polypharmacy were defined as the concomitant use of 5-9 and 10 or more drugs, respectively. The cumulative anticholinergic and sedative exposure was measured using the drug burden index (DBI). The DBI score was presented in 4 differentiated scores: a null score (DBI = 0), a combined score (anticholinergic and sedative score), an anticholinergic score, and a sedative score. The association between medication and frailty was assessed by logistic regression models controlled for multiple potential confounders. Main outcome measure Association between medication exposure (polypharmacy, anticholinergic and sedative exposure) and frailty. Results In this study, 403 patients were included: 44.7% were frail and 40.7% were pre-frail. Polypharmacy and excessive polypharmacy affected 44.7% and 17.1% of the population respectively. The mean DBI was 0.33 ± 0.43, with 16.4% of patients with only sedative exposure, 9.7% with only anticholinergic exposure and 33.0% with both exposures. After adjustment, polypharmacy and excessive polypharmacy were associated with frailty with adjusted odds ratios (95% confidence interval) of 2.18 (1.03-4.22) and 2.72 (1.01-7.37) respectively. The cumulative exposure to anticholinergic and sedative drugs (combined score) was significantly associated to an increased risk for frailty with adjusted odds ratios (95% confidence interval) of 3.54 (1.47-8.57). Conclusion The study showed that polypharmacy and cumulative anticholinergic and sedative exposure are associated with frailty. Further research should address the potential benefit of collaborative medication review for preventing medication-associated frailty.

Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study).

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.

Risk Factors of Caregiver Burden Evolution, for Patients With Subjective Cognitive Decline or Neurocognitive Disorders: A Longitudinal Analysis.

BACKGROUND/OBJECTIVES: The identification of factors used to predict caregiver burden may help preventive care. This study aimed to assess the relationship between evolution of patients with subjective cognitive decline (SCD) or progressive neurocognitive disorder (NCD) and evolution of caregiver burden. DESIGN: Observational, longitudinal study. SETTING: The study was conducted in the Clinical and Research Memory Center of the University Hospital of Lyon (France), between the November 1, 2011 and the June 30, 2014, with a maximum follow-up of 30 months. PARTICIPANTS: The study population included outpatients with SCD or NCD at all stages, and their informal caregiver. MEASUREMENTS: The caregiver burden was assessed during 2 visits of the patients and their caregiver, with the short version of the Zarit Burden Inventory (ZBI). Functional, cognitive performance, and behavioral and psychological symptoms were measured twice, concomitantly with the ZBI, using the Instrumental Activities of Daily Living (IADL) scale, the Mini-Mental State Examination (MMSE), and the Neuropsychiatric Inventory (NPI), respectively. Etiology and stage of the cognitive impairment were collected. RESULTS: The population study included 222 patients (mean age at inclusion: 80 years old, 62.9% females), with an average follow-up 12.6 ± 6 months. Proportion of patients with major NCD at the second visit (62.2%) increased compared with inclusion (50.0%). MMSE and IADL decreased between the 2 visits (P < .001), whereas ZBI increased (mean ZBI: 3.2 ± 2 at baseline, mean ZBI: 3.8 ± 2 at follow-up, P < .001). In unadjusted analyses, ZBI tended to be higher for patients whose MMSE decreased of at least 3 points between the visits. ZBI increased over time when IADL decreased (P value for within-patient effect <.001), while it remained stable when the IADL increased. ZBI increased when NPI increased. After mutual adjustment for change of MMSE, IADL, NPI, and etiologies, increase of ZBI over time remained significant when MMSE decreased at least 3 points between baseline and follow-up, when IADL decreased, and when NPI increased of at least 4 points. CONCLUSIONS: In a study population of patients with SCD or NCD at all stages, concomitant decrease of cognitive performance, increase of functional impairment, and increase neuropsychiatric symptoms over time were independently associated with increased caregiver burden. The identification of risk factors associated with an increased caregiver burden over time may allow a better evaluation of the impact of specific interventions on cognitive, behavioral, and functional dimensions of NCD on caregivers. TRIAL REGISTRATION: ClinicalTrials.govNCT02825732.

Relationship Between Comorbidities in Patients With Cognitive Complaint and Caregiver Burden: A Cross-Sectional Study.

BACKGROUND/OBJECTIVES: Informal caregivers of patients with a cognitive impairment may face exhaustion while taking care of their relatives, and are themselves at higher risk of disease. The objective was to assess the relationship between patients' comorbidities evaluated with the Charlson index, and the caregiver burden, independently of health disorders related to cognitive impairment. DESIGN: Cross-sectional observational study. SETTING: Memory clinic at the University Hospital of Lyon. PARTICIPANTS: Outpatients with cognitive complaint and consulting a Clinical and Research Memory Centre of Lyon (n = 1300). MEASUREMENTS: Comorbidity was measured using the Charlson Comorbidity Index related to age (CCI). The caregiver burden was measured with the short version of the Zarit Burden Interview (ZBI). The relationship was assessed between the CCI and the mini-Zarit and other patients' characteristics: behavior, cognition, autonomy as assessed respectively by the Neuropsychiatric Inventory (NPI), Mini Mental State Examination (MMSE), Instrumental Activities of Daily Living (IADL), etiology, and stage of the cognitive impairment. RESULTS: The study included 1300 outpatients: mean age: 80.8 ± 7 years. The mean CCI was 4.8 ± 1.7. The mini-Zarit score: 3.1 ± 2.0. The caregiver burden increased by 0.22 per unit of CCI (95% confidence interval 0.15-0.28, P < .001) in unadjusted analysis. The caregiver burden remained significantly associated with CCI, after adjustment for the MMSE, IADL, and NPI. CONCLUSION: The caregiver burden is higher when patients' comorbidities increase, independently of behavioral and psychological symptoms, level of functional autonomy, and the stage of the cognitive disease. However, dementia may be the comorbidity that contributes the most to caregiver burden.

Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies.

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.