A multi-center, randomized, controlled trial to assess the efficacy of optimization of drug prescribing in an elderly population, at 18 months of follow-up, in the evolution of functional autonomy: the OPTIM study protocol

BMC Geriatrics

Study Protocol

Virginie Dauphinot¹  Pierre Krolak-Salmon²  Elodie Jean-Bart³  Christelle Mouchoux⁴ 

[1] Memory Research Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;Research Clinic Centre (CRC) - VCF (Aging – Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;Hôpital des Charpennes, 27 rue Gabriel Péri, 69100, Villeurbanne, France;Memory Research Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;Research Clinic Centre (CRC) - VCF (Aging – Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;University Lyon 1, INSERM, U1028; UMR CNRS 5292, Research Centre of Neurosciences of Lyon, Lyon, France;Research Clinic Centre (CRC) - VCF (Aging – Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;Pharmacy department, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;Research Clinic Centre (CRC) - VCF (Aging – Brain - Frailty), Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;Pharmacy department, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France;University Lyon 1, INSERM, U1028; UMR CNRS 5292, Research Centre of Neurosciences of Lyon, Lyon, France;University Lyon 1, ISPB, Pharmacie Clinique, Pharmacocinétique et Évaluation du Médicament, Lyon, France;

关键词: Randomized controlled trial;    Inappropriate prescribing;    Elderly;    Daily living activities;    Neurocognitive disorders;   

DOI  :  10.1186/s12877-017-0600-7

 received in 2017-03-22, accepted in 2017-08-24,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPharmacotherapy 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.MethodsA 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.DiscussionThe “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 clinicaltrialsNCT02740764

【 授权许可】

CC BY   
© The Author(s). 2017