Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home
试验速览
- 阶段
- 不适用
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
研究概览
简要总结
Aging is often associated with multiple chronic conditions conducting increased consumption of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy, increases the iatrogenic risks and can lead to adverse events such as falls, cognitive decline, increased use to the health system: hospital admissions, emergency room visits, and institutionalization. These problems are common since about 20% of emergency room use in elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events related to drug prescriptions could be avoided.
Interventions to optimize drug therapy showed a reduction in the number of potentially inappropriate medications, but their impact on health, has rarely been evaluated. If an association with death has been established, the link with the loss of functional autonomy, which leads to reduced quality of life and significant cost of care, has not been investigated. The evolution towards functional disabilities, frequent with aging has many causes, among which some could be prevented. The optimization of drug prescriptions could thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse events, such as falls or cognitive decline and improving the management of chronic diseases. Our hypothesis is that an optimization program of the drug prescribing may slow progression to functional dependence. To assess the effect of the optimization program of drug prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial will be conducted in geriatric and memory consultations.
Expected results The implementation of the "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to addiction. It should also help to develop and strengthen collaboration and communication between the team of geriatric consultation, the clinician pharmacist and referring physicians in town (private practice). In addition, pharmaceutical notice sent to referring physicians should help raise awareness of the prescription of drugs in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 and over;
- •Patients received for the first time in a geriatric or memory consultation of a study recruiting centers;
- •Patients living at home;
- •Patients with the ability to express themselves orally or in writing in French sufficiently to carry out clinical assessments;
- •Patients who led the last drugs prescription from his referring physician, at the geriatric/memory consultation (in current practice, patients should take the last prescription established by the referring physician);
- •Patients accompanied by a caregiver.
排除标准
- •Patients with no discernment;
- •Patient put under legal protection;
研究组 & 干预措施
Optimization of drug prescribing
The group with optimization program will have: (i) a medical history of the drug prescribing; (ii) analysis and pharmaceutical recommendations and (iii) preparation of a management plan. Notices will be sent only to referring physicians in this experimental group.
干预措施: Optimization of drug prescribing (Other)
No intervention
This group will receive the current management of patients in geriatric or memory consultation, during which the intervention of a clinician pharmacist is not provided. There will be a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital, but the recommendations will not be transmitted to the referring physicians of patients.
结局指标
主要结局
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
时间窗: At 18 months
The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale. The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
时间窗: At 18 months
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
次要结局
- Compliance of patients with treatment(Baseline, 6 months and 18 months)
- Occurrence of recourse to emergency service(Baseline, 1 month, 6 months and 18 months)
- Number of days before falls(Baseline, 1 month, 6 months and 18 months)
- acceptance rate by the referring physicians of pharmaceutical recommendation(Baseline, 1 month, 6 months and 18 months)
- Number of Hospitalizations(Baseline, 1 month, 6 months and 18 months)
- Number of days before hospitalizations(Baseline, 1 month, 6 months and 18 months)
- Number of days before admission in institution(Baseline, 1 month, 6 months and 18 months)
- Quality of life 1(Baseline, 6 months and 18 months)
- Number of days before the recourse to emergency service(Baseline, 1 month, 6 months and 18 months)
- The occurrence of admission in institution(Baseline, 1 month, 6 months and 18 months)
- Falls(Baseline, 1 month, 6 months and 18 months)
- Cognitive functions(Baseline, 6 months and 18 months)
- Problems associated with drug therapy(Baseline, 1 month, 6 months and 18 months)
- Death(Baseline, 1 month, 6 months and 18 months)
- Number of days before death(Baseline, 1 month, 6 months and 18 months)
- Quality of life 2(Baseline, 6 months and 18 months)
- depression disorders(Baseline, 6 months and 18 months)
- Anxiety disorders(Baseline, 6 months and 18 months)
- Proportion of potential inappropriate medication(Baseline, 1 month, 6 months and 18 months)
- Pain(Baseline, 6 months and 18 months)