Open Randomised Multicentric Controlled Trial to Evaluate the Impact of an Intervention to Improve Drug Appropriateness in Polymedicated Patients According to the Person-centered Care Model by a Multidisciplinary Team At Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- average on number of drugs per patient
研究概览
简要总结
Introduction: In recent years, multi-aging has increased by 25%. This is related to plutipatology, frailty, polymedications, elevated sanitary cost, low quality of life, adverse events and mortality. To improve this it is necessary to apply the people-centered care model that includes and individualized therapeutic plan taking into account medication appropriateness, frailty, complexity and patient preferences. A collaborative model by a multidisciplinary team is proposed to make decisions to optimize drug therapy.
Hypothesis: person-centered care model by a multidisciplinary team at primary care improve drug appropriateness in polymedicated elderly patients Material and Method: Design: Randomized (1:1), open-label, multicentre, parallel-arm clinical trial with 1-year follow-up. Study population: community-dwelling polymedicated (≥8 drugs) elderly (≥75 years old) people at 11 primary healthcare team in Bages, Osona and Anoia (Catalonian region). Period: May 2020 and ends at 12 months of follow-up of the last included subject. Method: 11 primary healthcare team will be randomized to control or intervention group, then volunteers basic healthcare team will participate in the study and they will be assigned to control or intervention group depending on which team they work, then the subjects assigned to theses basic healthcare teams that meet the inclusion criteria and not exclusion criteria will be selected and finally the informed consent of these will be obtained. In the intervention group the multidisciplinary work team comprised by the clinical pharmacist, expert collaborator doctor and the basic healthcare team will meet periodically to review subjects, a multidimensional review will be carried out by assessing the frailty, complexity, morbidity and the appropriateness drug therapy, if proposed changes in the therapeutic plan will have to be agreed with the patient taking into account their preferences. At 6 and 12 months or when their basic healthcare team requests it they will be reviewed again. In the control group the necessary study data collection will be carry out at the beginning and at 6 and 12 months, and the routine clinical practice in relation to the use of medication will be carried out. Measurements: variation of the mean of incidents (potencially prescription inadequate) per patient, variation of the number of prescribed drugs per patient, changes in the therapeutic plans implemented and variation of the number of hospitalizations.
详细描述
JUSTIFICATION:
The proposed project focuses on the clinical review from primary care because the healthcare team are close to the community-dwelling people and therefore offer integral care. The added value is given by the participation of a multidisciplinary team, in addition to the reference healthcare team, an expert chronicity physician and the primary care pharmacist are also involved, thus offer a greater amplitude in the centered vision and care in the patient and in the process of therapeutic appropriateness.
The Primary Care Pharmacist (FAP) in the Project ENAPISC, defined in Catalonia, positions itself as a necessary healthcare professional in the healthcare teams to ensure adequacy use of the medication.
Although the evidence published on the result of the implementation of these interventions in the primary care environment is multiple, its application is still scarce, which gives added value to the realization of the project.
OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polimedicated patients (>7 drugs of >1 month treatment duration, exclude topical drugs, ophtalmologic drugs, diaper and cure products)
- •Multiple chronic conditions
- •Advanced cronic disease with short life expectancy
排除标准
- •Subjects do not want participate at the study
- •<2 visits in the last year with the basic healthcare team
- •palliative care by PADES
结局指标
主要结局
average on number of drugs per patient
时间窗: 0 and 12 months
number of chronic (\>1 month of treatment duration) drugs (excluded topic drugs, ophthalmic drugs, diapers and cure material) prescribed in the therapeutic plan of the patient
average of medication changes
时间窗: 6 and 12 months
number of changes maked in the therapeutic plan of the patients
average number ofdetected incidents
时间窗: 0 and 12 months
Medication incidents defined as therapeutic duplicity, contraindications, security advice about a drug, avoidable medication, inadequate duration, combinations of anticholinergic drugs, medication not recommended in older people, inadequate dosage, drug more efficient, and medication not indicated.
average of hospitalizations
时间窗: 0 and 12 months
number of hospitalizations
次要结局
- Number of adverse events caudes by medication changes(6 and 12 months)
- Number of changes at the end of the study(6 and 12 months)