跳至主要内容
临床试验/NCT03640845
NCT03640845招募中不适用

Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2019年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
364
试验地点
2
主要终点
number of unplanned hospitalizations

研究概览

简要总结

The use of drugs in the elderly population remains a major public health problem worldwide. Technological advances and the development of new drugs have helped to extend life expectancy. However, the complex process of aging, resulting in changes in physiological functions, may affect the pharmacodynamics and kinetics of medications taken by the elderly. In addition, polypharmacy, due to multiple comorbidities, may also lead to an increased risk of drug or field interaction and the use of potentially inappropriate drugs (PID), increasing the risk of drug iatrogenic use in older users.

With a view to optimizing drug prescriptions and preventing drug iatrogenic disease in the elderly, and in the context of a university-based research and teaching approach, the AP-HM pharmacy initiated the setting up of clinical pharmacy activities for patients at high iatrogenic risk.

The contribution of clinical pharmacists to mobile geriatric teams who carry out more than 2,200 geriatric assessments a year, is a way to optimize the efficiency of the medication management of the elderly person hospitalized out of hospital. geriatric service and EHPAD. TIn order to promote the physician-pharmacist action synergy observed in practice, the investigators decided to integrate the pharmaceutical evaluation with the geriatric evaluation. This new cooperation makes it possible to improve the knowledge of the treatments taken by the patients, to raise awareness on the observance of the treatments and to facilitate the administration of the drugs, to reduce the risks of iatrogenic medicinal increase the acceptance of therapeutic interventions by the health care team. Indeed, the first results show that the mobile team's medico-pharmaceutical interventions have a much higher acceptance rate than medical or pharmaceutical interventions alone.

However, the economic context and the human resources allocated do not make it possible to ensure an efficient service throughout the territory and in particular in nursing homes outside the city where the CHU is located. In order to increase the number of evaluations, the investigators propose to develop a tele-expertise of a medico-pharmaceutical hospital team (MPHT) and evaluate the impact for patients residing in nursing homes in the context of a high-level study.

详细描述

The use of drugs in the elderly population remains a major public health problem worldwide. Technological advances and the development of new drugs have helped to extend life expectancy. However, the complex process of aging, resulting in changes in physiological functions, may affect the pharmacodynamics and kinetics of medications taken by the elderly. In addition, polypharmacy, due to multiple comorbidities, may also lead to an increased risk of drug or field interaction and the use of potentially inappropriate drugs (PID), increasing the risk of drug iatrogenic use in older users.

With a view to optimizing drug prescriptions and preventing drug iatrogenic disease in the elderly, and in the context of a university-based research and teaching approach, the AP-HM pharmacy initiated , in collaboration with certain clinical departments, the setting up of clinical pharmacy activities for patients at high iatrogenic risk. These activities were established and formalized in close collaboration with the doctors of the departments concerned, the geriatrics center and the geriatric mobile teams in particular, and were the subject of specific funding within the framework of the Instruction N ° DGOS / PF2 / 2016/49 of the 19/02/2016 relating to the call for project of implementation of the clinical pharmacy in health facility.

The contribution of clinical pharmacists to mobile geriatric teams (intra-hospital and outpatient), who carry out more than 2,200 geriatric assessments a year, is a way to optimize the efficiency of the medication management of the elderly person hospitalized out of hospital. geriatric service and EHPAD. In order to promote the physician-pharmacist action synergy observed in practice, the investigators decided to integrate the pharmaceutical evaluation (medication review) with the geriatric evaluation. This new cooperation makes it possible to improve the knowledge of the treatments taken by the patients, to raise awareness on the observance of the treatments and to facilitate the administration of the drugs (choice of the adapted galenic forms), to reduce the risks of iatrogenic medicinal increase the acceptance of therapeutic interventions by the health care team (attending physician, coordinator, nurse). Indeed, the first results show that the mobile team's medico-pharmaceutical interventions have a much higher acceptance rate than medical or pharmaceutical interventions alone.

However, the economic context and the human resources allocated do not make it possible to ensure an efficient service throughout the territory and in particular in nursing homes outside the city where the CHU (Marseille) is located. In order to increase the number of evaluations, the investigators propose to develop a tele-expertise of a medico-pharmaceutical hospital team (EHMP) and evaluate the impact for patients residing in nursing homes in the context of a high-level study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Age greater than or equal to 65
  • Resident in EHPAD
  • presenting a high iatrogenic drug risk (Trivalle score between 6-10).
  • Ability to provide free, informed and express consent (patient and / or trusted person)
  • Affiliated to a social security scheme

排除标准

  • Patient with a life expectancy <3 months
  • Patient under 65 years
  • Trivale score <6
  • Vulnerable persons within the meaning of French law (adults under guardianship or trusteeship, persons deprived of their liberty)
  • Participation in another research protocol in progress
  • Patient who has had a medication review (or medication review) known in the last 6 months.
  • Patient with severe dementia (MMSE <18)

结局指标

主要结局

number of unplanned hospitalizations

时间窗: 6 months

The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents

次要结局

  • Fall rate(6 months)
  • Description of patients whose general physician have taken account of recommendations(3 months)
  • Assessment of unplanned hospital admission(6 months)
  • Quality of life (QoL) of nursing home residents(6 months)
  • Proportion of residents subjected to at least 1 potentially inappropriate prescription(6 months)
  • Acceptation rate of general physician to therapeutic recommandations(6 months)
  • Incidence of behavioral disturbances(6 months)
  • Nursing staff satisfaction with oral medications dispensed(3 months)
  • Residents with at least 1 potentially inappropriate prescription(6 months)
  • Characteristics of patients whose GP have taken account of TMR recommendations(3 months)
  • Qualitative acceptability intervention survey(6 months)
  • Incremental cost-effectiveness ratio(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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