Impact of a Medication Review on Hospital Readmission: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 470
- 试验地点
- 2
- 主要终点
- Rate of readmission
研究概览
简要总结
The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:
- group receiving a pharmacist-led standardized medication review (experimental group); and
- group not receiving the medication review (control group).
The patients will be followed up at 30 days after initial hospitalization. Outcome measures include the number of readmissions; patient satisfaction, quality of medical admission prescription and number of consultation after initial hospitalization.
Discussion: A randomized controlled trial will provide the highest level of evidence on the impact of pharmacist-led standardized medication review on early hospital readmission for extreme age population.
详细描述
The impact of Medication Reconciliation on the early hospital readmission in the elderly is not clearly demonstrated. Moreover, the impact of medication reconciliation in the pediatric population is poorly studied.
In such context, it is important to demonstrate the effectiveness of the medication reconciliation as part of a standardized medication review process, in pediatric and in the elderly, on all cause readmissions in a large randomized control clinical trial. The standardized medication review process includes medication reconciliation, treatment review and medication liaison service.
The main objective of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge.
Methods/design: The study is a randomized controlled clinical trial. A total 1400 hospitalized patients will be randomized in two groups:
- group receiving a pharmacist-led standardized medication review (experimental group); and
- group not receiving the medication review (control group).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged under 18 or over 65 years
- •Subject hospitalized in the multidisciplinary pediatric service or internal medicine ward, after emergency department visit at Timone hospital (Marseille, France) regardless of the reason for admission
- •Subject with or without any comorbidity
- •Living in France
- •With national publicly-founded health insurance
- •Inclusion criteria for parents of minor child:
- •Major subject and/or holder of parental authority of a hospitalized child, who fulfills the eligibility criteria mentioned above, in the multidisciplinary pediatric ward;
- •Whatever the reason for hospitalization of the patient;
- •Inclusion criteria for the caregivers of patients older than 65 years:
- •Major subject, designated by the patient or designating himself as the person most involved in the daily life of the patient;
- •Whatever the reason for hospitalization of the patient;
- •Whatever relationship or proximity to the study patient (family member, friend, neighbor);
排除标准
- •Patients whose care requires regular re-hospitalization / programmed less than 30 days after discharge of initial hospitalization
- •Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)
结局指标
主要结局
Rate of readmission
时间窗: 30 days
次要结局
- Medication errors on medical admission prescription(24 hours)
- Satisfaction with Medicines Questionnaire (SatMed-Q®)(30 days)
- Number of consultations post discharge(30 days)