Impact of a Strategy Dedicated to Low Health Literacy Level Patients to Improve Their Understanding and Ownership of the Discharge Prescription in Cardio-vascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Patient-related medication errors or misuse within 30 days of discharge from hospital.
研究概览
简要总结
Health literacy is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy is known as a health determinant. Level of Health Literacy is low or limited within 47% of interrogated people in Europe, resulting in an inability to understand and/or use written texts and digital concepts about one's health.
There is a demonstrated link between low HL and low therapeutic adherence, an increase in the number of re-admissions, and more generally poor health or survival that is even more limited. An association between low LS and higher health care costs has also been reported in the USA and Switzerland. WHO highlight the central role of Health Literacyin health inequalities, regardless of the region of the world.
The investigator chose to conduct this study in patients hospitalized for an acute cardiovascular event: acute myocardial infarction or acute decompensated heart failure , as these patients have cumulative risk factors for misuse and medication errors. They are hospitalized in emergency, for shorter and shorter periods and are discharged with complex drug treatments. The data show that the return home after acute hospitalization for these conditions is a particularly high-risk period for medication errors and misuse, especially with low level of Health Literacy. The proportion of patients with preventable adverse events in the weeks following their return home ranges from 23% to 30% and nearly 60% are re-hospitalized within 6 months.
The hypothesis of the study is that in patients hospitalized for cute myocardial infarctionor acute decompensated heart failurewith low Health Literacy levels, information on discharge treatment using appropriate tools and techniques will reduce the risk of patient-related medication errors or misuse within 30 days of discharge.
The purpose of this study is to develop an educational intervention model adapted to low Health Literacy levels and routinely feasible, even in case of short stays, in complementarity with traditional therapeutic education programmes that require higher investments and are therefore not accessible to all patients. This innovative approach could then be applied to a large number of chronic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Hospitalization for at least a 2nd acute attack (systolic or diastolic)
- •Patient living at home before hospitalization for decompensation
- •Affiliated with a health insurance plan
排除标准
- •Short-term vital prognosis
- •Bipolar disorders, active psychoses
- •Severe dementia
- •Psychiatric or cognitive comorbidities making inclusion impossible, at the discretion of the investigator.
- •Pregnant, parturient or breastfeeding women
- •Persons deprived of liberty by a judicial or administrative decision
- •Persons admitted to a health or social establishment for purposes other than research
- •Adults subject to a legal protection measure (guardianship, curatorship)
- •Subject participating in another interventional research including an exclusion period still ongoing at inclusion
- •Score S-TOFHLA (>22)
- •Withdrawal of consent
结局指标
主要结局
Patient-related medication errors or misuse within 30 days of discharge from hospital.
时间窗: Day 30
This criterion is defined as the proportion of patients who have made a medication error or misuse, with or without a clinical consequence. We will focus on patient-related medication errors and misuse, i.e. non-compliance with prescription (shorter or longer treatment time, dosage changes, self-medication, etc.), based on the definition proposed by Kripalani et al. An adjudication committee composed of three independent experts will be responsible for defining the potential severity of drug errors or misuses related to the main judgement criterion. Data on primary endpoint will be collected by a clinical researcher, blinded to the randomization group, using a standardized questionnaire administered during the 30-day telephone interview. The patient will be asked the names of the treatments, how he/she took them (number of units per intake, frequency of intake,...), self-medication taken and medical follow-up (medical consultations, biological follow-up,...) over the past 30 days.
次要结局
未报告次要终点