Clinical trial NCT03951467: Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure
Acute Myocardial Infarction
Keywords: Literacy
Cardiovascular Diseases
Interventional study
Randomized Controlled Trial
Tertiary prevention
Health promotion
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient-related medication errors or misuse within 30 days of discharge from hospital.
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Lyon
country: France
facility: Public Health Department
city: Pierre-benite
country: France
facility: Hôpital Lyon Sud
city: Saint Didier Au Mont D'or
country: France
facility: SSR Val Rosay
Study officials:
affiliation: Hospices Civils de Lyon
name: Julie HAESEBAERT, MD
role: PRINCIPAL_INVESTIGATOR
References: