Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations (ILIADE)
Primary Purpose
Acute Decompensated Heart Failure, Acute Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.
Sponsored by
About this trial
This is an interventional health services research trial for Acute Decompensated Heart Failure focused on measuring Literacy, Cardiovascular Diseases, Interventional study, Randomized Controlled Trial, Tertiary prevention, Health promotion
Eligibility Criteria
Inclusion Criteria:
- Inadequate health literacy level according to the Brief Health Literacy Screening questionnaire
- Age greater than or equal to 18 years
- Hospitalization for acute myocardial infarction (myocardial infarction with or without ST segment elevation) or acute decompensated heart failure (systolic or diastolic)
- Return home after hospitalization
- Affiliated with a health insurance plan
Exclusion Criteria:
- Short-term vital prognosis
- Bipolar disorders, active psychoses
- Severe dementia
- Inability to manage drug treatment alone
- Institutionalization at the end of hospitalization
Sites / Locations
- Public Health Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional arm
Controlled arm
Arm Description
Patients within this arm will be follow as usual care of the cardiologic unit
Outcomes
Primary Outcome Measures
Patient-related medication errors or misuse within 30 days of discharge from hospital.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03951467
Brief Title
Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations
Acronym
ILIADE
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 (HL) 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 LS in health inequalities, regardless of the region of the world.
We chose to conduct this study in patients hospitalized for an acute cardiovascular event: acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF), 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 HL. The proportion of patients with preventable ADR in the weeks following their return home ranges from 23% to 30% and nearly 60% are re-hospitalized within 6 months.
Our hypothesis is that in patients hospitalized for AMI or ADHF with low HL 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 HL 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure, Acute Myocardial Infarction
Keywords
Literacy, Cardiovascular Diseases, Interventional study, Randomized Controlled Trial, Tertiary prevention, Health promotion
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
576 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional arm
Arm Type
Experimental
Arm Title
Controlled arm
Arm Type
No Intervention
Arm Description
Patients within this arm will be follow as usual care of the cardiologic unit
Intervention Type
Other
Intervention Name(s)
Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.
Intervention Description
Two interviews between the patient and the nurse trained for the study: before discharge from hospital and a telephone reminder between 3 and 5 days after discharge.
First interview: the nurse will evolve using tools developed in the first phase of the study. The nurse will provide detailed personalized information on the patient's discharge order and illness and the action to be taken depending on the potential situations the patient may encounter.
Telephone interview: 3 to 5 days after discharge, the nurse will repeat the elements of the first interview with the patient to verify that the information has been properly understood and retained and that the patient is able to adopt appropriate behaviors in high-risk situations.
Primary Outcome Measure Information:
Title
Patient-related medication errors or misuse within 30 days of discharge from hospital.
Description
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.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inadequate health literacy level according to the Brief Health Literacy Screening questionnaire
Age greater than or equal to 18 years
Hospitalization for acute myocardial infarction (myocardial infarction with or without ST segment elevation) or acute decompensated heart failure (systolic or diastolic)
Return home after hospitalization
Affiliated with a health insurance plan
Exclusion Criteria:
Short-term vital prognosis
Bipolar disorders, active psychoses
Severe dementia
Inability to manage drug treatment alone
Institutionalization at the end of hospitalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie HAESEBAERT, MD
Phone
04 72 68 49 05
Ext
+33
Email
julie.haesebaert@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle BRAVANT
Phone
04 27 85 63 18
Ext
+33
Email
estelle.bravant@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie HAESEBAERT, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Department
City
Lyon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie HAESEBAERT, MD
Phone
04 72 68 49 05
Ext
+33
Email
julie.haesebaert@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Estelle BRAVANT
Phone
04 27 85 63 18
Ext
+33
Email
estelle.bravant@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Julie HAESEBAERT, MD
12. IPD Sharing Statement
Learn more about this trial
Using an Intervention Adapted to the Health Literacy Level to Improve Adherence to Medical Recommendations
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