Ischemic Stroke
Conditions
Keywords
ischemic stroke, medication adherence, cardiovascular disease prevention
Brief summary
Medication adherence is a major factor to prevent vascular recurrence after a first ischemic stroke. Nevertheless, it is suboptimal and the implementation of specific interventions are needed to improve it. A patient - centered and pluriprofessional structured intervention, targeting the medication, introduced at hospital discharge and continued at home (by regular telephone contact) could improve medication adherence one year after stroke. This intervention would consist of semi structured interviews patient-pharmacist at different times during one year after stroke. The information about the therapeutic management of the patient will be shared between healthcare professionals : general practitioners (GP) and community pharmacists (CP), hospital clinical pharmacist (HCP) and physician (HPhys). It will allow for decrease of the recurrent stroke and others cardiovascular complications based on a better adherence to preventive medication. Furthermore the decrease of the iatrogenic events and the improvement of the quality of life of patients may be also associated.
Interventions
BEHAVIORALPharmaceutical care
Initial interview with pharmacist (at the hospital discharge): Evaluation aimed to identify barriers to adherence to drug treatment followed by an information session on the disease, the benefit of drugs and the importance of diet and lifestyle habits. Pharmacist advices focused on how to take medication and how to manage adverse events will be provided. Telephone interviews with hospital clinical pharmacist - patient (at M3 M6 and M9): The objective is to review with the patient its medication-taking routine and its potential difficulties, to motivate adherence to treatment and lifestyle/dietary rules, to give advices about therapeutics and how to take medication. HCP contacts CP to determine the prescription refill. Final interview with HCP pharmacist (at M12): The objective is to take stock with the patient about its taking drug load.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years * Patient with ischemic stroke hospitalized in physical medicine and rehabilitation unit or neurovascular unit * Return at home at the hospital discharge * Medication including an antiplatelet drug or an oral anticoagulant with at least an antihypertensive drug and/or a lipid lowering agent (statin) * Patient without either cognitive disorders or major psychiatric disorders * Patient with a sufficient autonomy for the management of medication at home (score of Barthel \> 30)
Exclusion criteria
* Patient ≤ 18 years * Patient with important cognitive or psychiatric disorders * Management of patient medication exclusively by the helper * No usual pharmacy (or more than 2 usual pharmacies) * Patient directed to an institution at the end of the hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of patient's adherence to medication. This adherence measurement is a composite measure | One year after inclusion | A patient will be considered adherent if: 1. For each secondary-preventive drug (antiplatelet, lipid lowering, and antihypertensive), evaluated by the pharmacy refills: Number of days of medication available to the patient (supplied by the pharmacy divided by the total number of days in the period of the study (365)), is higher than 80%. 2. And score obtained from self-reported adherence questionnaire, greater than 6/8 is obtained for all secondary preventative medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with drug-related iatrogenic events | 1 year after inclusion | To estimate the benefit of the intervention on the drug-related iatrogenic events, with a particular attention on the antiplatelet, VKA and the direct oral anticoagulants drugs |
| Percentage of patients with a new stroke or cardiovascular event | 1 year after inclusion | To estimate the benefit of the intervention on the recurrence of stroke or another cardiovascular event |
| Percentage of patients readmitted in hospitalization | 1 year after the inclusion | To estimate the benefit of the intervention on the rehospitalization |
| Realization of a questionnaire (Likert-type scale) | 1 year after inclusion | To estimate the benefit of the intervention on the lifestyle risk factors |
| Measure of glycemic and lipid balance. | 1 year after inclusion | To estimate the benefit of the intervention on laboratory tests |
| Analysis of pharmacy refills | 1 year after inclusion | To estimate the benefit of the intervention on the adherence for each drug, number of days of medication available to the patient (supplied by the pharmacy) divided by the total number of days in the period of the study (365) is higher than 80%. |
| Realization of a questionnaire (Brief IPQR) | 1 year after inclusion | Estimate the profit of the intervention on the representation of the disease for the patient |
| Brief IPQR score and medication adherence (treatment adherence score and pharmacy refills) correlation (composite measure) | 1 year after inclusion | To measure impact of the representation of the disease on adherence to medication |
| Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients | 1 year after inclusion | To estimate in each groups, the satisfaction of patients on their therapeutic follow-up, on their medication, and their relationship with the healthcare professionals (CP , GP , HCP, HPhys) |
| Realization of a questionnaire (Likert-type scale) assessment of satisfaction of GP and CP in relation to ADMED-AVC program. | 1 year after inclusion | To estimate the satisfaction of general practitioners and community pharmacists concerning the ADMED-AVC's program |
| Realization of a questionnaire scoring (SF-36 scale) | 1 year after inclusion | Estimate the benefit of the intervention on the quality of life of the patients |
Countries
France
Contacts
Primary ContactAudrey JANOLY-DUMENIL, Pharmacist
Backup ContactMarine DUPUIS
Outcome results
None listed