Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke

Study Overview
=================
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.

Official Title
-----------------
Impact of a Pluriprofessional Intervention to Improve Medication Adherence (Secondary Preventive Medication) in Patients After Ischemic Stroke (ADMED-AVC)

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Behavioral: Pharmaceutical care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Intervention<br>It will be a semi -structured interviews with patient and pharmacist over various time after the stroke (at Month0, M3, M6, M9) combined with patient's therapeutic follow-up from various healthcare professionals. | Behavioral: Pharmaceutical care<br>* 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.<br>|
| No Intervention: Control<br>No pharmacist intervention planned. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of patient's adherence to medication. This adherence measurement is a composite measure | A patient will be considered adherent if: 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%. And score obtained from self-reported adherence questionnaire, greater than 6/8 is obtained for all secondary preventative medication | One year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pharmacy refills | 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%. | 1 year after inclusion | 
| Percentage of patients with drug-related iatrogenic events | 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 | 1 year after inclusion | 
| Percentage of patients with a new stroke or cardiovascular event | To estimate the benefit of the intervention on the recurrence of stroke or another cardiovascular event | 1 year after inclusion | 
| Percentage of patients readmitted in hospitalization | To estimate the benefit of the intervention on the rehospitalization | 1 year after the inclusion | 
| Realization of a questionnaire (Likert-type scale) | To estimate the benefit of the intervention on the lifestyle risk factors | 1 year after inclusion | 
| Measure of glycemic and lipid balance. | To estimate the benefit of the intervention on laboratory tests | 1 year after inclusion | 
| Realization of a questionnaire scoring (SF-36 scale) | Estimate the benefit of the intervention on the quality of life of the patients | 1 year after inclusion | 
| Realization of a questionnaire (Brief IPQR) | Estimate the profit of the intervention on the representation of the disease for the patient | 1 year after inclusion | 
| Brief IPQR score and medication adherence (treatment adherence score and pharmacy refills) correlation (composite measure) | To measure impact of the representation of the disease on adherence to medication | 1 year after inclusion | 
| Realization of questionnaires (Likert-type scale and SATMED) assessment of satisfaction of patients | 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) | 1 year after inclusion | 
| Realization of a questionnaire (Likert-type scale) assessment of satisfaction of GP and CP in relation to ADMED-AVC program. | To estimate the satisfaction of general practitioners and community pharmacists concerning the ADMED-AVC's program | 1 year after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemic stroke, medication adherence, cardiovascular disease prevention