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

Not Applicable

• Conditions: Ischemic Stroke
• Interventions: Behavioral: Pharmaceutical care

• Registration Number: NCT02611440
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07-29
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-20
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist Intervention	Pharmaceutical care	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%.
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
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
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

Trial Locations

Locations (6)

Service de médecine physique et de réadaptation, Groupe hospitalier Lariboisière - Fernand Vidal, AP-HP; 🇫🇷 Paris, France

Service de médecine physique et de réadaptation, Hôpital Henry Gabrielle, Groupement Hospitalier Sud, HCL; 🇫🇷 Saint Genis Laval, France

Service de neurologie vasculaire, Hôpital P Wertheimer, HCL; 🇫🇷 Bron, France

Service de médecine physique et de réadaptation, Hôpital Nord, CHU de Clermont Ferrand; 🇫🇷 Cébazat, France

Service de médecine physique et de réadaptation, Hôpital Bellevue, CHU Saint Etienne; 🇫🇷 Saint-Etienne, France

Service de médecine physique et de réadaptation, Hôpital sud, CHU de Grenoble; 🇫🇷 Echirolles, France