Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

Study Overview
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Brief Summary
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Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group. The purpose of this study is to evaluate whether a complex tailored pharmacist intervention will lead to increased adherence to secondary stroke prevention medications and less new stroke events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.

Official Title
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Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients

Conditions
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Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Behavioral: Complex tailored intervention
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or older Patient admitted or receiving ambulatory treatment for an acute transient ischemic attack or ischemic stroke which has occurred within the previous 30 days. The patient or a carer usually dispenses the patient's medications Written consent Exclusion Criteria: Cognitive or physical impairment that would preclude comprehension of a conversation Terminal illness Lives in a care home or an institution Receives dose dispensed medicine from a pharmacy Medicine is dispensed by a nurse in the patient's home Correctional mental health patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complex tailored intervention<br>The intervention consists of 3 elements: Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications. Discharge consultation with an pharmacist using motivational interviewing techniques. Follow-up telephone calls one week, two months and six months after discharge. | Behavioral: Complex tailored intervention<br> <br> Behavioral: Usual care<br> <br> |
| Placebo Comparator: Usual care<br>Usual care | Behavioral: Usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC). |  | One year from inclusion | 
| For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8) |  | 1 year from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence to antihypertensives measured by proportion of days covered (PDC) |  | One year from inclusion | 
| Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives |  | One year from inclusion | 
| Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months |  | One year from inclusion | 
| Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge. |  | 3 months from discharge | 
| Composite endpoint: stroke, myocardial infarction or cardiovascular death |  | One year from inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Ischemic Attack, Transient, Medication adherence, Motivational interviewing, Stroke prevention