Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack

Study Overview
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Brief Summary
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Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised controlled trial aims to investigate whether a systematic follow up of drug treatment using medication reconciliation, medication reviews and patient counselling by clinical pharmacists, improves adherence and/or decreases cardiovascular events the first three months and the first year after TIA. Patient satisfaction will also be compared between the two groups.

Official Title
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Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack: Adherence and Cardiovascular Events in the First Three Months

Conditions
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Ischemic Attack, Transient, Stroke

Intervention / Treatment
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* Behavioral: Drug use counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Probable or possible transient ischemic attack Residing in Central Norway Examined within 2 weeks after the onset of symptoms Modified Rankin Scale 3 or less and living at home enrolled in the MIDNOR-TIA study NCT02038725 Informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug use counselling<br>Pharmacist conducting drug reconciliation, medication reviews and drug use counselling during hospitalisation. Follow up telephone calls 1 week, 1 month, 2 months and three months after discharge from hospital | Behavioral: Drug use counselling<br> <br> |
| No Intervention: Control group<br>The patients in the control group receive no intervention just treatment and follow up according to national standards | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to drug treatment in secondary prevention after TIA | self reporting of adherence | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to drug treatment in secondary prevention after TIA | self reporting of adherence | 1 year | 
| Persistence | Persistence measured by control of filled prescriptions | 3 months | 
| Incidence of stroke and cardiovascular events and deaths | Measured by using data from national health registries | 3 months | 
| degree of disability or dependence in the daily activities | measured by modified Rankin Scale and indirectly by level of care | 3 months | 
| patient satisfaction | Measured by using data from the Norwegian Stroke Registry | 3 months | 
| Persistence | Persistence measured by control of filled prescriptions | 1 year | 
| Incidence of stroke and cardiovascular events and deaths | Measured by using data from national health registries | 1 year | 
| degree of disability or dependence in the daily activities | measured by modified Rankin Scale and indirectly by level of care | 1 year | 
| patient satisfaction | Measured by using data from the Norwegian Stroke Registry | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Prevention, Pharmacists, Directive Counseling, Medication Adherence, Patient Compliance