A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the effectiveness of the active involvement of Community Pharmacists in improving adherence to medical prescriptions in patients with acute myocardial infarction (AMI), reducing the rate of adverse events and / or re-admissions due to cardiovascular disease and reducing overall health costs. The Hospital and Community Pharmacists will collaborate with each other, the patients, heart specialists and primary care physicians, throughout 12 months from the hospital discharge.

Official Title
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Adherence, Pharmacists and Secondary Prevention in Acute Myocardial Infarction: A Pilot Controlled Clinical Trial on the Role of Community Pharmacist in Monitoring Medication Adherence and Improving Clinical Outcomes in Post-infarction

Conditions
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Myocardial Infarction, Acute, ST Segment Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction (nSTEMI)

Intervention / Treatment
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* Behavioral: Patient-counseling
* Behavioral: Patient self-administered questionnaire
* Behavioral: Pills counts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Discharged with a primary diagnosis of Acute Myocardial Infarction (AMI, ICD-9 code: 410.x1) from a cardiological ward; Required treatment with antiplatelet therapy, beta-blockers, lipid-lowering therapy, Angiotensin-Converting Enzyme Inhibitors (ACEi), Renin Angiotensin System Inhibitors (RASi) and/or mineralocorticoid/aldosterone receptor antagonists at the hospital admission, alone or in combination; Agreeable to participate in adherence plan (if randomized to interventional arm) performed by the community pharmacist who has in charge the patient; Agreeable to understand and accept the purpose of the study; Signed of the informed consent to participate; Be complying with the protocols' procedures within the entire period of study. Exclusion Criteria: Any prior history of acute myocardial infarction within 6 months prior to study entry; Presence of physical or cognitive impairment or dementia; Permanent long-term residence in Hospice or facility residents; History or presence of any other cardiovascular disease with a life expectancy of < 1 year, hypertension excluded. Other protocol-defined inclusion/exclusion criteria may apply.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adherence plan<br>At the discharge, the hospital pharmacist will complete the medication reconciliation and assess the patient's medications. All patients enrolled will undergo three interventions in order to improve medication adherence: counseling, pill counts and self-questionnaire. The adherence plan concerns 6 classes of drugs recommended by the European Society of Cardiology in acute myocardial infarction. The adherence plan is performed by the community pharmacists. The hospital pharmacist will complete the discharge care form for the community pharmacist who has in charge the patient. Each patient will be scheduled for the first meeting with his community pharmacist within one month from the hospital discharge; afterward the adherence plan will be submitted every 3 months. | Behavioral: Patient-counseling<br>* After one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs.<br>Behavioral: Patient self-administered questionnaire<br>* The pharmacist will submit the questionnaire to the patient for the evaluation of drug adherence, life style, feelings and approach to therapies, at 30 days, 3, 6, 9 and 12 months from the enrollment. This self-questionnaire of 13 questions contains the 8 multiple choice questions of the Morisky medication adherence scale (MMAS-8-Item, Italian version).<br>Behavioral: Pills counts<br>* At the time of the monthly drug re-supply at the community pharmacy, the patient will bring the boxes of the drugs taken in the previous month (empty or not), for the pill counts. The pharmacist will verify the correct assumption of the pharmacological therapies.<br>|
| No Intervention: Control group<br>All the patients discharged from the cardiological ward between September 2017 and February 2018 with a primary diagnosis of acute myocardial infarction has been enrolled in the control arm. These patients have been discharged with the current standard therapy and without any adherence plan performed by the community pharmacists. The investigators will collect the data from the administrative pharmaceutical databases throughout 12 months from the hospital discharge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in medication adherence after 6 months in the interventional and control arms | Change in medication adherence as measured by the calculation of Proportion of Days Covered (PDC) in the two arms. The value of PDC will be compared with the results of the pill counts performed by the community pharmacist. The endpoint concerns all medications recommended by the European Society of Cardiology for the treatment of AMI. The composite PDC will be an average of the individual PDC for each drug class | baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in medication adherence after 12 months in the interventional and control arms | Change in medication adherence as measured by the calculation of Proportion of Days Covered (PDC) in the two arms | baseline, 12 months | 
| Change in re-admission rates due to cardiovascular events after 12 months between the interventional arm and the control arm | Rates of hospital re-admission in the two arms: any re-admission identified by the heart specialist and due to cardiovascular events will be categorized based on the International Classification of Diseases (ICD)-9 classification. The rate will be measured as the per cent ratio of the re-admissions in the interventional arm and the re-admissions in the control arm | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarct, Medication Adherence, Community Pharmacist, Patient counseling, Pill counts, Hospital re-admission, Antiplatelet therapy, Beta-blockers, Lipid-lowering therapy, Angiotensin-Converting Enzyme Inhibitors (ACEi), Renin Angiotensin System Inhibitors (RASi), Mineralocorticoid/aldosterone receptor antagonists