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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction, Acute
- Sponsor
- Azienda ULSS 5 Polesana
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from baseline in medication adherence after 6 months in the interventional and control arms
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Raffaella Ruzza
Hospital Pharmacist
Azienda ULSS 5 Polesana
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline in medication adherence after 6 months in the interventional and control arms
Time Frame: baseline, 6 months
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
Secondary Outcomes
- Change from baseline in medication adherence after 12 months in the interventional and control arms(baseline, 12 months)
- Change in re-admission rates due to cardiovascular events after 12 months between the interventional arm and the control arm(12 months)