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

Not Applicable

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

• Registration Number: NCT03621111
• Lead Sponsor: Azienda ULSS 5 Polesana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2018-07-18
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08
• Primary Completion: 2019-02-19
• Study Completion: 2019-08-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in medication adherence after 6 months in the interventional and control arms	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 Outcome Measures

Name	Time	Method
Change from baseline in medication adherence after 12 months in the interventional and control arms	baseline, 12 months	Change in medication adherence as measured by the calculation of Proportion of Days Covered (PDC) in the two arms
Change in re-admission rates due to cardiovascular events after 12 months between the interventional arm and the control arm	12 months	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

Trial Locations

Locations (1)

Azienda ULSS 5 Polesana; 🇮🇹 Rovigo, Italy