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

Azienda ULSS 5 Polesana

Status: Unknown

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

Treatments: Behavioral: Patient-counseling; Behavioral: Patient self-administered questionnaire; Behavioral: Pills counts

Study type: Interventional

Funder types: Other

Identifiers

NCT03621111

2017/18

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Adherence plan

Experimental group

Description:

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.

Treatment:

Behavioral: Patient self-administered questionnaire

Behavioral: Pills counts

Behavioral: Patient-counseling

Control group

No Intervention group

Description:

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.