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

Azienda ULSS 5 Polesana120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

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

Interventions

Patient-counselingBEHAVIORAL

After one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs.

Patient self-administered questionnaireBEHAVIORAL

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).

Pills countsBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: baseline, 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 12 months

Central Contacts

Erika Vighesso, University

CONTACT

+39 0425 394351 erika.vighesso@aulss5.veneto.it

Nucleo Ricerca Clinica - AULSS5