Myocardial Infarction, Acute, Non-ST Elevation Myocardial Infarction (nSTEMI), ST Segment Elevation Myocardial Infarction
Conditions
Keywords
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
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.
Interventions
BEHAVIORALPatient-counseling
After one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs.
BEHAVIORALPatient self-administered questionnaire
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).
BEHAVIORALPills counts
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.
Sponsors
University of Padova
Azienda ULSS 5 Polesana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in health care costs over 12 months in the interventional and control arms | 12 months | Change in average (mean) health care costs as measured by calculation of hospitalization and medication costs over 12 months for each patient in the interventional and control arms. The hospitalization and medication costs are assessed by the administrative pharmaceutical databases |
| Description of pluri-pharmacological therapies in the interventional and control arms | 12 months | Change from baseline in drugs' prescriptions as assessed by the administrative pharmaceutical databases. This is calculated by analysing drugs' prescriptions for both myocardial infarction and other chronic co-morbidities (such as hypertension, diabetes) |
| Change from baseline in adherence scores on the Morisky medication adherence scale after 12 months in the interventional arm | baseline, 12 months | Change in medication adherence as assessed by the Morisky medication adherence scale (MMAS) in the interventional arm. The MMAS is an international validated scale to assess the patient's medication adherence in chronic diseases. Each patient will answer the 8 multiple choice questions of the MMAS by completing the self-questionnaire every 3 months |
| Prescriptions of fixed dose drug combinations in the interventional and control arms | baseline, 12 months | Number of patients with one or more prescriptions of fixed dose drug combinations (FDCs) as measured by total months' supply dispensed in the interventional and control arms |
Countries
Italy
Contacts
Primary ContactErika Vighesso, University
Backup ContactNucleo Ricerca Clinica - AULSS5
Outcome results
None listed