A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction
- Conditions
- Myocardial Infarction, AcuteST Segment Elevation Myocardial InfarctionNon-ST Elevation Myocardial Infarction (nSTEMI)
- Interventions
- Behavioral: Patient-counselingBehavioral: Patient self-administered questionnaireBehavioral: Pills counts
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
- Arm && Interventions
Group Intervention Description Adherence plan Patient-counseling 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. Adherence plan Pills counts 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. Adherence plan Patient self-administered questionnaire 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.
- 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