- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621111
A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction (IM-ADHERENCE)
August 3, 2018 updated by: Raffaella Ruzza, Azienda ULSS 5 Polesana
Adherence, Pharmacists and Secondary Prevention in Acute Myocardial Infarction: A Pilot Controlled Clinical Trial on the Role of Community Pharmacist in Monitoring Medication Adherence and Improving Clinical Outcomes in Post-infarction
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Erika Vighesso, University
- Phone Number: +39 0425 394351
- Email: erika.vighesso@aulss5.veneto.it
Study Contact Backup
- Name: Nucleo Ricerca Clinica - AULSS5
- Email: nucleo.ricercaclinica@aulss5.veneto.it
Study Locations
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-
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Rovigo, Italy, 45100
- Recruiting
- Azienda ULSS 5 Polesana
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Contact:
- Erika Vighesso, University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adherence plan
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.
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After one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs.
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).
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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in medication adherence after 6 months in the interventional and control arms
Time Frame: baseline, 6 months
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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
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baseline, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in medication adherence after 12 months in the interventional and control arms
Time Frame: baseline, 12 months
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Change in medication adherence as measured by the calculation of Proportion of Days Covered (PDC) in the two arms
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baseline, 12 months
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Change in re-admission rates due to cardiovascular events after 12 months between the interventional arm and the control arm
Time Frame: 12 months
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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
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12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in health care costs over 12 months in the interventional and control arms
Time Frame: 12 months
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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
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12 months
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Change from baseline in adherence scores on the Morisky medication adherence scale after 12 months in the interventional arm
Time Frame: baseline, 12 months
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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
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baseline, 12 months
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Prescriptions of fixed dose drug combinations in the interventional and control arms
Time Frame: baseline, 12 months
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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
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baseline, 12 months
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Description of pluri-pharmacological therapies in the interventional and control arms
Time Frame: 12 months
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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)
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Raffaella Ruzza, University, Azienda ULSS 5 Polesana
- Principal Investigator: Erika Vighesso, University, University of Padova
- Principal Investigator: Gianni Bregola, University, Azienda ULSS 5 Polesana
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
- Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Gujral G, Winckel K, Nissen LM, Cottrell WN. Impact of community pharmacist intervention discussing patients' beliefs to improve medication adherence. Int J Clin Pharm. 2014 Oct;36(5):1048-58. doi: 10.1007/s11096-014-9993-y. Epub 2014 Aug 19.
- Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842.
- Ryan R, Santesso N, Lowe D, Hill S, Grimshaw J, Prictor M, Kaufman C, Cowie G, Taylor M. Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews. Cochrane Database Syst Rev. 2014 Apr 29;2014(4):CD007768. doi: 10.1002/14651858.CD007768.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2018
Primary Completion (Anticipated)
February 19, 2019
Study Completion (Anticipated)
August 19, 2019
Study Registration Dates
First Submitted
July 18, 2018
First Submitted That Met QC Criteria
August 3, 2018
First Posted (Actual)
August 8, 2018
Study Record Updates
Last Update Posted (Actual)
August 8, 2018
Last Update Submitted That Met QC Criteria
August 3, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
- Community Pharmacist
- Beta-blockers
- Lipid-lowering therapy
- Medication Adherence
- Antiplatelet therapy
- Patient counseling
- Angiotensin-Converting Enzyme Inhibitors (ACEi)
- Renin Angiotensin System Inhibitors (RASi)
- Myocardial Infarct
- Pill counts
- Hospital re-admission
- Mineralocorticoid/aldosterone receptor antagonists
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Investigators are committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies.
These requests are reviewed and approved by an independent Ethics Committee on the basis of scientific merit.
All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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