Myocardial Infarction, AcuteIM-ADHERENCENCT03621111
A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction
A study testing Patient-counseling, Patient self-administered questionnaire and Pills counts in people with Myocardial Infarction, Acute and ST Segment Elevation Myocardial Infarction, run by Azienda ULSS 5 Polesana at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute, ST Segment Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction (nSTEMI)
- What is being tested?
- Patient-counseling, Patient self-administered questionnaire and Pills counts
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2018to 19 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Nucleo Ricerca Clinica - AULSS5 contact
Italy1 site, 1 recruiting
- Recruiting
Azienda ULSS 5 Polesana
Rovigo, 45100
Erika Vighesso, University
About this study
Official title: 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.
- Conditions
- Myocardial Infarction, Acute, ST Segment Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction (nSTEMI)
- Being tested
- Patient-counseling, Patient self-administered questionnaire, Pills counts
- 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
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-counselingBehavioural
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 questionnaireBehavioural
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 countsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adherence plan | Experimental | 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. Receives: Behavioral: Patient-counseling; Behavioral: Patient self-administered questionnaire; Behavioral: Pills counts |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start19 Feb 2018
- Primary completion19 Feb 2019 (estimated)
- Study completion19 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda ULSS 5 Polesana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Raffaella Ruzza, Azienda ULSS 5 Polesana
- Investigators
- Raffaella Ruzza, University, Principal investigator, Azienda ULSS 5 PolesanaErika Vighesso, University, Principal investigator, University of PadovaGianni Bregola, University, Principal investigator, Azienda ULSS 5 Polesana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621111
- Sponsor's protocol ID
- 2017/18
- Acronym
- IM-ADHERENCE
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 25135805Roffi 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.
PubMed 26320110Ibanez 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.
PubMed 28886621Ho 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.
PubMed 17000940Ryan 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.
PubMed 24777444
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03621111
- Acronym / sponsor ID
- IM-ADHERENCE / 2017/18
- Conditions
- Myocardial Infarction, Acute, ST Segment Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction (nSTEMI)
- Keywords
- Myocardial Infarct, Medication Adherence, Community Pharmacist, Patient counseling, Pill counts, Hospital re-admission, Antiplatelet therapy, Beta-blockers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda ULSS 5 PolesanaUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 19 Feb 2019 (estimated)
- Study completion
- 19 Aug 2019 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence plan | Experimental | Behavioral: Patient-counseling, Behavioral: Patient self-administered questionnaire, Behavioral: Pills countsAt 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-counselingAfter one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs. | Behavioural | Adherence plan |
| Patient self-administered questionnaireThe 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). | Behavioural | Adherence plan |
| Pills countsAt 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. | Behavioural | Adherence plan |
Primary outcome
Change from baseline in medication adherence after 6 months in the interventional and control arms
Time frame: 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
2 secondary outcomes
Change from baseline in medication adherence after 12 months in the interventional and control 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
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 25135805Gujral 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.
- Results publication: PubMed 26320110Roffi 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.
- Results publication: PubMed 28886621Ibanez 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.
- Results publication: PubMed 17000940Ho 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.
- Results publication: PubMed 24777444Ryan 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nucleo Ricerca Clinica - AULSS5 contact
Raffaella Ruzza, University principal investigator
Azienda ULSS 5 Polesana
Erika Vighesso, University principal investigator
University of Padova
Gianni Bregola, University principal investigator
Azienda ULSS 5 Polesana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-counseling, Patient self-administered questionnaire and Pills counts in people with Myocardial Infarction, Acute and ST Segment Elevation Myocardial Infarction, run by Azienda ULSS 5 Polesana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erika Vighesso, University (+39 0425 394351, erika.vighesso@aulss5.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in medication adherence after 6 months in the interventional and control arms (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.