Clinical trial NCT03621111: A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lipid-lowering therapy
Angiotensin-Converting Enzyme Inhibitors (ACEi)
Renin Angiotensin System Inhibitors (RASi)
Mineralocorticoid/aldosterone receptor antagonists
Lead sponsor: Azienda ULSS 5 Polesana
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2018-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in medication adherence after 6 months in the interventional and control arms
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change from baseline in medication adherence after 12 months in the interventional and control arms
timeFrame: baseline, 12 months
measure: Change in re-admission rates due to cardiovascular events after 12 months between the interventional arm and the control arm
timeFrame: 12 months
Other outcomes:
measure: Change in health care costs over 12 months in the interventional and control arms
timeFrame: 12 months
measure: Change from baseline in adherence scores on the Morisky medication adherence scale after 12 months in the interventional arm
timeFrame: baseline, 12 months
measure: Prescriptions of fixed dose drug combinations in the interventional and control arms
timeFrame: baseline, 12 months
measure: Description of pluri-pharmacological therapies in the interventional and control arms
timeFrame: 12 months
Locations:
city: Rovigo
country: Italy
facility: Azienda ULSS 5 Polesana
Study officials:
affiliation: Azienda ULSS 5 Polesana
name: Raffaella Ruzza, University
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova
name: Erika Vighesso, University
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda ULSS 5 Polesana
name: Gianni Bregola, University
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.