A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction

Myocardial Infarction, Acute Clinical Trial

— IM-ADHERENCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03621111
• Other study ID #: 2017/18
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: August 2018
• Source: Azienda ULSS 5 Polesana
• Contact: Erika Vighesso, University
• Phone: +39 0425 394351
• Email: erika.vighesso[@]aulss5.veneto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 19, 2019
• Est. primary completion date: February 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction (nSTEMI)
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Behavioral:
• Patient-counseling
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 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).
• Pills 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.

Locations

Country	Name	City	State
Italy	Azienda ULSS 5 Polesana	Rovigo

Sponsors (2)

Lead Sponsor	Collaborator
Azienda ULSS 5 Polesana	University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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, Widimský P; ESC Scientific Document Gr — View 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 . 201 — View 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;(4):CD007768. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in health care costs over 12 months in the interventional and control arms	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	12 months
Other	Change from baseline in adherence scores on the Morisky medication adherence scale after 12 months in the interventional arm	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	baseline, 12 months
Other	Prescriptions of fixed dose drug combinations in the interventional and control arms	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	baseline, 12 months
Other	Description of pluri-pharmacological therapies in the interventional and control arms	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)	12 months
Primary	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	baseline, 6 months
Secondary	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	baseline, 12 months
Secondary	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	12 months