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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Patient-counseling

Patient self-administered questionnaire

Pills counts

About this trial

This is an interventional prevention trial for Myocardial Infarction, Acute focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Azienda ULSS 5 PolesanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adherence plan

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03621111

First Posted

July 18, 2018

Last Updated

August 3, 2018

Sponsor

Azienda ULSS 5 Polesana

Collaborators

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT03621111

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 19, 2018 (Actual)

Primary Completion Date

February 19, 2019 (Anticipated)

Study Completion Date

August 19, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda ULSS 5 Polesana

Collaborators

University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adherence plan

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Patient-counseling

Intervention Description

After one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs.

Intervention Type

Behavioral

Intervention Name(s)

Patient self-administered questionnaire

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Pills counts

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change from baseline in medication adherence after 6 months in the interventional and control arms

Description

Time Frame

baseline, 6 months

Secondary Outcome Measure Information:

Title

Change from baseline in medication adherence after 12 months in the interventional and control arms

Description

Change in medication adherence as measured by the calculation of Proportion of Days Covered (PDC) in the two arms

Time Frame

baseline, 12 months

Title

Change in re-admission rates due to cardiovascular events after 12 months between the interventional arm and the control arm

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Change in health care costs over 12 months in the interventional and control arms

Description

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

Time Frame

12 months

Title

Change from baseline in adherence scores on the Morisky medication adherence scale after 12 months in the interventional arm

Description

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

Time Frame

baseline, 12 months

Title

Prescriptions of fixed dose drug combinations in the interventional and control arms

Description

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

Time Frame

baseline, 12 months

Title

Description of pluri-pharmacological therapies in the interventional and control arms

Description

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)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erika Vighesso, University

Phone

+39 0425 394351

erika.vighesso@aulss5.veneto.it

First Name & Middle Initial & Last Name or Official Title & Degree

Nucleo Ricerca Clinica - AULSS5

nucleo.ricercaclinica@aulss5.veneto.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raffaella Ruzza, University

Organizational Affiliation

Azienda ULSS 5 Polesana

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Erika Vighesso, University

Organizational Affiliation

University of Padova

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gianni Bregola, University

Organizational Affiliation

Azienda ULSS 5 Polesana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Azienda ULSS 5 Polesana

City

Rovigo

ZIP/Postal Code

45100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erika Vighesso, University

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Citations:

PubMed Identifier

25135805

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.

Results Reference

background

PubMed Identifier

26320110

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.

Results Reference

result

PubMed Identifier

28886621

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.

Results Reference

result

PubMed Identifier

17000940

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.

Results Reference

result

PubMed Identifier

24777444

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.

Results Reference

result

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

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