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

NCT03621111 | Unknown DMC

• 1 other identifier: 2017/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  baseline, 12 months

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

  12 months

Other Outcomes (4)

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

  12 months

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

  baseline, 12 months

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

  baseline, 12 months

Study Arms (2)

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.

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.

Interventions

Patient-counseling BEHAVIORAL

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

Adherence plan

Patient self-administered questionnaire BEHAVIORAL

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).

Adherence plan

Pills counts BEHAVIORAL

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.

Adherence plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda ULSS 5 Polesana: lead
• University of Padova: collaborator

Study Sites (1)

Azienda ULSS 5 Polesana

Rovigo, 45100, Italy

RECRUITING

Related 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.

  PMID: 25135805 BACKGROUND

• 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.

  PMID: 26320110 RESULT

• 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.

  PMID: 28886621 RESULT

• 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.

  PMID: 17000940 RESULT

• 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.

  PMID: 24777444 RESULT

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Medication Adherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Raffaella Ruzza, University

  Azienda ULSS 5 Polesana

  PRINCIPAL INVESTIGATOR

• Erika Vighesso, University

  University of Padova

  PRINCIPAL INVESTIGATOR

• Gianni Bregola, University

  Azienda ULSS 5 Polesana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Vighesso, University

CONTACT

+39 0425 394351; erika.vighesso@aulss5.veneto.it

Nucleo Ricerca Clinica - AULSS5

CONTACT

nucleo.ricercaclinica@aulss5.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Pharmacist

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 8, 2018
• Study Start: February 19, 2018
• Primary Completion: February 19, 2019
• Study Completion: August 19, 2019
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

IT (1)