Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome

March 14, 2023 updated by: Betul Okuyan, Marmara University

Evaluation of a Clinical Pharmacist-led Discharge Education Service in Patients With Acute Coronary Syndrome: A Randomized Controlled Study

To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized controlled study was conducted in patients with acute coronary syndrome in an cardiology service of tertiary training and research hospital. The clinical pharmacist, within the scope of the discharge education services, provided medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model). The control group received standard care.

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to the cardiology department due to acute coronary syndrome
  • Older than 18 years old

Exclusion Criteria:

  • Patients who transferred to another ward
  • Patients with active malignancy
  • Patients with alzheimer and/or dementia diagnosis
  • Patient with >%80 visual loss or deaf muteness reported at medical record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Usual care
Experimental: Clinical Pharmacist-led discharge education program
Clinical pharmacist-led services
Behavioral: Discharge Education Program
medication reconciliation, medication review, individually prepared patient medicine (pill) card, patient education (based on Health Belief Model by using written material and video, and verbally [by using Teach back method especially for patients with low health literacy]) and counseling (using behavior change techniques based on The Capability, Opportunity, and Motivation Behavior model).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 days hospital re-admission for cardiac reasons
Time Frame: 30 days
Proportion of patients readmitted to hospital for cardiac cause at 1 month
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital re-admission for cardiac reasons
Time Frame: 3 months, 6 months, and 12 months
Proportion of patients readmitted to hospital for cardiac cause through 1 year.
3 months, 6 months, and 12 months
Hospital re-admission for any reasons
Time Frame: 1 month, 3 months, 6 months, and 12 months
Proportion of patients readmitted to hospital for any cause through 1 year.
1 month, 3 months, 6 months, and 12 months
Emergency service visits
Time Frame: 1 month, 3 months, 6 months, and 12 months
Proportion of patients visited to emergency service through 1 year.
1 month, 3 months, 6 months, and 12 months
Major Adverse Cardiovascular Event
Time Frame: 1 month, 3 months, 6 months, and 12 months
Proportion of patients had major adverse cardiovascular event through 1 year.
1 month, 3 months, 6 months, and 12 months
Death for cardiac reason
Time Frame: 1 month, 3 months, 6 months, and 12 months
Proportion of patients died for cardiac cause through 1 year.
1 month, 3 months, 6 months, and 12 months
Death for any reason
Time Frame: 1 month, 3 months, 6 months, and 12 months
Proportion of patients dying for any cause through 1 year.
1 month, 3 months, 6 months, and 12 months
Medication Adherence
Time Frame: 1 month, 3 months, 6 months, and 12 months
Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta-blockers, Angiotensin-converting enzyme (ACE) inhibitors/ Angiotensin receptor blocker (ARB) through 1 year assessed by Medication Adherence Report Scale (MARS). MARS assesses adherence through 5-item, summed to give a scale score ranging from 5 to 25, where higher scores indicate higher levels of reported adherence.
1 month, 3 months, 6 months, and 12 months
Quality of Life Measurement
Time Frame: 1 month, 3 months, 6 months, and 12 months

Change in quality of life from baseline assessed with EuroQol questionnaire EQ-5D-3L through 1 year. (EQ-5D-3L) is a standardized scale for use as a measure of the quality of life. The EQ-5D-3L descriptive system comprises the following 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels (3L): no problems (1 point), some problems (2 points), extreme problems (3 points).

This gives a total of 245 different health states, adding unconscious and dead.
1 month, 3 months, 6 months, and 12 months
Achieved Target Low-density Lipoprotein Value
Time Frame: 6 months, 12 months
Rate of patients achieved target low-density lipoprotein value
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Betul Okuyan, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARCPD-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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