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Completed

NCT Number: NCT05153707

Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome

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

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discharge Education Program

Behavioral

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).

Primary outcomes

  1. 30 days hospital re-admission for cardiac reasons

    Time frame: 30 days

    Proportion of patients readmitted to hospital for cardiac cause at 1 month

Secondary outcomes

  1. 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.

  2. 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.

  3. Emergency service visits

    Time frame: 1 month, 3 months, 6 months, and 12 months

    Proportion of patients visited to emergency service through 1 year.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Achieved Target Low-density Lipoprotein Value

    Time frame: 6 months, 12 months

    Rate of patients achieved target low-density lipoprotein value

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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