Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153707
• Other study ID #: MARCPD-0001
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: March 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 days hospital re-admission for cardiac reasons	Proportion of patients readmitted to hospital for cardiac cause at 1 month	30 days
Secondary	Hospital re-admission for cardiac reasons	Proportion of patients readmitted to hospital for cardiac cause through 1 year.	3 months, 6 months, and 12 months
Secondary	Hospital re-admission for any reasons	Proportion of patients readmitted to hospital for any cause through 1 year.	1 month, 3 months, 6 months, and 12 months
Secondary	Emergency service visits	Proportion of patients visited to emergency service through 1 year.	1 month, 3 months, 6 months, and 12 months
Secondary	Major Adverse Cardiovascular Event	Proportion of patients had major adverse cardiovascular event through 1 year.	1 month, 3 months, 6 months, and 12 months
Secondary	Death for cardiac reason	Proportion of patients died for cardiac cause through 1 year.	1 month, 3 months, 6 months, and 12 months
Secondary	Death for any reason	Proportion of patients dying for any cause through 1 year.	1 month, 3 months, 6 months, and 12 months
Secondary	Medication Adherence	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
Secondary	Quality of Life Measurement	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
Secondary	Achieved Target Low-density Lipoprotein Value	Rate of patients achieved target low-density lipoprotein value	6 months, 12 months