Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Discharge Education Program
Sponsored by
About this trial
This is an interventional health services research trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
- Marmara University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Clinical Pharmacist-led discharge education program
Control group
Arm Description
Clinical pharmacist-led services
Usual care
Outcomes
Primary Outcome Measures
30 days hospital re-admission for cardiac reasons
Proportion of patients readmitted to hospital for cardiac cause at 1 month
Secondary Outcome Measures
Hospital re-admission for cardiac reasons
Proportion of patients readmitted to hospital for cardiac cause through 1 year.
Hospital re-admission for any reasons
Proportion of patients readmitted to hospital for any cause through 1 year.
Emergency service visits
Proportion of patients visited to emergency service through 1 year.
Major Adverse Cardiovascular Event
Proportion of patients had major adverse cardiovascular event through 1 year.
Death for cardiac reason
Proportion of patients died for cardiac cause through 1 year.
Death for any reason
Proportion of patients dying for any cause through 1 year.
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.
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.
Achieved Target Low-density Lipoprotein Value
Rate of patients achieved target low-density lipoprotein value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05153707
Brief Title
Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome
Official Title
Evaluation of a Clinical Pharmacist-led Discharge Education Service in Patients With Acute Coronary Syndrome: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the impact of clinical pharmacist-led discharge education service in patients with acute coronary syndrome.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinical Pharmacist-led discharge education program
Arm Type
Experimental
Arm Description
Clinical pharmacist-led services
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Discharge Education Program
Intervention Description
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 Outcome Measure Information:
Title
30 days hospital re-admission for cardiac reasons
Description
Proportion of patients readmitted to hospital for cardiac cause at 1 month
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital re-admission for cardiac reasons
Description
Proportion of patients readmitted to hospital for cardiac cause through 1 year.
Time Frame
3 months, 6 months, and 12 months
Title
Hospital re-admission for any reasons
Description
Proportion of patients readmitted to hospital for any cause through 1 year.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Emergency service visits
Description
Proportion of patients visited to emergency service through 1 year.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Major Adverse Cardiovascular Event
Description
Proportion of patients had major adverse cardiovascular event through 1 year.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Death for cardiac reason
Description
Proportion of patients died for cardiac cause through 1 year.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Death for any reason
Description
Proportion of patients dying for any cause through 1 year.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Medication Adherence
Description
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.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Quality of Life Measurement
Description
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.
Time Frame
1 month, 3 months, 6 months, and 12 months
Title
Achieved Target Low-density Lipoprotein Value
Description
Rate of patients achieved target low-density lipoprotein value
Time Frame
6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betul Okuyan
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Pharmacist-led Discharge Education Service in Acute Coronary Syndrome
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