Effect of proactive and retroactive medication reconciliation in the admission time on the reduction of medication error in patients with acute coronary syndrome: a randomized clinical trial study
To assess the effect of proactive and retroactive medication reconciliation in the admission time on the reduction of medication error in patients with acute coronary syndrome
Design
This is a Phase III randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Farshchian Heart Hospital in Hamadan city, involving 162 eligible patients with acute coronary syndrome. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Taking at least 5 medications per day, including medications with high interactions or with a narrow therapeutic window
Exclusion criteria:
Discharge in less than 24 hours
Hospitalization in the evening or night shift or on holidays
Intervention groups
Intervention group:
In the proactive group, after the patient is hospitalized and before the physician prescribes medication, the researcher prepares a complete history of the patient's medications by referring to the patient's bedside and provides them to the physician in order to prescribe medication according to the obtained medication history.
Control group:
In the retroactive group, after the patient is hospitalized and the physician prescribes medication, the researcher prepares a complete history of the patient's medications by referring to the patient's bedside, and then the perform medication integration (including the medications prescribed by the physician and previous medications of the disease).
Main outcome variables
Inconsistencies and medication errors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N494
Registration date:2024-01-02, 1402/10/12
Registration timing:prospective
Last update:2024-01-02, 1402/10/12
Update count:0
Registration date
2024-01-02, 1402/10/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of proactive and retroactive medication reconciliation in the admission time on the reduction of medication error in patients with acute coronary syndrome: a randomized clinical trial study
Public title
Effect of proactive and retroactive medication reconciliation in the admission time on the reduction of medication error in patients with acute coronary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years
Taking at least 5 medications per day, including medications with high interactions or with a narrow therapeutic window
Exclusion criteria:
Discharge in less than 24 hours
Hospitalization in the evening or night shift or on holidays
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
162
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-12-30, 1402/10/09
Ethics committee reference number
IR.UMSHA.REC.1402.624
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.0
ICD-10 code description
Acute coronary thrombosis not resulting in myocardial infarction
Primary outcomes
1
Description
Inconsistencies and medication errors
Timepoint
In the first 24 hours of hospitalization
Method of measurement
By taking history and reviewing the medical record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the proactive group, after the patient is hospitalized and before the physician prescribes medication, the researcher prepares a complete history of the patient's medications by referring to the patient's bedside and provides them to the physician in order to prescribe medication according to the obtained medication history.
Category
Other
2
Description
Control group: In the retroactive group, after the patient is hospitalized and the physician prescribes medication, the researcher prepares a complete history of the patient's medications by referring to the patient's bedside, and then the perform medication integration (including the medications prescribed by the physician and previous medications of the disease).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Mahdiyeh Fateminejad
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
mahdiyehfateminjd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahdiyeh Fateminejad
Position
Student of Pharmacology
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahdiyehfateminjd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Mehrpooya
Position
Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available