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CTRI Number  CTRI/2024/12/078370 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   An observational study to determine the nature of medication errors occuring in a Tertiary care hospital and to plan strategies to reduce the errors. 
Scientific Title of Study   An observational analysis of medication errors in tertiary care hospital 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dikshit 
Designation  PharmD student 
Affiliation  Indus International Hospital 
Address  Department of Clinical Trials Chandigarh Ambala Highway Derabassi
Chandigarh Ambala Highway
Rupnagar
PUNJAB
140507
India 
Phone  6239261922  
Fax    
Email  dikshit2404@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parminder Kaur 
Designation  Medical Superintendent 
Affiliation  Indus International Hospital 
Address  Admin Department Chandigarh Ambala Highway Derabassi
Department of General Medicine Chandigarh Ambala Highway Derabassi
Rupnagar
PUNJAB
140507
India 
Phone  8872735888  
Fax    
Email  msiih@indushospitals.com  
 
Details of Contact Person
Public Query
 
Name  Dharmender Singh Lather 
Designation  Senior manager clinical trials department 
Affiliation  Indus International Hospital 
Address  Admin Department Chandigarh Ambala Highway Derabassi

Rupnagar
PUNJAB
140507
India 
Phone  9215810327  
Fax    
Email  clinicalmanager@indushospitals.com  
 
Source of Monetary or Material Support  
Indus International Hospital, Derabassi, Punjab 140507 
 
Primary Sponsor  
Name  Indus International Hospital 
Address  Clinical Trial Department Chandigarh Ambala Highway Derabassi SAS Nagar Punjab India 140507 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dikshit  Indus International Hospital  Department of clinical trails Lower Ground floor Chandigarh Ambala Highway Derabassi SAS Nagar Punjab India 140507
Rupnagar
PUNJAB 
6239261922

dikshit2404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indus International Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z48||Encounter for other postproceduralaftercare,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Review medication charts  Standard operating procedures to be followed in each medication phase and department. 
Intervention  Review medication charts  To create awareness regarding the medication error to the health care professionals. the duration for intervention will be a period of 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient hospitalized at IIH for treatment under :-
Surgical ward
Onco ward
Executive ward
FICU
Private room ward
Medical ward 
 
ExclusionCriteria 
Details  Pateint below 18
HIV Patient & Leprosy patients
Medico legal cases
Death cases
LAMA patient.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will be helpful to identify the occurrence of Medication Errors at each phase of medication use cycle.
Along with the drug drug interaction.
Also to plan a suitable strategy which can be implemented throughout the hospital effectively to reduce all the medication errors including administration errors, transcription errors and prescription errors. The outcomes measured in terms of percentage of types of medication errors, adverse events, length of hospital stay. 
Data will be collected at baseline during hospital stay of the patient.
Daily data will be reviewed and analyzed within 3 hours.
Alert to be raised immediately for major errors.
All data with strategies to be completed in 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) 20/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) has defined medication errors (ME) as, “Any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health care professional, patient, or consumer.” American Society of Hospital Pharmacists guidelines for ME stated that incidence of ME is not exactly known because of variations in different definitions of ME, different methods, or subject populations. In India, studies done in Uttarakhand and Karnataka have documented ME rate to be as high as 25.7% and 15.34%, respectively, in hospitalized patients. Unfortunately, most of the ME remain undetected, if clinical significance or outcome does not adversely affect the patient. While some of the ME also result into serious morbidity or mortality and have a significant economic impact on the patient and health care system. 

OBJECTIVES:

 1) To study the incidence, severity, outcomes, and various factors influencing the medication errors in ICU settings.

 2)Development of strategies to overcome the medication errors through qualitative interview of various stake holders.

3)Implementation and evaluation of strategies in ICU settings through pre and post interventional assessment.

 
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