| 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
|
|
|
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
|
|
|
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. |