| CTRI Number |
CTRI/2025/01/079494 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PRAGMATIC RANDOMIZED CONTROLLED TRIAL] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of electronic prescribing compared to traditional hand-written prescribing on medication errors among patients attending outpatient setting |
|
Scientific Title of Study
|
Effect of electronic prescribing compared to traditional hand-written prescribing on medication errors among patients attending outpatient setting in a tertiary care institute of western Rajasthan: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room No. 230, Department of Pharmacology, Medical College Building, AIIMS JODHPUR
Room No. 230, Department of Pharmacology, Medical College Building, AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9599634860 |
| Fax |
|
| Email |
kumart@aiimsjodhpur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaykaran Charan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room No. 233, Department of Pharmacology, Medical College Building, AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9825219196 |
| Fax |
|
| Email |
charanj@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jaykaran Charan |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room No. 233, Department of Pharmacology, Medical College Building, AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9825219196 |
| Fax |
|
| Email |
charanj@aiimsjodhpur.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India. Pincode: 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Jodhpur, Basni, Jodhpur, Rajasthan, India. PIN: 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS JODHPUR |
BASNI, JODHPUR, RAJASTHAN, INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tarun Kumar |
AIIMS Jodhpur Hospital |
Department of General Medicine,
First Floor, OPD block,
AIIMS,
Basni, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN |
9599634860
kumart@aiimsjodhpur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (CLINICAL TRIAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electronic prescribing |
Intervention group will be provided a prescription computer typed by a trained para-medical or medical staff.
The participants will be asked to return to the OPD after purchasing the prescribed medications and thereby any deviations in dispensing will be noted by the research assistants. Later on, the prescriptions will be reviewed by an expert committee (Committee on Medication Error, Drug Information and Prescription Audit) consisting of four members regarding any medication errors like prescribing errors, illegible handwriting, omission errors, improper dosing, etc. by using the NCC MERP Index for Categorizing Medication Errors.
Electronic prescribing will continue for a period of four months. |
| Comparator Agent |
Traditional hand-written prescribing |
The control group will be provided the traditional hand-written prescription by the treating doctor.
The participants will be asked to return to the OPD after purchasing the prescribed medications and thereby any deviations in dispensing will be noted by the research assistants. Later on, the prescriptions will be reviewed by an expert committee (Committee on Medication Error, Drug Information and Prescription Audit) consisting of four members regarding any medication errors like prescribing errors, illegible handwriting, omission errors, improper dosing, etc. by using the NCC MERP Index for Categorizing Medication Errors.
Traditional hand-written prescribing will continue for a period of four months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who are willing to return to the OPD to show the medicines bought from any pharmacy of their choice. |
|
| ExclusionCriteria |
| Details |
All those patients who refuse to give consent for the study and severely ill patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find an association between the medication errors in electronic and traditional handwritten prescribing. |
Not applicable as there is no follow-up required. Medication errors will be checked and the patient will be guided. Thus, all the data will be collected at the first visit / baseline visit itself from February to May. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the frequency of medication errors in electronic & traditional handwritten prescribing. |
Not applicable as there is no follow-up required. Medication errors will be checked & the patient will be guided. Thus, all the data will be collected at the first visit / baseline visit itself from February to May. |
| To compare the types of medication errors in electronic & traditional handwritten prescribing. |
Not applicable as there is no follow-up required. Medication errors will be checked & the patient will be guided. Thus, all the data will be collected at the first visit / baseline visit itself from February to May. |
| Challenges and barriers faced by the clinician in electronic and traditional handwritten prescribing. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1280"
Sample Size from India="1280"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Effect
of electronic prescribing compared to traditional hand-written prescribing on
medication errors among patients attending outpatient setting in a tertiary
care institute of western Rajasthan: A Randomized Controlled Trial
Research question: Does electronic prescribing have any
effect on the medication errors?
Aims and Objectives:
AIM: To find an association between the
medication errors in electronic and traditional
handwritten prescribing.
Objectives:
1.
To find out the frequency of medication
errors in electronic and traditional handwritten prescribing.
2.
To compare the types of medication errors in electronic and traditional handwritten prescribing.
3.
Challenges and barriers faced by the
clinician in electronic and traditional handwritten prescribing.
Inclusion
criteria: All the patients who are
willing to return to the OPD to show the medicines bought from any pharmacy of
their choice.
Exclusion
criteria: All those patients who
refuse to give consent for the study and severely ill patients.
Expected outcome of the proposed
study: Electronic
administration of Prescription can reduce Medication Error in clinical setup. |