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CTRI Number  CTRI/2024/04/065750 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [educational teaching learning method]  
Study Design  Other 
Public Title of Study   Teaching learning method on prescription writing by the nursing undergraduates under the supervision of doctors using Simulation method 
Scientific Title of Study   Supplementary prescription writing for the nursing undergraduate students- Simulation- based Interprofessional Education 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandralekha N 
Designation  Associate Professor 
Affiliation  Father Muller Medical College, Mangalore 
Address  Department of Pharmacology Father Muller Medical College, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9743701662  
Fax    
Email  smilekha25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandralekha N 
Designation  Associate Professor 
Affiliation  Father Muller Medical College, Mangalore 
Address  Department of Pharmacology Father Muller Medical College, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9743701662  
Fax    
Email  smilekha25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandralekha N 
Designation  Associate Professor 
Affiliation  Father Muller Medical College, Mangalore 
Address  Department of Pharmacology Father Muller Medical College, Mangalore

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9743701662  
Fax    
Email  smilekha25@gmail.com  
 
Source of Monetary or Material Support  
Father Muller Medical College, Kankanady, Mangalore, Dakshina Kannada, Karnataka State, India, 575002 
 
Primary Sponsor  
Name  Father Muller Medical College Mangalore 
Address  Father Muller Medical College, Kankanady, Mangalore, Dakshina Kannada, Karnataka State, India, 575002 
Type of Sponsor  Private medical college 
 
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 Chandralekha N  Father Muller Medical College, Mangalore  Department of Pharmacology, Medical College A block, Kankanady, Mangalore DK, Karnataka, India, 575002
Dakshina Kannada
KARNATAKA 
9743701662

smilekha25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  participants are medical and nursing undergraduates who consent for the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Quasi Experimental prospective study   Methodology a) Readiness for prescription writing by the nursing students will be checked using a pre-validated closed-ended questionnaire . Readiness for interprofessional education will be checked among medical and nursing undergraduates using Readiness for Interprofessional Learning Scale Questionnaire (RIPLS) b) A supplementary prescription writing training module will be developed as per the requirement of the nursing curriculum inclusive of topics- introduction, Prescriptive role of Nurse Practitioners; Professional, legal, and ethical issues relevant to prescribing practice; Principles of prescribing and factors influencing it; process and steps of prescribing; prescribing competencies, prescription writing template with the help of an interprofessional team. Interprofessional team is inclusive of PI, Co-PIs, Mentors, Pharmacology department HOD & faculty, Simulation- head, technician and adjunct faculty, Physician, Cardiologist, MEU faculty, Medicolegal expert and nursing staff. This module will be validated by using the Delphi method Evaluation of the effectiveness of the supplementary prescription writing training module by the nursing students will be done using simulation-based interprofessional education   The following sessions will be conducted i) A workshop session Participants will be trained in prescription writing inclusive of topics- Prescriptive role of Nurse Practitioners, Professional, legal, and ethical issues relevant to prescribing practice, Principles of prescribing and factors influencing it, process and steps of prescribing, and prescribing competencies. Prescription writing for suspected STEMI in an interprofessional setup will be taught to the nursing students Assessment • Their level of understanding will be assessed using pre-test and post-test • Case scenarios will be given to the participants for prescription writing and will be assessed using the validated checklist ii) Simulation-based suspected STEMI case scenario run in the simulation center with the nursing and medical undergraduate participants. Interprofessional collaboration, clinical reasoning, decision-making and critical thinking will be assessed using the validated checklist. There will be a pre-brief and debrief sessions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Medical undergraduate students- medical interns, Medical postgraduates who are willing to participate in the study and who give consent will be included- permission will be taken from the Medical College Dean
Third year BSc nursing undergraduate students- who are willing to participate in the study and who give consent will be included- permission will be taken from the Nursing College Principal
 
 
ExclusionCriteria 
Details  medical students and nursing students who are not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Nursing students able to write prescription for the given case scenario   Nursing students able to write prescription for the given case scenario at the end of the workshop
Immediate Outcome after the workshop based on the checklist and also with comparison of pretest and post test scores 
 
Secondary Outcome  
Outcome  TimePoints 
Nursing students able to do critical thinking, clinical reasoning, decision making   At the end of workshop and simulation case scenario run 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   24/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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
Modification(s)  

Supplementary prescription writing for the nursing undergraduate students- Simulation- based Interprofessional Education

The nursing curriculum is revised into competency-based and gazetted notification is released in 2021 in which ‘fundamentals of prescribing’ is a mandatory module for IV semester for BSc Nursing undergraduate students (9). Under this, the nursing undergraduate students must be taught prescription writing.  With this study, a training module for supplementary prescription writing by nursing undergraduate students will be developed.

The aim of this study is

 To develop a training module for supplementary prescription writing by the nursing undergraduate students using simulation-based interprofessional education

 The objectives of this study are

 

·       To check for the readiness of

 Nursing students to write the prescription

 Medical and nursing students for interprofessional education

·       To develop a supplementary prescription writing training module on suspected ST elevated myocardial infarction for nursing undergraduates with an interprofessional team

·       To evaluate the effectiveness of the supplementary prescription writing training module using simulation-based Interprofessional education as a pilot study


Methodology

a)  Readiness for prescription writing by the nursing students will be checked using a pre-validated closed-ended questionnaire. Readiness for interprofessional education will be checked among medical and nursing undergraduates using Readiness for Interprofessional Learning Scale Questionnaire (RIPLS) 

b) A supplementary prescription writing training module will be developed as per the requirement of the nursing curriculum inclusive of topics- introduction, Prescriptive role of Nurse Practitioners; Professional, legal, and ethical issues relevant to prescribing practice; Principles of prescribing and factors influencing it; process and steps of prescribing; prescribing competencies, prescription writing template with the help of an interprofessional team.

Interprofessional team is inclusive of

PI, Co-PIs, Mentors, Pharmacology department HOD & faculty, Simulation- head, technician and adjunct faculty, Physician, Cardiologist, MEU faculty, Medicolegal expert and nursing staff.

This module will be validated by using the Delphi method 

c)  Evaluation of the effectiveness of the supplementary prescription writing training module by the nursing students will be done using simulation-based interprofessional education

The following sessions will be conducted

i)               A workshop session

Participants will be trained in prescription writing inclusive of topics- Prescriptive role of Nurse Practitioners, Professional, legal, and ethical issues relevant to prescribing practice, Principles of prescribing and factors influencing it, process and steps of prescribing, and prescribing competencies

Prescription writing for suspected STEMI in an interprofessional setup will be taught to the nursing students

Assessment

Their level of understanding will be assessed using pre-test and post-test

Case scenarios will be given to the participants for prescription writing and will be assessed using the validated checklist

ii)        Simulation-based suspected STEMI case scenario run in the simulation center with the nursing and medical undergraduate participants.  Interprofessional collaboration, clinical reasoning, decision-making and critical thinking will be assessed using the validated checklist. There will be a pre-brief and debrief sessions.




 
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