| 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
|
|
|
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
|
|
|
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.
|