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CTRI Number  CTRI/2022/02/039877 [Registered on: 01/02/2022] Trial Registered Prospectively
Last Modified On: 28/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational]  
Study Design  Other 
Public Title of Study   Understanding the different methods of teaching methods through imaginary cases 
Scientific Title of Study   Evaluation of different modalities of case based learning- A qualitative approach 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaveri Narayanan 
Designation  PG Student 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9207152220  
Fax    
Email  kaverinarayanan1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Girish Thunga P 
Designation  Assistant Professor- Selection Grade 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Girish Thunga P 
Designation  Assistant Professor- Selection Grade 
Affiliation  Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Source of Monetary or Material Support  
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 
Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G Nagara, Nagamangala, Mandya, Karnataka , 571448 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Girish Thunga P  Manipal College of Pharmaceutical Sciences  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
9880151127

girish.thunga@manipal.edu 
Dr Rajesh Venkataraman  Sri Adichunchanagiri College of Pharmacy  Room no:5,Ground floor, Adichunchanagiri Hospital and Research Center, Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, B.G Nagara, Nagamangala, Mandya, Karnataka, 571148
Mandya
KARNATAKA 
9980038331

rajeshvenky_research@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PG Students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive virtual case-based learning  Comprehensive virtual case-based learning consisting of assessment of case through virtual simulation consisting of audio-visual conversation and obtaining the relevant information along with SOAP analysis, ADR assessment, drug information and patient counselling for specific case scenarios. The intervention group will be exposed for 4 weeks 
Comparator Agent  Traditional SOAP Analysis  Comparator group follows the traditional SOAP analysis by collecting cases during ward rounds.  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  PharmD students who completed their 3rd year and posted in wards/ward rounds and given their consent for study 
 
ExclusionCriteria 
Details  Students did not give consent and who are not interested in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Development of a new technique for students during pandemic and assessment of the quality of the tool. Students perspective will be through the qualitative
feedback 
End of the interview 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/02/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Title of the project: Evaluation of different modalities of case-based learning- A qualitative approach.

Justification for study: With the pandemic ongoing, students from all health fields have been facing difficulty for their clinical rotations, laboratory studies, clerkships and interactive learning. Use of technology has helped learners to continue their case-based learning amid the pandemic. Case Based Learning is a teaching mode used for effectively providing better understanding of practical aspects using live or simulated patient cases to solve, or examine a clinical problem, with the guidance of a teacher and stated learning objectives which helps in better patient care and knowledge building. Due to the absence of bed side learning amid the pandemic, virtual ward rounds are used as a new learning tool which simulates a ward round on a hospital ward. It engages the students in an active decision-making process on medical treatment using a standardized set of medical cases. When enhanced with the aid of audiovisual elements, e-learning can offer educational content and various tests supporting these contents, can facilitate access to necessary relevant information, and most importantly, provide an interactive environment for students and the faculty. Thus, through this study we aim to understand students’ perspective of importance of ward rounds in covid situation and evaluate different modalities of case-based learning. The findings will help identify the required changes in the current scenario and make it more practical and effective.

Aims & objectives: To understand students’ perspective on importance of ward rounds in COVID situation and to evaluate different modalities of case-based learning.

Methodology:
This is an interventional study in PharmD students comparing the standard and an interventional group.
ʉۢ Standard group: Follows the traditional SOAP analysis by collecting cases during ward rounds.
ʉۢ Interventional group: Follows comprehensive virtual case-based learning consisting of assessment of case through virtual simulation consisting of audio-visual conversation and obtaining the relevant information along with SOAP analysis, ADR assessment, drug information and patient counselling for specific case scenarios.
 
 Step 1- Need assessment for implementation of comprehensive virtual case-based learning: This will be assessed through a semi-structured in-depth interview for which an interview guide was developed. 
Development of interview guide- with the literature review and expert opinion a draft interview guide was developed which consists of different aspects like your concerns, needs, expectations, barriers and experiences faced in the current pandemic scenario. 

Step 2- Validation: Validation of interview guide will be done by interview protocol refinement methodology. There are four different phases in validation:
1. Confirming the alignment of interview questions and the research questions: This will be achieved by mapping the interview and research questions in the form of a matrix. 
2. Building an inquiry-based conversation: An inquiry-based conversation will be achieved by incorporating introductory questions, transition questions, key questions, closing questions.
3. Collecting feedback on interview guide: Feedback will be collected to obtain an expert opinion on the developed interview guide. 
4. Piloting the interview guide: To see whether there is proper feedback obtained from participants and ease of understanding of the participants. 

Step 3-In Depth interview: Interview process- Telephonic/ face to face interview will be conducted for approximately 30-45 minutes using a validated interview guide. Interview session will be recorded only with their consent and transferred into a password protected laptop. The audio recordings will be transcribed verbatim and validated and the transcripts will be analyzed using NVivo software for theme generation.

 Step 4- Development of comprehensive virtual case-based learning: Five diseases will be selected for development of a comprehensive virtual case-based learning tool. An audio conversation will be recorded as the case scenario where a physician will present the case along with patient and pharmacist conversation. Each case scenario will consist of complaints on admission, medical history, medication history, social history, family history, physical examination, general vital signs, provisional diagnosis, final diagnosis, drug treatment chart and discussions regarding any treatment modality overlapping with the pharmacist. Patient profile form will be prepared by students from the audio conversation based on which they will present SOAP analysis, ADR assessment, drug information and patient counselling for specific case scenarios. Each case will be about a 30-minute conversation recorded in English. The five diseases selected are Hypertension, Diabetes, Asthma, Iron deficiency anemia, Deep Vein Thrombosis. Validation of the tool: Once the tool is developed it will be validated by a physician and different experts in the area of pharmacy practice regarding its clarity, authenticity, by using feedback forms. 

Step 5- Implementation of the comprehensive virtual case-based learning Vs standard SOAP practice: Once the tool is developed, 30 students from 4th Year PharmD and 30 students from 5th Year PharmD will be divided into 2 groups. One group will be asked to collect the cases from the ward in 5 different topics. Case will be recorded from case sheets from ward and they will be presenting cases in normal SOAP format. Another group will be receiving a comprehensive virtual case-based learning tool where 15 members will be divided into equal groups and each group will perform the following task.  Developing PPF from audio visual conversation, SOAP analysis,  ADR assessment, patient counselling, drug information. This experiment will be conducted for 5 different cases as per the standard group. Each group will be exposed for a total time duration of 2 months and then cross-overed. Feedback is taken through a qualitative interview.
 
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