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CTRI Number  CTRI/2024/02/062303 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Empirical discourse analysis 
Study Design  Other 
Public Title of Study   Understanding the Conversations on Future Care preferences during Family meetings in a Critical Illness Setting 
Scientific Title of Study   Conversations on Future Care preferences during Family meetings in a Critical Illness Setting: An Empirical Discourse Analysis 
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 Arnavi Udapure 
Designation  JUNIOR RESIDENT 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Palliative Medicine and Supportive Care, Room no. 4, Ground Floor, Shirdi Sai Baba Cancer Hospital and Research Centre, KMC Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8237780830  
Fax    
Email  arnavi.udapure@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen Salins 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Palliative Medicine and Supportive Care, Room no. 4, Ground Floor, Shirdi Sai Baba Cancer Hospital and Research Centre, KMC Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9969683669  
Fax    
Email  naveen.salins@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Naveen Salins 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Palliative Medicine and Supportive Care, Room no. 4, Ground Floor, Shirdi Sai Baba Cancer Hospital and Research Centre, KMC Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9969683669  
Fax    
Email  naveen.salins@manipal.edu  
 
Source of Monetary or Material Support  
KASTURBA MEDICAL COLLEGE MANIPAL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [self] 
 
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 ARNAVI UDAPURE  KASTURBA MEDICAL COLLEGE  DEPARTMENT OF PALLIATIVE MEDICINE AND SUPPORTIVE CARE, ROOM NUMBER 4, GROUND FLOOR, SHIRDI SAIBABA CANCER HOSPITAL AND RESEARCH CENTRE, KMC MANIPAL, ESHWAR NAGAR, MANIPAL- 576104.
Udupi
KARNATAKA 		 8237780830

arnavi.udapure@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE- 2 (STUDENT RESEARCH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary caregivers and healthcare workers of patients with critical illnesses  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Setting- Data will be collected from family meetings in an ICU counselling room setting.
Meetings conducted during first point of contact.

Participants (Health Care Providers)- Faculty-Level Doctors primarily responsible for the care of the patient
Faculty-Level ICU doctors primarily responsible for care of the patient or directly involved in patient management.
Faculty-Level Palliative Care doctors primarily responsible for care of the patient or consulted to be involved in patient management.
Consenting to participate in the study and recording the meeting.

Participants (Family Members)- Next of Kin (Spouse, Adult Children, Parents, Adult Siblings).
Patient nominated medical decision maker if any (supported by a written document).
Consenting to participate in the study and recording the meeting.

 
 
ExclusionCriteria 
Details  Setting- Family meetings conducted for patients with critical or terminal illness in a non-ICU setting.
Repeat or follow up meetings.

Participants (Health Care Providers)- Doctors in training
Junior doctors appointed for service provision

Participants (Family Members)- Blood relatives other than next of kin in the inclusion
Friends of the patient.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The purpose of the study is to explore the language and meaning making of the conversations while discussing future care preferences during family meetings in the setting of a critical illness settings. We believe that these conversations are unique in a given socio-cultural context and the findings of this study might inform health communication during family meetings.

 		 One year 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   20/02/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Conversations on Future Care Preferences during Family Meetings in a Critical Illness Setting: An Empirical Discourse Analysis

 Study Aim: To analyse conversations on future care preferences during family meetings in a critical illness setting.

 Study Objectives:

 To analyse the use of language by the doctors and the families during meetings on future care preferences for their patients in a critical illness setting.

 To identify themes and patterns generated that share similar structure, meaning and context during these conversations.

Justification: 

A very small number of studies currently available look at analysing the conversations surrounding future care preferences during family meeting in a critical illness. Furthermore, discourse analysis was not conducted in any of these studies making it a novel area of research.

Discourse analysis research involves the audio or video recording of social interaction (e.g. telephone conversations or family mealtimes), or the collecting together of textual documents (e.g. personal diaries or health promotion literature) and Discourse analysis is a useful methodological approach for researching medical education, which affords several viewpoints, including the relationship between language and power in society (macro), discursive practice in a social context (meso), and discourse structure and function (micro) and is a useful methodological approach for researching medical education, which affords several viewpoints, including the relationship between language and power in society (macro), discursive practice in a social context (meso), and discourse structure and function (micro).

It can help to identify communication barriers, cultural differences, and other factors that may impact the quality of healthcare. allowing researchers to explore complex social phenomena in depth. 

 
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