| CTRI Number |
CTRI/2025/11/096953 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Making Better Decisions in Intensive Care Units in India: Creating and Trying Out a New Way to Manage Care Delivery using the Critical Care Review Board |
|
Scientific Title of Study
|
Developing Context-Sensitive Guidelines for Intensive Care Unit Governance Through Critical Care Review Boards in India: A Mixed-Methods Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECI - 447 - 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Ghoshal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Palliative Medicine and Supportive Care, Room #4, Ground floor, Manipal Comprehensive Cancer Care Centre, Kasturba Medical College Manipal, 576104, India
Udupi
KARNATAKA
576104
India |
| Phone |
9434890160 |
| Fax |
|
| Email |
arun.ghoshal@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Ghoshal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Palliative Medicine and Supportive Care, Room #4, Ground floor, Manipal Comprehensive Cancer Care Centre, Kasturba Medical College Manipal, 576104, India
KARNATAKA
576104
India |
| Phone |
9434890160 |
| Fax |
|
| Email |
arun.ghoshal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Arun Ghoshal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Palliative Medicine and Supportive Care, Room #4, Ground floor, Manipal Comprehensive Cancer Care Centre, Kasturba Medical College Manipal, 576104, India
KARNATAKA
576104
India |
| Phone |
9434890160 |
| Fax |
|
| Email |
arun.ghoshal@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Health Research, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Arun Ghoshal |
Kasturba Medical College Manipal |
Department of Palliative Medicine and Supportive Care, Room #4, Ground floor
Udupi
KARNATAKA |
9434890160
arun.ghoshal@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital lnstitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Critical Care Review Board (CCRB) framework |
A structured governance framework implemented in Intensive Care Units (ICUs) to guide ethical and clinical decision-making for critically ill patients.
The CCRB consists of multidisciplinary members (ICU physicians, palliative care specialists, nurses, administrators, and ethicists).
It functions through standardized referral triggers, case deliberations, and transparent documentation to improve ICU governance.
It aims to reduce non-beneficial ICU days, promote early palliative care referrals, and improve clinician and family satisfaction.
Evaluated through a mixed-methods, 60-month interventional study with retrospective analysis, qualitative inquiry, national Delphi consensus, and pilot implementation at Kasturba Medical College (KMC), Manipal.
During the pilot phase, all ICU cases referred to CCRB (150–200 patients) will be reviewed prospectively, and outcomes such as ICU utilization, satisfaction (Clinician Satisfaction Questionnaire, FS-ICU, QODD short form), and cost reduction will be measured. |
| Comparator Agent |
Standard ICU decision-making practices (without CCRB involvement) |
Refers to routine ICU governance prior to or without CCRB implementation.
Decisions about continuation or withdrawal of life-sustaining treatment are made through ad hoc discussions between attending physicians and families, without structured governance or ethical oversight.
Lacks systematic documentation, standardized referral triggers, or multidisciplinary review.
Associated challenges include non-beneficial ICU stays, delayed palliative care, clinician moral distress, and inefficient resource use.
This comparator will be evaluated using retrospective ICU data (about 1000 records from the previous 4 years at KMC) to establish a baseline for comparison with post-CCRB implementation outcomes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1 Retrospective Quantitative Analysis of ICU Records
Inclusion Criteria
Adult patients aged 18 years and older.
Admitted to ICU at Kasturba Medical College Manipal for 7 days or more.
Phase 2 Qualitative Inquiry Stakeholder Perspectives
Inclusion Criteria
ICU clinicians, CCRB members, nurses, palliative care providers, and hospital administrators directly involved in ICU care or CCRB deliberations.
Family caregivers of patients who had CCRB discussions or extended ICU stays.
Phase 3 Delphi Consensus National Experts
Inclusion Criteria
Experts with more than or equal to 5 years of experience in ICU care, palliative medicine, clinical ethics, or healthcare governance.
Affiliated with recognized institutions, professional societies, or policy bodies.
Phase 4 Pilot Implementation KMC CCRB Evaluation
Inclusion Criteria
Adult patients aged 18 years and older.
All ICU cases referred to the CCRB during the 6-month pilot period. |
|
| ExclusionCriteria |
| Details |
Phase 1 Retrospective Quantitative Analysis ICU Records
Exclusion Criteria
Patients with incomplete or missing medical records.
Patients discharged against medical advice.
Phase 2 Qualitative Inquiry Stakeholder Perspectives
Exclusion Criteria
Professionals with less than 6 months of tenure in their current role.
Family caregivers unable to provide informed consent due to language barriers, acute distress, or cognitive limitations.
Phase 3 Delphi Consensus National Experts
Exclusion Criteria
Experts without direct experience in ICU, palliative care, or governance.
Experts who fail to respond across two Delphi rounds.
Phase 4 Pilot Implementation KMC CCRB Evaluation
Exclusion Criteria
Patients with an ICU stay of less than 7 days.
Cases with missing or incomplete CCRB documentation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in non-beneficial ICU days, about 15% more than or equal to baseline retrospective data.
Earlier palliative care referral, where the median time is reduced by more than or equal to 3 days.
Nationally validated CCRB guideline getting about 75% via Delphi consensus. |
Baseline with retrospective data,
At the discharge of pilot cases,
Post-Delphi consensus moving towards guideline validation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinician and caregiver satisfaction with ICU decision-making and governance, assessed using validated tools (Clinician Satisfaction Questionnaire, FS-ICU).
2. Quality of dying and death (QODD) scores among families of deceased ICU patients (QODD-short form).
3. Change in ICU costs per patient, measured through hospital billing data before and after CCRB implementation.
4. Qualitative outcomes: Barriers, facilitators, and acceptability of the CCRB framework identified through thematic analysis of interviews and FGDs. |
• Retrospective (baseline): Months 7–18.
• Post-implementation (pilot): Months 25–30.
• Endline (analysis, refinement, and dissemination): Months 31–60. |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This 60-month, sequential mixed-methods implementation study aims to evaluate, refine, and scale a structured Critical Care Review Board (CCRB) framework for ethical and effective decision-making in Indian Intensive Care Units (ICUs). The CCRB is a multidisciplinary governance mechanism that involves ICU physicians, palliative care specialists, nurses, administrators, and ethicists, designed to reduce non-beneficial ICU stays, promote the timely integration of palliative care, and improve satisfaction among clinicians and family caregivers.
The study will be conducted in four phases:
Retrospective quantitative analysis of approximately 1000 ICU records at Kasturba Medical College (KMC), Manipal, to assess patterns of ICU utilization and palliative referrals.
Qualitative inquiry involving 45–60 stakeholders (clinicians, administrators, caregivers) to explore experiences and feasibility of CCRB functioning.
National Delphi consensus with 30–50 experts to develop and validate a standardized CCRB guideline (Version 1.0).
Pilot implementation of the refined CCRB model in the KMC ICU (150–200 patients over 6 months) to evaluate impact on ICU utilization, palliative integration, satisfaction (using FS-ICU, QODD-short, and Clinician Satisfaction tools), and cost reduction.
The intervention arm will involve CCRB-facilitated ICU governance, whereas the comparator will consist of standard ICU decision-making practices without CCRB involvement.
Primary outcomes include a reduction of 15% or more in non-beneficial ICU days and initiation of palliative care 3 days or more earlier. Secondary outcomes include improved clinician and family satisfaction, enhanced quality of end-of-life care, and reduced ICU costs.
This study will culminate in the development of India’s first nationally validated, context-sensitive ICU governance guideline (CCRB Guidelines v1.0) and implementation toolkit for dissemination under the National Digital Health Mission and Ayushman Bharat framework. |