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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

Developing Context-Sensitive Guidelines for Intensive Care Unit Governance Through Critical Care Review Boards in India: A Mixed-Methods Study - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096953
Enrollment
280
Registered
2025-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 3- Administration

Interventions

Intervention1: 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 il
serves as a real-world baseline for evaluating the effectiveness of the CCRB framework. Washout / Run-in period Not applicable. Phase of intervention Not applicable (non-drug / non-device). Control In

Sponsors

Department of Health Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline with retrospective data, At the discharge of pilot cases, Post-Delphi consensus moving towards guideline validation.

Secondary

MeasureTime frame
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.Timepoint: Retrospective (baseline): Months 7 18. Post-implementation (pilot): Months 25 30. Endline (analysis, refinement, and dissemination): Months 31 60.

Countries

India

Contacts

Public ContactArun Ghoshal

Kasturba Medical College Manipal

arun.ghoshal@manipal.edu9434890160

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026