Developing Context-Sensitive Guidelines for Intensive Care Unit Governance Through Critical Care Review Boards in India: A Mixed-Methods Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Nationally validated CCRB guideline getting about 75% via Delphi consensus.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Nationally validated CCRB guideline getting about 75% via Delphi consensus.
时间窗: Baseline with retrospective data, | At the discharge of pilot cases, | Post-Delphi consensus moving towards guideline validation.
Reduction in non-beneficial ICU days, about 15% more than or equal to baseline retrospective data.
时间窗: Baseline with retrospective data, | At the discharge of pilot cases, | Post-Delphi consensus moving towards guideline validation.
Earlier palliative care referral, where the median time is reduced by more than or equal to 3 days.
时间窗: Baseline with retrospective data, | At the discharge of pilot cases, | Post-Delphi consensus moving towards guideline validation.
次要结局
- 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).)
研究者
Arun Ghoshal
Kasturba Medical College Manipal