Abstract / Summary
Abstract Background People with advanced or terminal illnesses may experience critical deterioration for which admission to intensive care, escalation of life-sustaining treatment, or continuation of invasive treatment offers limited clinically meaningful benefit or is inconsistent with their values and goals. Indian intensive care units (ICUs) vary substantially in governance, resources, sociocultural context, and access to specialist palliative care. Consequently, evidence-based end-of-life and palliative care practices are implemented inconsistently. This study was designed to co-develop, implement, and evaluate a context-sensitive care package for people with advanced or terminal illnesses who require ICU support. Methods Implementing a Multifaceted, Comprehensive, Appropriate Care Package for People with Advanced and Terminal Illnesses Needing Intensive Care Support in India (MATHRU) was designed as a five-year, multicentre, multiphase, sequential mixed-methods implementation study. The intervention—the Multifaceted, Comprehensive, Appropriate Care Package (MCACP)—comprised seven domains: prognostication and recognition; interdisciplinary review and consensus; communication; shared decision-making; comprehensive anticipatory care planning; care delivery; and care evaluation and learning. Phase 1 used evidence synthesis, a two-step Delphi process, Nominal Group Technique, human-centred co-design, and usability testing to develop and specify the intervention. Phase 2 piloted MCACP in one open and one closed ICU. Phases 3 and 4 were designed to evaluate implementation across four ICUs with established palliative care access and four without, using mixed-methods process evaluation and a quasi-experimental pre–post effectiveness design, respectively. Phase 5 was designed to develop a national technical resource hub and a minimum viable set of interventions. The study was informed by Medical Research Council guidance for complex interventions, the Consolidated Framework for Implementation Research, Normalization Process Theory, and the Implementation Research Logic Model. Implementation outcomes included feasibility, acceptability, fidelity, reach, workflow compatibility and normalisation. Patient, family, and system outcomes included ICU Quality of Dying and Death, Family Satisfaction in the ICU, care process indicators, resource utilisation, and costs. The planned effectiveness sample was 150 patient episodes per ICU in each pre- and post-implementation period. At the time of revision, Phases 1 and 2 were ongoing, whereas Phases 3 and 4 had not commenced. Discussion MATHRU was designed to evaluate whether a defined but adaptable appropriate-care package can be integrated across heterogeneous Indian ICUs. Its non-randomised design was recognised as susceptible to secular trends, regression to the mean, and residual confounding; the findings were therefore intended to be interpreted using covariate-adjusted analyses alongside data on context, fidelity, reach, and implementation mechanisms. Trial registration Clinical Trials Registry–India: CTRI/2025/06/107155. Prospectively registered on 11 June 2025; protocol version 1.0.