A type 2 hybrid effectiveness-implementation study of time limited trials to reduce potentially non-beneficial treatments for critically ILL patients with advanced medical illnesses

The National Institute on Aging (NIA) awarded $632,507 to the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center under the Aging Research program (CFDA 93.866) on September 25, 2025, to conduct a pragmatic Type 2 hybrid effectiveness-implementation clinical trial examining the use of time-limited trials (TLTs) as a standardized communication strategy for critically ill patients with advanced medical illnesses. The five-year project, concluding August 31, 2030, will employ a stepped-wedge study design across 10 intensive care units (ICUs)—five in the Los Angeles County Department of Health Services and five in Southern California Kaiser Permanente—to evaluate whether implementing TLTs as the default care-planning approach reduces utilization of potentially non-beneficial ICU treatments, improves shared decision-making between clinicians and patients or surrogate decision-makers, and can be scaled pragmatically within real-world healthcare systems.

The research deliverables include physician training protocols on time-limited trial implementation, clinical outcome data collected through electronic health records at participating institutions, and qualitative assessments of implementation factors and effectiveness conducted with physicians and patients/surrogate decision-makers. Sub-awardees contributing specialized services include the University of Southern California (providing co-investigator support and quality improvement implementation activities through the Pulmonary and Critical Care Fellowship program), Olive View/UCLA Education and Research Institute (supporting implementation activities at Olive View Medical Center), and the University of California, Los Angeles (leading qualitative research protocols, focus groups, and data analysis for the Los Angeles County Department of Health Services hospitals).

Abstract

Overutilization of invasive intensive care unit (ICU) treatments for patients with advanced medical illnesses may lead to medical care that provides minimal benefit and prolongs suffering. Although the factors that lead to overuse of potentially non-beneficial treatments are complex, an important contributor is poor communication between clinicians, patients and surrogate decision makers. Time limited trials (TLT) involve detailed discussions of patients' preferences for care and prognosis followed by agreements between clinicians and patients/surrogate decision-makers to use certain medical therapies for defined periods of time. Tlts promote regular structured dialogue between providers, patients and families, reassure them that all indicated interventions have been pursued, and set rational boundaries to treatments based on patients' goals of care. In a pilot study our team showed that utilizing tlts as the default communication approach for critically-ILL patients with advanced medical illnesses improved shared decision-making and reduced utilization of potentially non-beneficial ICU treatments. However, key gaps in our knowledge include whether the TLT intervention can be scaled-up pragmatically in real-life healthcare systems and understanding the factors that affect implementation and effectiveness. We will conduct a pragmatic type 2 hybrid effectiveness- implementation stepped wedge clinical trial of the TLT intervention in the icus of the LOS angeles county department of health services (LAC DHS) and southern california kaiser permanente (KPSC) hospitals. LAC DHS is the second largest public healthcare system in the united states, and KPSC is the largest integrated healthcare system in southern california. The patient population in these healthcare systems are racially and culturally diverse, and many have high risk for breakdowns in shared decision-making due to socioeconomic disadvantages, language discordance, and low health literacy. The TLT intervention strategy was CO-designed with stakeholders in LAC DHS and KPSC. The specific aims are to: (1) examine whether the TLT intervention reduces ICU length of stay and utilization of invasive treatments, (2) identify characteristics of the intervention, participants, and healthcare environment that affect implementation using the consolidated framework for implementation research (CFIR) and (3) perform a mixed methods evaluation of implementation outcomes using the RE-aim framework. The project team has the transdisciplinary expertise, established partnerships with stakeholders in LAC DHS and KPSC, and institutional support to complete the aims of this project. By examining the effectiveness and implementation, this study has the potential to improve the quality of ICU care in two essential healthcare systems in southern california and guide implementation of approaches to improve shared decision-making in other healthcare environments.