Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses to Reduce Nonbeneficial Intensive Care Unit Treatments: Protocol for a Multicenter Quality Improvement Study

Abstract

BackgroundInvasive intensive care unit (ICU) treatments for patients with advanced medical illnesses and poor prognoses may prolong suffering with minimal benefit. Unfortunately, the quality of care planning and communication between clinicians and critically ill patients and their families in these situations are highly variable, frequently leading to overutilization of invasive ICU treatments. Time-limited trials (TLTs) are agreements between the clinicians and the patients and decision makers to use certain medical therapies over defined periods of time and to evaluate whether patients improve or worsen according to predetermined clinical parameters. For patients with advanced medical illnesses receiving aggressive ICU treatments, TLTs can promote effective dialogue, develop consensus in decision making, and set rational boundaries to treatments based on patients’ goals of care.ObjectiveThe aim of this study will be to examine whether a multicomponent quality-improvement strategy that uses protocoled TLTs as the default ICU care-planning approach for critically ill patients with advanced medical illnesses will decrease duration and intensity of nonbeneficial ICU care without changing hospital mortality.MethodsThis study will be conducted in medical ICUs of three public teaching hospitals in Los Angeles County. In Aim 1, we will conduct focus groups and semistructured interviews with key stakeholders to identify facilitators and barriers to implementing TLTs among ICU patients with advanced medical illnesses. In Aim 2, we will train clinicians to use protocol-enhanced TLTs as the default communication and care-planning approach in patients with advanced medical illnesses who receive invasive ICU treatments. Eligible patients will be those who the treating ICU physicians consider to be at high risk for nonbeneficial treatments according to guidelines from the Society of Critical Care Medicine. ICU physicians will be trained to use the TLT protocol through a curriculum of didactic lectures, case discussions, and simulations utilizing actors as family members in role-playing scenarios. Family meetings will be scheduled by trained care managers. The improvement strategy will be implemented sequentially in the three participating hospitals, and outcomes will be evaluated using a before-and-after study design. Key process outcomes will include frequency, timing, and content of family meetings. The primary clinical outcome will be ICU length of stay. Secondary outcomes will include hospital length of stay, days receiving life-sustaining treatments (eg, mechanical ventilation, vasopressors, and renal replacement therapy), number of attempts at cardiopulmonary resuscitation, frequency of invasive ICU procedures, and disposition from hospitalization.ResultsThe study began in August 2017. The implementation of interventions and data collection were completed at two of the three hospitals. As of September 2019, the study was at the postintervention stage at the third hospital. We have completed focus groups with physicians ...

Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments

“…Barriers to ICU communication, conceptual frameworks for developing interventions, and implementation strategy were previously described. 25 Quality improvement interventions targeted clinicians and medical ICUs, not individual patients or family members. Training of clinicians was divided into 3 components delivered over the course of 4 to 6 weeks: (1) focus groups of physicians to identify barriers to using TLTs, (2) didactic sessions to define TLTs and review protocols for using TLTs, and…”

Postponed Withholding: Balanced Decision-Making at the Margins of Viability

“…TLT typically applies for patients with limited reserves and quality of life, where the benefits of intensive care treatment are uncertain. The aim is to promote effective dialogue, develop consensus in decision-making and set rational boundaries to treatments based on patients' goals of care (Chang et al 2019).…”

Development and validation of the VitaL CLASS score to predict mortality in stage IV solid cancer patients with septic shock in the emergency department: a multi-center, prospective cohort study

“…This simple and objective prognostic model for stage IV cancer patients with septic shock uses data available within hours after ED admission. The majority of patients with advanced medical illness would prefer palliative approaches to invasive ICU treatments when they were informed of their therapeutic options, and such invasive ICU treatments should be aligned with patients’ values and prognostic information [ 10 , 29 – 31 ]. Furthermore, the demand for ICU care usually exceeds supply, and consequently, the triage and allocation decisions for ICU care for critically ill patients are important.…”

“…Treatment recommendations for these patients could be different depending on the specialties [ 6 , 7 ]. Also, the patient-physician communication in such situations frequently leads to overutilization of invasive ICU treatments, which can produce more costly and invasive care without improving outcomes [ 8 – 10 ].…”