In the United States, 1 in 5 people die using intensive care unit (ICU) services, frequently receiving invasive treatments despite minimal anticipated benefit [1,2]. Investigators in our research group found that 20% of ICU patients in the University of California Los Angeles (UCLA) health care system were perceived by physicians to be receiving futile care [3]. A recent study from our research group [4] and previous work from others [5-7] also showed that hospitals that utilize ICUs more frequently were more likely to perform invasive procedures and have higher costs with no improvement in hospital mortality. Interestingly, most patients with advanced medical illnesses prefer not to receive such aggressive care at the end of life [1,8-12] but ICU care in this population is increasing [2,13]. This trend represents an important health care problem; a multicenter controlled study estimated that patients with advanced medical illnesses who died in ICUs spent an average of 8 days in undesirable states, such as being comatose or receiving mechanical ventilation [14]. Among conscious ICU patients who died, 50% experienced significant pain for more than half the time during the final week of life [14]. Furthermore, terminal hospitalizations account for 7.5% of total inpatient costs in the United States, with ICU care accounting for nearly 80% of these costs [1,15]. Overall, these findings show that optimizing ICU utilization among patients with advanced medical illnesses is an opportunity to improve the quality and efficiency of care in this high-risk, high-cost population.

Like many health care systems, ICU overutilization is highly prevalent in the hospitals of the Los Angeles County (LAC) Department of Health Services (DHS), the second-largest public health care system in the United States. A recent study from our group showed that among 808 medical ICU patients at Harbor-UCLA Medical Center (HUMC), over 20% had reduced likelihoods of benefit from ICU care due to advanced medical illnesses, such as advanced dementia and metastatic cancer (see Table 1) [16]. Of these patients, 86% died or were discharged in severely compromised health states and only 6% were discharged home. This subset of patients is at the highest risk to have invasive treatments that prolong suffering without improving outcomes. As such, we focus this proposal on improving ICU utilization on these critically ill patients with advanced medical illnesses.

In order to understand why patients with advanced medical illnesses received ICU care so frequently, we conducted semistructured interviews of ICU physicians and nurses at LAC DHS hospitals. Key themes that emerged from these interviews were that health care providers do not comprehensively discuss prognoses, risks and benefits, and patient preferences for ICU treatments, which lead to inaccurate expectations from ICU care and unrealistic fears of prematurely forgoing potentially beneficial treatments. Barriers to effective shared decision making included (1) underappreciation of the value of ICU care planning, (2) lack of institutional standards and tools for ICU care planning, and (3) difficulty in scheduling meetings between providers and families.

Prior work has shown that developing ICU interventions that change physician behaviors, facilitate communication between providers and families, and improve patient care is challenging [14,17,18]. A large multicenter clinical trial—the Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment (SUPPORT)—did not improve the quality of end-of-life care by providing physicians with patients’ prognostic information and nurse-facilitated advanced-care planning [14]. A hypothesis for why SUPPORT failed to change outcomes is that it did not use a multifaceted, systems approach to changing physicians’ behaviors [19,20]. Furthermore, even when prognoses are understood and risks and benefits of ICU care are discussed, it is likely that clinicians, patients, and families frequently remain uncertain about the appropriateness of ICU care [21-23]. In such situations, the default decision in most ICUs is to pursue aggressive ICU treatments, often without reassessment of that decision [24].

For patients with advanced illnesses, this approach places them at risk for prolonged suffering with minimal anticipated benefit [3,4]. Time-limited trials (TLTs) are agreements between the clinicians and the patients and decision makers to use certain medical therapies over a defined period of time and evaluate whether patients improve or worsen according to predetermined clinical parameters [24]. TLTs involve detailed discussions of patients’ preferences for care, prognosis, and what would constitute clinical improvement based on patients’ values and preferences. Follow-up meetings are held to see if patients improve or worsen according to predetermined clinical parameters and next steps in care are negotiated based on these results [24]. TLTs promote regular structured dialogue between providers and patients and their families, promote consensus in decision making through iterative assessments of clinical trajectory, and set rational boundaries to treatments based on patients’ goals of care. TLTs have been used effectively for outpatient advanced-care planning in patients with end-stage kidney disease, stroke, cancer, and chronic obstructive pulmonary disease [25-30]. However, to our knowledge there have been no studies that examined their effectiveness in ICU patients. Schenker et al examined audio-recordings of ICU family meetings for 72 patients at high risk for death or severe impairment and found that TLTs were offered only 13% of the time [31]. When TLTs were offered, clinicians frequently did not discuss key elements, such as outcomes used to determine improvement, worsening, or possible next steps after the trial [31].

In summary, nonbeneficial treatments are frequently delivered in medical ICUs to patients with advanced medical illnesses. Although the appropriateness of ICU care in this population is subject to varying opinions, there is general consensus that intensity of ICU treatments should align with patients’ prognoses, preferences, and values [32]. Previous studies suggest that most patients with advanced medical illnesses, when informed of their therapeutic options, would forgo invasive treatments and would prefer palliative approaches [1,8-12]. Unfortunately, structured care planning between clinicians and critically ill patients and their families is infrequent [33,34]. TLTs are a promising, but underutilized, care-planning approach for ICU patients with advanced medical illnesses. An intervention utilizing TLTs as a default care-planning approach for ICU patients with advanced medical illnesses has the potential to address key barriers to shared decision making identified in our preliminary studies [35]. However, given the paucity of studies on their use in critically ill patients and the complexity of ICU communication, input from key stakeholders on how best to implement TLTs in this group is crucial.

The objective of this proposal is to test an intervention that seeks to reduce invasive and nonbeneficial ICU treatments by improving communication between providers, surrogate decision makers, and critically ill patients with advanced medical illnesses. We propose to implement an intervention that facilitates communication and shared decision making between providers and patients and their families by using protocoled TLTs for ICU patients with advanced medical illnesses who receive aggressive care (see Figure 1).

We hypothesize that a multicomponent quality-improvement intervention, informed by stakeholder input and that uses protocoled TLTs as the default ICU care-planning approach for critically ill patients with advanced medical illnesses, will decrease the duration and intensity of nonbeneficial ICU care without changing hospital mortality. We will examine our hypothesis with the specific aims discussed in the following sections.

Aim 1 consists of identifying barriers and facilitators to performing TLTs in ICU patients with advanced medical illnesses using focus groups of physicians and semistructured interviews of patients and their families.

Aim 2 consists of examining whether a multicomponent quality-improvement intervention using TLTs as the default care-planning approach for ICU patients with advanced medical illnesses reduces duration and intensity of nonbeneficial ICU treatments

In the first phase of the proposed study, we will conduct focus groups with ICU physicians and interviews with patients and/or surrogate decision makers to explore attitudes toward ICU care among patients with advanced medical illnesses and strategies to optimally implement TLTs. We anticipate that themes from these sessions will include perceived barriers to conducting family meetings, knowledge and skill deficits among clinicians in conducting meetings, clinical outcomes most effective in decision making, optimal timing and frequency of meetings, optimal duration of TLTs, and communicating sensitive medical topics to lay populations.

Analysis of data from focus groups and interviews will be descriptive, summarizing the range of issues that ICU physicians, patients, and surrogate decision makers discuss. Using the audio-recordings and moderators’ notes, content analysis of the group discussions and interviews will be performed to systematically define themes, emphasizing those that represent facilitators and barriers to implementation of our intervention [36-39]. These themes will be used to modify the implementation of the quality-improvement intervention in Aim 2.