Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial

Patients with cancer often experience physical and emotional distress, utilize unplanned acute care, and undergo medical interventions that are discordant with their wishes at the end of life [1‐6]. Serious illness conversations (SICs) that elicit patients’ values, goals, and care preferences, particularly earlier in the disease trajectory, are an evidence-based practice that improves patient mood and quality of life [7‐12] and are recommended by national guidelines, including those of the American Society of Clinical Oncology and National Academies of Medicine [13‐15]. However, most patients with cancer die without a documented SIC, contributing to unwarranted and unwanted aggressive care at the end of life [7]. Moreover, SICs are implemented inequitably. Those more likely to experience social and health inequities, such as Black or African American patients, are less likely than non-Hispanic White patients to have SICs [16‐21]. Current implementation strategies [22] to promote SICs—including the Serious Illness Care Program (SICP) developed by Ariadne Labs [23]—focus primarily on clinician education and training and have only marginally increased the timeliness and frequency of SICs [11, 12]. While core elements of this program are scalable, such as its structured conversation guide for clinicians, SIC completion in routine practice remains low. For example, even after formal SICP training, medical oncology clinicians at our large academic cancer center documented SICs for fewer than 5% of patients with cancer seen in medical oncology practices [24].

Efforts to implement SICs can be enhanced using approaches from behavioral economics, a discipline that encompasses a set of principles, theories, and strategies derived from economics, cognitive psychology, and social psychology to understand human decision-making. Behavioral economics posits that individuals deploy common mental heuristics that may account for behavior that is “non-rational” (i.e., not consistent with maximizing individual utility). Clinician heuristics that may undermine the initiation of SICs include optimism bias, or the belief that one’s own patient is unlikely to experience a negative event; uncertainty about prognosis and optimal SIC timing; and fear that bringing up end-of-life issues may be distressing to patients [25, 26]. Due to optimism bias, clinicians routinely overestimate the life expectancy of patients with advanced cancer, particularly in the era of novel and personalized therapeutics [27‐29], and delay SICs until too late in the disease course. Delaying SICs reinforces a social norm that SICs are not part of routine oncology care and are not appropriate until late in the disease course, often after unplanned acute care utilization [15, 30‐32]. Such norms are powerful behavioral determinants: individuals desire to conform to an approved behavior (an injunctive norm) and the behavior of others (a descriptive norm). These norms may be influenced by broader factors such as structural racism—most notably, beliefs that non-White patients may be less receptive to end-of-life conversations—that contribute to inequitable access to SICs [33]. Scant research has evaluated strategies designed to harness norms directly and align clinicians and patients toward engaging in SICs [34].

Implementation strategies informed by behavioral economics are well-suited to address these barriers, which fundamentally imply the need for strategies directed towards clinicians and patients. By intentionally modifying the way choices are framed, nudges can counter behavioral pathways that might thwart behavior change or harness those pathways to redirect decisions toward better outcomes, while preserving principles of autonomy and choice [24, 35‐37]. Nudges to clinicians have been shown to increase rates of evidence-based behaviors such as influenza vaccination [38‐40]. We demonstrated the effectiveness of a clinician-directed nudge designed to counteract optimism bias and aid clinicians in identifying patients at high risk of predicted 180-day mortality based on a validated machine-learning prognostic algorithm (i.e., those most likely to benefit from SICs). This strategy led to a near fourfold increase in SIC documentation for high-risk patients, with particular improvement seen among non-White patients, and is now in routine use across sites at our large academic cancer center [25]. However, clinicians still did not have SICs for over half of high-risk patients, illustrating gaps that remain with a clinician-directed implementation strategy alone [25].

As a signature project of our National Cancer Institute-funded Penn Implementation Science Center in Cancer Control (P50 CA244690), this study will evaluate the effect of nudges to clinicians, nudges to patients, or nudges to both, on SIC completion. The clinician nudge will build on our prior approach to clinician nudges by adding performance feedback via peer comparison. This addition will serve to remind clinicians of their performance on SIC documentation by providing both an injunctive norm (institutional guidelines) and a descriptive norm (displaying the behavior of peers). The patient nudge will be a digital communication designed to normalize SICs as a routine part of cancer care and to prime patients (and, in turn, their clinicians) to have earlier SICs. Priming is a type of nudge that frames information to activate one’s self-efficacy and willingness to engage in behavior change [41] and may also signal an injunctive norm for both clinicians and patients. A prior study with patients that had serious illnesses (including some with cancer) demonstrated promise to this approach [42]. The clinician and patient nudges will be compared with usual care at our institution, which consists of a basic clinician-directed nudge identifying high-risk patients and providing performance feedback without peer comparison; importantly, this arm will serve as an active control. We hypothesize that providing a clinician nudge that counteracts optimism bias and targets injunctive and descriptive norms via peer comparison, and a patient nudge that normalizes and primes patients towards serious illness communication, will lead to increased rates of SICs for patients with cancer at risk of short-term mortality [35, 43, 44].

This randomized controlled trial will test the effect of nudges to clinicians, patients, or both, versus usual care, as implementation strategies to improve SIC completion among patients with cancer at high risk of mortality. By harnessing heuristics of both clinicians and patients and thereby addressing multilevel barriers to SIC engagement, it builds on our prior work demonstrating the moderate effectiveness of a clinician-directed nudge alone [25]. Through incorporation of this basic clinician nudge into an active control arm, this study is uniquely positioned to assess the added impact of clinician peer comparison within the clinician nudge, as well as the impact of a patient nudge designed to normalize SICs and prime patients (and clinicians) to participate in them.

We expect the study to yield essential insights into the effectiveness of patient-level nudges, clinician-level nudges, or both as implementation strategies to increase the uptake of evidence-based practices in cancer care, and to advance our understanding of the multilevel contextual factors and mechanisms that drive response to these strategies. Specifically, we will advance the science of implementation by exploring patient, clinician, and inner-setting factors that contribute to response to patient and/or clinician nudges, including assessing effectiveness across a diverse group of patients and practice settings. We expect that this will lend critical insights into the external validity of these novel approaches. Furthermore, if successful, this study will provide a generalizable approach to integrate predictive analytics with nudges to engage both clinicians and patients in evidence-based conversations about treatment goals and end-of-life wishes. These results will lay the foundation for how care settings can ensure that patients with cancer and their clinicians engage in more frequent and earlier SICs and feel empowered to initiate optimally timed conversations. This may help drive goal-concordant care, improve quality of life, and reduce unwanted end-of-life care utilization. Furthermore, our study will enhance understanding of the extent to which clinician and/or patient nudges affect health inequities in cancer care delivery.

Our study has several limitations. First, this is a single-health system study and thus our approach, even if successful, may not generalize to other health systems—particularly institutions without robust electronic medical record infrastructure, clinician training on serious illness communication, or buy-in from administrative leaders and the clinical workforce. Despite this limitation, our study consists of a racially and ethnically diverse patient population, spanning academic and community oncology settings with a common electronic medical record infrastructure, and thus lessons should generalize to diverse settings. Second, our primary outcome of SIC documentation is not a robust measure of SIC quality or patient satisfaction. While SIC documentation has been used as an outcome in several supportive care studies [12, 25], future studies of nudges should assess patient-reported outcomes and other conversation quality metrics as their primary outcome; we will measure such outcomes in an exploratory fashion as part of aim 3.

If successful, future directions of this work include a large, multi-health system study to test the generalizability of patient and/or clinician nudges to improve SIC rates and a well-powered study to assess the impact of clinician and patient SIC nudges on end-of-life care utilization and outcomes.