The COVID-19 Pandemic Led To A Large Decline In Physician Gross Revenue Across All Specialties In 2020.

US health care use declined during the initial phase of the COVID-19 pandemic in 2020. Although utilization is known to have recovered in 2021 and 2022, it is unknown how revenue in 2020-22 varied by physician specialty and practice setting. This study linked medical claims from a large national federation of commercial health plans to physician and practice data to estimate pandemic-associated impacts on physician revenue (defined as payments to eligible physicians) by specialty and practice characteristics. Surgical specialties, emergency medicine, and medical subspecialties each experienced a greater than 9 percent adjusted gross revenue decline in 2020 relative to prepandemic baselines. By 2022, pathology and psychiatry revenue experienced robust recovery, whereas surgical and oncology revenue remained at or below baseline. Revenue recovery in 2022 was greater for physicians practicing in hospital-owned practices and in practices participating in accountable care organizations. Pandemic-associated revenue recovery in 2021 and 2022 varied by specialty and practice type. Given that physician financial instability is associated with health care consolidation and leaving practice, policy makers should closely monitor revenue trends among physicians in specialties or practice settings with sustained gross revenue reductions during the pandemic.

Cancer Treatment Before and After Physician-Pharmacy Integration.

Importance: Integration of pharmacies with physician practices, also known as medically integrated dispensing, is increasing in oncology. However, little is known about how this integration affects drug use, expenditures, medication adherence, or time to treatment initiation. Objective: To examine the association of physician-pharmacy integration with oral oncology drug expenditures, use, and patient-centered measures. Design, Setting, and Participants: This cohort study used claims data from a large commercial insurer in the US to analyze changes in outcome measures among patients treated by pharmacy-integrating vs nonintegrating community oncologists in 14 states between January 1, 2011, and December 31, 2019. Commercially insured patients were aged 18 to 64 years with 1 of the following advanced-stage diagnoses: breast cancer, colorectal cancer, kidney cancer, lung cancer, melanoma, or prostate cancer. Data analysis was conducted from May 2023 to March 2024. Exposure: Treatment by a pharmacy-integrating oncologist, ascertained by the presence of an on-site pharmacy or nonpharmacy dispensing site. Main Outcomes and Measures: Oral, intravenous (IV), total, and out-of-pocket drug expenditures for a 6-month episode of care; share of patients prescribed oral drugs; days' supply of oral drugs; medication adherence measured by proportion of days covered; and time to treatment initiation. The association between an oncologist's pharmacy integration and each outcome of interest was estimated using the difference-in-differences estimator. Results: Between 2012 and 2019, 3159 oncologists (745 females [27.1%], 2002 males [72.9%]) treated 23 968 patients (66.4% female; 53.4% aged 55-64 years). Of the 3159 oncologists, 578 (18.3%) worked in practices that integrated with pharmacies (with a low rate in 2011 of 0% and a high rate in 2019 of 31.5%). In the full sample (including all cancer sites), after physician-pharmacy integration, no significant changes were found in oral drug expenditures, IV drug expenditures, or total drug expenditures. There was, however, an increase in days' supply of oral drugs (5.96 days; 95% CI, 0.64-11.28 days; P = .001). There were no significant changes in out-of-pocket expenditures, medication adherence, or time to treatment initiation of oral drugs. In the breast cancer sample, there was an increase in oral drug expenditures ($244; 95% CI, $41-$446; P = .02) and a decrease in IV drug expenditures (-$4187; 95% CI, -$8293 to -$80; P = .05). Conclusions and Relevance: Results of this cohort study indicated that the integration of oncology practices with pharmacies was not associated with significant changes in expenditures or clear patient-centered benefits.

Trends in low-value cancer care during the COVID-19 pandemic.

OBJECTIVE: To assess the association between the onset of the COVID-19 pandemic and change in low-value cancer services. STUDY DESIGN: In this retrospective cohort study, we used administrative claims from the HealthCore Integrated Research Environment, a repository of medical and pharmacy data from US health plans representing more than 80 million members, between January 1, 2016, and March 31, 2021. METHODS: We used linear probability models to investigate the relation between the onset of the COVID-19 pandemic and 4 guideline-based metrics of low-value cancer care: (1) conventional fractionation radiotherapy instead of hypofractionated radiotherapy for early-stage breast cancer; (2) non-guideline-based antiemetic use for minimal-, low-, or moderate- to high-risk chemotherapies; (3) off-pathway systemic therapy; and (4) aggressive end-of-life care. We identified patients with new diagnoses of breast, colorectal, and/or lung cancer. We excluded members who did not have at least 6 months of continuous insurance coverage and members with prevalent cancers. RESULTS: Among 117,116 members (median [IQR] age, 60 [53-69] years; 72.4% women), 59,729 (51.0%) had breast cancer, 25,751 (22.0%) had colorectal cancer, and 31,862 (27.2%) had lung cancer. The payer mix was 18.7% Medicare Advantage or Medicare supplemental and 81.2% commercial non-Medicare. Rates of low-value cancer services exhibited minimal changes during the pandemic, as adjusted percentage-point differences were 3.93 (95% CI, 1.50-6.36) for conventional radiotherapy, 0.82 (95% CI, -0.62 to 2.25) for off-pathway systemic therapy, -3.62 (95% CI, -4.97 to -2.27) for non-guideline-based antiemetics, and 2.71 (95% CI, -0.59 to 6.02) for aggressive end-of-life care. CONCLUSIONS: Low-value cancer care remained prevalent throughout the pandemic. Policy makers should consider changes to payment and incentive design to turn the tide against low-value cancer care.

US Medicare Hospice and Palliative Medicine Physician Workforce and Service Delivery in 2008-2020.

CONTEXT: Despite clinical benefits of early palliative care, little is known about Medicare physician workforce specialized in Hospice and Palliative Medicine (HPM) and their service delivery settings. OBJECTIVES: To examine changes in Medicare HPM physician workforce and their service delivery settings in 2008-2020. METHODS: Using the Medicare Data on Provider Practice and Specialty from 2008 to 2020, we identified 2375 unique Medicare Fee-For-Service (FFS) physicians (15,565 physician-year observations) with self-reported specialty in "Palliative Care and Hospice". We examined changes in the annual number of HPM physicians, average number of Medicare services overall and by care setting, total number of Medicare FFS beneficiaries, and total Medicare allowed charges billed by the physician. RESULTS: The number of Medicare HPM physicians increased 2.32 times from 771 in 2008 to 1790 in 2020. The percent of HPM physicians practicing in metropolitan areas increased from 90% to 96% in 2008-2020. Faster growth was also observed in female physicians (52.4% to 60.1%). Between 2008 and 2020, we observed decreased average annual Medicare FFS beneficiaries (170 to 123), number of FFS services (467 to 335), and Medicare allowed charges billed by the physician ($47,230 to $37,323). The share of palliative care delivered in inpatient settings increased from 47% to 68% in 2008-2020; whereas the share of services delivered in outpatient settings decreased from 37% to 19%. CONCLUSION: Despite growth in Medicare HPM physician workforce, access is disproportionately concentrated in metropolitan and inpatient settings. This may limit receipt of early outpatient specialized palliative care, especially in nonmetropolitan areas.

Eliminating Algorithmic Racial Bias in Clinical Decision Support Algorithms: Use Cases from the Veterans Health Administration.

The Veterans Health Administration uses equity- and evidence-based principles to examine, correct, and eliminate use of potentially biased clinical equations and predictive models. We discuss the processes, successes, challenges, and next steps in four examples. We detail elimination of the race modifier for estimated kidney function and discuss steps to achieve more equitable pulmonary function testing measurement. We detail the use of equity lenses in two predictive clinical modeling tools: Stratification Tool for Opioid Risk Mitigation (STORM) and Care Assessment Need (CAN) predictive models. We conclude with consideration of ways to advance racial health equity in clinical decision support algorithms.

Spending patterns among commercially insured individuals during the COVID-19 pandemic.

OBJECTIVES: To describe trends in US health care spending in a large, national, and commercially insured population during the COVID-19 pandemic. STUDY DESIGN: Cross-sectional study of commercially insured members enrolled between May 1, 2018, and December 31, 2021. METHODS: The study utilized a population-based sample of continuously enrolled members in a geographically diverse federation of Blue Cross Blue Shield plans across the United States. Our sample excluded Medicare and Medicare Advantage beneficiaries. The COVID-19 exposure period was defined as 2020-2021; 2018-2019 were pre-COVID-19 years. We defined 4 post-COVID-19 periods: March 1 to April 30, 2020; May 1 to December 31, 2020; January 1 to March 31, 2021; and April 1 to December 31, 2021. The primary outcome was inflation-adjusted overall per-member per-month (PMPM) medical spending adjusted for age, sex, Elixhauser comorbidities, area-level racial composition, income, and education. RESULTS: Our sample included 97,319,130 individuals. Mean PMPM medical spending decreased from $370.92 in January-February 2020 to $281.00 in March-April 2020. Between May and December 2020, mean PMPM medical spending recovered to-but did not exceed-prepandemic levels. Mean PMPM medical spending stayed below prepandemic levels between January and March 2021, rose above prepandemic baselines between April and June 2021, and decreased below baseline between July and December 2021. CONCLUSIONS: The COVID-19 pandemic induced a spending shock in 2020, and health care spending did not recover to near baseline until mid-2021, with some emerging evidence of pent-up demand. The observed spending below baseline through the end of 2021 will pose challenges to setting spending benchmarks for alternative payment and shared savings models.

Creating a culture for change: Lessons from behavioral economics and complexity science to increase serious illness conversations for patients with cancer.

Patient-centered cancer care requires communication between patients and clinicians about patients' goals, values, and preferences. Serious illness communication improves patient and caregiver outcomes, the value and quality of cancer care, and the well-being of clinicians. Despite these benefits, there are competing factors including time, capacity, bandwidth, and resistance. Health systems and oncology practices have opportunities to invest in pathways that assist patients and clinicians to engage in serious illness conversations. We discuss how applying insights from behavioral economics and complexity science may help clinicians engage in serious illness conversation and improve patient-centered cancer care.

Medicaid Expansion Associated With Increase In Palliative Care For People With Advanced-Stage Cancers.

Clinical guidelines have endorsed early palliative care for patients with advanced malignancies, but receipt remains low in the US. This study examined the association between Medicaid expansion under the Affordable Care Act and receipt of palliative care among patients newly diagnosed with advanced-stage cancers. Using the National Cancer Database, we found that the percentage of eligible patients who received palliative care as part of first-course treatment increased from 17.0 percent preexpansion to 18.9 percent postexpansion in Medicaid expansion states and from 15.7 percent to 16.7 percent, respectively, in nonexpansion states, resulting in a net increase of 1.3 percentage points in expansion states in adjusted analyses. Increases in receipt of palliative care associated with Medicaid expansion were largest for patients with advanced pancreatic, colorectal, lung, and oral cavity and pharynx cancers and non-Hodgkin lymphoma. Our findings suggest that increasing Medicaid coverage facilitates access to guideline-based palliative care for advanced cancer, and they provide additional evidence of benefit in cancer care from states' expansion of income eligibility for Medicaid.

Incorporating Cost Measures Into the Merit-Based Incentive Payment System: Implications for Oncologists.

PURPOSE: The Merit-Based Incentive Payment System (MIPS) is currently the only federally mandated value-based payment model for oncologists. The weight of cost measures in MIPS has increased from 0% in 2017 to 30% in 2022. Given that cost measures are specialty-agnostic, specialties with greater costs of care such as oncology may be unfairly affected. We investigated the implications of incorporating cost measures into MIPS on physician reimbursements for oncologists and other physicians. METHODS: We evaluated physicians scored on cost and quality in the 2018 MIPS using the Doctors and Clinicians database. We used multivariable Tobit regression to identify physician-level factors associated with cost and quality scores. We simulated composite MIPS scores and payment adjustments by applying the 2022 cost-quality weights to the 2018 category scores and compared changes across specialties. RESULTS: Of 168,098 identified MIPS-participating physicians, 5,942 (3.5%) were oncologists. Oncologists had the lowest cost scores compared with other specialties (adjusted mean score, 58.4 for oncologists v 71.0 for nononcologists; difference, -12.66 [95% CI, -13.34 to -11.99]), while quality scores were similar (82.9 v 84.2; difference, -1.31 [95% CI, -2.65 to 0.03]). After the 2022 cost-quality reweighting, oncologists would receive a 4.3-point (95% CI, 4.58 to 4.04) reduction in composite MIPS scores, corresponding to a four-fold increase in magnitude of physician penalties ($4,233.41 US dollars [USD] in 2018 v $18,531.06 USD in 2022) and greater reduction in exceptional payment bonuses compared with physicians in other specialties (-42.8% [95% CI, -44.1 to -41.5] for oncologists v -23.6% [95% CI, -23.8 to -23.4] for others). CONCLUSION: Oncologists will likely be disproportionally penalized after the incorporation of cost measures into MIPS. Specialty-specific recalibration of cost measures is needed to ensure that policy efforts to promote value-based care do not compromise health care quality and outcomes.

Behavioural economic interventions to embed palliative care in community oncology (BE-EPIC): study protocol for the BE-EPIC randomised controlled trial.

INTRODUCTION: Palliative care (PC) is a medical specialty focusing on providing relief from the symptoms and stress of serious illnesses such as cancer. Early outpatient specialty PC concurrent with cancer-directed treatment improves quality of life and symptom burden, decreases aggressive end-of-life care and is an evidence-based practice endorsed by national guidelines. However, nearly half of patients with advanced cancer do not receive specialty PC prior to dying. The objective of this study is to test the impact of an oncologist-directed default PC referral orders on rates of PC utilisation and patient quality of life. METHODS AND ANALYSIS: This single-centre two-arm pragmatic randomised trial randomises four clinician-led pods, caring for approximately 250 patients who meet guideline-based criteria for PC referral, in a 1:1 fashion into a control or intervention arm. Intervention oncologists receive a nudge consisting of an electronic health record message indicating a patient has a default pended order for PC. Intervention oncologists are given an opportunity to opt out of referral to PC. Oncologists in pods randomised to the control arm will receive no intervention beyond usual practice. The primary outcome is completed PC visits within 12 weeks. Secondary outcomes are change in quality of life and absolute quality of life scores between the two arms. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board at the University of Pennsylvania. Study results will be disseminated in peer-reviewed journals and scientific conferences using methods that describe the results in ways that key stakeholders can best understand and implement. TRIAL REGISTRATION NUMBER: NCT05365997.

Oncologist Participation and Performance in the Merit-Based Incentive Payment System.

The merit-based incentive payment system (MIPS) is a value-based payment model created by the Centers for Medicare & Medicaid Services (CMS) to promote high-value care through performance-based adjustments of Medicare reimbursements. In this cross-sectional study, we examined the participation and performance of oncologists in the 2019 MIPS. Oncologist participation was low (86%) compared to all-specialty participation (97%). After adjusting for practice characteristics, higher MIPS scores were observed among oncologists with alternative payment models (APMs) as their filing source (mean score, 91 for APMs vs. 77.6 for individuals; difference, 13.41 [95% CI, 12.21, 14.6]), indicating the importance of greater organizational resources for participants. Lower scores were associated with greater patient complexity (mean score, 83.4 for highest quintile vs. 84.9 for lowest quintile, difference, -1.43 [95% CI, -2.48, -0.37]), suggesting the need for better risk-adjustment by CMS. Our findings may guide future efforts to improve oncologist engagement in MIPS.

Next-Generation Alternative Payment Models in Oncology-Will Precision Preclude Participation?

This Viewpoint proposes 3 changes to the Enhancing Oncology Model of the US Centers for Medicare & Medicaid Services.

The Enhancing Oncology Model: Leveraging improvement science to increase health equity in value-based care.

The Oncology Care Model (OCM), launched in 2016 by the Centers for Medicare and Medicaid Services, was the first demonstration of value-based payment in oncology. Although the OCM delivered mixed results in terms of quality of care and total episode costs, the model had no statistically significant impact on remediating racial, ethnic, and socioeconomic disparities among beneficiaries. These deficits have been prominent in other aspects of US healthcare, and as a result, the Institute for Healthcare Improvement has advocated for stakeholders to leverage improvement science, an applied science that focuses on implementing rapid cycles for change, to identify and overcome barriers to health equity. With the announcement of the new Enhancing Oncology Model, a continuation of the OCM's efforts in introducing value to cancer care for episodes surrounding chemotherapy administration, both policymakers and providers must apply tenets of improvement science and make eliminating disparities in alternative payment models a forefront objective. In this commentary, we discuss previous inequities in alternative payment models, the role that improvement science plays in addressing health-care disparities, and steps that stakeholders can take to maximize equitable outcomes in the Enhancing Oncology Model.

Trends in Enrollment in Employer-Sponsored Health Insurance in the US Before and During the COVID-19 Pandemic, January 2019 to June 2021.

This cross-sectional study compares trends in employer-sponsored health insurance coverage in the US before and during the COVID-19 pandemic.

Association of Oncologist Participation in Medicare's Oncology Care Model With Patient Receipt of Novel Cancer Therapies.

Importance: Medicare's Oncology Care Model (OCM) was an alternative payment model that tied performance-based payments to cost and quality goals for participating oncology practices. A major concern about the OCM regarded inclusion of high-cost cancer therapies, which could potentially disincentivize oncologists from prescribing novel therapies. Objective: To examine whether oncologist participation in the OCM changed the likelihood that patients received novel therapies vs alternative treatments. Design, Setting, and Participants: This cohort study of Surveillance, Epidemiology, and End Results (SEER) Program data and Medicare claims compared patient receipt of novel therapies for patients treated by oncologists participating vs not participating in the OCM in the period before (January 2015-June 2016) and after (July 2016-December 2018) OCM initiation. Participants included Medicare fee-for-service beneficiaries in SEER registries who were eligible to receive 1 of 10 novel cancer therapies that received US Food and Drug Administration approval in the 18 months before implementation of the OCM. The study excluded the Hawaii registry because complete data were not available at the time of the data request. Patients in the OCM vs non-OCM groups were matched on novel therapy cohort, outcome time period, and oncologist specialist status. Analysis was conducted between July 2021 and April 2022. Exposures: Oncologist participation in the OCM. Main Outcomes and Measures: Preplanned analyses evaluated patient receipt of 1 of 10 novel therapies vs alternative therapies specific to the patient's cancer for the overall study sample and for racial subgroups. Results: The study included 2839 matched patients (760 in the OCM group and 2079 in the non-OCM group; median [IQR] age, 72.7 [68.3-77.6] years; 1591 women [56.0%]). Among patients in the non-OCM group, 33.2% received novel therapies before and 40.1% received novel therapies after the start of the OCM vs 39.9% and 50.3% of patients in the OCM group (adjusted difference-in-differences, 3.5 percentage points; 95% CI, -3.7 to 10.7 percentage points; P = .34). In subgroup analyses, second-line immunotherapy use in lung cancer was greater among patients in the OCM group vs non-OCM group (adjusted difference-in-differences, 17.4 percentage points; 95% CI, 4.8-30.0 percentage points; P = .007), but no differences were seen in other subgroups. Over the entire study period, patients with oncologists participating in the OCM were more likely to receive novel therapies than those with oncologists who were not participating (odds ratio, 1.47; 95% CI, 1.09-1.97; P = .01). Conclusions and Relevance: This study found that participation in the OCM was not associated with oncologists' prescribing novel therapies to Medicare beneficiaries with cancer. These findings suggest that OCM financial incentives did not decrease patient access to novel therapies.

Evaluation of Spending Differences Between Beneficiaries in Medicare Advantage and the Medicare Shared Savings Program.

Importance: The 2 primary efforts of Medicare to advance value-based care are Medicare Advantage (MA) and the fee-for-service-based Medicare Shared Savings Program (MSSP). It is unknown how spending differs between the 2 programs after accounting for differences in patient clinical risk. Objective: To examine how spending and utilization differ between MA and MSSP beneficiaries after accounting for differences in clinical risk using data from administrative claims and electronic health records. Design, Setting, and Participants: This retrospective economic evaluation used data from 15 763 propensity score-matched beneficiaries who were continuously enrolled in MA or MSSP from January 1, 2014, to December 31, 2018, with diabetes, congestive heart failure (CHF), chronic kidney disease (CKD), or hypertension. Participants received care at a large nonprofit academic health system in the southern United States that bears risk for Medicare beneficiaries through both the MA and MSSP programs. Differences in beneficiary risk were mitigated by propensity score matching using validated clinical criteria based on data from administrative claims and electronic health records. Data were analyzed from January 2019 to May 2022. Exposures: Enrollment in MA or attribution to an accountable care organization in the MSSP program. Main Outcomes and Measures: Per-beneficiary annual total spending and subcomponents, including inpatient hospital, outpatient hospital, skilled nursing facility, emergency department, primary care, and specialist spending. Results: The sample of 15 763 participants included 12 720 (81%) MA and 3043 (19%) MSSP beneficiaries. MA beneficiaries, compared with MSSP beneficiaries, were more likely to be older (median [IQR] age, 75.0 [69.9-81.8] years vs 73.1 [68.3-79.8] years), male (5515 [43%] vs 1119 [37%]), and White (9644 [76%] vs 2046 [69%]) and less likely to live in low-income zip codes (2338 [19%] vs 750 [25%]). The mean unadjusted per-member per-year spending difference between MSSP and MA disease-specific subcohorts was $2159 in diabetes, $4074 in CHF, $2560 in CKD, and $2330 in hypertension. After matching on clinical risk and demographic factors, MSSP spending was higher for patients with diabetes (mean per-member per-year spending difference in 2015: $2454; 95% CI, $1431-$3574), CHF ($3699; 95% CI, $1235-$6523), CKD ($2478; 95% CI, $1172-$3920), and hypertension ($2258; 95% CI, $1616-2,939). Higher MSSP spending among matched beneficiaries was consistent over time. In the matched cohort in 2018, MSSP total spending ranged from 23% (CHF) to 30% (CKD) higher than MA. Adjusting for differential trends in coding intensity did not affect these results. Higher outpatient hospital spending among MSSP beneficiaries contributed most to spending differences between MSSP and MA, representing 49% to 62% of spending differences across disease cohorts. Conclusions and Relevance: In this study, utilization and spending were consistently higher for MSSP than MA beneficiaries within the same health system even after adjusting for granular metrics of clinical risk. Nonclinical factors likely contribute to the large differences in MA vs MSSP spending, which may create challenges for health systems participating in MSSP relative to their participation in MA.

Trends in Medically Integrated Dispensing Among Oncology Practices.

PURPOSE: The integration of pharmacies with oncology practices-known as medically integrated dispensing or in-office dispensing-could improve care coordination but may incentivize overprescribing or inappropriate prescribing. Because little is known about this emerging phenomenon, we analyzed historical trends in medically integrated dispensing. METHODS: Annual IQVIA data on oncologists were linked to 2010-2019 National Council for Prescription Drug Programs pharmacy data; data on commercially insured patients diagnosed with any of six common cancer types; and summary data on providers' Medicare billing. We calculated the national prevalence of medically integrated dispensing among community and hospital-based oncologists. We also analyzed the characteristics of the oncologists and patients affected by this care model. RESULTS: Between 2010 and 2019, the percentage of oncologists in practices with medically integrated dispensing increased from 12.8% to 32.1%. The share of community oncologists in dispensing practices increased from 7.6% to 28.3%, whereas the share of hospital-based oncologists in dispensing practices increased from 18.3% to 33.4%. Rates of medically integrated dispensing varied considerably across states. Oncologists who dispensed had higher patient volumes (P < .001) and a smaller share of Medicare beneficiaries (P < .001) than physicians who did not dispense. Patients treated by dispensing oncologists had higher risk and comorbidity scores (P < .001) and lived in areas with a higher % Black population (P < .001) than patients treated by nondispensing oncologists. CONCLUSION: Medically integrated dispensing has increased significantly among oncology practices over the past 10 years. The reach, clinical impact, and economic implications of medically integrated dispensing should be evaluated on an ongoing basis.

Oncology alternative payment models: lessons from commercial insurance.

Many payers and clinicians are committed to advancing value-based care through the establishment of alternative payment models (APMs) that incentivize practices and clinicians to improve quality and reduce cost. A multistakeholder working group has observed that in specialty fields such as oncology, despite many attempts to design and implement APM pilots for commercial and Medicare Advantage populations, practical challenges and small numbers of episodes and patients present headwinds to viability and scalability. Despite this, some payers report emerging good practices and are optimistic about APMs. Careful and realistic consideration of the specific goals of a proposed model is warranted, as is close examination of the feasibility of transferring risk.

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

BACKGROUND: Serious illness conversations (SICs) are an evidence-based approach to eliciting patients' values, goals, and care preferences that improve patient outcomes. However, most patients with cancer die without a documented SIC. Clinician-directed implementation strategies informed by behavioral economics ("nudges") that identify high-risk patients have shown promise in increasing SIC documentation among clinicians. It is unknown whether patient-directed nudges that normalize and prime patients towards SIC completion-either alone or in combination with clinician nudges that additionally compare performance relative to peers-may improve on this approach. Our objective is to test the effect of clinician- and patient-directed nudges as implementation strategies for increasing SIC completion among patients with cancer. METHODS: We will conduct a 2 × 2 factorial, cluster randomized pragmatic trial to test the effect of nudges to clinicians, patients, or both, compared to usual care, on SIC completion. Participants will include 166 medical and gynecologic oncology clinicians practicing at ten sites within a large academic health system and their approximately 5500 patients at high risk of predicted 6-month mortality based on a validated machine-learning prognostic algorithm. Data will be obtained via the electronic medical record, clinician survey, and semi-structured interviews with clinicians and patients. The primary outcome will be time to SIC documentation among high-risk patients. Secondary outcomes will include time to SIC documentation among all patients (assessing spillover effects), palliative care referral among high-risk patients, and aggressive end-of-life care utilization (composite of chemotherapy within 14 days before death, hospitalization within 30 days before death, or admission to hospice within 3 days before death) among high-risk decedents. We will assess moderators of the effect of implementation strategies and conduct semi-structured interviews with a subset of clinicians and patients to assess contextual factors that shape the effectiveness of nudges with an eye towards health equity. DISCUSSION: This will be the first pragmatic trial to evaluate clinician- and patient-directed nudges to promote SIC completion for patients with cancer. We expect the study to yield insights into the effectiveness of clinician and patient nudges as implementation strategies to improve SIC rates, and to uncover multilevel contextual factors that drive response to these strategies. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04867850 . Registered on April 30, 2021. FUNDING: National Cancer Institute P50CA244690.