1. Nalley, Catlin

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Findings from a randomized controlled trial that combined two evidence-based interventions were recently presented at the 2021 ASCO Quality Care Symposium. The researchers demonstrated that the CAREPlan (Coaches Activating Reaching and Engaging Patients) program increased goals of care documentation by the primary oncologist (Abstract 2).

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"Goals-of-care documentation is essential for high-quality cancer care to ensure that the care our patients receive, whether in their oncology clinician's office or hospitalized on the inpatient wards, is consistent with their preferences," noted study author Divya Ahuja Parikh, MD, Staff Oncologist at VA Palo Alto Health Care System and Clinical Assistant Professor of Oncology at Stanford University.


Combining Two Interventions

Recognizing that the rate of documentation of goals of care remains low in many care settings, the researchers sought to fill this gap. In their prior work, they found that community or lay health worker-led goals of care interventions improved goals of care documentation by clinicians and decreased health care use at the end of life.


"Other studies have demonstrated improvements in provider-patient communication and goals of care documentation using the Serious Illness Care Program," according to the study authors. "The objective of this study was to determine whether the combination of these two interventions could improve goals of care documentation among patients with advanced stages of genitourinary cancers at an academic center."


The CAREPlan tested a combination of both of these evidence-based interventions. "Lay health workers, who we call care coaches, were trained in a series of skills-based seminars to hold advanced care planning conversations with urologic oncology patients," explained Parikh. "They were also trained along with providers to use a serious illness conversation guide."


Care coaches reached out to patients on the intervention arm via phone or in person, according to Parikh. Everything was documented in a standardized template on the electronic medical record.


"Our eligibility criteria were determined by the urologic oncology providers in order to help identify patients who they thought would most benefit from the intervention," said Parikh. This included patients who had metastatic or recurrent prostate, kidney, urothelial, or adrenal cancer with ongoing care at Stanford Cancer Center.


Eligible patients had completed at least two lines of systemic therapy in the metastatic setting. Exclusion criteria included patients who were not under medical oncology care at the institution, diagnosis of germ cell tumor, and were younger than 18 years old.


Study Findings

The researchers assessed 1,090 patients for eligibility and 334 were enrolled. Of those, 149 were assigned to the control arm and 185 were included in the intervention arm.


"Our analysis involved descriptive statistics to compare demographics and clinical characteristics, a logistic regression to look at goals-of-care documentation by the care coach as a process metric within the 12-month follow-up period, [and] a generalized logistic regression for primary outcome, which is goals-of-care documentation by the oncologist in the 12-month follow-up period," explained Parikh. "All models were adjusted for unbalanced characteristics."


In terms of patient demographics, the majority of patients in both arms were male and non-Hispanic White. Parikh noted that there was an imbalance of significantly more female patients on the control arm, which was adjusted for in the regression analysis. The majority of patients had prostate cancer, followed by kidney cancer and urothelial cancer. Most study participants had Stage IV disease at diagnosis.


The adjusted analysis showed that at 12-months follow-up, the intervention significantly increased goals of care documentation by the primary oncologist compared to the control group (41% vs. 20%), Parikh reported during her presentation.


"We are excited to see this improvement in goals-of-care documentation with a combination of these two evidence-based interventions," she said. "However, I think it is important to look back at the original study done by Dr. Patel at the VA Palo Alto. And although we can't compare across two different clinical trials, note the difference in the effect size at the VA versus in our study at a single academic medical center.


"We can hypothesize that differences in the actual health care system-the VA being one of the largest integrated health care systems in the U.S. with a strong effort for quality improvement-potentially making this difference possible," she continued.


The current study has a number of strengths, including that it was a randomized controlled trial that implemented and adapted two evidence-based solutions with input from the urologic oncology providers, Parikh noted. "It also provided significant improvements in goals-of-care documentation. However, it was done at a single academic medical center and may not be generalizable."


Parikh also acknowledged two other study limitations. The inclusion criteria resulted in a complex screening process that was time-consuming and provider documentation was primarily in the clinic notes. Additional analyses, including health care utilization, hospice use at the end of life, and patient-reported outcomes are ongoing and will be published in the final manuscript.


Catlin Nalley is a contributing writer.