Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, 10S-113, Philadelphia, PA, 19104, USA.
Penn Center for Cancer Care Innovation, Abramson Cancer Center, Penn Medicine, Philadelphia, PA, USA.
Implement Sci. 2021 Sep 25;16(1):90. doi: 10.1186/s13012-021-01156-6.
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.
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.
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.
ClinicalTrials.gov , NCT04867850 . Registered on April 30, 2021.
National Cancer Institute P50CA244690.
严重疾病对话（SIC）是一种基于证据的方法，可以引出患者的价值观、目标和护理偏好，从而改善患者的结局。然而，大多数癌症患者在没有记录 SIC 的情况下死亡。以行为经济学为基础的临床医生指导实施策略（“推动”），识别高危患者，已显示出在增加临床医生记录 SIC 方面的前景。目前尚不清楚针对患者的推动措施是否可以单独或与临床医生的推动措施结合使用，这些推动措施除了与同行进行绩效比较外，还可以将重点放在完成 SIC 上，从而提高这种方法的效果。我们的目标是测试临床医生和患者指导推动措施作为增加癌症患者完成 SIC 的实施策略的效果。
我们将进行一项 2×2 析因、聚类随机实用试验，以测试与常规护理相比，针对临床医生、患者或两者的推动措施对 SIC 完成的影响。参与者将包括在一家大型学术医疗系统的十个地点工作的 166 名医学和妇科肿瘤学临床医生及其大约 5500 名高危患者，这些患者根据经过验证的机器学习预测算法预测在 6 个月内死亡的风险较高。数据将通过电子病历、临床医生调查以及对临床医生和患者进行半结构化访谈获得。主要结果是高危患者的 SIC 记录时间。次要结果将包括所有患者的 SIC 记录时间（评估溢出效应）、高危患者的姑息治疗转介，以及高危死亡者的积极临终关怀利用（包括死亡前 14 天内的化疗、死亡前 30 天内的住院治疗或死亡前 3 天内的入院治疗）。我们将评估实施策略效果的调节因素，并对部分临床医生和患者进行半结构化访谈，以评估影响推动措施效果的背景因素，以期关注健康公平。
这将是第一项评估针对癌症患者促进 SIC 完成的临床医生和患者指导推动措施的实用试验。我们预计该研究将深入了解临床医生和患者推动措施作为提高 SIC 率的实施策略的有效性，并揭示推动这些策略的多层次背景因素。
ClinicalTrials.gov，NCT04867850。注册于 2021 年 4 月 30 日。
美国国立癌症研究所 P50CA244690。
