晚期癌症患者的预先护理计划（ACP）仍然较低。与临床医生级别的干预相比，多级干预可能更有效地改善 ACP。旨在评估与单独临床医生级别的干预相比，多级干预是否可以改善临床医生记录的 ACP。这项随机临床试验于 2019 年 9 月 12 日进行，至2021 年 5 月 12 日，研究对象包括一家学术三级医院患有晚期泌尿生殖系统癌症的成年人。数据分析是按意向治疗从 2023 年 5 月 1 日至 8 月 10 日进行的。参与者以 1:1 的比例随机接受为期 6 个月的患者级非专业卫生工作者结构化 ACP 教育以及由 3 小时 ACP 组成的临床医生级干预结构化电子健康记录文档模板的培训和集成（干预组）或仅临床医生级别的干预（对照组）。主要结果是肿瘤临床医生在随机化后 12 个月内将 ACP 记录在电子健康记录中。其次，探索性结果包括共同决策、姑息治疗的使用、临终关怀的使用、急诊科就诊以及随机分组后 12 个月内的住院治疗。在参与该研究的 402 名参与者中，中位年龄为 71 岁（范围为 21-102 岁） ; 361 人 (89.8%) 被确定为男性。与对照组参与者相比，干预组参与者有肿瘤临床医生记录的 ACP（82 人 [37.8%] vs 40 人 [21.6%]；比值比 [OR]，2.29；95% CI，1.44-3.64）。在 12 个月的随访中，比对照组参与者接受姑息治疗（72 人 [33.2%] vs 25 [13.5%]；OR，3.18；95% CI，1.91-5.28）和临终关怀服务（49 [22.6%] ] vs 19 [10.3%]；OR，2.54；95% CI，1.44-4.51）。急诊科就诊（65 [30.0%] vs 61 [33.0%]；OR，0.87；95% CI，0.57-1.33）或住院治疗（89 [41.0%] vs 85 [46.0%]；OR，0.82；95% CI，0.55-1.22）。干预组参与者的住院次数比对照组参与者少（平均[SD]每年住院次数，0.87 [1.60] vs 1.04 [1.77]），住院风险也较低（发病率比，0.80；95% CI，0.65- 0.98）。在这项随机临床试验中，与单独的临床医生水平干预相比，多水平干预改善了肿瘤临床医生记录的 ACP。该干预措施是有效增加癌症患者 ACP 的一种方法。ClinicalTrials.gov 标识符：NCT03856463。

Advance care planning (ACP) remains low among patients with advanced cancer. Multilevel interventions compared with clinician-level interventions may be more effective in improving ACP.To evaluate whether a multilevel intervention could improve clinician-documented ACP compared with a clinician-level intervention alone.This randomized clinical trial, performed from September 12, 2019, through May 12, 2021, included adults with advanced genitourinary cancers at an academic, tertiary hospital. Data analysis was performed by intention to treat from May 1 to August 10, 2023.Participants were randomized 1:1 to a 6-month patient-level lay health worker structured ACP education along with a clinician-level intervention composed of 3-hour ACP training and integration of a structured electronic health record documentation template (intervention group) or to the clinician-level intervention alone (control group).The primary outcome was ACP documentation in the electronic health record by the oncology clinician within 12 months after randomization. Secondary, exploratory outcomes included shared decision-making, palliative care use, hospice use, emergency department visits, and hospitalizations within 12 months after randomization.Among 402 participants enrolled in the study, median age was 71 years (range, 21-102 years); 361 (89.8%) identified as male. More intervention group participants had oncology clinician-documented ACP than control group participants (82 [37.8%] vs 40 [21.6%]; odds ratio [OR], 2.29; 95% CI, 1.44-3.64). At 12-month follow-up, more intervention than control group participants had palliative care (72 [33.2%] vs 25 [13.5%]; OR, 3.18; 95% CI, 1.91-5.28) and hospice use (49 [22.6%] vs 19 [10.3%]; OR, 2.54; 95% CI, 1.44-4.51). There were no differences in the proportion of participants between groups with an emergency department visit (65 [30.0%] vs 61 [33.0%]; OR, 0.87; 95% CI, 0.57-1.33) or hospitalization (89 [41.0%] vs 85 [46.0%]; OR, 0.82; 95% CI, 0.55-1.22). Intervention group participants had fewer hospitalizations than control group participants (mean [SD] number of hospitalizations per year, 0.87 [1.60] vs 1.04 [1.77]) and a lower risk of hospitalization (incidence rate ratio, 0.80; 95% CI, 0.65-0.98).In this randomized clinical trial, a multilevel intervention improved oncology clinician-documented ACP compared with a clinician-level intervention alone for patients with genitourinary cancer. The intervention is one approach to effectively increase ACP among patients with cancer.ClinicalTrials.gov Identifier: NCT03856463.