Rodriguez Gladys M, Parikh Divya A, Kapphahn Kris, Gupta Divya M, Fan Alice C, Shah Sumit, Srinivas Sandy, Teuteberg Winifred, Seevaratnam Briththa, Asuncion Khay, Chien Joanne, Moore Kaidi, Ruiz Shann Mika, Patel Manali I
Department of Medicine, Feinberg School of Medicine at Northwestern University, Chicago, Illinois.
Department of Medicine, Stanford University, Stanford, California.
JAMA Oncol. 2024 Jul 1;10(7):949-953. doi: 10.1001/jamaoncol.2024.1242.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
晚期癌症患者的预先护理计划（ACP）水平仍然较低。与临床医生层面的干预措施相比，多层次干预措施可能在改善ACP方面更有效。
评估与仅采用临床医生层面的干预措施相比，多层次干预措施是否能改善临床医生记录的ACP。
设计、地点和参与者：这项随机临床试验于2019年9月12日至2021年5月12日进行，纳入了一家学术性三级医院的晚期泌尿生殖系统癌症成年患者。数据分析于2023年5月1日至8月10日按意向性分析进行。
参与者按1:1随机分为接受为期6个月的患者层面的非专业健康工作者结构化ACP教育以及由3小时的ACP培训和结构化电子健康记录文档模板整合组成的临床医生层面的干预措施（干预组），或仅接受临床医生层面的干预措施（对照组）。
主要结局是随机分组后12个月内肿瘤临床医生在电子健康记录中记录的ACP。次要的探索性结局包括共同决策、姑息治疗使用情况、临终关怀使用情况、急诊就诊次数以及随机分组后12个月内的住院情况。
在纳入研究的402名参与者中，中位年龄为71岁（范围为21 - 102岁）；361名（89.8%）为男性。干预组中肿瘤临床医生记录有ACP的参与者比对照组更多（82名[37.8%]对40名[21.6%]；优势比[OR]为2.29；95%置信区间[CI]为1.44 - 3.64）。在12个月的随访中，接受干预的参与者比对照组更多地接受了姑息治疗（72名[33.2%]对25名[13.5%]；OR为3.18；95% CI为1.91 - 5.28）和临终关怀（49名[22.6%]对19名[10.3%]；OR为2.54；95% CI为1.44 - 4.51）。两组之间急诊就诊的参与者比例（65名[30.0%]对61名[33.0%]；OR为0.87；95% CI为0.57 - 1.33）或住院的参与者比例（89名[41.0%]对85名[46.0%]；OR为0.82；95% CI为0.55 - 1.22）没有差异。干预组参与者的住院次数少于对照组参与者（每年住院次数的均值[标准差]，0.87[1.60]对1.04[1.77]），且住院风险较低（发病率比为0.80；95% CI为0.65 - 0.98）。
在这项随机临床试验中，与仅针对泌尿生殖系统癌症患者的临床医生层面的干预措施相比，多层次干预措施改善了肿瘤临床医生记录的ACP。该干预措施是有效提高癌症患者ACP的一种方法。
ClinicalTrials.gov标识符：NCT03856463。
