Wolff Jennifer L, Scerpella Danny, Giovannetti Erin R, Roth David L, Hanna Valecia, Hussain Naaz, Colburn Jessica L, Saylor Martha Abshire, Boyd Cynthia M, Cotter Valerie, McGuire Maura, Rawlinson Christine, Sloan Danetta H, Richards Thomas M, Walker Kathryn, Smith Kelly M, Dy Sydney M
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
MedStar Health, Columbia, Maryland.
JAMA Intern Med. 2025 Feb 1;185(2):162-170. doi: 10.1001/jamainternmed.2024.6215.
Primary care is a key setting for advance care planning (ACP).
To test the effects of a multicomponent primary care-based ACP intervention (SHARING Choices) on documented end-of-life preferences and potentially burdensome care at end of life.
DESIGN, SETTING, AND PARTICIPANTS: This pragmatic cluster randomized clinical trial in primary care practices from 2 health systems was conducted between March 2021 and April 2022. Adults 65 years and older with a scheduled in-person or telehealth visit with clinicians from participating practices were eligible for inclusion.
The treatment protocol encompassed an introductory letter from the clinic, access to a designated facilitator trained in ACP, a person-family agenda-setting checklist, shared access to the patient portal, a mailed advance directive, and print education. The control protocol encompassed usual care.
Primary outcomes included (1) new electronic health record-documented end-of-life preferences (advance directive or medical orders for life-sustaining treatment) at 12 months among those without documentation at baseline and (2) receipt of potentially burdensome care within 6 months of death among a subsample of Maryland residents with serious illness who died within 18 months of study entry from health information exchange data.
There were 19 practices in the intervention arm and 32 practices in the control arm. The study included 22 949 patients in the intervention group (13 575 women [59.2%]; mean [SD] age, 73.9 [7.2] years; 1674 [7.3%] with diagnosed dementia) and 41 966 in the control group (25 057 women [59.7%]; mean [SD] age, 74.0 [7.1] years; 3223 [7.9%] with diagnosed dementia). A total of 17 907 patients (27.6%) were Black, 1373 (2.1%) were Hispanic, 40 345 (62.2%) were White, and 5290 (8.2%) were another race (including American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander, and missing race). Grant-funded facilitators initiated 17 931 outreach attempts by phone (13 963 [77.9%]) and through the patient portal (3968 [22.1%]) to patients from intervention practices, and 1181 engaged in facilitator-led ACP conversations. New end-of-life preferences were documented for 2190 of 18 314 patients in the intervention arm (12.0%) and 2130 of 32 321 in the control arm (6.6%). This treatment effect was significant for the overall cohort (adjusted odds ratio, 2.15; 95% CI, 2.02-2.30) and present but attenuated for Black patients, those 75 years and older, and those diagnosed dementia. Among 1498 Maryland resident decedents, potentially burdensome care was higher in the intervention group (150 of 521 [28.8%] vs 204 of 977 [20.9%]; adjusted odds ratio, 1.40; 95% CI, 1.08-1.81).
In this pragmatic cluster randomized clinical trial, the SHARING Choices intervention increased new documentation of end-of-life preferences but also increased potentially burdensome care at end of life. Mixed findings underscore the importance of comprehensive support for those with serious illness and prioritizing patient-relevant outcomes in ACP interventional research.
ClinicalTrials.gov Identifier: NCT04819191.
初级保健是预先护理计划（ACP）的关键场所。
测试基于初级保健的多成分ACP干预措施（共享选择）对记录在案的临终偏好以及临终时潜在的负担性护理的影响。
设计、设置和参与者：这项实用的整群随机临床试验于2021年3月至2022年4月在2个卫生系统的初级保健机构中进行。年龄在65岁及以上、计划与参与机构的临床医生进行面对面或远程医疗就诊的成年人符合纳入条件。
治疗方案包括诊所的介绍信、获得经过ACP培训的指定协调员、个人-家庭议程设定清单、共享患者门户网站访问权限、邮寄的预先医疗指示以及印刷品教育。对照方案包括常规护理。
主要结局包括：（1）在基线时无记录的患者中，12个月时新的电子健康记录记录的临终偏好（预先医疗指示或维持生命治疗医嘱）；（2）从健康信息交换数据中，在研究入组后18个月内死亡的患有严重疾病的马里兰州居民子样本中，死亡后6个月内接受潜在负担性护理的情况。
干预组有19个机构，对照组有32个机构。该研究纳入了干预组的22949名患者（13575名女性[59.2%]；平均[标准差]年龄，73.9[7.2]岁；1674名[7.3%]患有痴呆症）和对照组的41966名患者（25057名女性[59.7%]；平均[标准差]年龄，74.0[7.1]岁；3223名[7.9%]患有痴呆症）。共有17907名患者（27.6%）为黑人，1373名（2.1%）为西班牙裔，40345名（62.2%）为白人，5290名（8.2%）为其他种族（包括美洲印第安人或阿拉斯加原住民、亚洲人、夏威夷原住民或其他太平洋岛民，以及种族信息缺失者）。由赠款资助的协调员通过电话（13963次[77.9%]）和患者门户网站（3968次[22.1%]）对干预机构的患者发起了17931次外展尝试，1181名患者参与了由协调员主导的ACP对话。干预组18314名患者中有2190名（12.0%）记录了新的临终偏好，对照组32321名患者中有2130名（6.6%）记录了新的临终偏好。这种治疗效果在整个队列中具有显著性（调整后的优势比，2.15；95%置信区间，2.02-2.30），在黑人患者、75岁及以上患者以及患有痴呆症的患者中也存在但有所减弱。在1498名马里兰州居民死亡者中，干预组的潜在负担性护理更高（521名中的150名[28.8%]对977名中的204名[20.9%]；调整后的优势比，1.40；95%置信区间，1.08-1.81）。
在这项实用的整群随机临床试验中，共享选择干预增加了临终偏好的新记录，但也增加了临终时潜在的负担性护理。混合结果强调了对患有严重疾病的人提供全面支持以及在ACP干预研究中优先考虑与患者相关结局的重要性。
ClinicalTrials.gov标识符：NCT04819191。
