Abstract：
UNASSIGNED: Serious illness conversations (SICs) that elicit patients\' values, goals, and care preferences reduce anxiety and depression and improve quality of life, but occur infrequently for patients with cancer. Behavioral economic implementation strategies (nudges) directed at clinicians and/or patients may increase SIC completion.
UNASSIGNED: To test the independent and combined effects of clinician and patient nudges on SIC completion.
UNASSIGNED: A 2 × 2 factorial, cluster randomized trial was conducted from September 7, 2021, to March 11, 2022, at oncology clinics across 4 hospitals and 6 community sites within a large academic health system in Pennsylvania and New Jersey among 163 medical and gynecologic oncology clinicians and 4450 patients with cancer at high risk of mortality (≥10% risk of 180-day mortality).
UNASSIGNED: Clinician clusters and patients were independently randomized to receive usual care vs nudges, resulting in 4 arms: (1) active control, operating for 2 years prior to trial start, consisting of clinician text message reminders to complete SICs for patients at high mortality risk; (2) clinician nudge only, consisting of active control plus weekly peer comparisons of clinician-level SIC completion rates; (3) patient nudge only, consisting of active control plus a preclinic electronic communication designed to prime patients for SICs; and (4) combined clinician and patient nudges.
UNASSIGNED: The primary outcome was a documented SIC in the electronic health record within 6 months of a participant\'s first clinic visit after randomization. Analysis was performed on an intent-to-treat basis at the patient level.
UNASSIGNED: The study accrued 4450 patients (median age, 67 years [IQR, 59-75 years]; 2352 women [52.9%]) seen by 163 clinicians, randomized to active control (n = 1004), clinician nudge (n = 1179), patient nudge (n = 997), or combined nudges (n = 1270). Overall patient-level rates of 6-month SIC completion were 11.2% for the active control arm (112 of 1004), 11.5% for the clinician nudge arm (136 of 1179), 11.5% for the patient nudge arm (115 of 997), and 14.1% for the combined nudge arm (179 of 1270). Compared with active control, the combined nudges were associated with an increase in SIC rates (ratio of hazard ratios [rHR], 1.55 [95% CI, 1.00-2.40]; P = .049), whereas the clinician nudge (HR, 0.95 [95% CI, 0.64-1.41; P = .79) and patient nudge (HR, 0.99 [95% CI, 0.73-1.33]; P = .93) were not.
UNASSIGNED: In this cluster randomized trial, nudges combining clinician peer comparisons with patient priming questionnaires were associated with a marginal increase in documented SICs compared with an active control. Combining clinician- and patient-directed nudges may help to promote SICs in routine cancer care.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04867850.
UNASSIGNED: To test the independent and combined effects of clinician and patient nudges on SIC completion.
UNASSIGNED: A 2 × 2 factorial, cluster randomized trial was conducted from September 7, 2021, to March 11, 2022, at oncology clinics across 4 hospitals and 6 community sites within a large academic health system in Pennsylvania and New Jersey among 163 medical and gynecologic oncology clinicians and 4450 patients with cancer at high risk of mortality (≥10% risk of 180-day mortality).
UNASSIGNED: Clinician clusters and patients were independently randomized to receive usual care vs nudges, resulting in 4 arms: (1) active control, operating for 2 years prior to trial start, consisting of clinician text message reminders to complete SICs for patients at high mortality risk; (2) clinician nudge only, consisting of active control plus weekly peer comparisons of clinician-level SIC completion rates; (3) patient nudge only, consisting of active control plus a preclinic electronic communication designed to prime patients for SICs; and (4) combined clinician and patient nudges.
UNASSIGNED: The primary outcome was a documented SIC in the electronic health record within 6 months of a participant\'s first clinic visit after randomization. Analysis was performed on an intent-to-treat basis at the patient level.
UNASSIGNED: The study accrued 4450 patients (median age, 67 years [IQR, 59-75 years]; 2352 women [52.9%]) seen by 163 clinicians, randomized to active control (n = 1004), clinician nudge (n = 1179), patient nudge (n = 997), or combined nudges (n = 1270). Overall patient-level rates of 6-month SIC completion were 11.2% for the active control arm (112 of 1004), 11.5% for the clinician nudge arm (136 of 1179), 11.5% for the patient nudge arm (115 of 997), and 14.1% for the combined nudge arm (179 of 1270). Compared with active control, the combined nudges were associated with an increase in SIC rates (ratio of hazard ratios [rHR], 1.55 [95% CI, 1.00-2.40]; P = .049), whereas the clinician nudge (HR, 0.95 [95% CI, 0.64-1.41; P = .79) and patient nudge (HR, 0.99 [95% CI, 0.73-1.33]; P = .93) were not.
UNASSIGNED: In this cluster randomized trial, nudges combining clinician peer comparisons with patient priming questionnaires were associated with a marginal increase in documented SICs compared with an active control. Combining clinician- and patient-directed nudges may help to promote SICs in routine cancer care.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT04867850.
摘要：
■引发患者价值观的严重疾病对话（SIC），目标,和护理偏好减少焦虑和抑郁，提高生活质量，但癌症患者很少发生。针对临床医生和/或患者的行为经济实施策略（轻推）可能会增加SIC完成。
■测试临床医生和患者轻推对SIC完成的独立和综合影响。
■A2×2阶乘，本研究于2021年9月7日至2022年3月11日在宾夕法尼亚州和新泽西州大型学术卫生系统内的4家医院和6个社区中心的肿瘤科诊所进行,纳入163名内科和妇科肿瘤临床医师和4450名具有高死亡风险(180日死亡率风险≥10%)的癌症患者中.
■临床医师集群和患者被独立随机分配接受常规治疗和轻推，产生4个武器：(1)主动控制，在试验开始前运行2年，由临床医生短信提醒组成，以完成高死亡率风险患者的SIC；(2)仅临床医生轻推，包括主动控制加上每周同行比较临床医生水平的SIC完成率；(3)仅患者微动，由主动控制和临床前电子通信组成，旨在为患者提供SIC；（4）结合临床医生和患者的轻推。
主要结果是参与者在随机分组后首次就诊后6个月内电子健康记录中记录的SIC。在患者水平的意向治疗基础上进行分析。
■该研究累积了4450名患者(中位年龄，67年[IQR，59-75岁]；163名临床医生观察到2352名女性[52.9%]，随机分为主动对照（n=1004），临床医生轻推(n=1179)，患者轻推（n=997），或组合推动(n=1270)。主动控制臂的6个月SIC完成的总体患者水平率为11.2％（1004个中的112个），临床医生推臂的11.5%(1179个中的136个)，11.5%的患者推臂（115/997），和14.1%的组合推动臂（1270个中的179个）。与主动控制相比，综合推动与SIC率的增加相关(风险比[rHR]，1.55[95%CI，1.00-2.40]；P=0.049），而临床医生轻推(HR，0.95[95%CI，0.64-1.41；P=0.79)和患者轻推(HR，0.99[95%CI，0.73-1.33]；P=.93）没有。
■在这项整群随机试验中，与主动对照相比，结合临床医生同伴比较和患者启动问卷的轻推与记录在案的SIC略有增加相关。结合临床和患者指导的轻推可能有助于在常规癌症护理中促进SIC。
■ClinicalTrials.gov标识符：NCT04867850。
■测试临床医生和患者轻推对SIC完成的独立和综合影响。
■A2×2阶乘，本研究于2021年9月7日至2022年3月11日在宾夕法尼亚州和新泽西州大型学术卫生系统内的4家医院和6个社区中心的肿瘤科诊所进行,纳入163名内科和妇科肿瘤临床医师和4450名具有高死亡风险(180日死亡率风险≥10%)的癌症患者中.
■临床医师集群和患者被独立随机分配接受常规治疗和轻推，产生4个武器：(1)主动控制，在试验开始前运行2年，由临床医生短信提醒组成，以完成高死亡率风险患者的SIC；(2)仅临床医生轻推，包括主动控制加上每周同行比较临床医生水平的SIC完成率；(3)仅患者微动，由主动控制和临床前电子通信组成，旨在为患者提供SIC；（4）结合临床医生和患者的轻推。
主要结果是参与者在随机分组后首次就诊后6个月内电子健康记录中记录的SIC。在患者水平的意向治疗基础上进行分析。
■该研究累积了4450名患者(中位年龄，67年[IQR，59-75岁]；163名临床医生观察到2352名女性[52.9%]，随机分为主动对照（n=1004），临床医生轻推(n=1179)，患者轻推（n=997），或组合推动(n=1270)。主动控制臂的6个月SIC完成的总体患者水平率为11.2％（1004个中的112个），临床医生推臂的11.5%(1179个中的136个)，11.5%的患者推臂（115/997），和14.1%的组合推动臂（1270个中的179个）。与主动控制相比，综合推动与SIC率的增加相关(风险比[rHR]，1.55[95%CI，1.00-2.40]；P=0.049），而临床医生轻推(HR，0.95[95%CI，0.64-1.41；P=0.79)和患者轻推(HR，0.99[95%CI，0.73-1.33]；P=.93）没有。
■在这项整群随机试验中，与主动对照相比，结合临床医生同伴比较和患者启动问卷的轻推与记录在案的SIC略有增加相关。结合临床和患者指导的轻推可能有助于在常规癌症护理中促进SIC。
■ClinicalTrials.gov标识符：NCT04867850。
