Fischer Stacy M, Min Sung-Joon, Kline Danielle M, Lester Kathleen, Gozansky Wendolyn, Schifeling Christopher, Himberger John, Lopez Joseph, Fink Regina M
Division of General Internal Medicine, University of Colorado School of Medicine, Aurora.
University of Colorado School of Medicine, Aurora.
JAMA Intern Med. 2024 Apr 1;184(4):384-393. doi: 10.1001/jamainternmed.2023.8145.
Disparities persist across the trajectory of serious illness, including at the end of life. Patient navigation has been shown to reduce disparities and improve outcomes for underserved populations.
To determine the effectiveness of a lay patient navigator intervention, Apoyo con Cariño, in improving palliative care outcomes among Hispanic patients.
DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter randomized clinical trial that took place across academic, nonprofit, safety-net, and community health care systems in urban, rural, and mountain/frontier regions of Colorado from January 2017 to January 2021. Self-identifying Hispanic adults with serious noncancer medical illness and limited prognosis were recruited. Data were collected and analyzed from July 2022 to July 2023.
Participants randomized to the intervention group received 5 home visits from a bilingual, bicultural lay patient navigator; participants randomized to control received care as usual. Both groups received culturally tailored educational materials. Investigators/outcome accessors remained blinded to participant assignment.
Change in score from baseline to 3 months on the Functional Assessment of Chronic Illness Therapy (FACIT) General quality of life (QOL) scale (primary outcome), Advance Care Planning (ACP) Engagement Survey, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and FACIT Spiritual Well-Being subscale; at 6 months, advance directive (AD) documentation; and at 46 months or death, hospice utilization and length of stay, as well as aggressiveness of care at end of life.
Of 209 patients enrolled (mean [SD] age, 63.6 [14.3] years; 108 [51.7%] male), 105 patients were randomized to control and 104 patients to the intervention. There were no statistically significant differences in the change in mean (SD) QOL score between the intervention and control groups (5.0 [16.5] vs 4.3 [15.5]; P = .75). Participants in the intervention group, compared with the control group, had statistically significant greater increases in mean (SD) ACP engagement (0.8 [1.3] vs 0.1 [1.4]; P < .001) and were more likely to have a documented AD (62 of 104 [59.6%] vs 28 of 105 [26.9%]; P < .001). There were no statistically significant differences in mean (SD) change in pain intensity score (0-10) between patients in the intervention group compared with control (-0.4 [2.6] vs -0.5 [2.8]; P = .79), nor pain interference (-0.2 [3.7] vs -0.4 [3.7]; P = .71). Patients receiving the intervention were more likely to be referred to hospice compared with patients receiving control (19 of 43 patients [44.2%] vs 7 of 33 patients [21.2%]; P = .04) and less likely to receive aggressive care at end of life (27 of 42 patients [64.3%] vs 28 of 33 patients [84.8%]; P = .046).
In this randomized clinical trial, a culturally tailored patient navigator intervention did not improve QOL for patients. However, the intervention did increase ACP engagement, AD documentation, and hospice utilization in Hispanic persons with serious medical illness.
ClinicalTrials.gov Identifier: NCT03181750.
在严重疾病的整个过程中，包括在生命末期，差异依然存在。患者导航已被证明可以减少差异并改善弱势群体的治疗效果。
确定非专业患者导航干预措施“关爱支持”（Apoyo con Cariño）对改善西班牙裔患者姑息治疗效果的有效性。
设计、设置和参与者：这是一项多中心随机临床试验，于2017年1月至2021年1月在科罗拉多州城市、农村和山区/边境地区的学术、非营利性、安全网和社区医疗系统中进行。招募了自我认定为患有严重非癌症疾病且预后有限的西班牙裔成年人。数据于2022年7月至2023年7月收集和分析。
随机分配到干预组的参与者接受了一位双语、双文化的非专业患者导航员的5次家访；随机分配到对照组的参与者接受常规护理。两组均收到根据文化定制的教育材料。研究人员/结果评估人员对参与者的分组情况保持盲态。
从基线到3个月时慢性疾病治疗功能评估（FACIT）总体生活质量（QOL）量表的得分变化（主要结局）、预先护理计划（ACP）参与度调查、简明疼痛量表、埃德蒙顿症状评估量表和FACIT精神健康子量表；6个月时，预先指示（AD）文件记录；46个月或死亡时，临终关怀的使用情况和住院时间，以及生命末期的积极治疗情况。
在纳入的209名患者中（平均[标准差]年龄为63.6[14.3]岁；108名[51.7%]为男性），105名患者被随机分配到对照组，104名患者被随机分配到干预组。干预组和对照组之间平均（标准差）QOL得分的变化没有统计学上的显著差异（5.0[16.5]对4.3[15.5]；P = 0.75）。与对照组相比，干预组患者在平均（标准差）ACP参与度方面有统计学上显著更大的增加（0.8[1.3]对0.1[1.4]；P < 0.001），并且更有可能有AD文件记录（104名中的62名[59.6%]对105名中的28名[26.9%]；P < 0.001）。干预组患者与对照组相比，疼痛强度得分（0 - 10）的平均（标准差）变化没有统计学上的显著差异（-0.4[2.6]对-0.5[2.8]；P = 0.79），疼痛干扰方面也没有差异（-0.2[3.7]对-0.4[3.7]；P = 0.71）。与接受对照的患者相比，接受干预的患者更有可能被转介至临终关怀（43名患者中的19名[44.2%]对33名患者中的7名[21.2%]；P = 0.04），并且在生命末期接受积极治疗的可能性较小（42名患者中的27名[64.3%]对33名患者中的28名[84.8%]；P = 0.046）。
在这项随机临床试验中，一项根据文化定制的患者导航干预措施并未改善患者的生活质量。然而，该干预措施确实提高了患有严重疾病的西班牙裔人群的ACP参与度、AD文件记录和临终关怀利用率。
ClinicalTrials.gov标识符：NCT03181750。
