Bakitas Marie A, Gazaway Shena, Underwood Felicia, Ekelem Christiana, Heard Vantrice T, Kennedy Richard, Azuero Andres, Tucker Rodney, McCammon Susan, Hauser Joshua M, McElwain Lucas, Elk Ronit
Acute, Chronic and Continuing Care, School of Nursing, University of Alabama at Birmingham.
Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Medicine, Heersink School of Medicine, University of Alabama at Birmingham.
JAMA Netw Open. 2025 Jul 1;8(7):e2519426. doi: 10.1001/jamanetworkopen.2025.19426.
Palliative care has been shown to improve important patient outcomes but is rarely available in small or rural hospitals.
To assess whether culturally based palliative care video consultation could improve symptom distress compared with usual inpatient care without palliative care.
DESIGN, SETTING, AND PARTICIPANTS: Recruitment for this multisite, single-blind randomized clinical trial occurred from July 20, 2020, to December 20, 2023; data collection was completed on January 15, 2024. A community-aided approach was used to recruit inpatients from 3 rural hospitals lacking palliative care services in Alabama, Mississippi, and South Carolina. Self-identified non-Hispanic Black or African American and non-Hispanic White adults aged 55 years or older admitted with a serious chronic illness and a willing caregiver were invited to participate. Randomization was stratified by site and race.
Participants were randomized 1:1 to Community Tele-Pal, culturally based video consultation by a palliative care specialist followed by research coordinator (RC) contacts 3 and 6 days after video consultation (intervention arm), or to routine hospital care (control arm).
The primary outcome was the between-group difference in the change in patient-reported symptom distress from baseline to day 7, assessed by the Edmonton Symptom Assessment Scale (ESAS; range, 0-90; lower scores indicate lower symptom distress). Secondary outcomes were quality of life (QOL; Patient-Reported Outcomes Measurement Information System global physical and mental health mean T scores), resource use (emergency department visits and hospital readmissions), and an exploratory outcome of feeling heard and understood.
A total of 209 patients were randomized (104 to usual care; 105 to the intervention); mean (SD) age was 73.3 (8.3) years, 120 (57.4%) were female, 58 (27.8%) were Black or African American, 157 (75.1%) were retired, and 75 (35.9%) had a Palliative Performance Scale score less than 70% (indicating need for functional assistance). On day 7, the mean (SE) ESAS score change from baseline was -11.4 (1.5) points in the intervention group and -7.3 (1.5) points in the control group; the between-group difference in change in ESAS scores was not statistically significant (Westfall d, -0.28; 95% CI, -0.56 to 0.01; P = .055). The mean (SE) day 7 between-group difference in ESAS score of -4.0 (1.8) points met the criteria for a minimal clinically important difference of 3 to 4 points. No between-group differences were observed for QOL, resource use, or feeling heard and understood.
In this randomized clinical trial, the intervention was not associated with reduced symptom distress at day 7 vs baseline or with improved QOL or reduced resource use compared with usual care. However, the between-group difference in the ESAS score met the criteria for a minimal clinically important difference of 3 to 4 points. Palliative video consultation to reduce health care inequities for hospitalized rural-dwelling individuals may warrant further investigation.
ClinicalTrials.gov Identifier: NCT03767517.
姑息治疗已被证明可改善患者的重要预后,但在小型或农村医院中却很少能获得。
评估与没有姑息治疗的常规住院治疗相比,基于文化的姑息治疗视频会诊是否能减轻症状困扰。
设计、地点和参与者:这项多中心、单盲随机临床试验的招募时间为2020年7月20日至2023年12月20日;数据收集于2024年1月15日完成。采用社区辅助方法从阿拉巴马州、密西西比州和南卡罗来纳州3家缺乏姑息治疗服务的农村医院招募住院患者。邀请自我认定为非西班牙裔黑人或非裔美国人以及55岁及以上、患有严重慢性病且有意愿的照顾者的非西班牙裔白人成年人参与。随机分组按地点和种族进行分层。
参与者按1:1随机分为接受社区远程姑息治疗组(由姑息治疗专家进行基于文化的视频会诊,随后研究协调员在视频会诊后第3天和第6天进行联系,干预组)或常规医院护理组(对照组)。
主要结局是从基线到第7天患者报告的症状困扰变化的组间差异,采用埃德蒙顿症状评估量表(ESAS;范围为0 - 90;分数越低表明症状困扰越低)进行评估。次要结局包括生活质量(QOL;患者报告结局测量信息系统全球身心健康平均T分数)、资源利用(急诊就诊和再次住院)以及被倾听和理解的探索性结局。
共有209名患者被随机分组(104名接受常规护理;105名接受干预);平均(标准差)年龄为73.3(8.3)岁,120名(57.4%)为女性,58名(27.8%)为黑人或非裔美国人,157名(75.1%)已退休,75名(35.9%)的姑息治疗表现量表得分低于70%(表明需要功能协助)。在第7天,干预组ESAS评分从基线的平均(标准误)变化为 - 11.4(1.5)分,对照组为 - 7.3(1.5)分;ESAS评分变化的组间差异无统计学意义(韦斯特福尔d值, - 0.28;95%置信区间, - 0.56至0.01;P = 0.055)。第7天两组间ESAS评分差异平均(标准误)为 - 4.0(1.8)分,达到了3至- 分的最小临床重要差异标准。在生活质量、资源利用或被倾听和理解方面未观察到组间差异。
在这项随机临床试验中,与常规护理相比,干预措施在第7天与基线相比并未减少症状困扰,也未改善生活质量或减少资源利用。然而,ESAS评分的组间差异达到了3至4分的最小临床重要差异标准。通过姑息治疗视频会诊减少农村住院患者的医疗保健不平等现象可能值得进一步研究。
ClinicalTrials.gov标识符:NCT03767517。