Harvard Medical School, Boston, Massachusetts.
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts.
JAMA Intern Med. 2019 Jun 1;179(6):751-759. doi: 10.1001/jamainternmed.2019.0077.
High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently.
To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes.
DESIGN, SETTING, AND PARTICIPANTS: A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat.
Tools, training, and system changes.
The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated.
Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups.
The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study.
ClinicalTrials.gov identifier: NCT01786811.
临床医生与重病患者之间就价值观和目标进行高质量的对话与改善结局相关，但这种对话很少发生。
研究一种沟通质量改进干预措施（严重疾病护理计划）对患者结局的可行性、可接受性和效果。
设计、地点和参与者：一项在门诊肿瘤环境中进行的严重疾病护理计划的集群随机临床试验。2012 年 9 月 1 日至 2016 年 6 月 30 日期间，纳入了 278 例晚期癌症患者和 91 例肿瘤临床医生。数据分析于 2016 年 9 月 1 日至 2018 年 12 月 27 日进行。所有分析均基于意向治疗。
工具、培训和系统变革。
两个主要结局包括生命优先事项（生活优先事项）和生命终末期的平静感（癌症体验问卷中的平和、平静和接受）。次要结局包括治疗联盟（人际连接量表）、焦虑（广泛性焦虑障碍 7 量表）、抑郁（患者健康问卷 9）和生存。评估了临床医生培训的接受度和有效性、临床医生使用对话工具的情况以及对话持续时间。
分析了来自 41 个集群中的 91 名临床医生（72.9%的参与率；干预组，n=48；对照组，n=43；52[57.1%]名女性）和 278 名患者（45.8%的参与率；干预组，n=134；对照组，n=144；148[53.2%]名女性）的数据。47 名临床医生（97.9%）认为培训有效（平均[标准差]评分，5.0 分制中的 4.3[0.7]分）；在接受提醒的 39 名临床医生中，有 34 名（87.2%）至少完成了 1 次对话（中位数持续时间，19 分钟；范围，5-70 分钟）。基线时，平静感、治疗联盟、焦虑和抑郁没有差异。主要结局在 64 例患者中进行了评估；干预组和对照组之间没有发现显著差异。然而，该试验显示，在基线后 14 周，干预组中度至重度焦虑（10.2%对 5.0%；P=0.05）和抑郁症状（20.8%对 10.6%；P=0.04）的患者比例显著降低。焦虑的减少在 24 周时仍持续（10.4%对 4.2%；P=0.02），但抑郁的减少不再持续（17.8%对 12.5%；P=0.31）。两组间的生存和治疗联盟没有差异。
本集群随机临床试验的结果在生命终末期目标一致的护理和平静感这两个主要结局方面为阴性。主要结局的方法学挑战，包括测量选择和样本量，限制了从研究中得出的结论。然而，干预组焦虑和抑郁的显著减少具有临床意义，需要进一步研究。
ClinicalTrials.gov 标识符：NCT01786811。
