Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure The CASA Randomized Clinical Trial
Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure The CASA Randomized Clinical Trial
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DOI：
10.1001/jamainternmed.2017.8667
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发表时间：
2018-04-01
影响因子：
39
通讯作者：
Meek, Paula M.
中科院分区：
文献类型：
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作者：
Bekelman, David B.;Allen, Larry A.;Meek, Paula M.
重要性许多慢性心力衰竭患者尽管接受常规治疗，但其健康状况仍有所下降。目的：确定症状和心理社会协作护理干预是否能改善心力衰竭患者的心力衰竭特异性健康状况、抑郁和症状负担。在2012年8月至2015年4月期间招募的科罗拉多有症状的心力衰竭和健康状况下降的门诊患者中，所有参与者的数据包括无论参与水平，使用intent-to-treatmentapproach.INTERVENTIONS患者随机1：1接受协作护理，以缓解症状和适应疾病（CASA）干预或常规护理。CASA干预包括由护士提供的协作症状护理和由社会工作者提供的心理社会护理，两者都与患者的初级保健临床医生一起工作，并由研究初级保健临床医生、心脏病专家和姑息治疗医生监督。通过6个月时堪萨斯城心肌病问卷（范围，0-100）的变化评分的差异来测量。次要结局包括抑郁症（通过9项患者健康问卷测量），焦虑（通过7项广泛性焦虑症问卷测量），总体症状困扰（通过一般症状困扰量表测量），具体症状（疼痛、疲劳和呼吸急促）、住院次数，结果314例随机分组的患者中，（干预组157例，对照组157例），女性67例，男性247例，平均（SD）年龄65.5（11.4）岁，射血分数降低178例（56.7%）。6个月时，干预组平均堪萨斯城心肌病问卷评分改善5.5分，对照组改善2.9分（差异为2.6; 95%CI，-1.3至6.6; P= 0.19）。在次要结局中，使用CASA后6个月，抑郁症状和疲劳有所改善（抑郁症状的效应量为-0.29 [95%CI，-0.53至-0.04]，疲劳的效应量为-0.30 [95%CI，-0.55至-0.06];两者P= 0.02）。总体症状困扰、疼痛、呼吸急促或住院次数无显著变化。两组12个月时的死亡率相似（10例患者死于CASA治疗，13例患者死于常规治疗; P= 0.52）。结论和相关性CASA干预的多中心随机临床试验并未显示心力衰竭特异性健康状况的改善。抑郁和疲劳的次要结局，这两个在心力衰竭中难以治疗的症状，得到改善。
IMPORTANCE Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy.OBJECTIVE To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure.DESIGN, SETTING, AND PARTICIPANTS A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach.INTERVENTIONS Patients were randomized 1: 1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician.MAIN OUTCOMES AND MEASURES The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality.RESULTS Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, -1.3 to 6.6; P=.19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of -0.29 [95% CI, -0.53 to -0.04] for depressive symptoms and -0.30 [95% CI, -0.55 to -0.06] for fatigue; P=.02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P=.52).CONCLUSIONS AND RELEVANCE This multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure-specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved.