护士和社会工作者姑息治疗远程护理团队与 COPD、心力衰竭或间质性肺病患者的生活质量:ADAPT 随机临床试验。
Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial.
机构信息
Department of Veterans Affairs, Eastern Colorado Health Care System, Aurora.
Seattle-Denver Center of Innovation for Veteran-Centered and Value-Driven Care, VA Eastern Colorado Health Care Systems, Aurora, Colorado.
出版信息
JAMA. 2024 Jan 16;331(3):212-223. doi: 10.1001/jama.2023.24035.
IMPORTANCE
Many patients with chronic obstructive pulmonary disease (COPD), heart failure (HF), and interstitial lung disease (ILD) endure poor quality of life despite conventional therapy. Palliative care approaches may benefit this population prior to end of life.
OBJECTIVE
Determine the effect of a nurse and social worker palliative telecare team on quality of life in outpatients with COPD, HF, or ILD compared with usual care.
DESIGN, SETTING, AND PARTICIPANTS: Single-blind, 2-group, multisite randomized clinical trial with accrual between October 27, 2016, and April 2, 2020, in 2 Veterans Administration health care systems (Colorado and Washington), and including community-based outpatient clinics. Outpatients with COPD, HF, or ILD at high risk of hospitalization or death who reported poor quality of life participated.
INTERVENTION
The intervention involved 6 phone calls with a nurse to help with symptom management and 6 phone calls with a social worker to provide psychosocial care. The nurse and social worker met weekly with a study primary care and palliative care physician and as needed, a pulmonologist, and cardiologist. Usual care included an educational handout developed for the study that outlined self-care for COPD, ILD, or HF. Patients in both groups received care at the discretion of their clinicians, which could include care from nurses and social workers, and specialists in cardiology, pulmonology, palliative care, and mental health.
MAIN OUTCOMES AND MEASURES
The primary outcome was difference in change in quality of life from baseline to 6 months between the intervention and usual care groups (FACT-G score range, 0-100, with higher scores indicating better quality of life, clinically meaningful change ≥4 points). Secondary quality-of-life outcomes at 6 months included disease-specific health status (Clinical COPD Questionnaire; Kansas City Cardiomyopathy Questionnaire-12), depression (Patient Health Questionnaire-8) and anxiety (Generalized Anxiety Disorder-7) symptoms.
RESULTS
Among 306 randomized patients (mean [SD] age, 68.9 [7.7] years; 276 male [90.2%], 30 female [9.8%]; 245 White [80.1%]), 177 (57.8%) had COPD, 67 (21.9%) HF, 49 (16%) both COPD and HF, and 13 (4.2%) ILD. Baseline FACT-G scores were similar (intervention, 52.9; usual care, 52.7). FACT-G completion was 76% (intervention, 117 of 154; usual care, 116 of 152) at 6 months for both groups. Mean (SD) length of intervention was 115.1 (33.4) days and included a mean of 10.4 (3.3) intervention calls per patient. In the intervention group, 112 of 154 (73%) patients received the intervention as randomized. At 6 months, mean FACT-G score improved 6.0 points in the intervention group and 1.4 points in the usual care group (difference, 4.6 points [95% CI, 1.8-7.4]; P = .001; standardized mean difference, 0.41). The intervention also improved COPD health status (standardized mean difference, 0.44; P = .04), HF health status (standardized mean difference, 0.41; P = .01), depression (standardized mean difference, -0.50; P < .001), and anxiety (standardized mean difference, -0.51; P < .001) at 6 months.
CONCLUSIONS AND RELEVANCE
For adults with COPD, HF, or ILD who were at high risk of death and had poor quality of life, a nurse and social worker palliative telecare team produced clinically meaningful improvements in quality of life at 6 months compared with usual care.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02713347.
重要性
许多患有慢性阻塞性肺疾病(COPD)、心力衰竭(HF)和间质性肺疾病(ILD)的患者尽管接受了常规治疗,但生活质量仍较差。姑息治疗方法可能在生命末期之前使这一人群受益。
目的
确定护士和社会工作者姑息治疗远程护理团队对 COPD、HF 或 ILD 门诊患者生活质量的影响,与常规护理相比。
设计、地点和参与者:单盲、2 组、多地点随机临床试验,于 2016 年 10 月 27 日至 2020 年 4 月 2 日在两个退伍军人事务部医疗保健系统(科罗拉多州和华盛顿州)和社区门诊诊所进行,包括 COPD、HF 或 ILD 高危住院或死亡的门诊患者,报告生活质量差。
干预措施
干预措施包括与护士进行 6 次电话沟通,帮助管理症状,与社会工作者进行 6 次电话沟通,提供社会心理关怀。护士和社会工作者每周与一名初级保健和姑息治疗医生以及按需与肺病专家和心脏病专家会面。常规护理包括为研究制定的教育手册,概述 COPD、ILD 或 HF 的自我护理。两组患者均根据其临床医生的建议接受护理,包括护士和社会工作者以及心脏病学、肺病学、姑息治疗和心理健康方面的专家的护理。
主要结果和测量
主要结果是干预组和常规护理组从基线到 6 个月时生活质量变化的差异(FACT-G 评分范围为 0-100,得分越高表示生活质量越好,临床有意义的变化≥4 分)。6 个月时的次要生活质量结果包括疾病特异性健康状况(临床 COPD 问卷;堪萨斯城心肌病问卷-12)、抑郁(患者健康问卷-8)和焦虑(广泛性焦虑障碍-7)症状。
结果
在 306 名随机患者中(平均[标准差]年龄,68.9[7.7]岁;276 名男性[90.2%],30 名女性[9.8%];245 名白人[80.1%]),177 名(57.8%)患有 COPD,67 名(21.9%)患有 HF,49 名(16%)同时患有 COPD 和 HF,13 名(4.2%)患有 ILD。基线 FACT-G 评分相似(干预组,52.9;常规护理组,52.7)。两组 6 个月时的 FACT-G 完成率均为 76%(干预组,117/154;常规护理组,116/152)。干预的平均(标准差)长度为 115.1(33.4)天,包括每名患者平均 10.4(3.3)次干预电话。在干预组中,154 名患者中有 112 名(73%)按随机分组接受了干预。6 个月时,干预组 FACT-G 评分平均提高 6.0 分,常规护理组提高 1.4 分(差异,4.6 分[95%CI,1.8-7.4];P = .001;标准化均数差,0.41)。干预还改善了 COPD 健康状况(标准化均数差,0.44;P = .04)、HF 健康状况(标准化均数差,0.41;P = .01)、抑郁(标准化均数差,-0.50;P < .001)和焦虑(标准化均数差,-0.51;P < .001)。
结论和相关性
对于 COPD、HF 或 ILD 高危死亡且生活质量较差的成年人,与常规护理相比,护士和社会工作者姑息治疗远程护理团队在 6 个月时可显著改善生活质量。
试验注册
ClinicalTrials.gov 标识符:NCT02713347。