PDF(Pubmed)
Abstract：
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.
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.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02713347.
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.
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.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02713347.
摘要：
许多慢性阻塞性肺疾病（COPD）患者，心力衰竭(HF),尽管有常规治疗,间质性肺病(ILD)的生活质量仍较差.姑息治疗方法可能会使该人群在生命结束前受益。
确定护士和社会工作者姑息性远程护理团队对COPD门诊患者生活质量的影响，HF,或ILD与常规护理相比。
单盲，2组,2016年10月27日至2020年4月2日期间在2个退伍军人管理局医疗保健系统（科罗拉多州和华盛顿州）进行的多中心随机临床试验，包括以社区为基础的门诊诊所。COPD门诊患者，HF,或报告生活质量差的住院或死亡高风险ILD参与。
干预措施包括与护士进行6次电话呼叫以帮助进行症状管理，与社会工作者进行6次电话呼叫以提供心理社会护理。护士和社会工作者每周会见一名研究初级保健和姑息治疗医生，并根据需要，肺科医生,和心脏病专家。通常的护理包括为该研究开发的教育讲义，概述了COPD的自我护理，ILD,或HF。两组患者都根据临床医生的判断接受护理，其中可能包括护士和社会工作者的护理，和心脏病学专家，肺科,姑息治疗,和心理健康。
主要结局是干预组和常规护理组之间从基线到6个月的生活质量变化差异（FACT-G评分范围，0-100，分数越高表明生活质量越好，临床意义的变化≥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（广泛性焦虑症-7）症状。
在306名随机患者中（平均[SD]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（57.8%）患有COPD，67（21.9%）HF，49（16％）COPD和HF，和13（4.2%）ILD。基线FACT-G评分相似(干预，52.9；常规护理，52.7)。FACT-G完成率为76%(干预，154人中的117人；常规护理，两组在6个月时为152个月的116个）。平均（SD）干预时间为115.1（33.4）天，每位患者的平均干预次数为10.4（3.3）。在干预组中，154名患者中有112名（73%）接受了随机干预。6个月时,平均FACT-G评分在干预组中提高了6.0分，在常规护理组中提高了1.4分（差异，4.6分[95%CI，1.8-7.4]；P=.001；标准化平均差，0.41)。干预还改善了COPD的健康状况(标准化均值差异，0.44；P=.04)，HF健康状况(标准化平均差，0.41；P=0.01），抑郁症(标准化平均差，-0.50;P<.001),和焦虑(标准化平均差，-0.51；P<.001）在6个月时。
对于患有COPD的成年人，HF,或ILD死亡风险高，生活质量差，与常规护理相比,一个护士和社会工作者姑息性远程护理团队在6个月时的生活质量有临床意义的改善.
ClinicalTrials.gov标识符：NCT02713347。
确定护士和社会工作者姑息性远程护理团队对COPD门诊患者生活质量的影响，HF,或ILD与常规护理相比。
单盲，2组,2016年10月27日至2020年4月2日期间在2个退伍军人管理局医疗保健系统（科罗拉多州和华盛顿州）进行的多中心随机临床试验，包括以社区为基础的门诊诊所。COPD门诊患者，HF,或报告生活质量差的住院或死亡高风险ILD参与。
干预措施包括与护士进行6次电话呼叫以帮助进行症状管理，与社会工作者进行6次电话呼叫以提供心理社会护理。护士和社会工作者每周会见一名研究初级保健和姑息治疗医生，并根据需要，肺科医生,和心脏病专家。通常的护理包括为该研究开发的教育讲义，概述了COPD的自我护理，ILD,或HF。两组患者都根据临床医生的判断接受护理，其中可能包括护士和社会工作者的护理，和心脏病学专家，肺科,姑息治疗,和心理健康。
主要结局是干预组和常规护理组之间从基线到6个月的生活质量变化差异（FACT-G评分范围，0-100，分数越高表明生活质量越好，临床意义的变化≥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（广泛性焦虑症-7）症状。
在306名随机患者中（平均[SD]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（57.8%）患有COPD，67（21.9%）HF，49（16％）COPD和HF，和13（4.2%）ILD。基线FACT-G评分相似(干预，52.9；常规护理，52.7)。FACT-G完成率为76%(干预，154人中的117人；常规护理，两组在6个月时为152个月的116个）。平均（SD）干预时间为115.1（33.4）天，每位患者的平均干预次数为10.4（3.3）。在干预组中，154名患者中有112名（73%）接受了随机干预。6个月时,平均FACT-G评分在干预组中提高了6.0分，在常规护理组中提高了1.4分（差异，4.6分[95%CI，1.8-7.4]；P=.001；标准化平均差，0.41)。干预还改善了COPD的健康状况(标准化均值差异，0.44；P=.04)，HF健康状况(标准化平均差，0.41；P=0.01），抑郁症(标准化平均差，-0.50;P<.001),和焦虑(标准化平均差，-0.51；P<.001）在6个月时。
对于患有COPD的成年人，HF,或ILD死亡风险高，生活质量差，与常规护理相比,一个护士和社会工作者姑息性远程护理团队在6个月时的生活质量有临床意义的改善.
ClinicalTrials.gov标识符：NCT02713347。
