推进姑息治疗缓解症状（ADAPT）试验以改善生活质量：一项随机临床试验研究方案。
Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial.
机构信息
Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.
University of Colorado Anschutz Medical Campus, Aurora, USA.
出版信息
Trials. 2019 Jun 13;20(1):355. doi: 10.1186/s13063-019-3417-1.
BACKGROUND
People living with chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (ILD) suffer impaired quality of life due to burdensome symptoms and depression. The Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial aims to determine the effect of a multidisciplinary, team-based intervention on quality of life in people with these common diseases.
METHODS/DESIGN: The ADAPT trial is a two-site, patient-level randomized clinical trial that examines the effectiveness of the ADAPT intervention compared to usual care on patient-reported quality of life at 6 months in veterans with CHF, COPD or ILD with poor quality of life and increased risk for hospitalization or death. The ADAPT intervention involves a multidisciplinary team-a registered nurse, social worker, palliative care specialist, and primary care provider (with access to a pulmonologist and cardiologist)-who meet weekly to make recommendations and write orders for consideration by participants' individual primary care providers. The nurse and social worker interact with participants over six visits to identify and manage a primary bothersome symptom and complete a structured psychosocial intervention and advance care planning. The primary outcome is change in patient-reported quality of life at 6 months as measured by the Functional Assessment of Chronic Illness Therapy-General questionnaire. Secondary outcomes at 6 months include change in symptom distress, depression, anxiety, disease-specific quality of life hospitalizations, and advance care planning communication and documentation. Intervention implementation will be assessed using a mixed-methods approach including a qualitative assessment of participants' and intervention personnel experiences and a quantitative assessment of care delivery, resources, and cost.
DISCUSSION
The ADAPT trial studies an innovative intervention designed to improve quality of life for veterans with common, burdensome illnesses by targeting key underlying factors-symptoms and depression-that impair quality of life but persist despite disease-specific therapies. Leveraging the skills of affiliate health providers with physician supervision will extend the reach of palliative care and improve quality of life for those with advanced disease within routine outpatient care. The hybrid effectiveness/implementation design of the ADAPT trial will shorten the time to broader dissemination if effective and create avenues for future research.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02713347 . Registered March 19, 2016.
背景
患有慢性心力衰竭（CHF）、慢性阻塞性肺疾病（COPD）和间质性肺病（ILD）的患者由于症状负担和抑郁而导致生活质量受损。推进缓解症状与姑息治疗（ADAPT）试验旨在确定多学科、团队为基础的干预措施对这些常见疾病患者生活质量的影响。
方法/设计：ADAPT 试验是一项在两个地点进行的、以患者为水平的随机临床试验，比较了 ADAPT 干预与常规护理对患有 CHF、COPD 或 ILD 且生活质量差、住院或死亡风险增加的退伍军人在 6 个月时患者报告的生活质量的影响。ADAPT 干预包括一个多学科团队-注册护士、社会工作者、姑息治疗专家和初级保健提供者（可获得肺病专家和心脏病专家的支持）-每周开会，为参与者的个人初级保健提供者提出建议和开医嘱。护士和社会工作者通过六次访问与参与者互动，以确定和管理主要的烦扰症状，并完成结构化的心理社会干预和预先护理计划。主要结局是通过慢性疾病治疗功能评估-一般问卷在 6 个月时患者报告的生活质量的变化。次要结局包括 6 个月时症状困扰、抑郁、焦虑、疾病特异性生活质量、住院和预先护理计划沟通和记录的变化。干预实施将通过使用参与者和干预人员经验的定性评估以及对护理提供、资源和成本的定量评估的混合方法进行评估。
讨论
ADAPT 试验研究了一种创新的干预措施，旨在通过针对影响生活质量的关键潜在因素-症状和抑郁-来改善患有常见、负担沉重疾病的退伍军人的生活质量，这些因素尽管存在疾病特异性治疗，但仍持续存在。利用附属卫生保健提供者的技能和医生监督将扩大姑息治疗的范围，并改善常规门诊护理中晚期疾病患者的生活质量。ADAPT 试验的混合有效性/实施设计如果有效，将缩短更广泛传播的时间，并为未来的研究创造途径。
试验注册
ClinicalTrials.gov，NCT02713347。2016 年 3 月 19 日注册。
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