The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer.-猫眼课题宝

DOI：

10.1016/j.cct.2021.106295

发表时间：

2021-02

期刊：

Contemporary clinical trials

影响因子：

2.2

通讯作者：

中科院分区：

医学4区

文献类型：

作者：

J. Steel;Vincent Reyes;D. Zandberg;M. Nilsen;L. Terhorst;G. Richards;B. Pappu;Gauri J. Kiefer;Jonas T. Johnson;M. Antoni;Y. Vodovotz;Michael B. Spring;Jon Walker;D. Geller

背景美国国立卫生研究院关于癌症相关症状的共识声明得出结论，最常见和最令人虚弱的是抑郁、疼痛和疲劳[1-6]。虽然这些症状的共病是众所周知的，并且可能有类似的潜在生物学机制，但还没有开发出同时减少这些症状的干预措施。这种由远程医疗提供的新型基于网络的阶梯式协作护理干预是第一次在被诊断为癌症的人中进行测试。方法我们计划在随机对照试验的背景下，对450名癌症患者和200名照顾者进行基于网络的阶梯式协作护理干预。主要终点是生活质量，其他主要结果包括患者报告的抑郁、疼痛、疲劳。次要结果包括患者血清促炎细胞因子水平和疾病进展。我们还将评估非正式的照顾者压力、抑郁和代谢异常，以确定患者症状的改善是否也与照顾者结果的改善有关。结果试验仍在进行中，总共382名患者被随机分配。对纳入研究的筛选工具的初步分析表明，流行病学研究中心抑郁量表(CESSingle BondD)具有良好的敏感性和特异性(0.81和0.813)，而用于评估疼痛和疲劳的量表(0.47和0.91)敏感性较差，但特异性较好。使用AUROC，CES-D的最佳切点是19，疼痛的最佳切点是4.5，疲劳的最佳切点是2.5。最初没有提出的结果包括医疗保健利用率和医疗费用。治疗后一年随访的前100名患者，他们的年龄小于75 ，并随机接受基于网络的阶梯式协作护理干预，术后并发症的发生率较低[χ2= 5.45，p= 0.02]。对于存活6个 月或更短时间并随机接受基于网络的阶梯式协作护理干预的患者，与随机接受筛查和转诊的患者相比，90天的再住院率较低[χ2= 4.0，p= 0.046]。与筛查和转诊组相比，被随机分配到协作护理干预组的患者基于医疗活动的总成本较低，为每位患者每年16,758美元。讨论这种通过远程医疗提供的基于Web的步进式协作护理干预措施，有望提供一种新的策略来改善癌症诊断患者及其照顾者的生活质量。试验注册临床试验。政府NCT02939755

BackgroundThe NIH consensus statement on cancer-related symptoms concluded the most common and debilitating were depression, pain and fatigue [1–6]. Although the comorbidity of these symptoms is well known and may have similar underlying biological mechanisms no intervention has been developed to reduce these symptoms concurrently. The novel web-based stepped collaborative care intervention delivered by telemedicine is the first to be tested in people diagnosed with cancer.MethodsWe plan to test a web-based stepped collaborative care intervention with 450 cancer patients and 200 caregivers in the context of a randomized controlled trial. The primary endpoint is quality of life with other primary outcomes including patient-reported depression, pain, fatigue. Secondary outcomes include patient serum levels of pro-inflammatory cytokines and disease progression. We also will assess informal caregiver stress, depression, and metabolic abnormalities to determine if improvements in patients' symptoms also relate to improvement in caregiver outcomes.ResultsThe trial is ongoing and a total of 382 patients have been randomized. Preliminary analyses of the screening tools used for study entry suggest that Center for Epidemiological Studies-Depression (CESsingle bondD) scale has good sensitivity and specificity (0.81 and 0.813) whereas the scale used to assess pain (0.47 and 0.91) and fatigue (0.11 and 0.91) had poor sensitivity but excellent specificity. Using the AUROC, the best cut point for the CES-D was 19, for pain was 4.5; and for fatigue was 2.5. Outcomes not originally proposed included health care utilization and healthcare charges. The first 100 patients who have been followed a year post-treatment, and who were less than 75 years and randomized to the web-based stepped collaborative care intervention, had lower rates of complications after surgery [χ2= 5.45,p= 0.02]. For patients who survived 6 months or less and were randomized to the web-based stepped collaborative care intervention, had lower rates of 90-day readmissions when compared to patients randomized to the screening and referral arm [χ2= 4.0,p= 0.046]. Patients randomized to the collaborative care intervention arm had lower overall health care activity-based costs of $16,758 per patient per year when compared to the screening and referral arm.DiscussionThis novel web-based stepped stepped collaborative care intervention, delivered via telemedicine, is expected to provide a new strategy to improve the quality of life in those diagnosed with cancer and their caregivers.Trial registrationClinicalTrials.gov NCT02939755

The next generation of collaborative care: The design of a novel web-based stepped collaborative care intervention delivered via telemedicine for people diagnosed with cancer.

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