Jakobsen Anna Svarre, Laursen Lars C, Rydahl-Hansen Susan, Østergaard Birte, Gerds Thomas Alexander, Emme Christina, Schou Lone, Phanareth Klaus
1 Research Unit of Clinical Nursing, Bispebjerg & Frederiksberg University Hospital , Copenhagen, Denmark .
Telemed J E Health. 2015 May;21(5):364-73. doi: 10.1089/tmj.2014.0098. Epub 2015 Feb 5.
Telehealth interventions for patients with chronic obstructive pulmonary disease (COPD) have focused primarily on stable outpatients. Telehealth designed to handle the acute exacerbation that normally requires hospitalization could also be of interest. The aim of this study was to compare the effect of home-based telehealth hospitalization with conventional hospitalization for exacerbation in severe COPD.
A two-center, noninferiority, randomized, controlled effectiveness trial was conducted between June 2010 and December 2011. Patients with severe COPD admitted because of exacerbation were randomized 1:1 either to home-based telehealth hospitalization or to continue standard treatment and care at the hospital. The primary outcome was treatment failure defined as re-admission due to exacerbation in COPD within 30 days after initial discharge. The noninferiority margin was set at 20% of the control group's risk of re-admission. Secondary outcomes were mortality, need for manual or mechanical ventilation or noninvasive ventilation, length of hospitalization, physiological parameters, health-related quality of life, user satisfaction, healthcare costs, and adverse events.
In total, 57 patients were randomized: 29 participants in the telehealth group and 28 participants in the control group. Testing the incidence of re-admission within 30 days after discharge could not confirm noninferiority (lower 95% confidence limit [CL], -24.8%; p=0.35). Results were also nonsignificant at 90 days (lower 95% CL, -16.2%; p=0.33) and 180 days (lower 95% CL, -16.6%; p =0.33) after discharge. Superiority testing on secondary outcomes showed nonsignificant differences between groups. Healthcare costs have not yet been evaluated.
Whether home-based telehealth hospitalization is noninferior to conventional hospitalization requires further investigation. The results indicate that a subgroup of patients with severe COPD can be treated for acute exacerbation at home using telehealth, without the physical presence of health professionals and with a proper organizational "back-up."
针对慢性阻塞性肺疾病（COPD）患者的远程医疗干预主要集中在病情稳定的门诊患者。旨在处理通常需要住院治疗的急性加重期的远程医疗也可能具有重要意义。本研究的目的是比较重度COPD急性加重期患者居家远程医疗住院治疗与传统住院治疗的效果。
2010年6月至2011年12月期间进行了一项双中心、非劣效性、随机对照有效性试验。因急性加重期入院的重度COPD患者按1:1随机分为居家远程医疗住院治疗组或继续在医院接受标准治疗和护理组。主要结局是治疗失败，定义为首次出院后30天内因COPD急性加重再次入院。非劣效性界值设定为对照组再次入院风险的20%。次要结局包括死亡率、是否需要人工或机械通气或无创通气、住院时间、生理参数、健康相关生活质量、用户满意度、医疗费用和不良事件。
总共57例患者被随机分组：远程医疗组2例参与者，对照组28例参与者。对出院后30天内再次入院发生率的检测未能证实非劣效性（95%置信区间下限[CL]，-24.8%；p = 0.35）。出院后90天（95%CL下限，-16.2%；p = 0.33）和180天（95%CL下限，-16.6%；p = 0.33）时结果也无统计学意义。次要结局的优效性检验显示两组间无显著差异。医疗费用尚未评估。
居家远程医疗住院治疗是否不劣于传统住院治疗需要进一步研究。结果表明，一部分重度COPD患者可以在家中通过远程医疗治疗急性加重期，无需医护人员现场照料，并具备适当的组织 “后援”。
