Yu Doris Sau Fung, Li Polly Wai-Chi, Lau Jason Chi-Chun, Cheung Pik Shan Alice, Ip Mary, Cheng Suet Lai Linda, Poon Henry Chung Leung, Iris Lee Fung Kam
School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Department of Medicine and Geriatrics, United Christian Hospital, Hong Kong, China.
JAMA Netw Open. 2024 Dec 2;7(12):e2451614. doi: 10.1001/jamanetworkopen.2024.51614.
Domiciliary noninvasive ventilation (NIV) is a standard treatment for improving health outcomes among patients with chronic hypercapnic respiratory failure (CHRF). However, poor adherence substantially limits its therapeutic effectiveness.
To determine the effect of an information-motivation-behavioral (IMB) skills-based intervention (IMB-NIV program) on NIV adherence, patient-reported health outcomes, and health service use among patients with CHRF.
DESIGN, SETTING, AND PARTICIPANTS: This multisite, assessor-blinded, randomized clinical trial was conducted from January 2022 to March 2023 at respiratory clinics of 2 regional hospitals in Hong Kong among patients with CHRF who had been nonadherent to prescribed domiciliary NIV.
The 6-week IMB-NIV program used a hybrid approach, combining in-person and telecare sessions, to provide patients with knowledge, skills, a positive attitude, and social motivation to enhance NIV adherence.
The primary outcome was NIV adherence data retrieved from the NIV machine. Secondary outcomes included the Pittsburgh Sleep Quality Index, Chinese Severe Respiratory Insufficiency questionnaire, venous bicarbonate (HCO3-) level, emergency department (ED) and hospital admissions, and mortality measured at baseline, program completion, and 3, 6, and 12 months.
Of the 124 participants (mean [SD] age, 73.7 [7.2] years; 67 [54.0%] female), the 62 patients in the IMB-NIV group were more likely to adhere to NIV compared with the 62 patients in the usual care group at 12 months (61.3% vs 27.4%; odds ratio, 2.78; 95% CI, 1.69 to 4.55), with a greater increase noted in daily NIV use in hours at that time (B = 2.37; 95% CI, 1.44 to 3.31). A generalized estimating equation indicated significantly greater improvements in sleep quality (B = -3.63; 95% CI, -5.14 to -2.12) and health-related quality of life (β = 14.84; 95% CI, 9.18 to 20.49) at 12 months in the IMB-NIV group. The IMB-NIV group had significantly lower ED admissions (incidence rate ratio, 0.47; 95% CI, 0.26 to 0.84) and a longer time to the first ED visit (hazard ratio, 0.51; 95% CI, 0.28 to 0.95). No significant treatment effect was observed on venous HCO3- levels or hospital admissions.
In this randomized clinical trial, the IMB-NIV program offered a promising behavioral approach to improve NIV adherence in patients with CHRF. Its sustained positive effects on sleep quality, health-related quality of life, and ED admissions highlight its potential to optimize the therapeutic benefits of NIV.
ClinicalTrials.gov Identifier: NCT05008211.
家庭无创通气（NIV）是改善慢性高碳酸血症呼吸衰竭（CHRF）患者健康结局的标准治疗方法。然而，依从性差严重限制了其治疗效果。
确定基于信息-动机-行为（IMB）技能的干预措施（IMB-NIV计划）对CHRF患者NIV依从性、患者报告的健康结局以及医疗服务使用情况的影响。
设计、地点和参与者：这项多中心、评估者盲法、随机临床试验于2022年1月至2023年3月在香港2家地区医院的呼吸诊所对未依从规定家庭NIV治疗的CHRF患者进行。
为期6周的IMB-NIV计划采用混合方法，结合面对面和远程护理课程，为患者提供知识、技能、积极态度和社会动机，以提高NIV依从性。
主要结局是从NIV机器中获取的NIV依从性数据。次要结局包括匹兹堡睡眠质量指数、中国严重呼吸功能不全问卷、静脉血碳酸氢盐（HCO3-）水平、急诊科（ED）就诊和住院情况，以及在基线、计划完成时、3个月、6个月和12个月时测量的死亡率。
在124名参与者中（平均[标准差]年龄为73.7[7.2]岁；67名[54.0%]为女性），IMB-NIV组的62名患者在12个月时比常规护理组的62名患者更有可能坚持使用NIV（61.3%对27.4%；优势比为2.78；95%置信区间为1.69至4.55），此时每日NIV使用小时数的增加幅度更大（B = 2.37；95%置信区间为1.44至3.31）。广义估计方程表明，IMB-NIV组在12个月时睡眠质量（B = -3.63；95%置信区间为-5.14至-2.12）和健康相关生活质量（β = 14.84；95%置信区间为9.18至20.49）有显著更大的改善。IMB-NIV组的ED就诊率显著较低（发病率比为0.47；95%置信区间为0.26至0.84），首次ED就诊时间更长（风险比为0.51；95%置信区间为0.28至0.95）。未观察到对静脉HCO3-水平或住院情况有显著治疗效果。
在这项随机临床试验中，IMB-NIV计划为提高CHRF患者的NIV依从性提供了一种有前景的行为方法。其对睡眠质量、健康相关生活质量和ED就诊的持续积极影响突出了其优化NIV治疗益处的潜力。
ClinicalTrials.gov标识符：NCT05008211。
