JAMA network open · 2024
Health Communication and Adherence to Noninvasive Ventilation in Chronic Hypercapnic Respiratory Failure: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
IMPORTANCE: 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.
OBJECTIVE: 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.
INTERVENTIONS: 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.
MAIN OUTCOMES AND MEASURES: 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.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05008211.
OBJECTIVE: 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.
INTERVENTIONS: 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.
MAIN OUTCOMES AND MEASURES: 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.
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05008211.