Health Communication and Adherence to Noninvasive Ventilation in Chronic Hypercapnic Respiratory Failure: A Randomized Clinical Trial

Abstract

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.

Figure 1.. Study Flowchart

CHRF indicates chronic hypercapnic respiratory failure; IMB, information-motivation-behavioral; and NIV, noninvasive ventilation.

Figure 2.. Kaplan-Meier Curves for Time to Emergency Department Attendance Since Randomization

After controlling the clinical-demographic variables which were different at P < .25, the information-motivation-behavioral noninvasive ventilation (IMB-NIV) group had significantly delayed time to emergency department admission, with a hazard ratio of 0.51 (95% CI, 0.28-0.95).

Figure 3.. Kaplan-Meier Curves for Time to Hospital Admission Since Randomization

After controlling the clinical-demographic variables which were different at P < .25, there was no significant between-group difference in the time to hospital admission (hazard ratio, 0.69; 95% CI, 0.38-1.24). IMB-NIV indicates information-motivation-behavioral noninvasive ventilation.