Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial

Abstract

Rationale: Lung-protective ventilation (LPV) improves outcomes for patients with acute respiratory distress syndrome (ARDS), but adherence remains inadequate. Objectives: To measure the process and clinical impacts of implementation of a science-based intervention to improve LPV adherence for patients with ARDS, in part by increased use of clinical decision support (CDS). Methods: We conducted a type III hybrid implementation/effectiveness pilot trial enrolling adult patients with ARDS admitted to three hospitals before and after the launch of a multimodal implementation intervention to increase the use of mechanical ventilation CDS and improve LPV adherence. The primary outcome was patients' percentage of time adherent to low tidal volume (⩽6.5 ml/kg predicted body weight) ventilation (LTVV). Secondary outcomes included adherence to prescribed oxygenation settings, the use of the CDS tool's independent oxygenation and ventilation components, ventilator-free days, and mortality. Analyses employed multivariable regression to compare adjusted pre- versus postintervention outcomes after the exclusion of a postintervention wash-in period. A sensitivity analysis measured process outcomes' level and trend change postintervention using segmented regression. Results: The 446 included patients had a mean age of 60 years, and 43% were female. Demographic and clinical characteristics were similar pre- versus postintervention. The adjusted proportion of adherent time increased postintervention for LTVV (9.2%; 95% confidence interval [CI], 3.8-14.5%) and prescribed oxygenation settings (11.9%; 95% CI, 7.2-16.5%), as did the probability patients spent ⩾90% of ventilated time on LTVV (adjusted odds ratio [aOR] 2.58; 95% CI, 1.64-4.10) and use of ventilation CDS (aOR, 41.3%; 95% CI, 35.9-46.7%) and oxygenation CDS (aOR, 54.3%; 95% CI, 50.9-57.7%). Ventilator-free days (aOR, 1.15; 95% CI, 0.81-1.62) and 28-day mortality (aOR, 0.78; 95% CI, 0.50-1.20) did not change significantly after intervention. Segmented regression analysis supported a causal relationship between the intervention and improved CDS usage but suggested trends before intervention rather than the studied intervention could explain increased LPV adherence after the intervention. Conclusions: In this pilot trial, a multimodal implementation intervention was associated with increased use of ventilator management CDS for patients with ARDS but was not associated with differences in clinical outcomes and may not have independently caused the observed postintervention improvements in LPV adherence. Clinical trial registered with www.clinicaltrials.gov (NCT03984175).

Keywords: acute respiratory distress syndrome; clinical decision support; implementation science; invasive mechanical ventilation; low tidal volume ventilation.

Figure 1.

Study timeline and data analysis periods. LPV = lung-protective ventilation.

Figure 2.

CONSORT-style patient inclusion/exclusion diagram. *Some patients met >1 exclusion criterion. ARDS = acute respiratory distress syndrome; CONSORT = consolidated standards of reporting trials; ICU = intensive care unit; P/F = PaO₂/FiO₂ ratio; PCWP = pulmonary capillary wedge pressure.

Figure 3.

Results of adjusted interrupted times series analysis for adherence to (A) low tidal volume ventilation and (B) positive end-expiratory pressure/Fi_O2 and use of (C) ventilation and (D) oxygenation clinical decision support tools. Each measurement window represents 2 weeks; window 0 is the 2-week period beginning with the intervention launch at each study site. Observed data is indicated in red, and standardized data is in blue. Gray shading indicates the postintervention wash-in period. Fi_O2 = fraction of inspired oxygen; PEEP = positive end-expiratory pressure.