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

RATIONALE
Lung protective ventilation (LPV) improves outcomes for patients with acute respiratory distress syndrome (ARDS), but adherence remains inadequate.


OBJECTIVE
To measure the process and clinical impacts of an implementation science-based intervention to improve LPV adherence for patients with ARDS in part by increased utilization of clinical decision support (CDS).


METHODS
We conducted a pilot type III hybrid implementation/effectiveness trial enrolling adult patients with ARDS admitted to three hospitals before and after launch of a multimodal implementation intervention to increase utilization 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, utilization of the CDS tool's independent oxygenation and ventilation components, ventilator-free days (VFDs), and mortality. Analyses employed multivariable regression to compare adjusted pre- versus post-intervention outcomes after exclusion of a post-intervention wash-in period. A sensitivity analysis measured process outcomes' level and trend changes post-intervention using segmented regression.


RESULTS
The 446 included patients had mean age 60 years and 43% were female. Demographic and clinical characteristics were similar pre- versus post-intervention. The adjusted proportion of adherent time increased post-intervention for LTVV (+9.2%, 95% 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 utilization of ventilation CDS (+41.3%, 95% CI 35.9-46.7%) and oxygenation CDS (+54.3%, 50.9-57.7%). VFDs (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 post-intervention. Segmented regression analysis supported a causal relationship between the intervention and improved CDS utilization but suggested pre-intervention trends rather than the studied intervention could explain increased LPV adherence post-intervention.


CONCLUSIONS
In this pilot trial, a multimodal implementation intervention was associated with increased utilization of ventilator management CDS for ARDS patients but was not associated with differences in clinical outcomes and may not have independently caused the observed post-intervention improvements in LPV adherence. Clinical trial registered with ClinicalTrials.gov (NCT03984175).