Implementing nudges to promote utilization of low tidal volume ventilation (INPUT): a stepped-wedge, hybrid type III trial of strategies to improve evidence-based mechanical ventilation management

Abstract

Background: Behavioral economic insights have yielded strategies to overcome implementation barriers. For example, default strategies and accountable justification strategies have improved adherence to best practices in clinical settings. Embedding such strategies in the electronic health record (EHR) holds promise for simple and scalable approaches to facilitating implementation. A proven-effective but under-utilized treatment for patients who undergo mechanical ventilation involves prescribing low tidal volumes, which protects the lungs from injury. We will evaluate EHR-based implementation strategies grounded in behavioral economic theory to improve evidence-based management of mechanical ventilation.

Methods: The Implementing Nudges to Promote Utilization of low Tidal volume ventilation (INPUT) study is a pragmatic, stepped-wedge, hybrid type III effectiveness implementation trial of three strategies to improve adherence to low tidal volume ventilation. The strategies target clinicians who enter electronic orders and respiratory therapists who manage the mechanical ventilator, two key stakeholder groups. INPUT has five study arms: usual care, a default strategy within the mechanical ventilation order, an accountable justification strategy within the mechanical ventilation order, and each of the order strategies combined with an accountable justification strategy within flowsheet documentation. We will create six matched pairs of twelve intensive care units (ICUs) in five hospitals in one large health system to balance patient volume and baseline adherence to low tidal volume ventilation. We will randomly assign ICUs within each matched pair to one of the order panels, and each pair to one of six wedges, which will determine date of adoption of the order panel strategy. All ICUs will adopt the flowsheet documentation strategy 6 months afterwards. The primary outcome will be fidelity to low tidal volume ventilation. The secondary effectiveness outcomes will include in-hospital mortality, duration of mechanical ventilation, ICU and hospital length of stay, and occurrence of potential adverse events.

Discussion: This stepped-wedge, hybrid type III trial will provide evidence regarding the role of EHR-based behavioral economic strategies to improve adherence to evidence-based practices among patients who undergo mechanical ventilation in ICUs, thereby advancing the field of implementation science, as well as testing the effectiveness of low tidal volume ventilation among broad patient populations.

Trial registration: ClinicalTrials.gov , NCT04663802 . Registered 11 December 2020.

Keywords: Acute respiratory distress syndrome; Behavioral economics; Hybrid implementation-effectiveness trial; Low tidal volume; Mechanical ventilation; Nudge.

Conflict of interest statement

Rinad Beidas receives royalties from Oxford University Press. She has served as a consultant to Camden Coalition of Healthcare Providers. She provides consultation to United Behavioral Health. She serves on the Clinical and Scientific Advisory Board for Optum Behavioral Health. Scott Halpern is a paid member of the Steering Committee for the NIA-funded IMPACT Collaboratory and receives consulting fees from Atrium Health and Georgia State University. The rest of the authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1

Conceptual model of relationships under study. The conceptual model maps the relationships under study to the Proctor model for implementation research. Dashed arrows indicated factors that may interact with the implementation strategies with respect to implementation and effectiveness outcomes. Aim 1 will test implementation outcomes, and aim 2 will test effectiveness outcomes

Fig. 2

Trial schematic. Stepped wedge roll-out of three strategies to promote the use of lung-protective ventilation. Strategy A is a default order panel for MV that is auto-populated with lung-protective settings. Strategy B is an order panel that incorporates accountable justification requiring a user to provide a reason when LPV settings are not entered. Strategy C is an accountable justification strategy embedded in the flowsheet documentation

Fig. 3

Screenshots of EHR-based strategies. A The default order strategy, in which the ventilation mode (red arrow) and tidal volume (purple arrow) are pre-populated. B The accountable justification order strategy, in which a reason must be provided (red arrow) if the set tidal volume entered is above 6.5 ml/kg PBW. If the reason is not provided upon order submission, an alert pops up and prevents order submission until the field is completed. C The accountable justification flowsheet strategy, in which a reason must be provided by the RT if a set tidal volume is documented to be above 6.5 ml/kg PBW