Prognosticating Outcomes and Nudging Decisions with Electronic Records in the Intensive Care Unit Trial Protocol

Abstract

Expert recommendations to discuss prognosis and offer palliative options for critically ill patients at high risk of death are variably heeded by intensive care unit (ICU) clinicians. How to best promote such communication to avoid potentially unwanted aggressive care is unknown. The PONDER-ICU (Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU) study is a 33-month pragmatic, stepped-wedge cluster randomized trial testing the effectiveness of two electronic health record (EHR) interventions designed to increase ICU clinicians' engagement of critically ill patients at high risk of death and their caregivers in discussions about all treatment options, including care focused on comfort. We hypothesize that the quality of care and patient-centered outcomes can be improved by requiring ICU clinicians to document a functional prognostic estimate (intervention A) and/or to provide justification if they have not offered patients the option of comfort-focused care (intervention B). The trial enrolls all adult patients admitted to 17 ICUs in 10 hospitals in North Carolina with a preexisting life-limiting illness and acute respiratory failure requiring continuous mechanical ventilation for at least 48 hours. Eligibility is determined using a validated algorithm in the EHR. The sequence in which hospitals transition from usual care (control), to intervention A or B and then to combined interventions A + B, is randomly assigned. The primary outcome is hospital length of stay. Secondary outcomes include other clinical outcomes, palliative care process measures, and nurse-assessed quality of dying and death.Clinical trial registered with clinicaltrials.gov (NCT03139838).

Keywords: artificial respiration; clinical trial; critical care; palliative care.

Figure 1.

Conceptual model of barriers to intensive-care-unit clinicians’ offering palliative approaches to care.

Figure 2.

Schematic of the PONDER-ICU (Prognosticating Outcomes and Nudging Decisions with Electronic Records in the Intensive Care Unit) pragmatic, stepped-wedge cluster randomized trial. The sequence and timing with which each hospital transitions between phases is randomly assigned. Wedge intervals are 3 months after all hospitals spend a minimum of 5 months in the usual-care phase; the total trial duration is 33 months.

Figure 3.

Patient-identification and intervention-delivery schema. *Eligible life-limiting illnesses: amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, cirrhosis, congestive heart failure, dementia, end-stage renal disease, leukemia or lymphoma, pulmonary fibrosis/interstitial lung disease, or solid organ malignancy. EHR = electronic health record; ICU = intensive care unit; VCC = virtual critical care.