Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial

The PONDER-ICU trial aims to generate large-scale, experimental evidence regarding the
real-world effectiveness of two different electronic health record (EHR) behavioral
interventions in improving a number of patient- and family-centered processes and outcomes of
care among seriously ill hospitalized patients. The interventions are designed to increase
intensive care unit (ICU) physicians' and advanced practitioners' (physician assistants and
nurse practitioners) engagement of critically ill patients and caregivers in discussions
about alternative treatment options, including care focused on comfort. To achieve this goal,
the investigators will conduct a 33-month pragmatic, stepped-wedge cluster randomized
clinical trial at 19 ICUs within 10 Carolinas HealthCare System hospitals. The investigators
hypothesize that outcomes can be improved without raising costs by requiring ICU clinicians
to (i) document a prognostic estimate (Intervention A) and (ii) provide a justification if
they choose not to offer patients the option of comfort-oriented care (Intervention B).
Approximately 4,750 adult patients (1) with chronic life-limiting illness and receiving
continuous mechanical ventilation for ≥48 hours will be enrolled. Participating hospitals
will be randomized into 5 clusters of 2 hospitals each. Each hospital will first contribute a
minimum of 5 months of data collection during usual care in a control phase. Then, using the
step-wedge design, all hospitals will implement the two EHR-based interventions. The order in
which the interventions will be adopted and the timing of adoption at each hospital will both
be determined by random assignment. After 12 months of utilizing Intervention A or
Intervention B, each hospital will adopt and implement the second intervention in combination
with the other. By the end of the trial, all hospitals will have utilized the combined
interventions for at least 4 months. The primary outcome is a composite measure of hospital
length of stay and mortality. Secondary outcomes include an array of clinical outcomes, as
well as palliative care-related process measures.

Inclusion Criteria:

1. ≥18 years old; AND

2. Admitted to 1 of the 19 participating ICUs; AND

3. Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption);
AND

4. ≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical
history data from EHR in prior 12 months):

1. Chronic obstructive pulmonary disease

2. Cirrhosis

3. Congestive heart failure

4. Dementia (all types)

5. End-stage renal disease

6. Hematologic malignancy

7. Metastatic malignancy

8. Motor neuron disease

9. Pulmonary fibrosis

10. Solid organ malignancy

Exclusion Criteria:

1) Patients younger than 18 years old are excluded.