Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial (PONDER-ICU)

University of Pennsylvania

Status: Completed

Conditions: Critical Illness

Treatments: Behavioral: EHR-Based Intervention B; Behavioral: EHR-Based Intervention A

Study type: Interventional

Funder types: Other

Identifiers

NCT03139838

52635 (Other Grant/Funding Number)

UPenn IRB #826933

Details and patient eligibility

About

This is a pragmatic, stepped-wedge, cluster randomized trial testing 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 investigators hypothesize that outcomes can be improved without raising costs by requiring intensive care unit clinicians to (i) document a prognostic estimate and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care. To test this hypothesis the investigators will conduct a 33-month trial at 17 intensive care units in 10 hospitals using the same Cerner EHR within Atrium Health System.

Full description

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 17 ICUs within 10 Atrium Health 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.

Enrollment: 3,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years old; AND

2. Admitted to 1 of the 17 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3,500 participants in 4 patient groups

EHR-Based Intervention A

Active Comparator group

Description:

Intervention A (Prognostication) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner.

Treatment:

Behavioral: EHR-Based Intervention A

EHR-Based Intervention B

Active Comparator group

Description:

Intervention B (Accountable Justification) will be an EHR-based screen prompt triggered for eligible patients. The intervention will consist of no more than two questions that can be completed in two minutes or less. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner.

Treatment:

Behavioral: EHR-Based Intervention B

Combined EHR-Based Intervention (A+B)

Active Comparator group

Description:

Intervention A and B prompts will be combined and triggered for eligible patients simultaneously. Completion of the prompt will be encouraged but not required, and adherence will be assessed in a minimally intrusive manner.

Treatment:

Behavioral: EHR-Based Intervention A

Behavioral: EHR-Based Intervention B

Pre-Intervention (Control)

No Intervention group

Description:

There is no trial-driven approach to care. All hospitals contribute a minimum of 5 months of outcomes data prior to adopting the intervention. Pre-specified outcomes data will be electronically extracted for patients meeting eligibility criteria but there will be no attempt to influence delivery of usual care within the hospital. The length of the control phase will differ at each hospital, dependent on the sequence in which hospitals are assigned to switch to the intervention phase.