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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EHR-Based Intervention A

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.

Group Type ACTIVE_COMPARATOR

EHR-Based Intervention A

Intervention Type BEHAVIORAL

Intervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive.

EHR-Based Intervention B

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.

Group Type ACTIVE_COMPARATOR

EHR-Based Intervention B

Intervention Type BEHAVIORAL

Intervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery.

Combined EHR-Based Intervention (A+B)

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.

Group Type ACTIVE_COMPARATOR

EHR-Based Intervention A

Intervention Type BEHAVIORAL

Intervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive.

EHR-Based Intervention B

Intervention Type BEHAVIORAL

Intervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery.

Pre-Intervention (Control)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EHR-Based Intervention A

Intervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive.

Intervention Type BEHAVIORAL

EHR-Based Intervention B

Intervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery.

Intervention Type BEHAVIORAL

Other Intervention Names

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Prognostication Accountable Justification

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott D Halpern, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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