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

Study Overview
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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.

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.

Official Title
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Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients

Conditions
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Critical Illness

Intervention / Treatment
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* Behavioral: EHR-Based Intervention A
* Behavioral: EHR-Based Intervention B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old; AND Admitted to 1 of the 17 participating ICUs; AND Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND ≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months): Chronic obstructive pulmonary disease Cirrhosis Congestive heart failure Dementia (all types) End-stage renal disease Hematologic malignancy Metastatic malignancy Motor neuron disease Pulmonary fibrosis Solid organ malignancy Exclusion Criteria: 1) Patients younger than 18 years old are excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EHR-Based Intervention A<br>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. | Behavioral: EHR-Based Intervention A<br>* 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.<br>* Other names: Prognostication;|
| Active Comparator: EHR-Based Intervention B<br>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. | Behavioral: EHR-Based Intervention B<br>* 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.<br>* Other names: Accountable Justification;|
| Active Comparator: Combined EHR-Based Intervention (A+B)<br>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. | Behavioral: EHR-Based Intervention A<br>* 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.<br>* Other names: Prognostication;Behavioral: EHR-Based Intervention B<br>* 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.<br>* Other names: Accountable Justification;|
| No Intervention: Pre-Intervention (Control)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Measure: Length of Stay and In-Hospital Mortality | The primary outcome is a composite measure of hospital length-of-stay and mortality that ranks deaths along the length-of-stay distribution | Duration of hospital stay, an expected average of 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in code status | Change in documented code status during hospital admission | Duration of hospital stay, an expected average of 16 days | 
| Initiation of additional forms of life-support | Initiation of additional form of life-support (e.g. surgical feeding tube, dialysis) during hospital admission | Duration of hospital stay, an expected average of 16 days | 
| Palliative care consult | Receipt of palliative care consult during hospital admission | Duration of hospital stay, an expected average of 16 days | 
| Time to palliative care consult | The number of hours from ICU admission to inpatient palliative care consult | Duration of hospital stay, an expected average of 16 days | 
| Palliative withdrawal of mechanical ventilation | Palliative withdrawal of mechanical ventilation during hospital admission | Duration of hospital stay, an expected average of 16 days | 
| Receipt of cardiopulmonary resuscitation (CPR) | CPR prior to death or discharge | Duration of hospital stay, an expected average of 16 days | 
| ICU mortality | ICU mortality | Duration of hospital stay, an expected average of 16 days | 
| ICU length of stay | ICU length of stay (hours) | Duration of hospital stay, an expected average of 16 days | 
| ICU readmission | Readmission to an ICU within the same hospitalization | Duration of hospital stay, an expected average of 16 days | 
| Duration of mechanical ventilation | Hours of mechanical ventilation during hospital admission | Duration of hospital stay, an expected average of 16 days | 
| Time to withdrawal of life-support | The number of hours from trial enrollment to time that comfort-care order is placed | Duration of hospital stay, an expected average of 16 days | 
| Hospital discharge disposition | Hospital discharge disposition to home, hospice, long-term acute care, nursing facility, or rehabilitation | Duration of hospital stay, an expected average of 16 days | 
| Quality of Dying & Death (1-item) | Nurse-reported postmortem rating of a patient's dying experience | 48-72 hours following an in-hospital death | 
| 30-day hospital readmission | 30-day hospital readmission | 30 days | 
| 90-day hospital readmission | 30-day hospital readmission | 30 days | 
| 180-day hospital readmission | 30-day hospital readmission | 30 days | 
| 30-day mortality | Mortality rate at 30 days | 30 days | 
| 90-day mortality | Mortality rate at 90 days | 90 days | 
| 180-day mortality | Mortality rate at 180 days | 180 days | 
| Hospital free days | Hospital free days within 180 days | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Pragmatic Clinical Trial, Electronic Health Records, Economics, Behavioral