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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
3,500
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 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.
Carolinas HealthCare System Stanly
Albemarle, North Carolina, United States
Carolinas HealthCare System, NorthEast
Charlotte, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Atrium Health CMC-Mercy
Charlotte, North Carolina, United States
Atrium Health Pineville
Charlotte, North Carolina, United States
Atrium Health University City
Charlotte, North Carolina, United States
Atrium Health Lincoln
Lincolnton, North Carolina, United States
Atrium Health Union
Monroe, North Carolina, United States
Carolinas HealthCare System Blue Ridge-Morganton
Morganton, North Carolina, United States
Atrium Health Cleveland
Shelby, North Carolina, United States
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
Time frame: Duration of hospital stay, an expected average of 16 days
Change in code status
Change in documented code status during hospital admission
Time frame: 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
Time frame: Duration of hospital stay, an expected average of 16 days
Palliative care consult
Receipt of palliative care consult during hospital admission
Time frame: 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
Time frame: Duration of hospital stay, an expected average of 16 days
Palliative withdrawal of mechanical ventilation
Palliative withdrawal of mechanical ventilation during hospital admission
Time frame: Duration of hospital stay, an expected average of 16 days
Receipt of cardiopulmonary resuscitation (CPR)
CPR prior to death or discharge
Time frame: Duration of hospital stay, an expected average of 16 days
ICU mortality
ICU mortality
Time frame: Duration of hospital stay, an expected average of 16 days
ICU length of stay
ICU length of stay (hours)
Time frame: Duration of hospital stay, an expected average of 16 days
ICU readmission
Readmission to an ICU within the same hospitalization
Time frame: Duration of hospital stay, an expected average of 16 days
Duration of mechanical ventilation
Hours of mechanical ventilation during hospital admission
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48-72 hours following an in-hospital death
30-day hospital readmission
30-day hospital readmission
Time frame: 30 days
90-day hospital readmission
30-day hospital readmission
Time frame: 30 days
180-day hospital readmission
30-day hospital readmission
Time frame: 30 days
30-day mortality
Mortality rate at 30 days
Time frame: 30 days
90-day mortality
Mortality rate at 90 days
Time frame: 90 days
180-day mortality
Mortality rate at 180 days
Time frame: 180 days
Hospital free days
Hospital free days within 180 days
Time frame: 180 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.