Critical Illness
Conditions
Keywords
Palliative Care, Pragmatic Clinical Trial, Electronic Health Records, Economics, Behavioral
Brief summary
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
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.
Interventions
BEHAVIORALEHR-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.
BEHAVIORALEHR-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.
Sponsors
Wake Forest University Health Sciences
Donaghue Medical Research Foundation
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Measure: Length of Stay and In-Hospital Mortality | Duration of hospital stay, an expected average of 16 days | The primary outcome is a composite measure of hospital length-of-stay and mortality that ranks deaths along the length-of-stay distribution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to palliative care consult | Duration of hospital stay, an expected average of 16 days | The number of hours from ICU admission to inpatient palliative care consult |
| Change in code status | Duration of hospital stay, an expected average of 16 days | Change in documented code status during hospital admission |
| Initiation of additional forms of life-support | Duration of hospital stay, an expected average of 16 days | Initiation of additional form of life-support (e.g. surgical feeding tube, dialysis) during hospital admission |
| Palliative withdrawal of mechanical ventilation | Duration of hospital stay, an expected average of 16 days | Palliative withdrawal of mechanical ventilation during hospital admission |
| Receipt of cardiopulmonary resuscitation (CPR) | Duration of hospital stay, an expected average of 16 days | CPR prior to death or discharge |
| ICU mortality | Duration of hospital stay, an expected average of 16 days | ICU mortality |
| ICU length of stay | Duration of hospital stay, an expected average of 16 days | ICU length of stay (hours) |
| ICU readmission | Duration of hospital stay, an expected average of 16 days | Readmission to an ICU within the same hospitalization |
| Duration of mechanical ventilation | Duration of hospital stay, an expected average of 16 days | Hours of mechanical ventilation during hospital admission |
| Palliative care consult | Duration of hospital stay, an expected average of 16 days | Receipt of palliative care consult during hospital admission |
| Hospital discharge disposition | Duration of hospital stay, an expected average of 16 days | Hospital discharge disposition to home, hospice, long-term acute care, nursing facility, or rehabilitation |
| Quality of Dying & Death (1-item) | 48-72 hours following an in-hospital death | Nurse-reported postmortem rating of a patient's dying experience |
| 30-day hospital readmission | 30 days | 30-day hospital readmission |
| 90-day hospital readmission | 30 days | 30-day hospital readmission |
| 180-day hospital readmission | 30 days | 30-day hospital readmission |
| 30-day mortality | 30 days | Mortality rate at 30 days |
| 90-day mortality | 90 days | Mortality rate at 90 days |
| 180-day mortality | 180 days | Mortality rate at 180 days |
| Hospital free days | 180 days | Hospital free days within 180 days |
| Time to withdrawal of life-support | Duration of hospital stay, an expected average of 16 days | The number of hours from trial enrollment to time that comfort-care order is placed |
Countries
United States
Outcome results
None listed