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

Critical Illness Clinical Trial

— PONDER-ICU  

Official title:

Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139838
• Other study ID #: UPenn IRB #826933
• Secondary ID: 52635
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: June 30, 2022
• Est. primary completion date: April 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Carolinas HealthCare System Stanly	Albemarle	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	Carolinas HealthCare System, NorthEast	Charlotte	North Carolina
United States	Carolinas Medical Center	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

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Donaghue Medical Research Foundation, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in code status	Change in documented code status during hospital admission	Duration of hospital stay, an expected average of 16 days
Secondary	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
Secondary	Palliative care consult	Receipt of palliative care consult during hospital admission	Duration of hospital stay, an expected average of 16 days
Secondary	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
Secondary	Palliative withdrawal of mechanical ventilation	Palliative withdrawal of mechanical ventilation during hospital admission	Duration of hospital stay, an expected average of 16 days
Secondary	Receipt of cardiopulmonary resuscitation (CPR)	CPR prior to death or discharge	Duration of hospital stay, an expected average of 16 days
Secondary	ICU mortality	ICU mortality	Duration of hospital stay, an expected average of 16 days
Secondary	ICU length of stay	ICU length of stay (hours)	Duration of hospital stay, an expected average of 16 days
Secondary	ICU readmission	Readmission to an ICU within the same hospitalization	Duration of hospital stay, an expected average of 16 days
Secondary	Duration of mechanical ventilation	Hours of mechanical ventilation during hospital admission	Duration of hospital stay, an expected average of 16 days
Secondary	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
Secondary	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
Secondary	Quality of Dying & Death (1-item)	Nurse-reported postmortem rating of a patient's dying experience	48-72 hours following an in-hospital death
Secondary	30-day hospital readmission	30-day hospital readmission	30 days
Secondary	90-day hospital readmission	30-day hospital readmission	30 days
Secondary	180-day hospital readmission	30-day hospital readmission	30 days
Secondary	30-day mortality	Mortality rate at 30 days	30 days
Secondary	90-day mortality	Mortality rate at 90 days	90 days
Secondary	180-day mortality	Mortality rate at 180 days	180 days
Secondary	Hospital free days	Hospital free days within 180 days	180 days