Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial (PONDER-ICU)

Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Behavioral: EHR-Based Intervention A; Behavioral: EHR-Based Intervention B

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.

• Study Type: Interventional
• Enrollment (Actual): 3500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Albemarle, North Carolina, United States, 28001
      • Carolinas HealthCare System Stanly
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28025
      • Carolinas HealthCare System, NorthEast
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health CMC-Mercy
    • Charlotte, North Carolina, United States, 28210
      • Atrium Health Pineville
    • Charlotte, North Carolina, United States, 28262
      • Atrium Health University City
    • Lincolnton, North Carolina, United States, 28092
      • Atrium Health Lincoln
    • Monroe, North Carolina, United States, 28112
      • Atrium Health Union
    • Morganton, North Carolina, United States, 28655
      • Carolinas HealthCare System Blue Ridge-Morganton
    • Shelby, North Carolina, United States, 28150
      • Atrium Health Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.; Other Names: Prognostication
ACTIVE_COMPARATOR: 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.	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.; Other Names: Accountable Justification
ACTIVE_COMPARATOR: 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.	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.; Other Names: Prognostication; 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.; Other Names: Accountable Justification
NO_INTERVENTION: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Wake Forest University Health Sciences; Donaghue Medical Research Foundation
• Investigators: Principal Investigator: Scott D Halpern, PhD, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Courtright KR, Dress EM, Singh J, Bayes BA, Chowdhury M, Small DS, Hetherington T, Plickert L, Detsky ME, Doctor JN, Harhay MO, Burke HL, Green MB, Huynh T, Sullivan DM, Halpern SD; PONDER-ICU Investigative Team. Prognosticating Outcomes and Nudging Decisions with Electronic Records in the Intensive Care Unit Trial Protocol. Ann Am Thorac Soc. 2021 Feb;18(2):336-346. doi: 10.1513/AnnalsATS.202002-088SD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): April 24, 2021
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Palliative Care; Electronic Health Records; Pragmatic Clinical Trial; Economics, Behavioral
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: UPenn IRB #826933; 52635 (Patrick and Catherine Weldon Donaghue Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No