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

August 3, 2022 updated by: University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Measure: Length of Stay and In-Hospital Mortality
Time Frame: 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
Duration of hospital stay, an expected average of 16 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in code status
Time Frame: Duration of hospital stay, an expected average of 16 days
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
Time Frame: 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
Duration of hospital stay, an expected average of 16 days
Palliative care consult
Time Frame: Duration of hospital stay, an expected average of 16 days
Receipt of palliative care consult during hospital admission
Duration of hospital stay, an expected average of 16 days
Time to palliative care consult
Time Frame: Duration of hospital stay, an expected average of 16 days
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
Time Frame: Duration of hospital stay, an expected average of 16 days
Palliative withdrawal of mechanical ventilation during hospital admission
Duration of hospital stay, an expected average of 16 days
Receipt of cardiopulmonary resuscitation (CPR)
Time Frame: Duration of hospital stay, an expected average of 16 days
CPR prior to death or discharge
Duration of hospital stay, an expected average of 16 days
ICU mortality
Time Frame: Duration of hospital stay, an expected average of 16 days
ICU mortality
Duration of hospital stay, an expected average of 16 days
ICU length of stay
Time Frame: Duration of hospital stay, an expected average of 16 days
ICU length of stay (hours)
Duration of hospital stay, an expected average of 16 days
ICU readmission
Time Frame: Duration of hospital stay, an expected average of 16 days
Readmission to an ICU within the same hospitalization
Duration of hospital stay, an expected average of 16 days
Duration of mechanical ventilation
Time Frame: Duration of hospital stay, an expected average of 16 days
Hours of mechanical ventilation during hospital admission
Duration of hospital stay, an expected average of 16 days
Time to withdrawal of life-support
Time Frame: 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
Duration of hospital stay, an expected average of 16 days
Hospital discharge disposition
Time Frame: Duration of hospital stay, an expected average of 16 days
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)
Time Frame: 48-72 hours following an in-hospital death
Nurse-reported postmortem rating of a patient's dying experience
48-72 hours following an in-hospital death
30-day hospital readmission
Time Frame: 30 days
30-day hospital readmission
30 days
90-day hospital readmission
Time Frame: 30 days
30-day hospital readmission
30 days
180-day hospital readmission
Time Frame: 30 days
30-day hospital readmission
30 days
30-day mortality
Time Frame: 30 days
Mortality rate at 30 days
30 days
90-day mortality
Time Frame: 90 days
Mortality rate at 90 days
90 days
180-day mortality
Time Frame: 180 days
Mortality rate at 180 days
180 days
Hospital free days
Time Frame: 180 days
Hospital free days within 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wake Forest University Health Sciences
Donaghue Medical Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott D Halpern, PhD, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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