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

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ClinicalTrials.gov Identifier: NCT03139838
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : October 10, 2018
Sponsor:
Collaborators:
Carolinas Healthcare System
Donaghue Medical Research Foundation
Information provided by (Responsible Party):
University of Pennsylvania

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 19 intensive care units in 10 hospitals using the same Cerner EHR within Carolinas HealthCare System.

Condition or disease Intervention/treatment Phase
Critical Illness Behavioral: EHR-Based Intervention A Behavioral: EHR-Based Intervention B Not Applicable

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 19 ICUs within 10 Carolinas HealthCare 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  (Clinical Trial)
Estimated Enrollment : 4750 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

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 Name: 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 Name: 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 Name: 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 Name: 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Process Measure: Change in Goals of Care [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    Change in documented goals of care during hospital admission

  2. Process Measure: Initiation of Additional Form 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

  3. Process Measure: Receipt of Palliative Care Consult [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    Receipt of palliative care consult during hospital admission

  4. Process Measure: Hours Until 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

  5. Process Measure: Referral to Hospice [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    Referral to hospice upon hospital discharge

  6. Outcome Measure: ICU Mortality [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    ICU mortality

  7. Outcome Measure: ICU Length of Stay [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    ICU length of stay

  8. Outcome Measure: ICU Readmission [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    Readmission to an ICU within the same hospitalization

  9. Outcome Measure: Cardiopulmonary resuscitation (CPR) [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    CPR prior to death or discharge

  10. Outcome Measure: Days of Mechanical Ventilation [ Time Frame: Duration of hospital stay, an expected average of 16 days ]
    Days of mechanical ventilation during hospital admission

  11. Outcome Measure: 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

  12. Outcome Measure: Hospital Readmission [ Time Frame: 30 days ]
    30-day hospital readmission

  13. Outcome Measure: Quality of Dying & Death questionnaire (nurse-QODD-1) [ Time Frame: 48-72 hours following an in-hospital death ]
    Single-item, overall rating of a patient's dying experience from the nurse's perspective

  14. Outcome Measure: 30-day mortality [ Time Frame: 30 days ]
    Mortality rate at 30 days

  15. Outcome Measure: 90-day mortality [ Time Frame: 90 days ]
    Mortality rate at 90 days

  16. Outcome Measure: 180-day mortality [ Time Frame: 180 days ]
    Mortality rate at 180 days

  17. Outcome Measure: 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 withdrawal of life support



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 years old; AND
  2. Admitted to 1 of the 19 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139838


Contacts
Contact: Erich M Dress, MPH, MBE 215-746-4920 dress@pennmedicine.upenn.edu
Contact: Katherine Courtright, MD, MS katherine.courtright@uphs.upenn.edu

Locations
United States, North Carolina
Carolinas HealthCare System, Stanly Recruiting
Albemarle, North Carolina, United States, 28001
Carolinas HealthCare System, NorthEast Recruiting
Charlotte, North Carolina, United States, 28025
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Carolinas Medical Center, Mercy Recruiting
Charlotte, North Carolina, United States, 28207
Carolinas HealthCare System, Pineville Recruiting
Charlotte, North Carolina, United States, 28210
Carolinas HealthCare System, University Recruiting
Charlotte, North Carolina, United States, 28262
Carolinas HealthCare System, Lincoln Recruiting
Lincolnton, North Carolina, United States, 28092
Carolinas HealthCare System, Union Recruiting
Monroe, North Carolina, United States, 28112
Carolinas HealthCare System, Blue Ridge Recruiting
Morganton, North Carolina, United States, 28655
Carolinas HealthCare System, Cleveland Recruiting
Shelby, North Carolina, United States, 28150
Sponsors and Collaborators
University of Pennsylvania
Carolinas Healthcare System
Donaghue Medical Research Foundation
Investigators
Principal Investigator: Scott D Halpern, PhD, MD University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03139838     History of Changes
Other Study ID Numbers: UPenn IRB #826933
52635 ( Other Grant/Funding Number: Patrick and Catherine Weldon Donaghue Foundation )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:
Palliative Care
Pragmatic Clinical Trial
Electronic Health Records
Economics, Behavioral

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes