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

NCT03139838 | Completed DMC

• 2 other identifiers: UPenn IRB #82693352635
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 10

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.

Conditions

Critical Illness

Keywords

Palliative Care; Pragmatic Clinical Trial; Electronic Health Records; Economics, Behavioral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Change in code status

  Duration of hospital stay, an expected average of 16 days

• Initiation of additional forms of life-support

  Duration of hospital stay, an expected average of 16 days

• Palliative care consult

  Duration of hospital stay, an expected average of 16 days

• Time to palliative care consult

  Duration of hospital stay, an expected average of 16 days

• Palliative withdrawal of mechanical ventilation

  Duration of hospital stay, an expected average of 16 days

Study Arms (4)

EHR-Based Intervention A

ACTIVE COMPARATOR

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

EHR-Based Intervention B

ACTIVE COMPARATOR

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

Combined EHR-Based Intervention (A+B)

ACTIVE COMPARATOR

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; Behavioral: EHR-Based Intervention B

Pre-Intervention (Control)

NO INTERVENTION

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.

Interventions

EHR-Based Intervention A BEHAVIORAL

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.

Also known as: Prognostication

Combined EHR-Based Intervention (A+B); EHR-Based Intervention A

EHR-Based Intervention B BEHAVIORAL

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.

Also known as: Accountable Justification

Combined EHR-Based Intervention (A+B); EHR-Based Intervention B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old; AND
• Admitted to 1 of the 17 participating ICUs; AND
• Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
• ≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months):
• Chronic obstructive pulmonary disease
• Cirrhosis
• Congestive heart failure
• Dementia (all types)
• End-stage renal disease
• Hematologic malignancy
• Metastatic malignancy
• Motor neuron disease
• Pulmonary fibrosis
• Solid organ malignancy

You may not qualify if:

• \) Patients younger than 18 years old are excluded.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Wake Forest University Health Sciences: collaborator
• Donaghue Medical Research Foundation: collaborator

Study Sites (10)

Carolinas HealthCare System Stanly

Albemarle, North Carolina, 28001, United States

Location

Carolinas HealthCare System, NorthEast

Charlotte, North Carolina, 28025, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Atrium Health CMC-Mercy

Charlotte, North Carolina, 28207, United States

Location

Atrium Health Pineville

Charlotte, North Carolina, 28210, United States

Location

Atrium Health University City

Charlotte, North Carolina, 28262, United States

Location

Atrium Health Lincoln

Lincolnton, North Carolina, 28092, United States

Location

Atrium Health Union

Monroe, North Carolina, 28112, United States

Location

Carolinas HealthCare System Blue Ridge-Morganton

Morganton, North Carolina, 28655, United States

Location

Atrium Health Cleveland

Shelby, North Carolina, 28150, United States

Location

Related Publications (2)

• Courtright KR, Singh J, Dress EM, Bayes B, Harhay MO, Chowdhury M, Lu Y, Lee KM, Small DS, Whitman C, Tian J, Madden V, Hetherington T, Placket L, Sullivan DM, Burke HL, Green MB, Halpern SD. Nudging Clinicians to Promote Serious Illness Communication for Critically Ill Patients: A Pragmatic Cluster Randomized Trial. JAMA Intern Med. 2025 May 1;185(5):510-520. doi: 10.1001/jamainternmed.2025.0090.

  PMID: 40094649 DERIVED

• 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.

  PMID: 32936675 DERIVED

MeSH Terms

Conditions

Critical Illness; Behavior

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott D Halpern, PhD, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 4, 2017
• Study Start: February 1, 2018
• Primary Completion: April 24, 2021
• Study Completion: June 30, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)