Prognostic Estimates Among ICU Clinicians

Prognostic Estimates Among ICU Clinicians Caring for Patients Requiring Prolonged Mechanical Ventilation

One challenge with decision making for mechanically ventilated is that their prognosis is often uncertain. The ProVent-14 score incorporates clinical variables measured on the 14th day of mechanical ventilation to predict risk of death in one year. The ProVent-14 is easy to calculate has been externally validated. However, it is unclear how often clinicians use the ProVent-14 score to predict long-term outcomes for patients requiring 14 days of mechanical ventilation or if it helps clinicians make more accurate predictions. The purpose of this study is to determine whether ICU clinicians who receive a patient's ProVent-14 score make more accurate predictions for mortality at one year than ICU clinicians who do not.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Behavioral: ProVent-14 score

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jared Greenberg, MD; Phone Number: 312-942-6744; Email: jared_greenberg@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Jared A Greenberg, MD; Phone Number: 312-942-6744; Email: jared_greenberg@rush.edu
    • Oak Park, Illinois, United States, 60304
      • Active, not recruiting
      • Rush Oak Park Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina
      • Contact: David Y Hwang, MD; Phone Number: 919-966-8178; Email: david_hwang@med.unc.edu
      • Principal Investigator: David Y Hwang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ICU day-shift attending physician, fellow physician, advanced practice provider, or nurse
• Caring directly for a patient who requires invasive mechanical ventilation, 14-16 days after initial intubation, not actively transitioning to comfort-focused care and not with a neuromuscular disease (i.e. ALS) as a cause of respiratory failure.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Prognostic Approach; Participants will make form a prognosis using their usual approach
Experimental: ProVent-14 Guided Prognostic Approach; Participants will be asked to form a prognosis after being provided the patient's ProVent-14 score and its meaning	Behavioral: ProVent-14 score; A score to estimate one-year mortality for patients requiring at least 14 days of mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of one-year mortality rate predictions	Associations between participant predictions (0-100% risk of death) and patient outcomes (death or not) will be determined using logistic regression. Accuracy will be determined by Area Under the Receiver Operating Characteristic (AUROC) analysis.	One-year after participant enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confidence in prediction	1-10 scale, 10 being most confident	Upon enrollment
Comfort communicating prognosis to patient/surrogate	1-10 scale, 10 being most comfortable	Upon enrollment
Recommendation to transition to comfort-focused care	Yes or No	Upon enrollment
Accuracy of timing of patient death	Participants who predict the patient has a <50% chance of survival will be asked to predict the month the patient will pass away	One-year after participant enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of factors influencing prediction	Participants will list up to 5 characteristics of the patient's situation that influenced their prediction	One-year after participant enrollment

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Hough CL, Caldwell ES, Cox CE, Douglas IS, Kahn JM, White DB, Seeley EJ, Bangdiwala SI, Rubenfeld GD, Angus DC, Carson SS; ProVent Investigators and the National Heart Lung and Blood Institute's Acute Respiratory Distress Syndrome Network. Development and Validation of a Mortality Prediction Model for Patients Receiving 14 Days of Mechanical Ventilation. Crit Care Med. 2015 Nov;43(11):2339-45. doi: 10.1097/CCM.0000000000001205.
• Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
• Detsky ME, Harhay MO, Bayard DF, Delman AM, Buehler AE, Kent SA, Ciuffetelli IV, Cooney E, Gabler NB, Ratcliffe SJ, Mikkelsen ME, Halpern SD. Discriminative Accuracy of Physician and Nurse Predictions for Survival and Functional Outcomes 6 Months After an ICU Admission. JAMA. 2017 Jun 6;317(21):2187-2195. doi: 10.1001/jama.2017.4078.
• Buehler AE, Ciuffetelli IV, Delman AM, Kent SA, Bayard DF, Cooney E, Halpern SD, Detsky ME. Contributors to Intensive Care Unit Clinicians' Predictions of Patient Outcomes: A Qualitative Analysis. Am J Crit Care. 2018 Nov;27(6):445-453. doi: 10.4037/ajcc2018100.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24030801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: to be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No