Prognostic Estimates Among ICU Clinicians

NCT06452797 | Recruiting

• 1 other identifier: 24030801
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Confidence in prediction

  Upon enrollment

• Comfort communicating prognosis to patient/surrogate

  Upon enrollment

• Recommendation to transition to comfort-focused care

  Upon enrollment

• Accuracy of timing of patient death

  One-year after participant enrollment

Other Outcomes (1)

• Accuracy of factors influencing prediction

  One-year after participant enrollment

Study Arms (2)

Usual Prognostic Approach

NO INTERVENTION

Participants will make form a prognosis using their usual approach

ProVent-14 Guided Prognostic Approach

EXPERIMENTAL

Participants will be asked to form a prognosis after being provided the patient's ProVent-14 score and its meaning

Behavioral: ProVent-14 score

Interventions

ProVent-14 score BEHAVIORAL

A score to estimate one-year mortality for patients requiring at least 14 days of mechanical ventilation

ProVent-14 Guided Prognostic Approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Rush Oak Park Hospital

Oak Park, Illinois, 60304, United States

ACTIVE NOT RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 30690645 BACKGROUND

• 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.

  PMID: 28528347 BACKGROUND

• 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.

  PMID: 26247337 BACKGROUND

• 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.

  PMID: 30385535 BACKGROUND

Central Study Contacts

Jared Greenberg, MD

CONTACT

312-942-6744; jared_greenberg@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (3)