Recruiting

ProVent-14

Sponsor:

Rush University Medical Center

Code:

NCT06452797

Conditions

Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

ProVent-14 score

Study Details

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

Study ID

NCT06452797

Start date

Jun 18, 2024

Status verified date

Sep, 2025

Completion date

Jun 15, 2027

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

238 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

Interventions

ProVent-14 score

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

Primary outcome measure

  • Accuracy of one-year mortality rate predictions [ Time Frame: One-year after participant enrollment ]

Central Contacts and Locations

Central contacts

Jared Greenberg, MD

312-942-6744jared_greenberg@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jared A Greenberg, MD

312-942-6744jared_greenberg@rush.edu

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

David Y Hwang, MD

919-966-8178david_hwang@med.unc.edu

Principal Investigator:

David Y Hwang

More Information

Sponsor

Rush University Medical Center

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-09-17.