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Recruiting NCT06452797

Prognostic Estimates Among ICU Clinicians

No phase Interventional Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ProVent-14 score.
Who it may be relevant to
Registry conditions: Mechanical Ventilation. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Accuracy of one-year mortality rate predictions [Time frame: One-year after participant enrollment]
Secondary outcome measures (4)
  • Confidence in prediction [Time frame: Upon enrollment]
  • Comfort communicating prognosis to patient/surrogate [Time frame: Upon enrollment]
  • Recommendation to transition to comfort-focused care [Time frame: Upon enrollment]
  • Accuracy of timing of patient death [Time frame: One-year after participant enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Rush University Medical Center — Chicago
  • Rush Oak Park Hospital — Oak Park
  • University of North Carolina — Chapel Hill

Publications

  • 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
  • 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
  • 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 PMID 26247337
  • 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

Identifiers

NCT: NCT06452797 · 24030801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗