Prognostic Estimates Among ICU Clinicians

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452797
• Other study ID #: 24030801
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2024
• Est. completion date: June 15, 2027

Study information

• Verified date: June 2024
• Source: Rush University Medical Center
• Contact: Jared Greenberg, MD
• Phone: 312-942-6744
• Email: jared_greenberg[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: June 15, 2027
• Est. primary completion date: June 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Confidence in prediction	1-10 scale, 10 being most confident	Upon enrollment
Secondary	Comfort communicating prognosis to patient/surrogate	1-10 scale, 10 being most comfortable	Upon enrollment
Secondary	Recommendation to transition to comfort-focused care	Yes or No	Upon enrollment
Secondary	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