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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06452797
Other study ID # 24030801
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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