- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06452797
Prognostiske skøn blandt ICU-klinikere
Prognostiske skøn blandt ICU-klinikere, der tager sig af patienter, der har behov for længerevarende mekanisk ventilation
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jared Greenberg, MD
- Telefonnummer: 312-942-6744
- E-mail: jared_greenberg@rush.edu
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- Rush University Medical Center
-
Kontakt:
- Jared A Greenberg, MD
- Telefonnummer: 312-942-6744
- E-mail: jared_greenberg@rush.edu
-
Oak Park, Illinois, Forenede Stater, 60304
- Aktiv, ikke rekrutterende
- Rush Oak Park Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- University of North Carolina
-
Kontakt:
- David Y Hwang, MD
- Telefonnummer: 919-966-8178
- E-mail: david_hwang@med.unc.edu
-
Ledende efterforsker:
- David Y Hwang
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Usual Prognostic Approach
Participants will make form a prognosis using their usual approach |
|
|
Eksperimentel: 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 |
A score to estimate one-year mortality for patients requiring at least 14 days of mechanical ventilation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of one-year mortality rate predictions
Tidsramme: One-year after participant enrollment
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Confidence in prediction
Tidsramme: Upon enrollment
|
1-10 scale, 10 being most confident |
Upon enrollment
|
|
Comfort communicating prognosis to patient/surrogate
Tidsramme: Upon enrollment
|
1-10 scale, 10 being most comfortable |
Upon enrollment
|
|
Recommendation to transition to comfort-focused care
Tidsramme: Upon enrollment
|
Yes or No |
Upon enrollment
|
|
Accuracy of timing of patient death
Tidsramme: One-year after participant enrollment
|
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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of factors influencing prediction
Tidsramme: One-year after participant enrollment
|
Participants will list up to 5 characteristics of the patient's situation that influenced their prediction |
One-year after participant enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 24030801
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
to be determined
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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