- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06452797
Prognostiska uppskattningar bland intensivvårdsläkare
Prognostiska uppskattningar bland intensivvårdsläkare som tar hand om patienter som behöver långvarig 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jared Greenberg, MD
- Telefonnummer: 312-942-6744
- E-post: jared_greenberg@rush.edu
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- Rekrytering
- Rush University Medical Center
-
Kontakt:
- Jared A Greenberg, MD
- Telefonnummer: 312-942-6744
- E-post: jared_greenberg@rush.edu
-
Oak Park, Illinois, Förenta staterna, 60304
- Aktiv, inte rekryterande
- Rush Oak Park Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- Rekrytering
- University of North Carolina
-
Kontakt:
- David Y Hwang, MD
- Telefonnummer: 919-966-8178
- E-post: david_hwang@med.unc.edu
-
Huvudutredare:
- David Y Hwang
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Usual Prognostic Approach
Participants will make form a prognosis using their usual approach |
|
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Accuracy of one-year mortality rate predictions
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Confidence in prediction
Tidsram: Upon enrollment
|
1-10 scale, 10 being most confident |
Upon enrollment
|
|
Comfort communicating prognosis to patient/surrogate
Tidsram: Upon enrollment
|
1-10 scale, 10 being most comfortable |
Upon enrollment
|
|
Recommendation to transition to comfort-focused care
Tidsram: Upon enrollment
|
Yes or No |
Upon enrollment
|
|
Accuracy of timing of patient death
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Accuracy of factors influencing prediction
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 24030801
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
to be determined
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