Impact of an Early Palliative Approach (LATAREA-IV)
Impact of a Computer-assisted Tool to Help Reflection on the Decision to Withhold or to Withdraw Treatments for Surgical Patients in Intensive Care Units
Rationale: Medicalized end of life rose profound society questions and debates. Major Laws and scientific society recommendations emerged from those reflections. These texts help withholding/withdrawing life-sustaining treatments allowing a palliative approach and to favor comfort treatments for end of life patients.
Main Objective: To evaluate the impact of a procedure to support reflection on the level of therapeutic involvement for surgical patient (who undergone surgery or not) in ICU after having identified vulnerability criteria early.
Secondary objectives: To assess the usual care of the control group and the impact of the procedure according to ICU type (medical, surgical, mixed); the characteristics of surgical patients concerned by a palliative strategy; the impact of an incentive approach on length of mechanical ventilation and length of stay in the ICU; To measure the extent of information collected concerning the collegial process; the impact of the procedure on caregivers' satisfaction; To count the number of identified conflicts Study type: Prospective, controlled, cluster randomized study of routine care Purpose: Study the implementation of the Act "Leonetti" released on 22 April 2005 calling for a compassionate approach and palliative care for patients at end of life.
Inclusion criteria: Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period Non-inclusion criteria: Patients hospitalized less than 24h; non-surgical patients; patients who don't need ICU care or surveillance; minors; brain-dead patients (at the time of admission) Primary endpoint: Rate of deaths with palliative strategy (withholding or withdrawing treatments) Randomization process: each center is randomized adjusting on type of ICU (medical, surgical, mixed) and number of annual hospitalization volume.
- Control group: ICU usual care
- Intervention group: vulnerability criteria lead to reflection on level of therapeutic involvement, with the help of a written guide.
Number of patients: 2750 surgical patients Number of centers: 45 Study design: usual data will be collected in a secured web-based Case Report Form (CRF) at ICU admission and each time therapeutic strategy will change. Additional data will be collected for the intervention group according to the initial presence or the later apparition of predefined criteria, a standardized reflection procedure will start helped by the implementation of a guide for collegial approach and decision making.
Length: 30 months
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Suresnes, Frankrijk, 92 150
- Hopital Foch
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Surgical patients (who undergone surgery or not) hospitalized in ICU during the study period
- No opposition to the use of data collected from the patient or a relative or inclusion in emergency and non-opposition collected offline
Exclusion Criteria:
- Patients admitted legally dead or brain-dead
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Group A
the centres applies their usual practices
|
|
|
Ander: Group B
strategy promoting early consideration and collegiate vulnerability of patients
|
One day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants dead with palliative strategy
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
Rate of death with collegial process and withdrawing/withholding treatment
|
From ICU hospitalization to 6 months after inclusion
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Impact of the procedure according to ICU type
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
From ICU hospitalization to 6 months after inclusion
|
|
Characteristics of surgical patients concerned by a palliative strategy
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
From ICU hospitalization to 6 months after inclusion
|
|
Impact of an incentive approach on length of mechanical ventilation and length of stay in the ICU.
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
From ICU hospitalization to 6 months after inclusion
|
|
Extent of information collected concerning the collegial process
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
From ICU hospitalization to 6 months after inclusion
|
|
Impact of the procedure on caregivers' satisfaction
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
From ICU hospitalization to 6 months after inclusion
|
|
Number of identified conflicts
Tijdsspanne: From ICU hospitalization to 6 months after inclusion
|
From ICU hospitalization to 6 months after inclusion
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Edouard FERRAND, MD, Hopital Foch
Publicaties en nuttige links
Algemene publicaties
- Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7. doi: 10.1164/ajrccm.158.4.9801108.
- Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hopital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hopital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.
- Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14. doi: 10.1016/s0140-6736(00)03564-9.
- Ferrand E, Lemaire F, Regnier B, Kuteifan K, Badet M, Asfar P, Jaber S, Chagnon JL, Renault A, Robert R, Pochard F, Herve C, Brun-Buisson C, Duvaldestin P; French RESSENTI Group. Discrepancies between perceptions by physicians and nursing staff of intensive care unit end-of-life decisions. Am J Respir Crit Care Med. 2003 May 15;167(10):1310-5. doi: 10.1164/rccm.200207-752OC. Epub 2003 Jan 24.
- Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48. doi: 10.1097/00003246-200112000-00017. No abstract available.
- Ferrand E, Marty J; French LATASAMU Group. Prehospital withholding and withdrawal of life-sustaining treatments. The French LATASAMU survey. Intensive Care Med. 2006 Oct;32(10):1498-505. doi: 10.1007/s00134-006-0292-5. Epub 2006 Aug 2.
- Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7. doi: 10.1001/jama.290.6.790.
- Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Herve C, Marty J. Participation of French general practitioners in end-of-life decisions for their hospitalised patients. J Med Ethics. 2006 Dec;32(12):683-7. doi: 10.1136/jme.2005.014084.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- K071203
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Criteria of Vulnerability
-
Cairo UniversityOnbekendKlinische prestaties met behulp van gewijzigde USPHS-criteriaEgypte
-
University of MessinaVoltooidGDM-screening tijdens COVID-pandemie | Vergelijking tussen IADPSG versus WHO '99-criteriaItalië
-
Sohag UniversityWervingPassende diagnostische criteria van baarmoederniche met detectie van prevalentie, risicofactoren en bijbehorende symptomenEgypte
-
Aristotle University Of ThessalonikiVoltooidSlechte ovariële respons | Overexpressie van het androgeenreceptorgen | Normale respondenten | Bologna-criteria
-
CHU de ReimsVoltooidProximale opperarmbeenbreuk | Reproduceerbaarheid | Vierdelige breuk | De criteria van HertelFrankrijk
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceVoltooidJongvolwassene | Opgenomen in het ziekenhuis | Tiener | Anorexia Nervosa (DSM-IV herziene criteria)Frankrijk
-
University of Southern CaliforniaNational Institute of Mental Health (NIMH); University of California, San FranciscoWervingMedicatie Refractaire epilepsiepatiënten bij wie al elektroden zijn geïmplanteerd op basis van klinische criteria voor standaardmonitoringVerenigde Staten
-
University Hospital, MontpellierVoltooidPsA-patiënten die voldoen aan CASPAR-criteria in remissieFrankrijk
-
University Hospital, GrenobleVoltooidChronische migraine zoals gedefinieerd door de criteria van de International Headache Society (IHS)Frankrijk
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Third Affiliated Hospital,... en andere medewerkersOnbekendResectabel hepatocellulair carcinoom buiten de Milanese criteriaChina