Impact of an Early Palliative Approach (MAHO2)
15 de mayo de 2019 actualizado por: Hopital Foch
Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"
In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al.
Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey.
Arch Intern Med.
2008 168: 867-875.)
evaluated the way 3793 patients died in 200 French hospitals and showed that their conditions of death were not optimal.
The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious.
Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In 2003, MAHO study evaluated the way 3793 patients died en 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.
Principal Objective: To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
Primary endpoint: Rate of withdraw/withhold of treatment in each group.
Secondary objectives: To evaluate the impact of early recognition of patients' vulnerability on death conditions ; to evaluate this strategy impact according to unit type on length of stay, palliative strategy modalities and caregivers' satisfaction.
Secondary endpoints: Rate of therapeutic involvement reflections ; rate of death following withholding or withdrawing of treatments ; traceability of the level of therapeutic involvement process ; Rate of patients deceased with their relatives next to them ; rate of patients deceased with comfort treatment ; rate of palliative care consultation before death ; rate of asks for euthanasia ; Doctor and nurse's perception of quality of support and death process of the patient
Methods: Prospective, controlled, cluster randomized study of routine care 2 groups:
- Group A: standard care and practice after 1 day of training
- Group B: 1 day of training, learning the vulnerability criteria that should induce early thinking about level of therapeutic involvement; web accessed forms will be available to help collegial process, withhold and withdraw decisions traceability, using legal requirements Number of patients to include: To detect a 20% absolute difference in palliative strategy used (30 to 50%), we determined that 5040 patients would provide a power of 80% with the use of a two-sided alpha level of 0.05. Sequential analysis is planned in order to early stop the study in case of efficacy or futility (minimal inclusion: 500 patients)
Inclusion criteria:
All patients hospitalized with at least one of the following vulnerability criteria will be included:
- Evolutive and symptomatic incurable cancer
- Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
- Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
- Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
- Care refusal and/or expressed will to die or repeated request for help to die
Exclusion criteria:
- Minors
- Patients without indication for treatment or surveillance with length of stay inferior to 24h
- Brain dead patients
- Not consent patients
Duration: 37 months (28 inclusion months for each center and a follow-up to hospital discharge, death or 9 months if the patient is still hospitalized).
Number of participating centers: 20 centers (28 services) were selected and recruit after training program among centers that did not used a formalized process to initiate level of therapeutic involvement reflection.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
1200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Amiens, Francia, 80000
- CHU
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Antony, Francia, 92160
- Hopital privé Oncologie Médicale
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Antony, Francia, 92160
- Hôpital Privé Medecine interne
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Bobigny, Francia, 93000
- Hopital Avicenne
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Boulogne Billancourt, Francia, 92100
- Hôpital Ambroise Paré
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Champcueil, Francia, 91750
- Hôpital Georges Clemenceau
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Dijon, Francia, 21000
- CHU
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Epernay, Francia, 51200
- Centre Hospitalier
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Le Kremlin Bicetre, Francia, 94270
- Hôpital Bicêtre
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Lille, Francia, 59000
- CHRU
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Paris, Francia, 75010
- Hopital Lariboisiere Medecine interne
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Paris, Francia, 75014
- Groupe Hospitalier Paris - Saint-Joseph
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Paris, Francia, 75014
- Hopital Cochin Gastro-Enterologie
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Poitiers, Francia, 86000
- Centre Hospitalier Universitaire
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Roubaix, Francia, 59100
- Centre Hospitalier
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Soissons, Francia, 02200
- Centre Hospitalier de Soissons
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Suresnes, Francia, 92150
- Hiopital Foch Néphrologie
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Suresnes, Francia, 92150
- Hopital Foch Cardiologie
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Suresnes, Francia, 92150
- Hopital Foch Chirurgie Urologique
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Suresnes, Francia, 92150
- Hopital Foch Médecine Interne
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Suresnes, Francia, 92150
- Hopital Foch Neurochirurgie
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Suresnes, Francia, 92150
- Hopîtal Foch Urgences
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Valenciennes, Francia, 59300
- CH
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient more than 18 years old hospitalized for at least 24h and who's prognosis (survival or quality of life) should lead to a palliative approach
Patient suffering with at least one of the following vulnerability criteria will be included:
- Evolutive and symptomatic incurable cancer
- Aged more than 75 years old and presenting several geriatric syndromes (cognitive disorders, isolation, malnutrition, bedridden more than 12h per day)
- Neurologic pathology, chronic, with loss of autonomy (Performance Status>3)
- Final organ failure (heart, lungs, liver, kidney) with loss of autonomy (Performance Status>3)
- Care refusal and/or expressed will to die or repeated request for help to die
- 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:
- Minors
- Patients without indication for treatment or surveillance with length of stay inferior to 24h
- Brain dead patients
- Not consent patients
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Usual Practices
|
the centres applies their usual practices
|
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Otro: Early consideration of vulnerability
Strategy promoting early consideration of patients' vulnerability
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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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of withdraw/withhold of treatment in each group
Periodo de tiempo: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
To evaluate the impact of an early palliative strategy using vulnerability criteria compared to standard care.
|
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Death conditions
Periodo de tiempo: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
rate of death relied to a withholding/withdrawing treatment decision, rate relatives present at the time of death, rate of death with comfort drugs, rate of patient/family/relatives interview with a psychologist. rate of death relied to a withholding/withdrawing treatment decision, rate relatives present at the time of death, rate of death with comfort drugs, rate of patient/family/relatives interview with a psychologist. |
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
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Early vulnerability consideration impact on length of stay
Periodo de tiempo: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
total length of stay in the hospital
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From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
|
Palliative strategy modalities
Periodo de tiempo: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
rate of reflections on level of therapeutic involvement
|
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
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Early vulnerability consideration impact on caregivers' satisfaction
Periodo de tiempo: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
Physician and nurses' perceptions about care management and conditions of death, caregivers interview with a psychologist
|
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Edouard Ferrand, MD, e.ferrand@hopital-foch.org
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
- Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
- 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, 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.
- 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, 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.
- 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.
- 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.
- 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.
- Kelley AS, Meier DE. Palliative care--a shifting paradigm. N Engl J Med. 2010 Aug 19;363(8):781-2. doi: 10.1056/NEJMe1004139. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2013
Finalización primaria (Actual)
1 de marzo de 2019
Finalización del estudio (Actual)
1 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
17 de febrero de 2016
Primero enviado que cumplió con los criterios de control de calidad
19 de septiembre de 2016
Publicado por primera vez (Estimar)
20 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
15 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2013/99
- 2012-A00444-39 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .