Impact of an Early Palliative Approach (MAHO2)
15 мая 2019 г. обновлено: 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.
Обзор исследования
Статус
Прекращено
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
1200
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Amiens, Франция, 80000
- CHU
-
Antony, Франция, 92160
- Hopital privé Oncologie Médicale
-
Antony, Франция, 92160
- Hôpital Privé Medecine interne
-
Bobigny, Франция, 93000
- Hopital Avicenne
-
Boulogne Billancourt, Франция, 92100
- Hôpital Ambroise Paré
-
Champcueil, Франция, 91750
- Hôpital Georges Clemenceau
-
Dijon, Франция, 21000
- CHU
-
Epernay, Франция, 51200
- Centre Hospitalier
-
Le Kremlin Bicetre, Франция, 94270
- Hôpital Bicêtre
-
Lille, Франция, 59000
- CHRU
-
Paris, Франция, 75010
- Hopital Lariboisiere Medecine interne
-
Paris, Франция, 75014
- Groupe Hospitalier Paris - Saint-Joseph
-
Paris, Франция, 75014
- Hopital Cochin Gastro-Enterologie
-
Poitiers, Франция, 86000
- Centre Hospitalier Universitaire
-
Roubaix, Франция, 59100
- Centre Hospitalier
-
Soissons, Франция, 02200
- Centre Hospitalier de Soissons
-
Suresnes, Франция, 92150
- Hiopital Foch Néphrologie
-
Suresnes, Франция, 92150
- Hopital Foch Cardiologie
-
Suresnes, Франция, 92150
- Hopital Foch Chirurgie Urologique
-
Suresnes, Франция, 92150
- Hopital Foch Médecine Interne
-
Suresnes, Франция, 92150
- Hopital Foch Neurochirurgie
-
Suresnes, Франция, 92150
- Hopîtal Foch Urgences
-
Valenciennes, Франция, 59300
- CH
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Usual Practices
|
the centres applies their usual practices
|
|
Другой: Early consideration of vulnerability
Strategy promoting early consideration of patients' vulnerability
|
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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rate of withdraw/withhold of treatment in each group
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Death conditions
Временное ограничение: 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
|
|
Early vulnerability consideration impact on length of stay
Временное ограничение: 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
|
From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
|
|
Palliative strategy modalities
Временное ограничение: 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
|
|
Early vulnerability consideration impact on caregivers' satisfaction
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Edouard Ferrand, MD, e.ferrand@hopital-foch.org
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 ноября 2013 г.
Первичное завершение (Действительный)
1 марта 2019 г.
Завершение исследования (Действительный)
1 марта 2019 г.
Даты регистрации исследования
Первый отправленный
17 февраля 2016 г.
Впервые представлено, что соответствует критериям контроля качества
19 сентября 2016 г.
Первый опубликованный (Оценивать)
20 сентября 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 мая 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 мая 2019 г.
Последняя проверка
1 мая 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2013/99
- 2012-A00444-39 (Другой идентификатор: ANSM)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .