Clinical trial NCT02906462: Impact of an Early Palliative Approach
Official title: Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incurable Disease
Keywords: Leonetti French law
Palliative care
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of withdraw/withhold of treatment in each group
timeFrame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Secondary outcomes:
measure: Death conditions
timeFrame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
measure: Early vulnerability consideration impact on length of stay
timeFrame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
measure: Palliative strategy modalities
timeFrame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
measure: Early vulnerability consideration impact on caregivers' satisfaction
timeFrame: From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Antony
country: France
facility: Hopital privé Oncologie Médicale
city: Antony
country: France
facility: Hôpital Privé Medecine interne
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Boulogne Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Champcueil
country: France
facility: Hôpital Georges Clemenceau
city: Dijon
country: France
facility: CHU
city: Epernay
country: France
facility: Centre Hospitalier
city: Le Kremlin Bicetre
country: France
facility: Hôpital Bicêtre
city: Lille
country: France
facility: CHRU
city: Paris
country: France
facility: Hopital Lariboisiere Medecine interne
city: Paris
country: France
facility: Groupe Hospitalier Paris - Saint-Joseph
city: Paris
country: France
facility: Hopital Cochin Gastro-Enterologie
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire
city: Roubaix
country: France
facility: Centre Hospitalier
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
city: Suresnes
country: France
facility: Hiopital Foch Néphrologie
city: Suresnes
country: France
facility: Hopital Foch Cardiologie
city: Suresnes
country: France
facility: Hopital Foch Chirurgie Urologique
city: Suresnes
country: France
facility: Hopital Foch Médecine Interne
city: Suresnes
country: France
facility: Hopital Foch Neurochirurgie
city: Suresnes
country: France
facility: Hopîtal Foch Urgences
city: Valenciennes
country: France
facility: CH
Study officials:
affiliation: e.ferrand@hopital-foch.org
name: Edouard Ferrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.