Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
1200 participants
INTERVENTIONAL
2013-11-30
2019-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Interventional Research With Mixed Methods on an Early Integrated Palliative Approach in Nursing Home
NCT04708002
Reasons of Transfer in Emergency Units of Patients in End of Life Situation.
NCT02861469
The Impact of Telemedicine to Support Palliative Care Resident in Nursing Home
NCT02821143
Home-based Nurse Intervention in the Care of High Risk of Death Patients After Discharge From Geriatric Department
NCT06481917
Palliative and End-of-life Care in Advanced Dementia: Evaluation of a Program of Organization of Care in Long-term Care
NCT01441726
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual Practices
Usual Practices
Usual practices
the centres applies their usual practices
Early consideration of vulnerability
Strategy promoting early consideration of patients' vulnerability
Early consideration of 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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early consideration of 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
Usual practices
the centres applies their usual practices
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients without indication for treatment or surveillance with length of stay inferior to 24h
* Brain dead patients
* Not consent patients
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hopital Foch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU
Amiens, , France
Hopital privé Oncologie Médicale
Antony, , France
Hôpital Privé Medecine interne
Antony, , France
Hôpital Avicenne
Bobigny, , France
Hôpital Ambroise Paré
Boulogne-Billancourt, , France
Hôpital Georges Clemenceau
Champcueil, , France
CHU
Dijon, , France
Centre Hospitalier
Épernay, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CHRU
Lille, , France
Hopital Lariboisiere Medecine interne
Paris, , France
Groupe Hospitalier Paris - Saint-Joseph
Paris, , France
Hopital Cochin Gastro-Enterologie
Paris, , France
Centre Hospitalier Universitaire
Poitiers, , France
Centre Hospitalier
Roubaix, , France
Centre Hospitalier de Soissons
Soissons, , France
Hiopital Foch Néphrologie
Suresnes, , France
Hopital Foch Cardiologie
Suresnes, , France
Hopital Foch Chirurgie Urologique
Suresnes, , France
Hopital Foch Médecine Interne
Suresnes, , France
Hopital Foch Neurochirurgie
Suresnes, , France
Hopîtal Foch Urgences
Suresnes, , France
CH
Valenciennes, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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, 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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-A00444-39
Identifier Type: OTHER
Identifier Source: secondary_id
2013/99
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.