Impact of an Early Palliative Approach

NCT02906462 | Terminated

• 2 other identifiers: 2013/992012-A00444-39
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 23

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.

Conditions

Incurable Disease

Keywords

Leonetti French law; Palliative care

Outcome Measures

Primary Outcomes (1)

• Rate of withdraw/withhold of treatment in each group

  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

Secondary Outcomes (4)

• Death conditions

  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

  From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital

• Palliative strategy modalities

  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

  From hospital admission to death or discharge or 9 months after inclusion if the patient is still in the hospital

Study Arms (2)

Usual Practices

OTHER

Usual Practices

Other: Usual practices

Early consideration of vulnerability

OTHER

Strategy promoting early consideration of patients' vulnerability

Other: Early consideration of vulnerability

Interventions

Early consideration of vulnerability OTHER

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

Early consideration of vulnerability

Usual practices OTHER

the centres applies their usual practices

Usual Practices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minors
• Patients without indication for treatment or surveillance with length of stay inferior to 24h
• Brain dead patients
• Not consent patients

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (23)

CHU

Amiens, 80000, France

Location

Hopital privé Oncologie Médicale

Antony, 92160, France

Location

Hôpital Privé Medecine interne

Antony, 92160, France

Location

Hôpital Avicenne

Bobigny, 93000, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Hôpital Georges Clemenceau

Champcueil, 91750, France

Location

CHU

Dijon, 21000, France

Location

Centre Hospitalier

Épernay, 51200, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHRU

Lille, 59000, France

Location

Hopital Lariboisiere Medecine interne

Paris, 75010, France

Location

Groupe Hospitalier Paris - Saint-Joseph

Paris, 75014, France

Location

Hopital Cochin Gastro-Enterologie

Paris, 75014, France

Location

Centre Hospitalier Universitaire

Poitiers, 86000, France

Location

Centre Hospitalier

Roubaix, 59100, France

Location

Centre Hospitalier de Soissons

Soissons, 02200, France

Location

Hiopital Foch Néphrologie

Suresnes, 92150, France

Location

Hopital Foch Cardiologie

Suresnes, 92150, France

Location

Hopital Foch Chirurgie Urologique

Suresnes, 92150, France

Location

Hopital Foch Médecine Interne

Suresnes, 92150, France

Location

Hopital Foch Neurochirurgie

Suresnes, 92150, France

Location

Hopîtal Foch Urgences

Suresnes, 92150, France

Location

CH

Valenciennes, 59300, France

Location

Related Publications (12)

• 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.

  PMID: 11801837 BACKGROUND

• 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.

  PMID: 18443263 RESULT

• 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.

  PMID: 11197395 RESULT

• 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.

  PMID: 12738597 RESULT

• 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.

  PMID: 16896861 RESULT

• 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.

  PMID: 9769276 RESULT

• 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.

  PMID: 12915432 RESULT

• 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.

  PMID: 17145904 RESULT

• 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.

  PMID: 20818875 RESULT

• 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.

  PMID: 20818881 RESULT

• 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.

  PMID: 22203758 RESULT

• 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.

  PMID: 23358690 RESULT

Study Officials

• Edouard Ferrand, MD

  e.ferrand@hopital-foch.org

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: September 20, 2016
• Study Start: November 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 17, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (23)