Impact of an Early Palliative Approach

Incurable Disease Clinical Trial

— MAHO2  

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02906462
• Other study ID #: 2013/99
• Secondary ID: 2012-A00444-39
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1200
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Incurable Disease

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU	Amiens
France	Hôpital Privé Medecine interne	Antony
France	Hopital privé Oncologie Médicale	Antony
France	Hôpital Avicenne	Bobigny
France	Hôpital Ambroise Paré	Boulogne Billancourt
France	Hôpital Georges Clemenceau	Champcueil
France	CHU	Dijon
France	Centre Hospitalier	Epernay
France	Hôpital Bicêtre	Le Kremlin Bicetre
France	CHRU	Lille
France	Groupe Hospitalier Paris - Saint-Joseph	Paris
France	Hopital Cochin Gastro-Enterologie	Paris
France	Hopital Lariboisiere Medecine interne	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

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (12)

Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Hervé 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. — View 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'Hôpital Group. Circum — View 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 intensi — View 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. Epub 2006 Aug 2. — View 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. — View 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):394-4 — View 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. — View 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. — View 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 Au — View 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 — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Death conditions	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
Secondary	Early vulnerability consideration impact on length of stay	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
Secondary	Palliative strategy modalities	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
Secondary	Early vulnerability consideration impact on caregivers' satisfaction	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