Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Hopital Foch
- Enrollment
- 1,200
- Locations
- 23
- Primary Endpoint
- Rate of withdraw/withhold of treatment in each group
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients without indication for treatment or surveillance with length of stay inferior to 24h
- •Brain dead patients
- •Not consent patients
Arms & Interventions
Usual Practices
Usual Practices
Intervention: Usual practices (Other)
Early consideration of vulnerability
Strategy promoting early consideration of patients' vulnerability
Intervention: Early consideration of vulnerability (Other)
Outcomes
Primary Outcomes
Rate of withdraw/withhold of treatment in each group
Time Frame: 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.
Secondary Outcomes
- Death conditions(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)
- 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)