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Interest of Pain Assessment by the Family of Patients in Limiting and Stopping Active Treatment Process Admitted in ER. Study DOFAMILA

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02844972
Acronym
DOFAMILIA
Enrollment
200
Registered
2016-07-26
Start date
2015-06-30
Completion date
2017-06-30
Last updated
2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient's Pain in Later Life

Keywords

arrest or limitation of active treatment, emergency treatment

Brief summary

Decisions to limit and stop active therapeutics are common in the emergency unit. They are framed by the Leonetti law of 22 April 2005 recommending the refusal of unreasonable obstinacy and care of the patient's pain in later life. The pain assessment is an issue for these patients whose in majority, are not communicating. Moreover, no specific tool and the teams in charge, not knowing the patient make the recognition and treatment of pain symptoms very complex. This is the potential interest of directly involving the family or the person of confidence in this management , the first step being the detection and evaluation of pain.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults older than 18 * non communicating patients admitted in emergency ward * unanimous decision of stopping and limiting active treatment according to Leonetti's law of April 22nd, 2005 * Presence of a member of the patients family or one of his legal representative

Exclusion criteria

* Children * no health insurance

Design outcomes

Primary

MeasureTime frameDescription
simplified verbal scaleadmission time in ER (Day 1)A simplified verbal scale with 5 levels used by caregivers and family to evaluate the intensity of pain, painless, little sore, moderately painful, very painful, extremely painful. Compare the pain assessment by the family or the person of trust and care teams within a population of non-communicating patients for whom a decision of limiting and stopping active treatment is taken emergency ward.

Secondary

MeasureTime frameDescription
simplified verbal scale24 hours after the decision of limiting or stopping active treatment in emergenciesA simplified verbal scale with 5 levels used by caregivers and family to evaluate the intensity of pain, painless, little sore, moderately painful, very painful, extremely painful . Compare the pain assessment by the family or the person of trust and care teams within a population of non-communicating patients 24 hours after the decision of limiting or stopping active treatment in emergencies
Algoplus scaleat admission (Day 1)Comparison of pain assessment between families and caregivers with support will be made using Algoplus scale defining a pain when the score is greater than 2. Compare the pain assessment by the family or the person of trust and care teams with the support of a rating scale in a population of non-communicating patients for whom a decision of limiting or stopping active treatment in emergencies.
PAINAD scaleat admission (Day 1)Comparison of pain assessment between families and caregivers with support will be made using PAINAD scale rated from 0 to 10, defining the intensity of pain. Compare the pain assessment by the family or the person of trust and care teams with the support of a rating scale in a population of non-communicating patients for whom a decision of limiting or stopping active treatment in emergencies
CAESAR scale24 hours after admissionAssess the feelings of nursing teams on the family involvement in the assessment of pain and not communicating patient discomfort for which is a determination of limiting or stopping active treatment in emergencies.

Countries

France

Contacts

Primary ContactLaurent JACQUIN, MD
laurent.jacquin@chu-lyon.fr(0)4 72 11 00 48
Backup ContactJulien BERTHILLER
julien.berthiller@chu-lyon.fr(0) 4 72 11 80 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026