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

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.

Study Overview

• Status: Unknown
• Conditions: Patient's Pain in Later Life

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Recruiting
    • ER unit Hospital Edouard Herriot, Hospices Civils de Lyon
    • Contact: Laurent JACQUIN, MD; Phone Number: +33 (0)4 72 11 00 48; Email: laurent.jacquin@chu-lyon.fr
    • Contact: Julien BERTHILLER; Phone Number: +33 (0)4 72 11 80 67; Email: julien.berthiller@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

non communicating patients admitted in emergency ward

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
simplified verbal scale	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.	admission time in ER (Day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
simplified verbal scale	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 24 hours after the decision of limiting or stopping active treatment in emergencies	24 hours after the decision of limiting or stopping active treatment in emergencies
Algoplus scale	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.	at admission (Day 1)
PAINAD scale	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	at admission (Day 1)
CAESAR scale	Assess 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.	24 hours after admission
CAESAR scale	The experience of the family will be described based on the questionnaire adapted from CAESAR scale ( rating scale of the quality of the care of the dying in intensive care) . Assess 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.	3 weeks after admission

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Laurent JACQUIN, MD, ER unit Hospital Edouard Herriot, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Douplat M, Daoud K, Berthiller J, Schott AM, Potinet V, Le Coz P, Tazarourte K, Jacquin L. Poor Involvement of General Practitioners in Decisions of Withholding or Withdrawing Life-Sustaining Treatment in Emergency Departments. J Gen Intern Med. 2020 Jan;35(1):177-181. doi: 10.1007/s11606-019-05464-y. Epub 2019 Nov 4.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: emergency treatment; arrest or limitation of active treatment
• Other Study ID Numbers: 69HCL14_0216