Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844972
Recruitment Status : Unknown
Verified July 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Patient's Pain in Later Life

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. simplified verbal scale [ Time Frame: admission 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 Outcome Measures :
  1. simplified verbal scale [ Time Frame: 24 hours after the decision of limiting or stopping active treatment in emergencies ]

    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


  2. Algoplus scale [ Time Frame: at 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.


  3. PAINAD scale [ Time Frame: at 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


  4. CAESAR scale [ Time Frame: 24 hours after admission ]
    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.

  5. CAESAR scale [ Time Frame: 3 weeks after admission ]

    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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non communicating patients admitted in emergency ward
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844972


Contacts
Layout table for location contacts
Contact: Laurent JACQUIN, MD (0)4 72 11 00 48 ext +33 laurent.jacquin@chu-lyon.fr
Contact: Julien BERTHILLER (0) 4 72 11 80 67 ext +33 julien.berthiller@chu-lyon.fr

Locations
Layout table for location information
France
ER unit Hospital Edouard Herriot, Hospices Civils de Lyon Recruiting
Lyon, France, 69003
Contact: Laurent JACQUIN, MD    (0)4 72 11 00 48 ext +33    laurent.jacquin@chu-lyon.fr   
Contact: Julien BERTHILLER    (0)4 72 11 80 67 ext +33    julien.berthiller@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Layout table for investigator information
Principal Investigator: Laurent JACQUIN, MD ER unit Hospital Edouard Herriot, Hospices Civils de Lyon
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02844972    
Other Study ID Numbers: 69HCL14_0216
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Hospices Civils de Lyon:
arrest or limitation of active treatment
emergency treatment