Evaluation of the Patient's Autonomy Vis-à-vis the Therapeutic Project Proposed in a Chronic Pain Structure
DoulEthic
1 other identifier
observational
30
1 country
1
Brief Summary
Patient autonomy is recognized throughout the world, by caregivers, as a value. The idea of autonomy has been the keystone of the changes accomplished in the contemporary history of health law. It is about respect for everyone to have their own health and to choose the options that correspond to their wishes, their values or their life projects. The recently revised definition of pain specifies that it is "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage". In this, pain is always a personal experience that is influenced to varying degrees by biological, psychological and social factors. The High Authority of Health considers pain as chronic is considered when it is persistent or recurrent beyond what is usual for its presumed initial cause (most often beyond 3 months), that it responds harm to treatment and that they induce a significant and progressive deterioration of functional and relational capacities. Chronic pain confines patients on a psychosocial level. It is no longer just a symptom, it is even a disease in its own right since 2019 with the new classification of diseases proposed by the World Health Organization.In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state".In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In current practice, this skill is assessed in case of doubt (generally when there is uncertainty about the patient's understanding of the issues and his involvement in the therapeutic project) intuitively, by following a Socratic questioning or from grids like the MacCAT-T. In the pain center, investigators use the MacCAT-T but investigators have not yet systematically measured the benefit and the cost of using this questionnaire in everyday practice. In particular, investigators want to know if the skill is not overestimated by the doctor in charge of the patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedFirst Submitted
Initial submission to the registry
May 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 5, 2023
May 1, 2023
3 months
May 26, 2023
May 26, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of patient autonomy
This outcome corresponds to the analysis of the distribution (means, standard deviations, medians, etc.) of MacCAT-T subscores (understanding, evaluation, appreciation and reasoning) of patients just after the pain consultation, where the personalized therapeutic plan was offered to them. analysis of the distribution (means, standard deviations, medians, etc.) of MacCAT-T subscores (understanding, evaluation, appreciation and reasoning) of patients just after the pain consultation, where the personalized therapeutic plan was offered to them
Day 1
Secondary Outcomes (1)
Good capacity for evaluation by the investigators of the autonomy of their patient
Day 1
Eligibility Criteria
Patient coming in 1st chronic pain consultation
You may qualify if:
- Patient whose age ≥ 18 years
- Patient coming in 1st chronic pain consultation
- French-speaking patient
You may not qualify if:
- Patient with a significant visual or auditory deficit
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under legal protection
- Patient objects to the use of their data for this research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Hôpital Saint-Joseph
Paris, 75014, France
Related Publications (7)
Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
PMID: 32694387BACKGROUNDTreede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
PMID: 25844555BACKGROUNDBouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.
PMID: 17888574BACKGROUNDEngel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977 Apr 8;196(4286):129-36. doi: 10.1126/science.847460.
PMID: 847460BACKGROUNDGrisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997 Nov;48(11):1415-9. doi: 10.1176/ps.48.11.1415.
PMID: 9355168BACKGROUNDRaffard S, Lebrun C, Laraki Y, Capdevielle D. Validation of the French Version of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) in a French Sample of Individuals with Schizophrenia: Validation de la version francaise de l'instrument d'evaluation des competences MacArthur-traitement (MacCAT-T) dans un echantillon francais de personnes souffrant de schizophrenie. Can J Psychiatry. 2021 Apr;66(4):395-405. doi: 10.1177/0706743720966443. Epub 2020 Oct 16.
PMID: 33064578BACKGROUNDEtchells E, Darzins P, Silberfeld M, Singer PA, McKenny J, Naglie G, Katz M, Guyatt GH, Molloy DW, Strang D. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999 Jan;14(1):27-34. doi: 10.1046/j.1525-1497.1999.00277.x.
PMID: 9893088BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2023
First Posted
June 5, 2023
Study Start
February 15, 2023
Primary Completion
May 15, 2023
Study Completion
December 31, 2023
Last Updated
June 5, 2023
Record last verified: 2023-05