Clinical trial NCT06811103: DEterminants of Decisional Autonomy In Chronic Pain Patients and Assessment of Treatment Effectiveness
Official title: DEterminants of Decisional Autonomy In Chronic Pain Patients and Assessment of Treatment Effectiveness
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pain
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient attending their first consultation for chronic pain

Brief summary: Chronic pain is defined as an unpleasant sensory and emotional experience that persists for three months or more, affecting 20-30% of the global adult population. It can arise from primary conditions or as a consequence of diseases and is a significant source of disability. Chronic pain is no longer merely a symptom but often a disease itself, with neurological and psychosocial mechanisms. The biopsychosocial model introduced by George Engel in 1977 helps to consider the biological, psychological, social, and societal dimensions of chronic pain. Patients with chronic pain must adapt to new circumstances, acquiring new knowledge and coping skills to reach a new homeostasis. The goal is not necessarily pain elimination but enabling patients to manage their pain and continue daily activities effectively.

International guidelines suggest a patient-centered, interdisciplinary approach to managing chronic pain, with an emphasis on empowering patients, motivating them, and involving them in decision-making. Autonomy in decision-making is crucial in this context, encompassing both negative freedom (absence of external constraints) and positive freedom (the ability to make choices and realize one's potential). However, chronic pain can limit cognitive and functional abilities, potentially impeding a patient's autonomy. Research indicates that a significant proportion of chronic pain patients experience a deficit in decision-making autonomy.

This mixed-methods study aims to explore the determinants of decision-making autonomy in chronic pain patients and its impact on their treatment. Using the MacCAT-T assessment tool, which evaluates understanding, reasoning, appreciation, and choice expression, the study will examine the relationship between patients' autonomy levels and their health outcomes. The study will also assess how clinicians perceive patients' autonomy compared to the tool's findings.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older Patient attending their first consultation for chronic pain between 01/01/2025 and 31/12/2025 Francophone patient Patient capable of expressing their non-opposition to participation

Exclusion Criteria:

* Patient with significant visual or hearing impairment Patient under guardianship or curatorship Patient deprived of liberty Patient under judicial protection Patient who opposes the use of their data for this research

Primary outcomes:
measure: influences on decision making
timeFrame: enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
Study officials:
References: