Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.
- Last Updated
- 4 years ago
Overview
Brief Summary
Hypothesis/Objective : Patient-centered health care and shared decision making are key components of increasing importance which are recommended by the French Haute Autorite de Sante (HAS) and World Health Organization (WHO).
In the context of dermatology and atopic dermatitis, European guidelines has promoted an active involvement from both patients and caregivers in therapeutic decisions at all stages to achieve therapeutic success and the Task Force on Atopic Dermatitis (ETFAD) has promoted the setting of treatment goals in a shared decision with the patient.
The main objective of this study is to develop and cross culturally validate a tool dedicated to shared-decision in atopic dermatitis that can be used during routine dermatological consultations.
The second objective is to better characterize patients seen in this context and to evaluate patients' satisfaction when empowered by shared decision.
Method : We aim to develop a SDMt in AD following the recommendations of the International Patient Decision Aid Standards (IPDAS) collaboration. Development will use a multistep approach: 1) identification of priority domains for patients; 2) Selection of domains to be included in the SDMt for AD; and 3) Creation and testing of the SDMt.
Participants will be consecutive adult (>18 years old) patients attending consultation for a AD in medical centres in France (Toulouse, Nantes and Créteil). All participants will provide written consent to participate. The study will be submitted for approbation to the local ethics committees of the University Hospital Centres of Paris and will be conducted according to the Declaration of Helsinki.
Step 1: Identification of priority domains for patients
Step 2: Selection of domains to be included in the SDMt for AD
Step 3: Creation and testing of the SDMt
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years, male or female.
- •Patient with atopic dermatitis
- •Written information given to the patient and no objection from the patient to participate to the study
Exclusion Criteria
- •Patient under guardianship or curatorship
- •Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire
- •Patient under AME
Outcomes
Primary Outcomes
Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.
Time Frame: through study completion, an average of 1 year
Qualitative descriptions of the topics discussed by the patient during the therapeutic decision in a specialized dermatology consultation for atopic dermatitis; in other words, to characterize the topics discussed by the patient during the consultation
Secondary Outcomes
- Patient satisfaction with the therapeutic decision-making process(during the intervention)
- Assessment of the perceived state of the patient about the intervention(during the intervention)
- Assessment of the psychological state of the patient(during the intervention)
- Description of treatment compliance in patients who received the validated tool(during the intervention)
- Assessment of the perceived health state of the patient(during the intervention)
- Assessment of the quality of life of the patient(during the intervention)
- Assessment of the stigmatization perceived by the patient(during the intervention)
- Assessment of the severity perceived by the patient(during the intervention)