Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis

Overview

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

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: November 2022

Interventions

• Other: Audio recordings during the consultations
  • 50 patients with audio recordings of the consultation
• Other: Audio recordings during the consultations and test of the shared medical decision-making tool for modification
  • 50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification
• Other: Audio recordings during the consultations and test of the shared medical decision-making tool for validation
  • 50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.

Arms, Groups and Cohorts

• Patients with Atopic dermatitis
  • 150 patients with Atopic dermatitis

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• Patient satisfaction with the therapeutic decision-making process
  • Time Frame: during the intervention
  • SURE satisfaction score
• Assessment of the perceived state of the patient about the intervention
  • Time Frame: during the intervention
  • Validation tool score CollaboRATE
• Assessment of the psychological state of the patient
  • Time Frame: during the intervention
  • Validation tool score GAD-7
• Assessment of the perceived health state of the patient
  • Time Frame: during the intervention
  • Score of PHQ-9 questionnaire
• Assessment of the quality of life of the patient
  • Time Frame: during the intervention
  • Score of DLQI questionnaire
• Assessment of the stigmatization perceived by the patient
  • Time Frame: during the intervention
  • 6-items Stigmatization scale
• Assessment of the severity perceived by the patient
  • Time Frame: during the intervention
  • Atopic Dermatitis Perceived Severity Scale
• Description of treatment compliance in patients who received the validated tool
  • Time Frame: during the intervention
  • Compliance with treatment received

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Assistance Publique – Hôpitaux de Paris
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Pierre-André Natella, PhD, Study Director, Assistance Publique – Hôpitaux Paris
• Overall Contact(s)
  • Khaled Ezzedine, MD, (0)149812504, khaled.ezzedine@aphp.fr