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

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 Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Audio recordings during the consultations; Other: Audio recordings during the consultations 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

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Khaled Ezzedine, MD; Phone Number: +33 (0)149812504; Email: khaled.ezzedine@aphp.fr

Study Locations

• France
  • Créteil, France, 64010
    • Hospital Henri Mondor
    • Contact: Khaled Ezzedine, MD; Phone Number: +33 (0)1 49 81 25 04; Email: khaled.ezzedine@aphp.fr
    • Principal Investigator: Khaled Ezzedine, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Atopic Dermatitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with Atopic dermatitis; 150 patients with Atopic dermatitis

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.	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	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Pierre-André Natella, PhD, Assistance Publique - Hopitaux Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; shared medical decision-making tool; e-Delphi
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: APHP211198; 2021-A01859-32 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: APHP IS DATA'S OWNER, PLEASE CONTACT BOARD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No