Our hypothesis is that the PDA Psoriasis improves the level of SDM (Shared Decision Making) the treatment decision for systemic therapy in patients with psoriasis vulgaris.
ID
Bron
Verkorte titel
Aandoening
Psoriasis Vulgaris
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Level of SDM measured with OPTION-5 score
Achtergrond van het onderzoek
Rationale: Patient decision aids (PDAs) are known to improve shared decision making (SDM) in various medical fields. They are scare in dermatology and the effect is never studied.
Objective: To assess the effect of a Dutch PDA Psoriasis ('Keuzehulp Psoriasis - Systemische Medicatie') on the level of SDM (objectively assessed by researchers, and subjectively assessed by patients and dermatologists), patients’ satisfaction with the physician’s consultation and patients decisional conflict’.
Study design: A before-and-after study in two dermatology departments.
Study population: Adult patients with chronic plaque type psoriasis eligible for systemic therapy according to the Dutch national guideline psoriasis.
Intervention (if applicable): A Dutch PDA psoriasis and corresponding implementation training for dermatologists.
Main study parameters/endpoints: Primary study parameter; level of SDM measured with OPTION-5 score and secondary study parameters; level of SDM measured with SDM-Q-9 score, SDM-Q-Doc score and CollaboRATE score; Patient Satisfaction with the consultation measured with VAS score 0-9, and decisional conflict measured with Decisional Conflict Scale.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The consultations will be audio taped. The patients who will be asked to use the PDA psoriasis this might take 30 minutes to complete, which can be done at home. The questionnaire for patients takes about 10 minutes to complete, for physicians this is approximately 2 minutes.
Doel van het onderzoek
Our hypothesis is that the PDA Psoriasis improves the level of SDM (Shared Decision Making) the treatment decision for systemic therapy in patients with psoriasis vulgaris.
Onderzoeksopzet
Sep 2019 - Jan 2020; before study
Jan 2020 - Feb 2020; after study
Onderzoeksproduct en/of interventie
A Dutch PDA psoriasis ('Keuzehulp Psoriasis - Systemische Medicatie') and corresponding implementation training for dermatologists.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-Age of ≥ 18
-Confirmed psoriasis by (resident) dermatologist
-Eligible for systemic therapy according to the Dutch national guideline psoriasis
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-Insufficient understanding of the Dutch language or cognitively unable to complete Dutch questionnaires.
-Absence of willingness to use the PDA Psoriasis
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8116 |
Ander register | Not applicable, this is a non-WMO (Medical Research Involving Human Subjects Act) study confirmed by METC AMC : W19_299 #19.356 app (reference number non-WMO study) |