Feasibility, comprehension and applicability of broad consent in the emergency department: an exploratory mixed-methods study

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BACKGROUND: The German Medical Informatics Initiative (MII) introduced a standardised Broad Consent (BC) form encompassing medical data, insurance data, contact information and biomaterials for health data research. This study assesses the feasibility of MII-BC in emergency departments (EDs), examining patient understanding and identifying implementation facilitators and barriers. Recommendations for implementation of MII-BC in EDs will be derived. METHODS: Mixed-method data were collected in EDs of four German university hospitals (UHs) using pseudonymised participant observation with a focus on patient perspective and surveys from patients. Data included MII-BC acceptance rates, patient understanding, motivation to consent and implementation facilitators and barriers. Quantitative data were analysed descriptively; qualitative data underwent content analysis with deductive-inductive category formation. RESULTS: The exploratory study involved 12 participant observations from four tertiary UHs, surfacing five key themes: (1) MII-BC patient information in the ED, (2) facilitators and (3) barriers in obtaining MII-BC in the ED, (4) patient perspectives on MII-BC and (5) recommendations for implementing MII-BC in EDs. Survey results (n=225) showed that most patients (89.8%) demonstrated high understanding of MII-BC patient information. Facilitators include empathetic engagement, clear communication and encouragement for questions. Hindering factors include estimating study time frames, ambient noises and study procedure interruptions. Adequate resources, such as trained staff and suitable premises, are crucial. CONCLUSION: Implementing MII-BC in the ED is feasible with appropriate resources, though ED-specific challenges must be addressed. Successful MII-BC implementation in EDs hinges on ensuring access to comprehensible information materials, transparent communication and a calm recruitment environment. TRIAL REGISTRATION NUMBER: DRKS00030054.

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