Status:
NOT_YET_RECRUITING
Online Access to Clinical Treatment Notes for Outpatients
Lead Sponsor:
Julian Schwarz
Collaborating Sponsors:
Universität zu Köln
Technische Hochschule Brandenburg
Conditions:
Mental Disorders
Chronic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study investigates the feasibility and impact of patient access to clinical notes written by their healthcare providers-a concept known as Open Notes. While international research has already dem...
Eligibility Criteria
Inclusion
- Patients (General, Module A \& D):
- Aged 18 years or older
- Outpatient treatment at one of the four study centers
- For intervention group: access to an internet-enabled device (e.g. smartphone, tablet, computer) and ability to receive text messages
- For Module D:
- Experience with the respective disease or medical field (e.g. via prior treatment experience or basic medical understanding)
- At least one documented clinical treatment in the internal system of a participating center within the 12 months prior to intervention start
- Availability of clinically relevant treatment notes (e.g. physician letters, progress notes, discharge summaries, consultation notes) suitable for anonymized analysis
- Patients (Control Group - Module A):
- •No requirement for access to an internet-enabled device
- Healthcare Practitioners (Modules A \& D):
- Aged 18 years or older
- Employed at one of the study centers
- Ability to give informed consent
- For Module D: experience in relevant clinical field and familiarity with medical terminology and treatment standards
- Relatives (Module B):
- Aged 18 years or older
- Ability to give informed consent
- Identified as family member, friend, or legal representative of a participating patient
- Experts (Module E):
- Demonstrated expertise or professional experience in digital health Relevant experience with telematics infrastructure (TI), HL7 FHIR®, ePA, KIM, TIM, or affiliation with relevant institutions (e.g. gematik GmbH, HL7 Deutschland e.V., mio42 GmbH)
- Participation in or co-design of health IT interoperability projects
- Patients and Physicians (Module E):
- Good proficiency in German (workshops conducted in German)
- Basic digital literacy and experience with digital technologies in healthcare
Exclusion
- General:
- Insufficient German language skills
- Severe organic brain disorders with cognitive impairment
- Intellectual disability
- Acute self-endangerment or danger to others at time of inclusion
- Lack of capacity to provide informed consent
- Lack of access to an internet-enabled device and inability to receive text messages (except in control group of Module A)
- Module D:
- Clinical notes that cannot be anonymized due to legal, ethical, or technical restrictions
- Presence of rare diagnoses or unique treatment histories that hinder effective anonymization
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2028
Estimated Enrollment :
1092 Patients enrolled
Trial Details
Trial ID
NCT07135726
Start Date
September 1 2025
End Date
February 29 2028
Last Update
August 22 2025
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