OpenNOTES: Online Access to Clinical Treatment Notes for Outpatients - an Interventional, Prospective, Controlled Mixed-methods Study
Trial ID: NCT07135726
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-09-01
Completion date: 2028-02-29
Sponsor: Julian Schwarz
Collaborators: Universität zu Köln; Technische Hochschule Brandenburg
Conditions: Mental Disorders; Chronic Disease; Primary Health Care; Outpatients; Internal Medicine; Aged; Comorbidity
Interventions: Patient Portal-Based Access to Clinical Notes
Enrollment: 1092
Age range: 18 Years - None
Sex: ALL

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 demonstrated positive effects of Open Notes on patient empowerment and treatment outcomes, there is a lack of corresponding evidence for the German healthcare context. The quasi-experimental study therefore combines quantitative and qualitative methods to evaluate the effects of Open Notes on patient-reported outcomes as well as clinical practice.

The study is structured into five modules, each addressing specific research questions:

Module A - Summative Outcome Evaluation in Patients: Does the use of Open Notes lead to a significant increase in patient-reported outcomes such as empowerment and self-efficacy? Module B - Formative Process Evaluation with Stakeholders: What experiences do patients, relatives and clinicians have with Open Notes and what challenges and barriers arise in their use? Module C - Changes in Clinical Documentation: How do language style and content of clinical notes change when they are shared with patients as Open Notes? Module D - Optimization through Artificial Intelligence: Can clinical notes be processed using artificial intelligence in a way that makes them easier for patients to understand compared to conventional medical documentation? Module E - Integration into National Data Infrastructure: What technical, organizational and legal requirements must be met to successfully integrate Open Notes into the national telematics infrastructure and the electronic health record or routine care? The overall goal is to identify both patient-related outcomes and structural conditions for the sustainable implementation of Open Notes in the German healthcare system. The use of artificial intelligence is intended to further enhance patient-centeredness while reducing the burden on clinical staff.

Eligibility criteria:
Inclusion Criteria:

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 Criteria:

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

Outcomes:
Change in Patient Empowerment Measured by the Health Care Empowerment Inventory; Stakeholder Experiences with Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide; Perceived Advantages and Challenges of Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide; Impact of Open Notes on Therapeutic Relationship and Communication Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide; Perspectives on Future Implementation of Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide; Change in Linguistic Complexity of Clinical Notes Measured by Flesch-Kincaid Readability Index; Change in Length of Clinical Notes Measured by Word and Sentence Count; Change in Thematic Content of Clinical Notes Measured by Linguistic Inquiry and Word Count (LIWC); Readability of AI-Modified vs. Original Clinical Notes Rated by Patients Description; Perceived Information Quality of AI-Modified vs. Original Clinical Notes Rated by Patients Description; Subjective Understanding of AI-Modified vs. Original Clinical Notes Rated by Patients Description; Technical and Organizational Requirements for Integrating Open Notes into the German Telematics Infrastructure (TI) and Electronic Health Record (ePA)