Online Access to Clinical Treatment Notes for Outpatients (OpenNOTES)

Julian Schwarz

Status: Not yet enrolling

Conditions: Internal Medicine; Chronic Disease; Mental Disorders; Outpatients; Primary Health Care; Aged; Comorbidity

Treatments: Device: Patient Portal-Based Access to Clinical Notes

Study type: Interventional

Funder types: Other

Identifiers

NCT07135726

271012025-BO-E

Details and patient eligibility

About

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.

Enrollment: 1,092 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,092 participants in 2 patient groups

Shared Notes Access

Experimental group

Treatment:

Device: Patient Portal-Based Access to Clinical Notes

No Notes Access

No Intervention group

Description:

Due to potential selection bias of the intervention group, which occurs due to voluntary participation in the intervention, a control group is surveyed at t0, which does not participate in the intervention, so that an adjustment for the systematic differences, if any, between the intervention and control group is possible at t0. The survey of a post-intervention control group (t1) serves to adjust for any time-varying effects so that a general time effect can be ruled out. n=91 patients with a pre-intervention and a post-intervention control group of n=91 patients