Online Access to Clinical Treatment Notes for Outpatients

Sponsor
Julian Schwarz
Study ID
NCT07135726
Status
Not Yet Recruiting

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Conditions

  • Aged
  • Chronic Disease
  • Comorbidity
  • Internal Medicine
  • Mental Disorders
  • Outpatients
  • Primary Health Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient Portal-Based Access to Clinical Notes — DEVICE
    An intra-individual comparison of patient-reported outcomes is planned for the intervention group. For this purpose, the pre-intervention survey of the intervention group is conducted upon inclusion in the study, the post-intervention survey at the earliest after the intervention has been used once (accessing their open note). 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.

Study Details

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.

Key Dates

First listed
Aug 22, 2025
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
1,092 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Shared Notes Access
  • No Intervention: No Notes Access
    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

Primary Outcome Measure

Change in Patient Empowerment Measured by the Health Care Empowerment Inventory [ Time Frame: From baseline to follow-up, up to 24 months per participant in the intervention group ]

Central Contacts

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