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.
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
Experience with the respective disease or medical field (e.g. via prior treatment experience or basic medical understanding)
Insufficient German language skills
Severe organic brain disorders with cognitive impairment
Intellectual disability
Acute self-endangerment or danger to others at time of inclusion
Parallel
Patient Portal-Based Access to Clinical Notes
DeviceAn 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.
Change in Patient Empowerment Measured by the Health Care Empowerment Inventory
This primary outcome measures change in patient empowerment using the Health Care Empowerment Inventory. The HCEI is a validated self-report instrument assessing a patient's sense of being informed, engaged, committed, collaborative, and tolerant of uncertainty in relation to their health care. Scores range from 1 to 5 per item and are aggregated for a total score. Data will be collected via the PEPPPSY patient portal before and after the first access to Open Notes. Analyses include intra-individual pre/post comparisons in the intervention group and comparisons with a non-exposed control group. Outcome modeling will take frequency of Open Notes use into account.
Stakeholder Experiences with Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide
This outcome captures user experiences with Open Notes, including knowledge and beliefs about the intervention, attitudes toward digital access to clinical notes, and digital literacy. Data will be collected through 88 semi-structured interviews (44 patients, 20 relatives, 24 practitioners) and 16 focus groups (\~80 participants), guided by an interview protocol based on the Consolidated Framework for Implementation Research (CFIR). This topic is primarily addressed in the interviews. Data will be analyzed using qualitative content analysis.
Perceived Advantages and Challenges of Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide
This outcome explores stakeholder views on the benefits and challenges of using Open Notes. Topics include perceived usefulness, empowerment, relative advantages, usability, and individual characteristics such as health literacy. Data will be collected through 88 semi-structured interviews and 16 focus groups using a CFIR-based guide. This outcome is primarily addressed in the interviews. Data will be analyzed using qualitative content analysis.
Impact of Open Notes on Therapeutic Relationship and Communication Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide
This outcome investigates how stakeholders perceive changes in therapeutic relationships and communication following the introduction of Open Notes. Topics include mutual trust, shared decision-making, and the involvement of relatives. Data are collected through semi-structured interviews and focus groups using a CFIR-based guide. This topic is primarily addressed in the interviews. Data will be analyzed using qualitative content analysis.
Change in Shared Decision Making Measured by the 9-Item Shared Decision Making Questionnaire (SDM-Q-9)
Assesses perceived shared decision making using the SDM-Q-9. This 9-item self-report instrument uses a 6-point Likert scale and is transformed to a 0-100 total score, with higher scores indicating more shared decision making. Data will be collected via the PEPPPSY patient portal before and after first access to Open Notes. Analyses include intra-individual pre/post comparisons and comparisons with a non-exposed control group. Outcome modeling will take frequency of use into account.
Change in Self-Efficacy Measured by the General Self-Efficacy Scale (GSE)
Assesses perceived self-efficacy using the General Self-Efficacy Scale, a 10-item measure scored from 1 to 4. Total scores range from 10 to 40, with higher scores indicating stronger self-efficacy expectations. Data will be collected via the PEPPPSY portal before and after first access to Open Notes. Analyses include intra-individual and between-group comparisons. Outcome modeling will account for usage frequency.
Change in Perceived Disease Management Measured by the EFK-HPC (Effektivität der Krankheitsbewältigung - Hochproblematische Chronizität)
Assesses coping strategies in patients with chronic illness using the EFK-HPC scale, a validated instrument designed to measure the effectiveness of coping with difficult chronic conditions. Items are rated on Likert scales; higher scores reflect better disease management. Data will be collected via the PEPPPSY portal pre- and post-intervention. Analyses include intra-individual and between-group comparisons; outcome modeling includes usage frequency.
Change in Patient Satisfaction Measured by the ZUF-8 Questionnaire
Assesses patient satisfaction using the ZUF-8, a validated short version of the Client Satisfaction Questionnaire (CSQ-8), with 8 items rated on a 4-point scale. Higher total scores indicate greater satisfaction with care. Data will be collected via the PEPPPSY portal before and after access to Open Notes. Analyses include intra-individual comparisons and group-level modeling that incorporates usage frequency.
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Julian Schwarz
Lead sponsor
Medizinische Hochschule Brandenburg Theodor Fontane
Sponsor institution
Universität zu Köln
Collaborator
Technische Hochschule Brandenburg
Collaborator
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