Online Access to Clinical Treatment Notes for Outpatients

Official title

OpenNOTES: Online Access to Clinical Treatment Notes for Outpatients - an Interventional, Prospective, Controlled Mixed-methods Study

Overview

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.

Interventions

• Device Patient Portal-Based Access to Clinical Notes
  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 n

Primary outcome measures

• 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]
• Stakeholder Experiences with Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide [Time frame: Four iterative sampling points over a 20-month period (t0 to t3, in 3-month intervals)]
• Perceived Advantages and Challenges of Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide [Time frame: Four iterative sampling points over a 20-month period (t0 to t3, in 3-month intervals)]
• Impact of Open Notes on Therapeutic Relationship and Communication Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide [Time frame: Four iterative sampling points over a 20-month period (t0 to t3, in 3-month intervals)]
• Perspectives on Future Implementation of Open Notes Assessed by Semi-Structured Interviews and Focus Groups Using a CFIR-Based Guide [Time frame: Four iterative sampling points over a 20-month period (t0 to t3, in 3-month intervals)]
• Change in Linguistic Complexity of Clinical Notes Measured by Flesch-Kincaid Readability Index [Time frame: 6 months for pre-Open Notes documentation and 6 months for post-Open Notes documentation]
• Change in Length of Clinical Notes Measured by Word and Sentence Count [Time frame: 6 months for pre-Open Notes documentation and 6 months for post-Open Notes documentation]
• Change in Thematic Content of Clinical Notes Measured by Linguistic Inquiry and Word Count (LIWC) [Time frame: 6 months for pre-Open Notes documentation and 6 months for post-Open Notes documentation]
• Readability of AI-Modified vs. Original Clinical Notes Rated by Patients Description [Time frame: 27 months (including chatbot testing, AI modification of notes, and data collection)]
• Perceived Information Quality of AI-Modified vs. Original Clinical Notes Rated by Patients Description [Time frame: 27 months (including chatbot testing, AI modification of notes, and data collection)]

Secondary outcome measures (5)

• Change in Shared Decision Making Measured by the 9-Item Shared Decision Making Questionnaire (SDM-Q-9) [Time frame: From baseline to follow-up, up to 24 months per participant in the intervention group]
• Change in Self-Efficacy Measured by the General Self-Efficacy Scale (GSE) [Time frame: From baseline to follow-up, up to 24 months per participant in the intervention group]
• Change in Perceived Disease Management Measured by the EFK-HPC (Effektivität der Krankheitsbewältigung - Hochproblematische Chronizität) [Time frame: From baseline to follow-up, up to 24 months per participant in the intervention group]
• Change in Patient Satisfaction Measured by the ZUF-8 Questionnaire [Time frame: From baseline to follow-up, up to 24 months per participant in the intervention group]
• Clarity, Accuracy, and Appropriateness of AI-Modified vs. Original Clinical Notes Rated by Health Professionals [Time frame: 27 months (including chatbot testing, AI modification of notes, and data collection)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30. PMID 19879711
• Johnson MO, Rose CD, Dilworth SE, Neilands TB. Advances in the conceptualization and measurement of Health Care Empowerment: development and validation of the Health Care Empowerment inventory. PLoS One. 2012;7(9):e45692. doi: 10.1371/journal.pone.0045692. Epub 2012 Sep 19. PMID 23029184
• Wurster, Florian, Eva Meier-Diedrich, I. Demirer, Catherine DesRoches, Nina Goldberg, Maria Hägglund, C. Herrmann, U. Karbach, A. Purohit, T. Schrader, J. Schwarz, 2024. "Online-Zugang Zu Klinischen Behandlungsnotizen Für Ambulant Versorgte Patienten (Studienprotokoll Zur OpenNOTES-Studie)." Nervenheilkunde, 43(12), 714-719.

Identifiers

NCT: NCT07135726 · 271012025-BO-E

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗