Online Access to Clinical Treatment Notes for Outpatients

NCT07135726 | Not Yet Recruiting

• 1 other identifier: 271012025-BO-E
• Study Type: interventional
• Target: 1,092
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• 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.

  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

  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.

  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

  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.

  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

  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.

  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

  This outcome captures stakeholder perspectives on the future integration of Open Notes into routine care. Topics include attitudes toward adoption, digital competencies, organizational readiness, infrastructure requirements, and implementation support needs (e.g., training, design adjustments). Data will be collected via semi-structured interviews and 16 focus groups using a CFIR-based guide. This outcome is primarily addressed in the focus groups. Data will be analyzed using qualitative content analysis.

  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

  This outcome assesses changes in linguistic complexity of clinical notes before and after Open Notes implementation using the Flesch-Kincaid readability index. A total of 20 notes before and 20 after implementation will be analyzed per study center using an online tool (https://conrics.com/features/). Higher scores indicate easier readability. Results will be compared across timepoints and study sites.

  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

  This outcome examines changes in the average length of clinical notes before and after Open Notes implementation. Word and sentence counts will be determined for 20 notes before and 20 after implementation per study center. Descriptive and inferential comparisons will be made between groups.

  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)

  This outcome investigates whether the thematic focus of clinical notes changes following the implementation of Open Notes. LIWC software will be used to analyze 20 notes before and 20 after implementation per study center. Changes in thematic categories such as affective tone, cognitive processing, and personal pronouns will be examined and compared descriptively.

  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

  This outcome assesses whether AI-modified clinical notes are rated as more readable than original notes. A total of 400 anonymized notes from the 12 months before the Open Notes rollout will be processed using large language models (e.g., ChatGPT, Neuroflash). Readability will be evaluated by patients using the Patient Education Materials Assessment Tool (PEMAT) and the Flesch-Kincaid Grade Level.

  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

  This outcome assesses whether AI-modified clinical notes are rated as providing higher-quality information compared to original notes. A total of 400 anonymized notes from the 12 months before the Open Notes rollout will be processed using large language models (e.g., ChatGPT, Neuroflash). Perceived information quality will be measured by patients using selected items from the Health Information National Trends Survey (HINTS).

  27 months (including chatbot testing, AI modification of notes, and data collection)

• Subjective Understanding of AI-Modified vs. Original Clinical Notes Rated by Patients Description

  This outcome assesses whether AI-modified clinical notes are rated as more understandable than original notes. A total of 400 anonymized notes from the 12 months before the Open Notes rollout will be processed using large language models (e.g., ChatGPT, Neuroflash). Subjective understanding will be evaluated by patients using the Single Item Literacy Screener (SILS) and brief comprehension tasks.

  27 months (including chatbot testing, AI modification of notes, and data collection)

• Technical and Organizational Requirements for Integrating Open Notes into the German Telematics Infrastructure (TI) and Electronic Health Record (ePA)

  This module will produce technical and legal specifications for integrating Open Notes into the German national telematics infrastructure (TI), including the electronic patient record (ePA), the KIM communication system, and the TIM messaging service. Integration prototypes will be developed in three design thinking workshops (6-8 experts and 4 users each), ensuring HL7 FHIR® compliance. A Delphi-like process will generate and rate implementation concepts. Measured outcomes will include the number and type of integration use cases, HL7 FHIR® conformance levels, and expert consensus scores for each proposed concept. All results will align with existing interoperability and legal standards.

  Up to 23 months

Secondary Outcomes (5)

• Change in Shared Decision Making Measured by the 9-Item Shared Decision Making Questionnaire (SDM-Q-9)

  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)

  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)

  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

  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

  27 months (including chatbot testing, AI modification of notes, and data collection)

Study Arms (2)

Shared Notes Access

EXPERIMENTAL

Device: Patient Portal-Based Access to Clinical Notes

No Notes Access

NO INTERVENTION

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

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.

Shared Notes Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• General:
• Insufficient German language skills
• Severe organic brain disorders with cognitive impairment
• Intellectual disability
• 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

Sponsors & Collaborators

• Julian Schwarz: lead
• Universität zu Köln: collaborator
• Technische Hochschule Brandenburg: collaborator

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

Related Links

• General information about the concept of open notes itself and the OpenNOTES-study

MeSH Terms

Conditions

Mental Disorders; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Florian Wurster, M.Sc. Health Services Research

  University of Cologne

  STUDY DIRECTOR

• Eva Meier-Diedrich, M.Sc. Psychology

  Medical School Brandenburg

  STUDY DIRECTOR

• Julian Schwarz, MD, Specialist in Psychiatry

  Medical School Brandenburg

  PRINCIPAL INVESTIGATOR

• Ute Karbach, Priv.-Doz. Dr. rer. pol.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Schwarz, MD, Specialist in Psychiatry

CONTACT

+ 49 33638 83 501; julian.schwarz@mhb-fontane.de

Eva Meier-Diedrich, M.Sc. Psychology

CONTACT

eva.meier-diedrich@mhb-fontane.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Julian Schwarz, MD Specialist in Psychiatry and Psychotherapy, Research Associate Mental Health Policy & Digitization Research Group

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share