The study population consists of patients who are 18 years of age or older and are all receiving outpatient treatment at one of the four study centers. The patients, who are often chronically ill due to the specialty of the study centers involved, include a wide variety of illnesses from the somatic and psychiatric spectrum.
Conditions
Interventions
Group 1: The effectiveness of the use of open notes in terms of improving patient-reported outcomes, such as empowerment, will be investigated using a non-equivalent control group design with pre- and
Sponsors
Medizinische Hochschule Brandenburg Theodor Fontane
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The target population are patients who are 18 years or older and all receive outpatient treatment at one of the four study centers. The patients, who are often chronically ill due to the specialty of the study centers involved, are mainly treated on a quarterly basis. Since access to the patient portal requires an internet-enabled device (e.g. smartphone, tablet, computer) and the ability to receive text messages as part of the secure registration process, these are inclusion criteria for enrollment in the study. Patients in the control group planned as part of Module A do not necessarily need an internet-enabled device. Participating healthcare practitioners must have reached the age of majority (18 years), be working at one of the study centers and be able to give their informed consent. Participating relatives must be 18 years of age or older, be able to give informed consent and be relatives (i.e. family, friend or legal representative) of a participating patient. For Module D, the patients included as reviewers must have experience with the respective disease or medical field in order to be able to assess the information content and comprehensibility of the notes. This means that they need a minimum level of basic medical education or understanding of medical terminology, e.g. through previous experience in treatment. The physicians (specialists or other medical practitioners) included as reviewers in Module D must have experience in the clinical field and be familiar with the medical terminology and treatment methods covered in the notes. The patients participating in the intervention, whose notes are to be analyzed in anonymized form, must have at least one documented clinical treatment in the internal information system of one of the participating practices or clinics in the 12-month period prior to the start of the intervention. Treatment-related notes must be available that are relevant for the clinical documentation (e.g. doctor's letters, progress notes, discharge reports, consultation notes). The data must be processed technically and legally in such a way that it is completely anonymized and no conclusions can be drawn about the identity of the patient. In Module E, the experts must have proven experience and/or professional experience in the field of digital health, in particular with reference to the telematics infrastructure (TI) or relevant technologies such as HL7 FHIR®, ePA, KIM and TIM either through affiliation with relevant institutions or organizations such as gematik GmbH, HL7 Deutschland e.V., mio42 GmbH or comparable institutions with expertise in the field of national health data infrastructure or experience through participation in or co-design of projects for the development or implementation of interoperable health IT solutions. Participating patients and physicians need a good level of German, as the workshops will be held in German, and basic digital skills and experience with the use of digital technologies in healthcare.
Exclusion criteria
Exclusion criteria: Exclusion criteria for participation in the study are insufficient language skills in German, severe organic brain diseases with cognitive deficits, intellectual disability, acute self-endangering or other-endangering behavior and/or lack of capacity to consent at the time of inclusion in the study, as well as lack of access to an internet-enabled device (e.g. smartphone, tablet, computer) and the ability to receive text messages. For patients in the control group planned as part of Module A, the lack of an internet-enabled device is not an exclusion criterion. Exclusion criteria for Module D are clinical notes of patients whose data cannot be processed anonymously due to legal, ethical or technical restrictions; as well as patients with rare or difficult to anonymize characteristics (e.g. rare diagnoses or unique treatment histories) could also be excluded from the analysis to ensure anonymity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the proposed study is to investigate the extent to which patient-side digital access to the clinical treatment notes (termed “Open Notes”) of outpatient medical treatment has an impact on patient empowerment. The project will investigate (1) the influence of open notes on patient-relevant outcomes and (2) the possibilities and conditions for implementing open notes in standard care. The project is divided into three modules with a short-term objective (A, B, C) and two modules with a long-term objective (D, E), whose research questions and working hypotheses are presented as follows: Module A (Summative outcome evaluation in patients): Primary hypothesis: (A1) Patient use of Open Notes will lead to a significant increase in perceived patient empowerment. Secondary hypotheses: Patient-side use of Open Notes leads to a significant increase in (A2) perceived shared decision making, (A3) perceived self-efficacy expectation, (A4) perceived disease management, (A5) perceived patient satisfaction. The survey of primary and secondary patient-reported outcomes to test the corresponding hypotheses is carried out using standardized instruments for self-assessment: •HCEI (Health Care Empowerment Inventory) •SDM-Q-9 (Shared Decision Making Questionnaire) •GSE (General Self-Efficacy Scale) •EFK (Essener Fragebogen zur Krankheitsbewältigung) •ZUF-8 (Fragebogen zur Patientenzufriedenheit) At the beginning of the survey , patients are enrolled in the intervention or control group of the study at each study center, depending on their personal preference. A target number of N=91 completed questionnaires is also set for the control group. Once this number of cases has been reached, no further people will be enrolled in the pre-intervention control group. Participants in the intervention group will receive access to the PEPPPSY patient portal after enrolling in the study. This is used to complete the pre-intervention survey upon initial login. After successful participati | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary endpoints in the classic definition. All endpoints can be found under "Primary outcome". | — |
Countries
Germany
Contacts
Public ContactJulian Schwarz
Medizinische Hochschule Brandenburg Theodor Fontane (MHB)
Outcome results
None listed