Study protocol OKRA: orientation compass for the preparing, delivering and following up on breaking bad news conversations in paediatric oncology.

INTRODUCTION: In paediatric oncology, 'breaking bad news'-BBN-like cancer diagnosis is perceived as particularly challenging. Enabling a trialogue between children with their relatives and health professionals requires profound communication skills. Lacking the skills, experience or adequate support tools might result in negative consequences for both paediatric oncologists as BBN transmitters and BBN receivers as children with cancer and their relatives.In contrast to oncology for adults, multiperspective studies that explore BBN experience and specific support needs are rare, especially in Germany. Systematically developed and practically piloted support instruments, which address the specific needs of paediatric oncology, are missing. OBJECTIVE: To systematically design and mature in practice an orientation compass for preparing, delivering and following up on BBN conversations in paediatric oncology-so-called Orientierungskompass zur Übermittlung schwerwiegender Nachrichten in der Kinderonkologie (OKRA). METHODS AND ANALYSIS: OKRA is based on a QUAL-quant mixed study design, comprising two phases. Four groups will contribute (1) experts through personal experience (representatives for children receiving BBN and their parents), (2) medical care providers and representatives of national medical societies, (3) ambulant psychosocial/psychological support providers and (4) researchers. In phase 1, multiperspective knowledge is generated through a participatory group Delphi that involves in-depth interviews, focus group discussions and questionnaires. This process culminates in formulating theses for a high-quality BBN process (output phase 1). In phase 2, based on the theses, a pilot orientation compass is designed. Through iterative cycles with the participatory action research method, this instrument will be piloted in three paediatric oncological settings and consequently optimised. ETHICS AND DISSEMINATION: OKRA was approved on 19 September 2023 by the ethics committee of the Medical Faculty of the University of Cologne (No. 23-1187). After project completion, the OKRA compass will be distributed to multidisciplinary paediatric oncology teams throughout Germany. TRIAL REGISTRATION NUMBER: DRKS00031691.

Contextual factors and mechanisms in the implementation of Value Stream Mapping in breast cancer centres - A multiple case study.

INTRODUCTION: Lean, especially Value Stream Mapping is increasingly used in hospitals to optimize processes. This method, which originated in the automotive industry, enables all staff involved in the process to make it more customer-friendly. Despite the widely reported success of Lean projects, they have failed in some cases. This study investigated the contextual factors and mechanisms that contribute to a successful implementation of Value Stream Mapping. METHODS: Value Stream Mapping was applied to the discharge process in four breast cancer centers. A mixed-method approach was used in two steps. First, to verify the successful implementation, defined as time optimization, time measurement was conducted at three points in time and analyzed using an ANOVA. Second, an analysis of contextual factors was combined with a qualitative content analysis of mechanisms based on normalization process theory, using routine data, meeting protocols, field notes, and interview transcripts as data source. RESULTS: At one of the four breast cancer centers, lead- and waiting time were significantly reduced; at the others, these reductions did not occur. Failure/success cannot be explained by the size of the hospital, the number of cases or staffing levels. The variable project team composition is evident, especially leadership involvement. DISCUSSION: A comparative analysis was conducted to identify the factors that led to success. These factors were: participation of all leaders relevant to the process, in the case of the discharge process including medical and nursing leaders; dissemination of the changes from the project team to colleagues including its sense and possibility to discuss it; joint reflection of the implementation process in regular work team meetings. CONCLUSIONS: These results confirm the important role of leadership in implementation projects. Leadership support enabled the mechanisms found. The used combination of theoretical approaches from management research and implementation science determined the interpretation and should be applied more often in implementation science.

The Implementation of an Electronic Medical Record in a German Hospital and the Change in Completeness of Documentation: Longitudinal Document Analysis.

BACKGROUND: Electronic medical records (EMR) are considered a key component of the health care system's digital transformation. The implementation of an EMR promises various improvements, for example, in the availability of information, coordination of care, or patient safety, and is required for big data analytics. To ensure those possibilities, the included documentation must be of high quality. In this matter, the most frequently described dimension of data quality is the completeness of documentation. In this regard, little is known about how and why the completeness of documentation might change after the implementation of an EMR. OBJECTIVE: This study aims to compare the completeness of documentation in paper-based medical records and EMRs and to discuss the possible impact of an EMR on the completeness of documentation. METHODS: A retrospective document analysis was conducted, comparing the completeness of paper-based medical records and EMRs. Data were collected before and after the implementation of an EMR on an orthopaedical ward in a German academic teaching hospital. The anonymized records represent all treated patients for a 3-week period each. Unpaired, 2-tailed t tests, chi-square tests, and relative risks were calculated to analyze and compare the mean completeness of the 2 record types in general and of 10 specific items in detail (blood pressure, body temperature, diagnosis, diet, excretions, height, pain, pulse, reanimation status, and weight). For this purpose, each of the 10 items received a dichotomous score of 1 if it was documented on the first day of patient care on the ward; otherwise, it was scored as 0. RESULTS: The analysis consisted of 180 medical records. The average completeness was 6.25 (SD 2.15) out of 10 in the paper-based medical record, significantly rising to an average of 7.13 (SD 2.01) in the EMR (t178=-2.469; P=.01; d=-0.428). When looking at the significant changes of the 10 items in detail, the documentation of diet (P<.001), height (P<.001), and weight (P<.001) was more complete in the EMR, while the documentation of diagnosis (P<.001), excretions (P=.02), and pain (P=.008) was less complete in the EMR. The completeness remained unchanged for the documentation of pulse (P=.28), blood pressure (P=.47), body temperature (P=.497), and reanimation status (P=.73). CONCLUSIONS: Implementing EMRs can influence the completeness of documentation, with a possible change in both increased and decreased completeness. However, the mechanisms that determine those changes are often neglected. There are mechanisms that might facilitate an improved completeness of documentation and could decrease or increase the staff's burden caused by documentation tasks. Research is needed to take advantage of these mechanisms and use them for mutual profit in the interests of all stakeholders. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023343; https://drks.de/search/de/trial/DRKS00023343.

The Analyzation of Change in Documentation due to the Introduction of Electronic Patient Records in Hospitals-A Systematic Review.

The major impact on healthcare through the ongoing digital transformation and new technologies results in opportunities for improving quality of care. Electronic patient records (EPR) are a substantial part in this transformation, even though their influence on documentation remains often unclear. This review aims to answer the question of which effect the introduction of the EPR has on the documentation proper in hospitals. To do this, studies are reviewed that analyze the documentation itself, rather than merely conducting interviews or surveys about it. Several databases were searched in this systematic review (PubMed including PubMed, PubMed Central and Medline; PDQ Evidence; Web of Science Core Collection; CINHAL). To be included, studies needed to analyze written documentation and empirical data, be in either German or English language, published between 2010 and 2020, conducted in a hospital setting, focused on transition from paper-based to electronic patient records, and peer reviewed. Quantitative, qualitative and mixed methods studies were included. Studies were independently screened for inclusion by two researchers in three stages (title, abstract, full text) and, in case of disagreement, discussed with a third person from the research team until consensus was reached. The main outcome assessed was whether the studies indicated a negative or positive effect on documentation (e.g. changing the completeness of documentation) by introducing an EPR. Mixed Methods Appraisal Tool was used to assess the individual risk of bias in the included studies. Overall, 264 studies were found. Of these, 17 met the inclusion criteria and were included in this review. Of all included studies, 11 of 17 proved a positive effect of the introduction of the EPR on documentation such as an improved completeness or guideline adherence of the documentation. Six of 17 showed a mixed effect with positive and negative or no changes. No study showed an exclusively negative effect. Most studies found a positive effect of EPR introduction on documentation. However, it is difficult to draw specific conclusions about how the EPR affects or does not affect documentation since the included studies examined a variety of outcomes. As a result, various scenarios are conceivable with higher or reduced burden for practitioners. Additionally, the impact on treatment remains unclear.

A qualitative study of the adoption of Value Stream Mapping in breast cancer centers.

PURPOSE: In order to design a patient-centered discharge process, the entire process is visualized in Value Stream Mapping. The duration of the process steps and waiting times are measured and presented. As a team, health professionals discuss problems and agree on suitable solutions. METHODS: After applying Value Stream Mapping, we conducted eight interviews in 2018, four with physicians and four with breast care nurses. We used the Consolidated Framework for Implementation Research to develop the interview guide and to identify categories for content analysis. To identify the differences in attitude and experience between the occupational groups, we conducted a framework analysis. RESULTS: Each team of health professionals developed action steps to optimize the discharge process. Obstacles became apparent in the implementation of these action steps. The lack of adequate staff and complex structures were identified as the main factors. These hierarchical structures also prevented a patient-centered discharge process independent of patient-centered care by health professionals. Self-efficacy varied more among breast care nurses than physicians. The group of physicians perceives standardization in the discharge process critically and therefore assumes limitations in transferring Value Stream Mapping to hospitals. The breast care nurses were open in their attitude. Financial incentives contribute to the acceptance of the method. CONCLUSION: Value Stream Mapping is a simple way to uncover waste and develop applicable action steps. Since the implementation of the action steps was hindered by hierarchical problems and a lack of resources, management involvement and a hospital-wide approach could be beneficial.

Electronic patient record and its effects on social aspects of interprofessional collaboration and clinical workflows in hospitals (eCoCo): a mixed methods study protocol.

BACKGROUND: The need for and usage of electronic patient records within hospitals has steadily increased over the last decade for economic reasons as well as the proceeding digitalization. While there are numerous benefits from this system, the potential risks of using electronic patient records for hospitals, patients and healthcare professionals must also be discussed. There is a lack in research, particularly regarding effects on healthcare professionals and their daily work in health services. The study eCoCo aims to gain insight into changes in interprofessional collaboration and clinical workflows resulting from introducing electronic patient records. METHODS: eCoCo is a multi-center case study integrating mixed methods from qualitative and quantitative social research. The case studies include three hospitals that undergo the process of introducing electronic patient records. Data are collected before and after the introduction of electronic patient records using participant observation, interviews, focus groups, time measurement, patient and employee questionnaires and a questionnaire to measure the level of digitalization. Furthermore, documents (patient records) as well as structural and administrative data are gathered. To analyze the interprofessional collaboration qualitative network analyses, reconstructive-hermeneutic analyses and document analyses are conducted. The workflow analyses, patient and employee assessment analyses and classification within the clinical adoption meta-model are conducted to provide insights into clinical workflows. DISCUSSION: This study will be the first to investigate the effects of introducing electronic patient records on interprofessional collaboration and clinical workflows from the perspective of healthcare professionals. Thereby, it will consider patients' safety, legal and ethical concerns and quality of care. The results will help to understand the organization and thereby improve the performance of health services working with electronic patient records. TRIAL REGISTRATION: The study was registered at the German clinical trials register (DRKS00023343, Pre-Results) on November 17, 2020.