Hellevoetsluis, Netherlands

45 Minutes Vs. Three Hours Educational Intervention on Communication and Play for Paediatric Healthcare Professionals

BACKGROUND: Communication is an essential skill for all healthcare professionals working with children and adolescents in hospitals. There is growing focus on child-centred communication, which emphasize communicating directly with children and adolescents in healthcare rather than focusing on the parents. However, educational programmes for this remain limited while those that exist are heterogenous and often assessed without comparison groups or validated tools. OBJECTIVE: To investigate the effect on healthcare professionals' self-efficacy of a 45-minute vs three-hour educational intervention on communication and the use of play in clinical paediatric practice INTERVENTION: This trial evaluates the educational programme "Communication and Play with Children and Adolescents in Healthcare", which focuses on age-appropriate communication with paediatric patients, including the deliberate use of play. The trial compares two educational interventions that differ in duration (45 minutes vs. three hours) and learning methods. While both interventions include didactic learning, reflection, and discussions, the three-hour session adds role-play activities, whereas the 45-minute session delivers a condensed version without role-play. DESIGN: Single-centre, randomized, controlled, two-arm, noninferiority trial. A noninferiority design is used to assess whether there is a difference between the two educational interventions or if the 45-minute educational intervention is comparable to the three-hour educational intervention. SETTING: The University Hospital of Copenhagen - Rigshospitalet, Denmark. RECRUITMENT: All healthcare professionals working in the Department of Paediatrics and Adolescent Medicine at Rigshospitalet will be eligible to participate. Potential participants will be contacted by their leaders and be informed of the study. A written consent will then be obtained. SAMPLE SIZE: The sample size calculation assumes that the 45-minute intervention is as effective as the three-hour intervention for the primary outcome (self-efficacy). A non-inferiority margin of 0.25 points is set, meaning the mean self-efficacy score for the 45-minute intervention can be up to 0.25 points lower than that of the three-hour intervention without being considered inferior. Based on a one-sided two-sample t-test with a margin of 0.25, an alpha of 0.025, a power of 80%, and a standard deviation of 0.45 derived from the pilot study, the required sample size is 52 participants per group. Since the intervention is conducted in clusters of 25 participants, the sample size calculation is adjusted for cluster randomization by multiplying by the design effect, calculated as 1 + (cluster size - 1) × ICC. Assuming an ICC of 0.01 results in a design effect of 1.24 and an adjusted sample size of 65 per group. Accounting for a 10% dropout rate, the final required sample size is 72 per group. It is planned to include a total of 150 participants. RANDOMIZATION: Eligible participants will be randomly assigned in a 1:1 ratio to either a 45-minute educational intervention or a three-hour educational intervention using computer-generated block randomization through REDCap. The randomization process will ensure an interprofessional distribution of participants in each intervention group. Both the statistician and the researchers conducting the analysis will be blinded to participant allocation. ETHICS: This trial complies with the principles outlined in the Declaration of Helsinki for biomedical research. Approval has been obtained from the Danish Data Protection Agency (P-2021-426). The study was approved but deemed exempt from requiring ethical approval by The Scientific Ethical Committees for the Capital Region of Denmark (Journal-nr.: H-21028050). Participation is entirely voluntary, and both educational interventions will take place during working hours at no cost to the participants. Participants may withdraw from the study at any time without any repercussions. To ensure confidentiality, all data will be securely stored in a protected database.

A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women with Osteoporosis After a Treatment Period Without Fractures

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Development and Implementation of an Intervention Enhancing Involvement of Relatives to Patients with Acquired Brain Injury or Malignant Brain Tumour

Background Relatives of patients with acquired brain injury (ABI) or primary malignant brain cancer (WHO grade III and IV) often face substantial caregiving burdens, which increase the risk of anxiety and depression. The patient's condition can significantly alter the daily lives of relatives, many of whom assume long-term caregiving responsibilities. These challenges are compounded by the emotional and practical difficulties faced by families, particularly when patients experience significant cognitive, physical, and emotional impairments. In cases of ABI, relatives often witness a gradual or sudden decline in the patient's functioning, leading to a profound sense of loss and a shift in family roles. Similarly, relatives of patients with PMBT are faced with the rapid progression of the disease, which demands constant adjustment to their caregiving responsibilities. Despite these challenges, research underscores the importance of involving relatives in the patient's care and treatment, as this involvement has been shown to improve patient outcomes and family satisfaction. Furthermore, it promotes better communication and collaboration between healthcare professionals and families, which is essential for the rehabilitation process. However, Denmark currently lacks a validated tool to assess the diverse needs of relatives during treatment and rehabilitation, considering their individual resources and capacities. This gap leaves healthcare professionals without a standardized means to engage relatives in a way that is both meaningful and beneficial for the patient's recovery. Furthermore, no intervention studies have specifically targeted the active engagement of relatives of patients with ABI or PMBT to provide direct support to relatives and indirectly benefit the patient. Given the growing body of evidence that highlights the importance of tailored support for relatives, there is an urgent need for a structured and evidence-based approach that can address the varying needs of families in different clinical settings. Purpose The primary aim of this study is to develop, pilot, and evaluate a tool designed to identify and address the varied needs and resources of relatives. This tool will ensure that the involvement needs of relatives are assessed throughout the patient's treatment and rehabilitation. Specifically, the tool will help identify the unique challenges faced by relatives based on their socio-economic, emotional, and practical circumstances, thereby providing a personalized support framework. This systematic approach aims to reduce caregiver strain, improve the well-being of relatives, and enhance the overall rehabilitation process for the patient. Methods The intervention was developed using the Medical Research Council's framework for complex interventions, with a focus on the participation of both relatives and healthcare professionals. The development process was iterative, incorporating theoretical models, evidence-based practices, and practical insights from caregiving contexts. Data was gathered through scoping reviews, field observations, and discussions with relatives and nurses across seven healthcare units in two regions of Denmark. These discussions provided diverse perspectives on the challenges faced by relatives in different clinical settings, including the specific needs of families coping with ABI and glioblastoma. Through this process, it became evident that relatives experience a wide range of needs, from emotional and psychological support to practical assistance with caregiving tasks. This input directly influenced the design of the intervention, ensuring that it would be both comprehensive and responsive to the varying circumstances of families. Results The intervention consists of five key components: 1. Nurse education: Equipping healthcare professionals to better support and involve relatives in the patient's care. 2. A dialogue tool: For structured conversations between healthcare professionals and relatives to address specific needs. 3. A relative-to-relative list: Tips for navigating the healthcare system, including guidance on how to access available resources, such as financial support, social services, and patient advocacy groups, which can help alleviate the strain on families. 4. Video resources for caregivers: A video explaining the background and rationale for the intervention, featuring stories from relatives sharing their experiences. 5. Guidelines for documenting relative involvement in the patient's electronic health record: Standardized tracking of relative participation in care. A panel of 18 relatives, selected based on geographic location, age, and gender, contributed to the development and evaluation of the intervention. Their roles ranged from informants to advisors, providing feedback on activities, refining ideas, and assisting in the creation of materials, such as videos and the relative-to-relative list. Additionally, they played a crucial role in training nurses, ensuring that the intervention met the needs of families in a real-world healthcare context. Clinical Perspectives The standardized tool is expected to systematically assess the needs and resources of relatives, ensuring tailored support according to their circumstances. By recognizing that relatives of patients with ABI and PMBT have different needs based on their personal situation and available resources, the tool aims to offer a more personalized and effective intervention. This personalized approach is anticipated to improve relative satisfaction, enhance their sense of agency in the caregiving role, and contribute to the rehabilitation process for the patient. The intervention also aims to improve communication and collaboration between relatives and healthcare professionals. By fostering a more supportive environment for both patients and families, the intervention is expected to lead to better care outcomes, greater family satisfaction, and a more efficient healthcare process. Ultimately, this will contribute to an overall improvement in the patient's rehabilitation and long-term quality of life.

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A Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice

Prostate cancer (PC) is the most common type of cancer among men in Denmark with an incidence of approximately 4.500 cases and 1.300 deaths every year. Usually prostate cancer develops very slowly and men with a detectable prostate tumor can live for many years without experiencing any symptoms. Autopsy studies of males who died of other causes finds PC in approximately 30 percent of males in their fifties and up to 70 percent of males in their seventies. From that perspective most men die with prostate cancer than because of it. In Denmark the first examinations of a possible prostate cancer diagnosis take place in general practice. Every citizen in Denmark with a social security number has free and direct access to a general practitioner (GP) and works as a gatekeeper to the healthcare system. If the GP suspects prostate cancer in a patient the GP has the possibility to measure the level of prostate specific antigen (PSA) in a blood sample. If the level of PSA is high it may indicate the presence of prostate cancer. However, according to the national clinical guidelines on detection and diagnostic investigation of prostate cancer the PSA-test is only recommended on a small patient group with very specific and rare symptoms. Furthermore they do not recommend neither systematic nor opportunistic screening with the PSA-test. The reason for the rather restrictive guidelines for PSA-testing is to avoid overdiagnosis and overtreatment of prostate cancer. A high level of PSA in a blood sample is not necessarily due to prostate cancer but could also be elevated by other conditions such as cystitis or an enlarged benign prostate. Even if the further examinations at a urology department in a hospital finds prostate cancer in the patient it is potentially indolent cancer and not a clinically important tumor which is an prostate cancer overdiagnosis and could lead to unnecessary treatment which is overtreatment. The treatment of prostate cancer could cause harms such as impotence, incontinence and faecal incontinence. Since 2018, GP's in Denmark has been encouraged to cluster in groups of other GP's from their local area to work with quality development and form so called quality clusters. The aim of these quality clusters was to create a medical professional forum where the GP's could meet 2-4 times a year and exchange experiences with each other in a specific clinically relevant area decided by the cluster itself. One of the main points of the quality cluster concept was that the quality development work should be based on descriptive data from their own GP clinics. At present 116 quality clusters exist in Denmark and includes 3.519 GP's in 1.542 GP clinics. By the same time of the establishment of the quality cluster a national organization called KiAP (a Danish acronym for Quality in General Practice) was founded. The primary purpose was to support the quality clusters with their quality development work. One of the supportive initiatives by KiAP is the development of cluster packages which is meeting material for the quality clusters on their cluster meetings. A cluster packages has one specific clinically relevant theme and consists of data, expert videos, reflection questions among other things. The investigators have chosen to develop a cluster package about PSA-tests in general practice with the purpose to promote an evidence-based practice. A pilot study will be conducted in the development process. The aim of the study is to evaluate the effectiveness of the cluster package. Since the study is a cluster randomized trial the investigators invited all the Danish quality clusters to agree to use the cluster package on one of their cluster meetings. The participating quality clusters are randomized to an intervention group and a control group.

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