Schäfer Ingmar, Menzel Agata, Lezius Susanne, Krause Linda, Zapf Antonia, Lühmann Dagmar, Scherer Martin, Paucke Valentina, Nothacker Julia
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
BMJ Open. 2025 Aug 3;15(8):e102086. doi: 10.1136/bmjopen-2025-102086.
Multimorbidity is prevalent and associated with complex treatment requirements. In order to assist general practitioners (GPs) addressing these requirements, the web application gp-multitool.de has been designed, which facilitates implementation of the German clinical practice guideline for multimorbidity. We will conduct a cluster-randomised clinical trial evaluating an intervention based on this tool. This protocol summarises methods and discusses ethics and dissemination of this study.
Participating patients are recruited by cooperating GP practices. Inclusion criteria are an age of 65 years or older, enrolment in any disease management programme and multimorbidity operationalised by two additional chronic conditions. To avoid postrandomisation selection bias, practices are randomised as clusters after baseline assessment of all participating patients from the respective practice. In our intervention, patients receive access to different assessments including patient preferences by email, fill out the electronic assessment forms on any device with access to the internet, receive a medication review and discuss the assessment results with their GPs. GPs in the control group do not have access to the digital tool and provide care as usual. The primary outcome is staying at least once for at least one night in hospital during the 12-month observation period. Secondary outcomes are contacts with GPs and outpatient specialists, self-reported health, health-related quality of life, patient satisfaction and GP-reported and patient-reported quality of care. A sample size of 660 patients from 66 GP practices is needed. Data are analysed by mixed effects regression models.
Ethics approval was obtained by the ethics committee of the Medical Association of Hamburg (2022-1 00 786-BO-ff). Study results will be presented on scientific conferences and published in journal articles. In addition, healthcare professionals, patient representatives and the interested public will be informed about study results at a symposium.
The study was registered in clinicaltrials.gov (NCT06831994).
多病共存情况普遍，且与复杂的治疗需求相关。为帮助全科医生满足这些需求，设计了网络应用程序gp - multitool.de，它有助于实施德国多病共存临床实践指南。我们将开展一项整群随机临床试验，评估基于该工具的干预措施。本方案总结了研究方法，并讨论了本研究的伦理问题及结果传播。
通过合作的全科医生诊所招募参与患者。纳入标准为年龄65岁及以上、参加任何疾病管理项目且患有另外两种慢性病以界定多病共存。为避免随机分组后选择偏倚，在对各诊所所有参与患者进行基线评估后，将诊所作为整群进行随机分组。在我们的干预措施中，患者可通过电子邮件获得包括患者偏好在内的不同评估，在任何能上网的设备上填写电子评估表，接受用药审查并与他们的全科医生讨论评估结果。对照组的全科医生无法使用该数字工具，照常提供护理。主要结局是在12个月观察期内至少有一次住院至少一晚。次要结局包括与全科医生和门诊专科医生的接触、自我报告的健康状况、健康相关生活质量、患者满意度以及全科医生报告和患者报告的护理质量。需要从66个全科医生诊所招募660名患者作为样本。数据通过混合效应回归模型进行分析。
获得了汉堡医学协会伦理委员会的伦理批准（2022 - 1 00 786 - BO - ff）。研究结果将在科学会议上展示，并发表在期刊文章中。此外，将在一次研讨会上向医疗保健专业人员、患者代表和感兴趣的公众通报研究结果。
该研究已在clinicaltrials.gov注册（NCT06831994）。
