{"title":"A cross-sectoral, short-stay hospital model in general medicine (STATAMED): study protocol for a cluster-randomised, stepped-wedge controlled trial.","authors":"Johannes Jahn, Eva-Maria Wild","doi":"10.1186/s13063-025-09072-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Ageing populations and the increasing prevalence of chronic diseases pose major challenges to health care systems in high-income countries, especially in rural areas affected by a decline in public services. This trial investigates a new short-stay hospital model, STATAMED, which adopts a general medical approach to addressing the needs of adult patients (18 years or older) with chronic diseases and/or acute infections, with a particular focus on the elderly. STATAMED short-stay wards will incorporate a mandatory case review between the referring physician and the lead STATAMED physician, as well as support from case managers and mobile nurses to ensure coordination and continuity of care after hospital discharge. The primary aim of the trial is to determine whether the care provided in STATAMED wards is more effective than usual hospital care in improving the combined primary outcome of hospital length of stay and 30-day hospital readmission rates.</p><p><strong>Methods: </strong>The study will be conducted as a prospective, cluster-randomised controlled trial using a stepped-wedge design. STATAMED wards will be implemented at six hospital sites, and the catchment areas will be divided into clusters. All referring entities in a catchment area-including general practitioners (GPs), office-based specialists, nursing homes, ambulatory care services, and emergency services-will be potential candidates for cluster formation. The intervention group is expected to consist of 4481 patients. Primary and secondary outcomes will be assessed using claims data from participating statutory health insurers. A health economic evaluation will also be conducted using these data to compare costs associated with STATAMED and usual care. To minimise the risk of bias, analyses will be conducted on both an intention-to-treat and actual treatment basis.</p><p><strong>Discussion: </strong>This trial will assess whether STATAMED improves health care utilisation outcomes that reflect the efficiency and quality of inpatient care and discharge planning compared to usual hospital care. The findings will provide novel evidence about how best to improve health care for patients with chronic diseases and/or acute infections and may offer evidence for cost-effective strategies to improve health care delivery.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00033096. Registered on 27 November 2023, last updated on 26 May 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"340"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439374/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-09072-6","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Ageing populations and the increasing prevalence of chronic diseases pose major challenges to health care systems in high-income countries, especially in rural areas affected by a decline in public services. This trial investigates a new short-stay hospital model, STATAMED, which adopts a general medical approach to addressing the needs of adult patients (18 years or older) with chronic diseases and/or acute infections, with a particular focus on the elderly. STATAMED short-stay wards will incorporate a mandatory case review between the referring physician and the lead STATAMED physician, as well as support from case managers and mobile nurses to ensure coordination and continuity of care after hospital discharge. The primary aim of the trial is to determine whether the care provided in STATAMED wards is more effective than usual hospital care in improving the combined primary outcome of hospital length of stay and 30-day hospital readmission rates.
Methods: The study will be conducted as a prospective, cluster-randomised controlled trial using a stepped-wedge design. STATAMED wards will be implemented at six hospital sites, and the catchment areas will be divided into clusters. All referring entities in a catchment area-including general practitioners (GPs), office-based specialists, nursing homes, ambulatory care services, and emergency services-will be potential candidates for cluster formation. The intervention group is expected to consist of 4481 patients. Primary and secondary outcomes will be assessed using claims data from participating statutory health insurers. A health economic evaluation will also be conducted using these data to compare costs associated with STATAMED and usual care. To minimise the risk of bias, analyses will be conducted on both an intention-to-treat and actual treatment basis.
Discussion: This trial will assess whether STATAMED improves health care utilisation outcomes that reflect the efficiency and quality of inpatient care and discharge planning compared to usual hospital care. The findings will provide novel evidence about how best to improve health care for patients with chronic diseases and/or acute infections and may offer evidence for cost-effective strategies to improve health care delivery.
Trial registration: German Clinical Trials Register DRKS00033096. Registered on 27 November 2023, last updated on 26 May 2025.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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