{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T06:50:43Z","timestamp":1792047043630,"version":"4.4.0"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,2,14]],"date-time":"2024-02-14T00:00:00Z","timestamp":1707868800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,2,14]],"date-time":"2024-02-14T00:00:00Z","timestamp":1707868800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002957","name":"Technische Universit\u00e4t Dresden","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002957","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Health Serv Res"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The Perinatal Center of the University Hospital Carl Gustav Carus Dresden has initiated the telemedical healthcare network \u201cSAFE BIRTH\u201d to coordinate and improve specialized care in non-metropolitan regions for pregnant women and newborns. The network incorporates five intervention bundles (IB): (1) Multi-professional, inter-disciplinary prenatal care plan; (2) Neonatal resuscitation; (3) Neonatal antibiotic stewardship; (4) Inter-facility transfer of premature and sick newborns; (5) Psycho-social support for parents. We evaluate if the network improves care close to home for pregnant women, premature and sick newborns.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>To evaluate the complex healthcare intervention \u201cSAFE BIRTH\u201d we will conduct a cluster-randomized controlled stepped-wedge trial in five prenatal medical outpatient offices and eight non-metropolitan hospitals in Saxony, Germany. The offices and hospitals will be randomly allocated to five respectively eight sequential steps over a 30-month period to implement the telemedical IB. We define one specific primary process outcome for each IB (for instance IB#1: \u201c<jats:italic>Proportion of patients with inclusion criterion IB#1 who have a prenatal care plan and psychosocial counseling within one week\u201d<\/jats:italic>). We estimated a separate multilevel logistic regression model for each primary process outcome using the intervention status as a regressor (control or intervention group). Across all IB, a total of 1,541 and 1,417 pregnant women or newborns need to be included in the intervention and control group, respectively, for a power above 80% for small to medium intervention effects for all five hypothesis tests. Additionally, we will assess job satisfaction and sense of safety of health professionals caring for newborns (questionnaire survey) and we will assess families\u2019 satisfaction, resilience, quality of life and depressive, anxiety and stress symptoms (questionnaire surveys). We will also evaluate the cost-effectiveness of \u201dSAFE BIRTH\u201d (statutory health insurance routine data, process data) and barriers to its implementation (semi-structured interviews). We use multilevel regression models adjusting for relevant confounders (e.g. socioeconomic status, age, place of residence), as well as descriptive analyses and qualitative content analyses.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>If the telemedical healthcare network \u201cSAFE BIRTH\u201d proves to be effective and cost-efficient, strategies for its translation into routine care should be developed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>German clinical trials register. DRKS-ID: DRKS00031482.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12913-024-10667-z","type":"journal-article","created":{"date-parts":[[2024,2,14]],"date-time":"2024-02-14T12:02:22Z","timestamp":1707912142000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Evaluation of the telemedical health care network \u201cSAFE BIRTH\u201d for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial"],"prefix":"10.1186","volume":"24","author":[{"given":"Helene","family":"Hense","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josephine","family":"Mathiebe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven","family":"Helfer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rick","family":"Glaubitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"R\u00fcdiger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cahit","family":"Birdir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochen","family":"Schmitt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,2,14]]},"reference":[{"issue":"9","key":"10667_CR1","doi-asserted-by":"publisher","first-page":"e037135","DOI":"10.1136\/bmjopen-2020-037135","volume":"10","author":"F Walther","year":"2020","unstructured":"Walther F, K\u00fcster DB, Bieber A, R\u00fcdiger M, Malzahn J, Schmitt J, Deckert S. 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Informed consent will be obtained from all subjects. If consent is declined, an anonymized process data record will be transmitted. Informed consent materials can be requested from the authors. The study is carried out in accordance with the WMA Declaration of Helsinki. We adhere to a data protection concept specifically developed for the study. Protocol modifications will be published in the German clinical trials register.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Helene Hense, Josephine Mathiebe, Sven Helfer, Rick Glaubitz, Cahit Birdir and Gabriele M\u00fcller declare no competing interests. Unrelated to this study, Mario R\u00fcdiger reports institutional grants for investigator-initiated research from the German GBA, the BMG, BMBF, EU and DFG. He received a personal fee for the following activities: advisor on the advisory board (companies), organization of training events (Chiesi, AstraZeneca), speaker (Chiesi). MR is active on the board of the German Society for Perinatal Medicine, on the board of the German Foundation for Sick Newborns and on the Neonatal Task Force of the International Liason Committee of Resuscitation (ILCOR) and the European Resuscitation Council (ERC). Unrelated to this study, Jochen Schmitt reports institutional grants for investigator-initiated research from the German GBA, the BMG, BMBF, Federal State of Saxony, Novartis, Sanofi, ALK, and Pfizer. He also participated in advisory board meetings as a paid consultant for Sanofi, Lilly, and ALK. JS is a member of the Expert Council for Health and Care at the Federal Ministry of Health and a member of the Government Commission for a Modern and Needs-Bases Hospital Care.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"200"}}