Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial
Abstract Background The Perinatal Center of the University Hospital Carl Gustav Carus Dresden has initiated the telemedical healthcare network “SAFE BIRTH” to coordinate and improve specialized care in non-metropolitan regions for pregnant women and newborns. The network incorporates five interventi...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | BMC Health Services Research |
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| Online Access: | https://doi.org/10.1186/s12913-024-10667-z |
| _version_ | 1827328085052096512 |
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| author | Helene Hense Josephine Mathiebe Sven Helfer Rick Glaubitz Mario Rüdiger Cahit Birdir Jochen Schmitt Gabriele Müller |
| author_facet | Helene Hense Josephine Mathiebe Sven Helfer Rick Glaubitz Mario Rüdiger Cahit Birdir Jochen Schmitt Gabriele Müller |
| author_sort | Helene Hense |
| collection | DOAJ |
| description | Abstract Background The Perinatal Center of the University Hospital Carl Gustav Carus Dresden has initiated the telemedical healthcare network “SAFE BIRTH” 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. Methods To evaluate the complex healthcare intervention “SAFE BIRTH” 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: “Proportion of patients with inclusion criterion IB#1 who have a prenatal care plan and psychosocial counseling within one week”). 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’ satisfaction, resilience, quality of life and depressive, anxiety and stress symptoms (questionnaire surveys). We will also evaluate the cost-effectiveness of ”SAFE BIRTH” (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. Discussion If the telemedical healthcare network “SAFE BIRTH” proves to be effective and cost-efficient, strategies for its translation into routine care should be developed. Trial registration German clinical trials register. DRKS-ID: DRKS00031482. |
| first_indexed | 2024-03-07T15:12:51Z |
| format | Article |
| id | doaj.art-33a9969df46643f5a5d86c30be99586d |
| institution | Directory Open Access Journal |
| issn | 1472-6963 |
| language | English |
| last_indexed | 2024-03-07T15:12:51Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj.art-33a9969df46643f5a5d86c30be99586d2024-03-05T18:05:44ZengBMCBMC Health Services Research1472-69632024-02-0124111110.1186/s12913-024-10667-zEvaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trialHelene Hense0Josephine Mathiebe1Sven Helfer2Rick Glaubitz3Mario Rüdiger4Cahit Birdir5Jochen Schmitt6Gabriele Müller7Center for Evidence-Based Healthcare, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenCenter for Evidence-Based Healthcare, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenSaxony Center for Feto/Neonatal Health, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenCenter for Evidence-Based Healthcare, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenSaxony Center for Feto/Neonatal Health, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenSaxony Center for Feto/Neonatal Health, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenCenter for Evidence-Based Healthcare, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenCenter for Evidence-Based Healthcare, University Hospital and Faculty of Medicine Carl Gustav Carus, Technische Universität DresdenAbstract Background The Perinatal Center of the University Hospital Carl Gustav Carus Dresden has initiated the telemedical healthcare network “SAFE BIRTH” 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. Methods To evaluate the complex healthcare intervention “SAFE BIRTH” 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: “Proportion of patients with inclusion criterion IB#1 who have a prenatal care plan and psychosocial counseling within one week”). 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’ satisfaction, resilience, quality of life and depressive, anxiety and stress symptoms (questionnaire surveys). We will also evaluate the cost-effectiveness of ”SAFE BIRTH” (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. Discussion If the telemedical healthcare network “SAFE BIRTH” proves to be effective and cost-efficient, strategies for its translation into routine care should be developed. Trial registration German clinical trials register. DRKS-ID: DRKS00031482.https://doi.org/10.1186/s12913-024-10667-zPerinatal careTelemedicineStepped-wedgeEvaluationHealth services researchImplementation |
| spellingShingle | Helene Hense Josephine Mathiebe Sven Helfer Rick Glaubitz Mario Rüdiger Cahit Birdir Jochen Schmitt Gabriele Müller Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial BMC Health Services Research Perinatal care Telemedicine Stepped-wedge Evaluation Health services research Implementation |
| title | Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial |
| title_full | Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial |
| title_fullStr | Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial |
| title_full_unstemmed | Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial |
| title_short | Evaluation of the telemedical health care network “SAFE BIRTH” for pregnant women at risk, premature and sick newborns and their families: study protocol of a cluster-randomized controlled stepped-wedge trial |
| title_sort | evaluation of the telemedical health care network safe birth for pregnant women at risk premature and sick newborns and their families study protocol of a cluster randomized controlled stepped wedge trial |
| topic | Perinatal care Telemedicine Stepped-wedge Evaluation Health services research Implementation |
| url | https://doi.org/10.1186/s12913-024-10667-z |
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