Table 1 Secondary outcomes and related data sources
Intervention bundle | Secondary outcome | Data source |
|---|---|---|
Care close to home | ||
1 | Proportion of patients referred to the Perinatal Center of the University Hospital | SHI routine data of the participating health insurance company |
Proportion of patients who gave birth in a defined facility level | project database, SHI routine data of the participating health insurance company | |
Proportion of patients and mean number of virtual feto-neonatal board meetings | project database | |
Frequency of disciplines involved in virtual feto-neonatal board meetings | project database | |
Proportion of patients with psychosocial consultation within two weeks after diagnosis or directly at patient contact | project database | |
Proportion of patients who make use of further offers of help | project database | |
Maternal risks and complications during inpatient stay measured by ICD and OPS codes | SHI routine data of the participating health insurance company | |
2 | Number of postnatal transports | project database |
Proportion of transferred newborns | project database | |
On transport: time of neonatologist at participating hospital | project database | |
Condition of newborn during transport measured by body temperature and blood glucose in each case in participating hospital and Perinatal Center of the University Hospital | project database | |
Time (in minutes) until a neonatologist is present in the delivery room postnatally (also virtually, if necessary) | project database | |
Proportion of infants with hypoglycemia in the first 24 h | project database | |
Number of teleconsultations in the delivery room | project database | |
Proportion of newborns with teleconsultation in case of deterioration of condition on ward | project database | |
Number of deceased newborns | project database, SHI routine data of the participating health insurance company | |
3 | Proportion of newborns with antibiotic therapy | project database |
Average duration of antibiotic therapy | project database | |
Proportion of newborns whose therapy was terminated after 36–72 h | project database | |
Proportion of newborns with pathogen-specific adjustment of therapy after pathogen identification | project database | |
Proportion of newborns with use of reserve antibiotics | project database | |
Proportion of reserve antibiotics in total antibiotic consumption | project database | |
Proportion of newborns with adequately performed pharmacologic surveillance | project database | |
4 | Length of stay of newborns at the Perinatal Center of the University Hospital originating from the participating hospitals | project database, SHI routine data of the participating health insurance company |
Total duration of inpatient care of newborns from participating hospitals | project database, SHI routine data of the participating health insurance company | |
Proportion of newborns who had to be transferred back to the Perinatal Center of the University Hospital after transfer to participating hospital | project database, SHI routine data of the participating health insurance company | |
5 | Proportion of patients for whom the previously individually assessed need for follow-up care and networking was achieved | project database |
Proportion of guardians with offers of help (conversations/guidance by staff of the clinic providing care, consultations with psychiatry or psychosomatics of the clinic providing care, referral to other offers of help (e.g. youth welfare office, family midwife, home help, etc.) by clinic providing care, help refused, no need for help seen on the part of the clinic providing care) | project database | |
Proportion of guardians who used IB#5 measures | project database | |
Satisfaction and sense of safety of participating health professionals in the care of pregnant women and newborns | ||
1–5 | Telemedicine contacts with the university hospital - helpful or not and reasons why | telemedicine questionnaire survey |
Can the questions be answered via telemedicine | telemedicine questionnaire survey | |
Job satisfaction | questionnaire survey, self-developed items based on COPSOQ (Kristensen et al., 2005; German version Nübling et al., 2006) | |
Sense of safety in neonatal care | questionnaire survey, self-developed case vignettes | |
When / why do health professionals in the respective participating facilities use the intervention bundle and when / why not? | questionnaire survey, self-developed items; qualitative interviews | |
What has changed as a result of the intervention bundle - both positively and negatively? | qualitative interviews | |
Reasons for (dis)satisfaction | qualitative interviews | |
Reasons for feeling safe | qualitative interviews | |
Satisfaction with medical care and resilience of patients and families (questionnaire survey 3 months after study inclusion for IB#1 and 3 months after calculated delivery date for IB#2–5; qualitative interviews with selected individuals) | ||
1–5 | Satisfaction with care | self-developed items |
Reasons for (dis)satisfaction | qualitative interviews | |
Resilience | BRS - Brief Resilience Scale (Chmitorz et al., 2018) | |
Reasons for resilience | qualitative interviews | |
Quality of life | WHOQOL-BREF (The WHOQOL Group, 1998) | |
Depressive, anxiety and stress symptoms | DASS-P: Depression Anxiety Stress Scale for the Peripartal Period (Martini et al., 2009) | |
Reasons for use of individual services | qualitative interviews | |
Economic impact | ||
1 | Number of duplicate clinic presentations: Referrals to the Perinatal Center of the University Hospital | project database |
Required travel distances to the medical examination at the Perinatal Center of the University Hospital: travel distance from the patient’s home to the university hospital and back | project database | |
Inpatient costs of mother (for 6 months before birth) | SHI routine data of the participating health insurance company | |
Number of transfers of the mother | SHI routine data of the participating health insurance company | |
Costs of transports between hospitals | SHI routine data of the participating health insurance company | |
Duration of inpatient stays of the mother (for 6 months before birth) | SHI routine data of the participating health insurance company | |
Outpatient costs for gynecological specialists and prenatal physicians | SHI routine data of the participating health insurance company | |
Periods of inability to work during pregnancy | SHI routine data of the participating health insurance company | |
Expenditures during the inpatient stay of the mother (measured by OPS codes) | SHI routine data of the participating health insurance company | |
2–5 | Inpatient costs of the child (up to 6 months after birth) | SHI routine data of the participating health insurance company |
Number of transfers of the child related to the inpatient stay at birth | SHI routine data of the participating health insurance company | |
Costs of transports between hospitals | SHI routine data of the participating health insurance company | |
Duration of ventilation time [hours] of the child | SHI routine data of the participating health insurance company | |
Number of inpatient stays of the child (for the 6 months after first discharge after birth) | SHI routine data of the participating health insurance company | |
Expenditures for the child during the inpatient stay (measured by OPS codes) | SHI routine data of the participating health insurance company | |
Expenditures for the novel form of care | ||
1–5 | Type, duration, number and type of participants are recorded for each measure | project database |