Table 4 The iceberg model of the organizational culture with study outcomes and data sources defined. The SAVE-method illustrating the practice and the implementation strategy and context illustrating the underlying determinants enabling the implementation of the SAVE-method
Questions | Outcomes | Data sources | |
|---|---|---|---|
SAVE-method (Intact cord resuscitation) | Is the SAVE-method clinically effective for the neonate? | Cardiovascular stability and recovery after asphyxia Neurodevelopment after resuscitation Attachment/Bonding patterns after resuscitation (for complete list of clinical outcomes see www.clinicaltrials.gov) | Analysis of clinical routine data Postnatal surveys (ASQ) with parents at 4 and 12 months of age Analysis of clinical data from examination of psycho-motor development at 2 and 5.5 years of age Postnatal surveys on: breastfeeding (BSES) at 2, 4 and 6 months of age parental bonding at 2 and 6 months of age |
How do parents experience the SAVE-method? | Acceptability | Postnatal surveys with parents after birth Individual interviews (qualitative study III and IV) | |
What are the attitudes and beliefs regarding cord clamping among different professionals present in the resuscitation situation? | Acceptability | Surveys with staff | |
What is current cord-clamping practice in standard care? | Acceptability, Adoption | Surveys with midwives and obstetricians | |
What are the experiences of ICR among staff in the labor- and neonatal units? | Acceptability | Implementation surveys with staff Individual interviews (qualitative study I and II) | |
Is the SAVE-method applied by staff? | Adoption | Implementation surveys with staff | |
What are the barriers and facilitators for using the SAVE-method? | Adoption | Implementation surveys with staff | |
Implementation strategies | Is staff participating in training incentives? | Fidelity of implementation strategy | Implementation surveys with staff |
Is the SAVE-method applied by staff? | Fidelity of the intervention (the SAVE-method) | Analysis of recruitment rate and cord clamping time registered for infants requiring resuscitation | |
Is staff adhering to the study protocol? | Fidelity of the intervention (the SAVE-method) | Risk-based monitoring of study database | |
Is staff comfortable with the training provided and instructions received? | Fidelity of implementation strategy | Implementation surveys with staff | |
Context | How is the organizational readiness level? | Acceptability | Surveys with staff |
How are resource levels? | Acceptability | Surveys with managers in the labor and neonatal unit | |
How are the health service level? | Safety, effectiveness, timeliness, and equity | Analysis of adverse events, cord clamping time and socio-demographics of participants | |
Equipment/setting/room | Acceptability | Surveys with managers in the labor and neonatal unit |