Table 3.
Intervention: Intact cord resuscitation using the SAVE-method Setting: Regional hospital level | |||
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Target: Role | Function | Adoption, Implementation and Maintenance Outcomes | Performance objectives |
Clinical decision maker |
Head of department Head of labor department Head of neonatal unit |
The management team at the labor department clarifies economic responsibility and decides to adopt to the SAVE-study protocol by signing the resource agreement |
1. Agree to participate in the SAVE-study 2. Gain support from local stakeholders 3. Provide a coordinating midwife and ambassador 4. Answer surveys on implementation outcomes |
Stakeholders |
Medical managing obstetrician Medical managing neonatologist CEPS instructors Medical technology department |
The medical managing obstetrician and neonatologist as well as CEPS-instructors participate in discussions on preparations to be made and local adoptions required for study set-up A dialogue with the medical technology department is needed to prepare facilities and equipment for the SAVE-method |
1. Plan and prepare the facilities and equipment 2. Identify practical barriers for implementation 3. Discuss and plan simulation training sessions for staff involved in resuscitation 4. Setting up for study start-up activities 5. Answer surveys on implementation outcomes |
Implementer – facilitators | Local SAVE-team: principal investigator (medically responsible), coordinating midwife, responsible for equipment and responsible for data entry | A local principal investigator is identified, and a local SAVE-team is set up. The local SAVE-team participates in the training sessions provided by the central study team, they allot time to prepare for study start-up at the local site and follow-up the study participation continuously. Communicate if any problems arise during the study period |
1. Study start-up activities including setting up equipment in collaboration with medical technician, organizing training sessions and simulations for staff 2. Communicate and prepare staff in labor, neonatal and intensive care units 3. Go through local routines and update if needed to adapt to SAVE-protocol 4. Follow-up potential barriers to apply the SAVE-method 5. Give feedback to central study team as well as local staff 6. Motivate and engage staff to maintain recruitment 7.Answer surveys on implementation outcomes |
Adopters |
Staff in labor departments: midwives, obstetricians, auxiliary nurses and residents Staff in neonatal units: nurses, neonatologists, pediatricians, assistants and residents Intensive care units: anesthesiologist (where relevant) |
Staff participates in required training sessions provided. The staff follow the randomization process and adhere to study protocol |
1. Follow the randomization process 2. Adhere to study protocol 3. Answer surveys on implementation outcomes 4. Participate in interviews |
End Users |
Patient – neonate Parents |
The parents to the neonate consent to participate in the SAVE-study allowing collection of clinical outcomes, relevant birth data to be used and by answering post-natal surveys |
1. The included neonate participates in required measurements of clinical data 2. Parents answer surveys on their experiences of resuscitation and participate in interviews |