Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02347241 |
| Other study ID # |
2013/12769 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 12, 2015 |
| Last updated |
September 30, 2016 |
| Start date |
January 2014 |
| Est. completion date |
May 2016 |
Study information
| Verified date |
September 2016 |
| Source |
Oslo University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Norway: Data Protection Authority |
| Study type |
Interventional
|
Clinical Trial Summary
The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation
Edu-cation intervention (INSPIRE-D) improves process of care associated with improved
newborn survival and neurologic outcomes.
Description:
This prospective interventional trial will be conducted in the delivery unit at OUS. The
planned studies consist of five distinct phases with step-wise interventions; 1) baseline
data collection, 2) introducing educational debriefing, 3) intensive
run-in/rolling-refresher phase, 4) INSPIRE-D phase and lastly 5) evaluation phase.
Phase 1: The baseline data collection phase
1. Needs assessment/questionnaires from participating healthcare providers will be
collected which include demographic data such as sex, age, education, and work
experience, as well as exposure to resuscitation training, simulation, self-perceived
confidence and suggestions for further training/educational topics.
2. Observations of the newborn in the resuscitation bays will be done by video recordings
and supplemented by resuscitation records, hospital quality improvement data and
medical records. Data points to be collected of the newborn are demographics,
gestational age, physiological parameters such as heart rate and
respirations/oxygenation, Apgar score, interventions performed, and outcomes during and
at discharge from hospital.
3. The healthcare providers adherence to guidelines in neonatal resuscitation (both
technical and non-technical skills like team collaboration) will be evaluated by
examining the video recordings and scored by validated scoring systems formerly tested
with good intra- and inter-rater reliability. The scoring systems is adapted to
guidelines from the Norwegian Council of Resuscitation and retested for intra- and
inter-rater reliability.
Phase 2: Intervention Phase with Educational Debriefings
1. Educational debriefings of healthcare providers involved in clinical situations with
newborn resuscitation: Selected resuscitation events will be debriefed facilitated by a
study team member with special competence in facilitation and an instructor in neonatal
resuscitation. The debriefing will be held depending on clinical schedule and
availability, to discuss process of care, performance, and provide education to
multidisciplinary staff with advocacy/inquiry debriefing techniques.
2. For healthcare providers; cont¬inued needs assessment and prospective observations by
video-recordings in resuscitation bays to document quality of care.
3. Baseline skills assessment will be collected using a novel manikin, the Newborn Lung
Simulator. Healthcare providers will be presented for a mini-simulation with a
compromised newborn and asked to perform high quality resuscitation. The performance
and adherence to guidelines will be evaluated and retested after the intervention.
Phase 3 - Intensive run-in of high frequency training and team reflection: "The rolling
refresher phase"
1. In this phase training triggers are identified at the start of each day shift. A
careful consideration of perinatal factors of both mother and infant will identify
"high risk" deliveries with babies who may need resuscitation. If no risk deliveries
are identified, a random Healthcare Provider team among the present staff will be
selected.
2. "Just-in-time" and "just-in-place" training; the novel "Rolling refresher", will be
introduced (target >80% of staff) at the beginning of day shifts. Health Care Providers
caring for labouring mothers with training triggers will be identified and exposed to
"low dose" simulation-based "just-in-time" and "just-in-place" skills training. The
short training session (<10 minutes) will take place on-site in the resuscitation bay
with relevant topics such as; timely assessment of need for intervention, effective
assisted ventilations on a Newborn Lung Simulator. We will use observations from the
video-films to target training with focus on rapid evaluation of respiratory distress,
correct ventilation technique and use of pulse oximetry.
3. Continued simulation training will be based on problem areas identified from baseline.
Performance during simulation training will be evaluated and registered.
4. Educational debriefings will continue, as in Phase 2
5. Continued needs assessment and prospective observations in resuscitation bays to
document provider confidence, simulation performance and quality of care during
implementation of the INSPIRE-D bundle described above.
Phase 4: Continued INSPIRE-D bundle. After successful implementation defined as >80% of
staff having been through at least one "just-in-time and just in place" training session,
all interventions above (phase 2 and 3) will continue on routine basis. Continued needs
assessment of confidence and performance are repeated as described above.
Phase 5: Evaluation. Evaluation of the INSPIRE-D bundle to identify and define key factors
and processes that we prove necessary to ensure timely and effective neonatal resuscitation
associated with improved newly born survival and neurologic outcomes.
