This study will evaluate the effectiveness and implementation process of TMD-COMFORT, a near-real-time pain management dashboard, in the NICU of Erasmus MC-Sophia Children*s Hospital.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Health condition
Pijnmanagement bij neonaten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to assess the effectiveness of Telemedrics in improving
patient comfort in the NICU, measured by the reduction in the duration of
inadequately treated discomfort in neonates.
Secondary outcome
The evaluation of the implementation process will assess implementation
outcomes, including acceptance, appropriateness, adherence to the protocol, and
penetration.
Background summary
Vertaal dit naar het Nederlands: Neonates in the NICU are frequently exposed to
pain, which can lead to significant long-term consequences such as impaired
neurological development and increased pain sensitivity later in life. Managing
pain in these vulnerable patients is challenging due to their rapidly changing
physiology and the difficulty of assessing pain in non-verbal patients.
Although pain management protocols exist, their application often depends on
individual clinical experience, leading to variability in care. Inadequate pain
management or overuse of analgesics like morphine can cause short- and
long-term side effects, emphasizing the need for a more structured approach. To
address these challenges, Telemedrics: Comfort (TMD-COMFORT) was developed as a
clinical dashboard to assist healthcare professionals in optimizing pain
management for neonates by providing real-time data and decision support. This
study aims to evaluate the effectiveness of TMD-COMFORT in improving pain
management and minimizing discomfort for NICU patients.
Study objective
This study will evaluate the effectiveness and implementation process of
TMD-COMFORT, a near-real-time pain management dashboard, in the NICU of Erasmus
MC-Sophia Children*s Hospital.
Study design
The study will employ a type 1 hybrid effectiveness-implementation design, with
a primary focus on investigating effectiveness and a secondary focus on the
implementation process. The study will be conducted in the NICU of Erasmus
MC-Sophia Children*s Hospital and will be divided into four phases:
pre-implementation (1 year), mid-implementation (4 weeks), buffer/monitoring (4
weeks), and post-implementation (1 year).
Intervention
The intervention involves the implementation of Telemedrics: Comfort, a
clinical dashboard designed to support healthcare professionals in optimizing
pain management for neonates in the NICU.
Study burden and risks
The implementation of TMD-COMFORT is expected to have minimal burden and risks,
primarily related to technical malfunctions and data privacy. These risks are
mitigated through rigorous software testing, comprehensive training, and robust
data security measures. The benefits include improved pain management for
neonates, enhanced workflow efficiency for healthcare professionals, and better
communication with parents, outweighing the minimal risks involved.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Primary outcome (Effectiveness evaluation):
- Patients admitted to the NICU of the Erasmus MC-Sophia Children*s Hospital
during the pre- and post-implementation phases of the study.
Secondary outcomes (Implementation process evaluation):
- Healthcare professional (e.g., physician, nurse, nurse-specialist) or parents
of patients that has been exposed to TMD.
Exclusion criteria
Primary outcome (Effectiveness evaluation):
- Patients not admitted and discharged during the pre- or post-implementation
phase.
Secondary outcomes (Implementation process evaluation):
- n/a
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88031.078.24 |