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NCT07629661
Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU
Conditions: Pain Management, Pain Assessment, Neonatal Intensive Care, Implementation Research, Decision Support Systems, Clinical
Sex: All
Healthy volunteers: Yes
Phase: NA
Enrollment: 1250
Sponsor: Erasmus Medical Center
Location: Erasmus MC-Sophia Children's hospital Rotterdam
Summary
This study protocol describes a type 1 hybrid effectiveness-implementation study evaluating a clinical decision support dashboard for neonatal pain management in a tertiary NICU. Using a pre- and post-implementation design, the study assesses whether the dashboard reduces the duration of inadequately managed neonatal discomfort during the first seven days of admission, while concurrently evaluating implementation outcomes such as acceptability, appropriateness, fidelity, and penetration. Quantitative EHR- and dashboard-derived data are complemented by qualitative interviews and observations to provide a comprehensive evaluation of both clinical impact and implementation processes.
Eligibility Criteria
Inclusion Criteria:
Primary endpoint - Effectiveness evaluation (neonates):
* Admitted to the NICU of Erasmus MC-Sophia Children's Hospital during either the pre-implementation or post-implementation phase
* Admitted and discharged during the respective phase
* Parental consent for use of medical information provided upon admission
Secondary endpoints - Implementation process evaluation (healthcare professionals):
* Physician, nurse, or nurse specialist working in the NICU during the study period who has been exposed to TMD-C
* Management staff who has been exposed to TMD-C
Secondary endpoints - Implementation process evaluation (parents):
\- Parent or guardian of an included neonate who was exposed to the dashboard during the samenzorgvisite (family-integrated ward round)
Primary endpoint - Effectiveness evaluation (neonates):
* Readmitted to the NICU during the same study phase
* Admitted to the NICU for less than 24 hours
* Discharged or transferred before 7 days of admission without complete pain management data available
Secondary endpoints - Implementation process evaluation:
\- None
Source: ClinicalTrials.gov (NCT07629661). StuddyBuddy aggregates publicly available trial information.