Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU (NCT07629661) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU
Netherlands1,250 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Main study parameter/endpoint - Effectiveness evaluation
Timeframe: Days 1-7 of NICU admission, assessed through study completion (approximately 13 months post go-live, November 2026).