Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU
1. června 2026 aktualizováno: Robert Flint, Erasmus Medical Center
A Hybrid Effectiveness-implementation Study on the Implementation of a Clinical Pain Management Dashboard for the NICU
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.
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Detailní popis
This protocol outlines a single-center, type 1 hybrid effectiveness-implementation study evaluating an in-house developed clinical decision support dashboard designed to optimize pain management in the Neonatal Intensive Care Unit (NICU). The study is conducted at a level III-IV NICU and follows a pre-implementation (retrospective), mid-implementation, buffer, and post-implementation (prospective) design over approximately 26 months.
The primary effectiveness objective is to determine whether implementation of the dashboard reduces the duration of inadequately managed neonatal discomfort during the first seven days of admission. Discomfort is operationalized as the cumulative duration a neonate is classified as "red" by the dashboard prioritization algorithm, indicating the need for immediate clinical attention. Pre-implementation "red" classifications are generated retrospectively from electronic health record data using the same algorithmic criteria applied prospectively post-implementation.
The secondary objective is to evaluate the implementation process of the dashboard within routine NICU workflows. Implementation outcomes, based on the framework of Proctor et al., include acceptability, appropriateness, fidelity (implementation and effectiveness), and penetration. These outcomes are assessed using a mixed-methods approach, combining quantitative measures such as dashboard use metrics, prescribing patterns, and timing of pain assessments with qualitative data from semi-structured interviews and observations involving healthcare professionals and parents.
The comfort-dashboard is implemented using a phased ward-based approach supported by targeted training, local champions, and ongoing facilitation. The study poses minimal risk, as the dashboard supports but does not replace clinical decision-making, and no changes are made to core algorithm logic or outcome definitions during the study. By integrating effectiveness and implementation evaluations, this protocol aims to generate clinically relevant evidence while supporting reproducibility, transparency, and future scalability of digital decision support tools in neonatal care.
Typ studie
Intervenční
Zápis (Odhadovaný)
1250
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Rotterdam, Holandsko
- Erasmus MC-Sophia Children's hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: Pre-implementation group (patients)
neonates admitted to the NICU BEFORE implementation of the dashboard.
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Experimentální: Post-implementation group (patients)
neonates admitted to the NICU AFTER implementation of the dashboard.
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The comfort-dashboard designed to assist healthcare professionals in managing neonatal pain within the Neonatal Intensive Care Unit (NICU).
The software aggregates and visualizes patient-specific data from connected systems, providing near-real-time metrics, patient prioritization, and clinical decision support.
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Jiný: Interviews - parents/guardians
Parents/guardians of patients admitted to the NICU during the post-implementation period.
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The comfort-dashboard designed to assist healthcare professionals in managing neonatal pain within the Neonatal Intensive Care Unit (NICU).
The software aggregates and visualizes patient-specific data from connected systems, providing near-real-time metrics, patient prioritization, and clinical decision support.
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Jiný: Interviews/observations - Healthcare professionals.
The healthcare professionals involved in the care of neonates AFTER implementation of the dashboard.
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The comfort-dashboard designed to assist healthcare professionals in managing neonatal pain within the Neonatal Intensive Care Unit (NICU).
The software aggregates and visualizes patient-specific data from connected systems, providing near-real-time metrics, patient prioritization, and clinical decision support.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Main study parameter/endpoint - Effectiveness evaluation
Časové okno: Days 1-7 of NICU admission, assessed through study completion (approximately 13 months post go-live, November 2026).
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For the primary aim of our study, we will assess the effectiveness of the dashboard in improving the comfort of patients admitted to the NICU, defined by the difference in the duration of inadequately managed discomfort in neonates during the first seven days of admission.
Here, the duration of inadequately managed discomfort is measured by the duration a patient has a 'red' status, as classified by the classification algorithm.
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Days 1-7 of NICU admission, assessed through study completion (approximately 13 months post go-live, November 2026).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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System Usability Scale (SUS) score among healthcare professionals
Časové okno: At 6 months post go-live (week 32-35)
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The SUS is a 10-item standardized questionnaire administered to healthcare professionals.
Each item is rated 1-5.
Odd-numbered item scores are reversed; all scores are summed and multiplied by 2.5 to yield a normalized score (range 0-100; higher = better usability).
The SUS score is interpreted as a percentile rank.
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At 6 months post go-live (week 32-35)
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Qualitative assessment of acceptability of the dashboard among healthcare professionals and parents
Časové okno: At 6 months post go-live (week 32-35)
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Semi-structured interviews exploring perceived barriers and facilitators to implementation, usefulness, ease of use, and overall satisfaction with TMD-C, conducted with healthcare professionals and parents.
Analysis uses direct content analysis guided by the Consolidated Framework for Implementation Research (CFIR).
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At 6 months post go-live (week 32-35)
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Qualitative assessment of appropriateness of the implementation strategies within NICU workflows
Časové okno: Through study completion, ~13 months
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Perceived fit, relevance, and compatibility of the chosen implementation strategies, assessed through semi-structured interviews and systematic observations with healthcare professionals, analyzed using CFIR constructs.
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Through study completion, ~13 months
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Proportion of healthcare professionals attending training sessions (%)
Časové okno: Weeks 0-7 (mid-implementation phase)
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Implementation fidelity measure: the proportion of healthcare professionals working in the NICU during the study period who attended at least one TMD-C training session.
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Weeks 0-7 (mid-implementation phase)
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Use of loading doses at therapy initiation and dose-escalation (n; %)
Časové okno: Days 1-7 of admission through study completion, ~13 months
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The difference in the proportion of therapy initiations and dose-escalation events accompanied by a loading dose within the protocol-specified timeframe, comparing pre- and post-implementation phases, stratified by moment (initiation vs. escalation).
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Days 1-7 of admission through study completion, ~13 months
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Continuous infusion duration in patients without discomfort (minutes)
Časové okno: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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The difference in the duration of continuous analgesic infusion in neonates classified as not experiencing discomfort, comparing pre- and post-implementation phases, stratified by drug and relevant patient characteristics.
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Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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Dose-escalation titration step size (mg/kg/hr)
Časové okno: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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The difference in starting dosage and height of subsequent dose escalation steps surrounding dose-escalation events, comparing pre- and post-implementation phases, stratified by drug and relevant patient characteristics.
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Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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Duration of oversedation (minutes)
Časové okno: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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The difference in the cumulative duration a patient is classified as oversedated, comparing pre- and post-implementation phases.
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Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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Proportion of timely pain measurements following key therapy events (%)
Časové okno: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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The difference in the proportion of pain measurements conducted within the protocol-specified timeframe after therapy initiation, dose-escalation, dose-decrease, and therapy discontinuation, comparing pre- and post-implementation phases, stratified by relevant patient characteristics.
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Days 1-7 of admission, through study completion (approximately 13 months post go-live)
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Number of dashboard accesses per morning round (n)
Časové okno: Through study completion, approximately 13 months post go-live
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The frequency of TMD-C access during morning rounds, used as a measure of penetration - the extent to which dashboard use has become part of routine NICU workflow.
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Through study completion, approximately 13 months post go-live
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sex distribution of included neonates (n; %)
Časové okno: Through study completion, ~ 13 months
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Descriptive statistic for included neonates.
Reported for both pre- and post-implementation cohorts.
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Through study completion, ~ 13 months
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Birth weight of included neonates (grams)
Časové okno: Through study completion, ~ 13 months
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Descriptive statistic for included neonates.
Expressed as mean (±SD) or median (±IQR) depending on data distribution.
Reported for both pre- and post-implementation cohorts.
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Through study completion, ~ 13 months
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Gestational age of included neonates (weeks)
Časové okno: Through study completion, ~ 13 months
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Descriptive statistic for included neonates.
Expressed as mean (±SD) or median (±IQR) depending on data distribution.
Reported for both pre- and post-implementation cohorts.
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Through study completion, ~ 13 months
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Profession of healthcare professionals (n; %)
Časové okno: Through study completion, ~ 13 months
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Descriptive statistic for healthcare professionals participating in the implementation evaluation.
Categories include physician, nurse, nurse specialist, and management.
Reported for the post-implementation cohort.
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Through study completion, ~ 13 months
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Years of clinical experience of healthcare professionals (years)
Časové okno: Through study completion, ~ 13 months
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Descriptive statistic for healthcare professionals.
Expressed as mean (±SD) or median (±IQR) depending on data distribution.
Reported for the post-implementation cohort.
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Through study completion, ~ 13 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. října 2025
Primární dokončení (Odhadovaný)
30. listopadu 2026
Dokončení studie (Odhadovaný)
30. listopadu 2026
Termíny zápisu do studia
První předloženo
7. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
1. června 2026
První zveřejněno (Aktuální)
5. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MEC-2025-0045
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data will not be proactively shared at this stage.
Sharing will be reconsidered after study completion and publication.
Requests for de-identified data may be considered on a case-by-case basis by the principal investigator.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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