Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU
1. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
1250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Rotterdam, Nederland
- Erasmus MC-Sophia Children's hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Pre-implementation group (patients)
neonates admitted to the NICU BEFORE implementation of the dashboard.
|
|
|
Eksperimentell: Post-implementation group (patients)
neonates admitted to the NICU AFTER implementation of the dashboard.
|
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.
|
|
Annen: Interviews - parents/guardians
Parents/guardians of patients admitted to the NICU during the post-implementation period.
|
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.
|
|
Annen: Interviews/observations - Healthcare professionals.
The healthcare professionals involved in the care of neonates AFTER implementation of the dashboard.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Main study parameter/endpoint - Effectiveness evaluation
Tidsramme: Days 1-7 of NICU admission, assessed through study completion (approximately 13 months post go-live, November 2026).
|
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.
|
Days 1-7 of NICU admission, assessed through study completion (approximately 13 months post go-live, November 2026).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
System Usability Scale (SUS) score among healthcare professionals
Tidsramme: At 6 months post go-live (week 32-35)
|
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.
|
At 6 months post go-live (week 32-35)
|
|
Qualitative assessment of acceptability of the dashboard among healthcare professionals and parents
Tidsramme: At 6 months post go-live (week 32-35)
|
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).
|
At 6 months post go-live (week 32-35)
|
|
Qualitative assessment of appropriateness of the implementation strategies within NICU workflows
Tidsramme: Through study completion, ~13 months
|
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.
|
Through study completion, ~13 months
|
|
Proportion of healthcare professionals attending training sessions (%)
Tidsramme: Weeks 0-7 (mid-implementation phase)
|
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.
|
Weeks 0-7 (mid-implementation phase)
|
|
Use of loading doses at therapy initiation and dose-escalation (n; %)
Tidsramme: Days 1-7 of admission through study completion, ~13 months
|
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).
|
Days 1-7 of admission through study completion, ~13 months
|
|
Continuous infusion duration in patients without discomfort (minutes)
Tidsramme: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
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.
|
Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
|
Dose-escalation titration step size (mg/kg/hr)
Tidsramme: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
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.
|
Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
|
Duration of oversedation (minutes)
Tidsramme: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
The difference in the cumulative duration a patient is classified as oversedated, comparing pre- and post-implementation phases.
|
Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
|
Proportion of timely pain measurements following key therapy events (%)
Tidsramme: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
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.
|
Days 1-7 of admission, through study completion (approximately 13 months post go-live)
|
|
Number of dashboard accesses per morning round (n)
Tidsramme: Through study completion, approximately 13 months post go-live
|
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.
|
Through study completion, approximately 13 months post go-live
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sex distribution of included neonates (n; %)
Tidsramme: Through study completion, ~ 13 months
|
Descriptive statistic for included neonates.
Reported for both pre- and post-implementation cohorts.
|
Through study completion, ~ 13 months
|
|
Birth weight of included neonates (grams)
Tidsramme: Through study completion, ~ 13 months
|
Descriptive statistic for included neonates.
Expressed as mean (±SD) or median (±IQR) depending on data distribution.
Reported for both pre- and post-implementation cohorts.
|
Through study completion, ~ 13 months
|
|
Gestational age of included neonates (weeks)
Tidsramme: Through study completion, ~ 13 months
|
Descriptive statistic for included neonates.
Expressed as mean (±SD) or median (±IQR) depending on data distribution.
Reported for both pre- and post-implementation cohorts.
|
Through study completion, ~ 13 months
|
|
Profession of healthcare professionals (n; %)
Tidsramme: Through study completion, ~ 13 months
|
Descriptive statistic for healthcare professionals participating in the implementation evaluation.
Categories include physician, nurse, nurse specialist, and management.
Reported for the post-implementation cohort.
|
Through study completion, ~ 13 months
|
|
Years of clinical experience of healthcare professionals (years)
Tidsramme: Through study completion, ~ 13 months
|
Descriptive statistic for healthcare professionals.
Expressed as mean (±SD) or median (±IQR) depending on data distribution.
Reported for the post-implementation cohort.
|
Through study completion, ~ 13 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2025
Primær fullføring (Antatt)
30. november 2026
Studiet fullført (Antatt)
30. november 2026
Datoer for studieregistrering
Først innsendt
7. april 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MEC-2025-0045
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .