Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU

NCT07629661 | Active Not Recruiting

• 1 other identifier: MEC-2025-0045
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Assessment; Implementation Research; Decision Support Systems, Clinical; Pain Management; Neonatal Intensive Care

Keywords

Pain; Pain management; Sedation; Analgesia; Dashboard; Paindashboard; Comfort; NICU; Neonatal intensive care unit; Implementation; Hybrid effectiveness-implementation

Outcome Measures

Primary Outcomes (1)

• Main study parameter/endpoint - Effectiveness evaluation

  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).

Secondary Outcomes (10)

• System Usability Scale (SUS) score among healthcare professionals

  At 6 months post go-live (week 32-35)

• Qualitative assessment of acceptability of the dashboard among healthcare professionals and parents

  At 6 months post go-live (week 32-35)

• Qualitative assessment of appropriateness of the implementation strategies within NICU workflows

  Through study completion, ~13 months

• Proportion of healthcare professionals attending training sessions (%)

  Weeks 0-7 (mid-implementation phase)

• Use of loading doses at therapy initiation and dose-escalation (n; %)

  Days 1-7 of admission through study completion, ~13 months

Other Outcomes (5)

• Sex distribution of included neonates (n; %)

  Through study completion, ~ 13 months

• Birth weight of included neonates (grams)

  Through study completion, ~ 13 months

• Gestational age of included neonates (weeks)

  Through study completion, ~ 13 months

Study Arms (4)

Pre-implementation group (patients)

NO INTERVENTION

neonates admitted to the NICU BEFORE implementation of the dashboard.

Post-implementation group (patients)

EXPERIMENTAL

neonates admitted to the NICU AFTER implementation of the dashboard.

Device: Implementation of clinical pain management dashboard

Interviews - parents/guardians

OTHER

Parents/guardians of patients admitted to the NICU during the post-implementation period.

Device: Implementation of clinical pain management dashboard

Interviews/observations - Healthcare professionals.

OTHER

The healthcare professionals involved in the care of neonates AFTER implementation of the dashboard.

Device: Implementation of clinical pain management dashboard

Interventions

Implementation of clinical pain management dashboard DEVICE

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.

Interviews - parents/guardians; Interviews/observations - Healthcare professionals.; Post-implementation group (patients)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC-Sophia Children's hospital

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A type 1 hybrid effectiveness-implementation approach. It is structured over a 26-month period and comprises four phases: 1. a pre-implementation phase in which baseline data are collected retrospectively, 2. a 4-week mid-implementation phase when the dashboard is first introduced, 3. a 4-week buffer phase for additional training and stabilization, and 4. a 12-month post-implementation phase for prospective data collection

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: June 5, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)