Decision Support Systems, Clinical, Implementation Research, Neonatal Intensive Care, Pain Assessment, Pain Management
Conditions
Keywords
Pain, Pain management, Sedation, Analgesia, Dashboard, Paindashboard, Comfort, NICU, Neonatal intensive care unit, Implementation, Hybrid effectiveness-implementation
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.
Detailed description
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.
Interventions
DEVICEImplementation of clinical pain management 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.
Sponsors
Erasmus Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main study parameter/endpoint - Effectiveness evaluation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) score among healthcare professionals | 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. |
| Qualitative assessment of acceptability of the dashboard among healthcare professionals and parents | 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). |
| Qualitative assessment of appropriateness of the implementation strategies within NICU workflows | 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. |
| Proportion of healthcare professionals attending training sessions (%) | 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. |
| Use of loading doses at therapy initiation and dose-escalation (n; %) | 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). |
| Continuous infusion duration in patients without discomfort (minutes) | 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. |
| Dose-escalation titration step size (mg/kg/hr) | 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. |
| Duration of oversedation (minutes) | 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. |
| Proportion of timely pain measurements following key therapy events (%) | 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. |
| Number of dashboard accesses per morning round (n) | 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. |
Countries
Netherlands
Outcome results
None listed