Pain ManagementNCT07629661
Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU
A study testing Implementation of clinical pain management dashboard in people with Pain Management and Pain Assessment, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Pain Assessment, Neonatal Intensive Care
- What is being tested?
- Implementation of clinical pain management dashboard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management, Pain Assessment, Neonatal Intensive Care, Implementation Research, Decision Support Systems, Clinical
- Being tested
- Implementation of clinical pain management dashboard
- Keywords
- Pain, Pain management, Sedation, Analgesia, Dashboard, Paindashboard, Comfort, NICU, Neonatal intensive care unit, Implementation, Hybrid effectiveness-implementation
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of clinical pain management dashboardDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Implementation of clinical pain management dashboard |
| Interviews - parents/guardians | Other | Parents/guardians of patients admitted to the NICU during the post-implementation period. Receives: 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. Receives: Device: Implementation of clinical pain management dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At 6 months post go-live (week 32-35)
Qualitative assessment of acceptability of the dashboard among healthcare professionals and parents
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).
Measured: At 6 months post go-live (week 32-35)
Qualitative assessment of appropriateness of the implementation strategies within NICU workflows
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.
Measured: Through study completion, ~13 months
Proportion of healthcare professionals attending training sessions (%)
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.
Measured: Weeks 0-7 (mid-implementation phase)
Use of loading doses at therapy initiation and dose-escalation (n; %)
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).
Measured: Days 1-7 of admission through study completion, ~13 months
Continuous infusion duration in patients without discomfort (minutes)
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.
Measured: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Dose-escalation titration step size (mg/kg/hr)
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.
Measured: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Duration of oversedation (minutes)
The difference in the cumulative duration a patient is classified as oversedated, comparing pre- and post-implementation phases.
Measured: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Proportion of timely pain measurements following key therapy events (%)
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.
Measured: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Number of dashboard accesses per morning round (n)
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.
Measured: Through study completion, approximately 13 months post go-live
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Flint, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629661
- Sponsor's protocol ID
- MEC-2025-0045
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-implementation Study on the Implementation of a Clinical Pain Management Dashboard for the NICU
- ClinicalTrials.gov ID
- NCT07629661
- Acronym / sponsor ID
- MEC-2025-0045
- Conditions
- Pain Management, Pain Assessment, Neonatal Intensive Care, Implementation Research, Decision Support Systems, Clinical
- Keywords
- Pain, Pain management, Sedation, Analgesia, Dashboard, Paindashboard, Comfort, NICU
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation group (patients) | No intervention | –neonates admitted to the NICU BEFORE implementation of the dashboard. |
| Post-implementation group (patients) | Experimental | Device: Implementation of clinical pain management dashboardneonates admitted to the NICU AFTER implementation of the dashboard. |
| Interviews - parents/guardians | Other | Device: Implementation of clinical pain management dashboardParents/guardians of patients admitted to the NICU during the post-implementation period. |
| Interviews/observations - Healthcare professionals. | Other | Device: Implementation of clinical pain management dashboardThe healthcare professionals involved in the care of neonates AFTER implementation of the dashboard. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of clinical pain management dashboardThe 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. | Device | Interviews - parents/guardians, Interviews/observations - Healthcare professionals., Post-implementation group (patients) |
Primary outcome
Main study parameter/endpoint - Effectiveness evaluation
Time frame: 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.
10 secondary outcomes
System Usability Scale (SUS) score among healthcare professionals
Time frame: At 6 months post go-live (week 32-35)
Qualitative assessment of acceptability of the dashboard among healthcare professionals and parents
Time frame: At 6 months post go-live (week 32-35)
Qualitative assessment of appropriateness of the implementation strategies within NICU workflows
Time frame: Through study completion, ~13 months
Proportion of healthcare professionals attending training sessions (%)
Time frame: Weeks 0-7 (mid-implementation phase)
Use of loading doses at therapy initiation and dose-escalation (n; %)
Time frame: Days 1-7 of admission through study completion, ~13 months
Continuous infusion duration in patients without discomfort (minutes)
Time frame: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Dose-escalation titration step size (mg/kg/hr)
Time frame: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Duration of oversedation (minutes)
Time frame: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Proportion of timely pain measurements following key therapy events (%)
Time frame: Days 1-7 of admission, through study completion (approximately 13 months post go-live)
Number of dashboard accesses per morning round (n)
Time frame: Through study completion, approximately 13 months post go-live
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of clinical pain management dashboard in people with Pain Management and Pain Assessment, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main study parameter/endpoint - Effectiveness evaluation (time frame: Days 1-7 of NICU admission, assessed through study completion (approximately 13 months post go-live, November 2026).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.