Effectiveness and Implementation of a Clinical Pain Management Dashboard for the NICU
A Hybrid Effectiveness-implementation Study on the Implementation of a Clinical Pain Management Dashboard for the NICU
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Rotterdam、オランダ
- Erasmus MC-Sophia Children's hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Pre-implementation group (patients)
neonates admitted to the NICU BEFORE implementation of the dashboard.
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実験的：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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他の：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Main study parameter/endpoint - Effectiveness evaluation
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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System Usability Scale (SUS) score among healthcare professionals
時間枠：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
時間枠：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
時間枠：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 (%)
時間枠：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; %)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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 (%)
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sex distribution of included neonates (n; %)
時間枠：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)
時間枠：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)
時間枠：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; %)
時間枠：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)
時間枠：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.
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Through study completion, ~ 13 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MEC-2025-0045
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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