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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rotterdam, 네덜란드
- Erasmus MC-Sophia Children's hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Pre-implementation group (patients)
neonates admitted to the NICU BEFORE implementation of the dashboard.
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실험적: 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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다른: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Main study parameter/endpoint - Effectiveness evaluation
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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System Usability Scale (SUS) score among healthcare professionals
기간: 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
기간: 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
기간: 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 (%)
기간: 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; %)
기간: 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)
기간: 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)
기간: 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)
기간: 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 (%)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sex distribution of included neonates (n; %)
기간: 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)
기간: 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)
기간: 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; %)
기간: 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)
기간: Through study completion, ~ 13 months
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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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MEC-2025-0045
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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