ArticleTrials2020
A cluster randomized clinical trial to evaluate the effectiveness of the Implementation of Infant Pain Practice Change (ImPaC) Resource to improve pain practices in hospitalized infants: a study protocol.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03825822 (A Cluster Randomized Clinical Trial to Evaluate the Effectiveness of a Multifaceted Knowledge Translation Intervention in Hospitalized Infants), which is not on this map. Cited by 5 papers.
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The trial behind it
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A Cluster Randomized Clinical Trial to Evaluate the Effectiveness of a Multifaceted Knowledge Translation Intervention in Hospitalized Infants: the Implementation of Infant Pain Practice Change (ImPaC) Resource
Who cites it
5 citing papers in PubMed.
- Enhancing infant pain assessment and treatment: investigating barriers, facilitators, and implementation outcomes with the ImPaC Resource.Implementation science communications · 2026Article
- Application of the Supportive Accountability Model in Digital Health Interventions: Scoping Review.Journal of medical Internet research · 2025Article
- Healthcare professionals' perspectives on optimizing pain care-related education at a Canadian children's hospital: A qualitative study.Paediatrics & child health · 2024Article
- Pain experiences of marginalized children in the emergency department: A scoping review protocol.PloS one · 2024Article
- Usability, acceptability, and feasibility of the Implementation of Infant Pain Practice Change (ImPaC) Resource.Paediatric & neonatal pain · 2020Article
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
backgroundHospitalized infants undergo multiple painful procedures daily. Despite the significant evidence, procedural pain assessment and management continues to be suboptimal. Repetitive and untreated pain at this vital developmental juncture is associated with negative behavioral and neurodevelopmental consequences. To address this knowledge to practice gap, we developed the web-based Implementation of Infant Pain Practice Change (ImPaC) Resource to guide change in healthcare professionals' pain practice behaviors. This protocol describes the evaluation of the intervention effectiveness and implementation of the Resource and how organizational context influences outcomes.
methodsAn effectiveness-implementation hybrid type 1 design, blending a cluster randomized clinical trial and a mixed-methods implementation study will be used. Eighteen Neonatal Intensive Care Units (NICUs) across Canada will be randomized to intervention (INT) or standard practice (SP) groups. NICUs in the INT group will receive the Resource for six months; those in the SP group will continue with practice as usual and will be offered the Resource after a six-month waiting period. Data analysts will be blinded to group allocation. To address the intervention effectiveness, the INT and SP groups will be compared on clinical outcomes including the proportion of infants who have procedural pain assessed and managed, and the frequency and nature of painful procedures. Data will be collected at baseline (before randomization) and at completion of the intervention (six months). Implementation outcomes (feasibility, fidelity, implementation cost, and reach) will be measured at completion of the intervention. Sustainability will be assessed at six and 12 months following the intervention. Organizational context will be assessed to examine its influence on intervention and implementation outcomes. DISCUSSION: This mixed-methods study aims to determine the effectiveness and the implementation of a multifaceted online strategy for changing healthcare professionals' pain practices for hospitalized infants. Implementation strategies that are easily and effectively implemented are important for sustained change. The results will inform healthcare professionals and decision-makers on how to address the challenges of implementing the Resource within various organizational contexts.
trial registrationClinicalTrials.gov, NCT03825822. Registered 31 January 2019.
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