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

Autor: Andrew R. Willan, Wanrudee Isaranuwatchai, Marsha Campbell-Yeo, Shirine Riahi, Christine T. Chambers, Melanie Noel, Janet Yamada, Shelly-Anne Li, Carole A. Estabrooks, Anne Synnes, Bonnie Stevens, Alexa Lanese, Sharyn Gibbins, Denise Harrison, Mariana Bueno, Jennifer Stinson, Sylvie LeMay, Melanie Barwick
Rok vydání: 2020
Předmět:
Male
Procedural
Medicine (miscellaneous)
Pain
Procedural
law.invention
Study Protocol
0302 clinical medicine
Resource (project management)
Randomized controlled trial
law
Medicine
Pharmacology (medical)
030212 general & internal medicine
Practice Patterns
Physicians'
Pain Measurement
Randomized Controlled Trials as Topic
media_common
Medical Audit
lcsh:R5-920
Standard of Care
Management
3. Good health
Female
lcsh:Medicine (General)
Infants
Internet-Based Intervention
Adult
Canada
Randomization
Health Personnel
media_common.quotation_subject
Pain
Fidelity
Context (language use)
Assessment
Young Adult
03 medical and health sciences
Nursing
Intensive Care Units
Neonatal
Intensive care
Intervention (counseling)
Humans
Pain Management
Patient Care Team
Protocol (science)
business.industry
Context
Health Plan Implementation
Infant
Newborn
Infant
Implementation
Feasibility Studies
business
Child
Hospitalized
030217 neurology & neurosurgery
Program Evaluation
Zdroj: Trials, Vol 21, Iss 1, Pp 1-11 (2020)
Trials
ISSN: 1745-6215
Popis: 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.DiscussionThis 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.
Databáze: OpenAIRE
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