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Trials. 2020 Jan 6;21(1):16. doi: 10.1186/s13063-019-3782-9.

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.

Author information

1
Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada.
2
Child Health and Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning (PGCRL), 686 Bay Street, 6th floor, Toronto, M5G 0A4, Canada. bonnie.stevens@sickkids.ca.
3
Lawrence S. Bloomberg Faculty of Nursing & Faculties of Medicine and Dentistry, University of Toronto, 155 College Street, M5T 1P8, Toronto, Canada. bonnie.stevens@sickkids.ca.
4
Department of Psychiatry, Faculty of Medicine, University of Toronto, 250 College Street, M5T 1R8, Toronto, Canada.
5
Dalla Lana School of Public Health, University of Toronto, 155 College Street, M5T 3M7, Toronto, Canada.
6
Lawrence S. Bloomberg Faculty of Nursing & Faculties of Medicine and Dentistry, University of Toronto, 155 College Street, M5T 1P8, Toronto, Canada.
7
University of British Columbia, Pediatrics, Rm. 1N18, 4480 Oak Street, Vancouver, British Columbia, V6H 3V4, Canada.
8
University of Alberta, Edmonton Health Clinic Academy, Rm 5-006 11405 87 Avenue NW, T6G 1C9, Edmonton, Alberta, Canada.
9
Departments of Pediatrics and Psychology & Neuroscience, Dalhousie University and Centre for Pediatric Pain Research, IWK Health Centre, P.O. Box 9700 5850-5980 University Ave, Halifax, Nova Scotia, B3K 6R8, Canada.
10
School of Nursing, Faculty of Health Sciences, University of Ottawa, and Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, K1H 8L1, Canada.
11
Ryerson University, Daphne Cockwell School of Nursing, 350 Victoria Street, Toronto, Ontario, M5B 2K3, Canada.
12
School of Nursing, Faculty of Health, Departments of Pediatrics and Psychology & Neuroscience, Dalhousie University and Centre for Pediatric Pain Research, IWK Health Centre, 5869 University Ave, Halifax, B3H 4R2, Canada.
13
Department of Psychology, University of Calgary, Psychology, Rm. 260, Administration Building, 539 Campus Place NW, T2N 4V8, Calgary, Canada.
14
Alberta Children's Hospital Research Institute, Hotchkiss Brain Institute, Owekro Centre, Calgary, Alberta, Canada.
15
Trillium Health Partners, Professional Practice, 2200 Eglinton Ave W, Mississauga, Ontario, L5M 2N1, Canada.
16
Université de Montréal, Faculty of Nursing and CHU Sainte-Justine's Research Centre, 3175 Chemin de la Côte-Sainte-Catherine, Montreal, Quebec, H3T 1C5, Canada.
17
Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College Street, M5T 3M7, Toronto, Canada.
18
St. Michael's Hospital, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada.

Abstract

BACKGROUND:

Hospitalized 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.

METHODS:

An 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 REGISTRATION:

ClinicalTrials.gov, NCT03825822. Registered 31 January 2019.

KEYWORDS:

Assessment; Context; Implementation; Infants; Management; Pain; Procedural

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