The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants
NCT ID: NCT03825822
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2019-04-05
2023-07-04
Brief Summary
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The aim of this study is (i) to evaluate the clinical effectiveness of the Resource (primary), (ii) to evaluate the implementation effectiveness of the Resource (secondary), and (iii) to explore how organizational context influences clinical and implementation outcomes (other).
Eighteen Level 2 or Level 3 Neonatal Intensive Care Units (NICUs) with a minimum of 15 beds across Canada will be included in a cluster randomized controlled trial (RCT). The NICUs will be randomized following baseline data collection using a computer-generated random allocation sequence (randomize.net) to either the intervention (INT) or standard practice (SP) arms. Those in INT arm will receive the Resource for a 6-month period. NICUs in the SP arm will continue as usual with their unit or institutional pain practices. They will be offered the Resource following outcomes assessment. Clinical outcomes will be assessed six months after randomization. Primary clinical outcomes include (1) the proportion of infants in the NICU who have procedural pain assessed with a valid pain measure, (2) the proportion of infants in the NICU who have procedural pain managed with an evidence-based pharmacological or physical intervention, and (3) the total number of painful procedures per infant in the NICU. Implementation outcomes will include feasibility, fidelity, cost, and reach. Organizational context will be assessed by using the Alberta Context Tool.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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ImPaC Resource Intervention (INT)
The INT arm will receive the 7-step web-based ImPaC intervention to use over 6 months. The intervention is divided into the Plan Stage and the Change Stage. The Plan Stage (steps 1-4) is expected to be completed in 1 month. The Change Stage (steps 5-7) is expected to be completed in 1-2 months. We anticipate that Change Teams will be able to complete 2 cycles of change over the 6-month intervention period.
ImPaC Resource Intervention (INT)
A Change Team will lead the implementation process of the ImPaC Resource using the steps:
Step 1: Complete a checklist to ensure its members can commit to responsibilities.
Step 2: Reflect on the unit's readiness for change.
Step 3: Perform an audit on 10 to 15 medical charts.
Step 4: Identify a practice change based on audit results (pain assessment or pain treatment). Develop an aim statement for the practice change.
Step 5: Select the KT strategies and plan the implementation.
Step 6: Perform an audit on 10 to 15 medical charts.
Step 7: Examine the effectiveness of the implementation and decide on the aim and KT strategies for the next cycle of change.
Standard Practice (SP)
The SP arm will continue as usual with their unit or institutional standard pain practices and any strategies that they would normally use to improve them (e.g. new staff orientation).
Standard Practice (SP)
The SP arm will continue as usual with their standard pain practices and will be offered the intervention 6 months after randomization and completion of data collection.
Interventions
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ImPaC Resource Intervention (INT)
A Change Team will lead the implementation process of the ImPaC Resource using the steps:
Step 1: Complete a checklist to ensure its members can commit to responsibilities.
Step 2: Reflect on the unit's readiness for change.
Step 3: Perform an audit on 10 to 15 medical charts.
Step 4: Identify a practice change based on audit results (pain assessment or pain treatment). Develop an aim statement for the practice change.
Step 5: Select the KT strategies and plan the implementation.
Step 6: Perform an audit on 10 to 15 medical charts.
Step 7: Examine the effectiveness of the implementation and decide on the aim and KT strategies for the next cycle of change.
Standard Practice (SP)
The SP arm will continue as usual with their standard pain practices and will be offered the intervention 6 months after randomization and completion of data collection.
Eligibility Criteria
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Exclusion Criteria
* parents request to opt out of the study.
Staff members of the NICU will be eligible to participate on the ImPaC change team if they:
* are a health care professional,
* are English speaking,
* have 3+ years of experience in the NICU,
* have flexibility within their role to engage in the study, and
Staff members of the NICU will be invited to complete the organizational context survey if they:
* have 6 months experience in the NICU, and
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
The Hospital for Sick Children
OTHER
Responsible Party
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Bonnie Stevens
Senior Scientist
Principal Investigators
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Bonnie Stevens, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Brooke, J. (2013). SUS: A Retrospective. Journal of Usability Studies, 8(2), 29-40. https://doi.org/10.1074/jbc.R115.675280
Brooke, J. (1996). SUS - A quick and dirty usability scale. Usability Evaluation in Industry, 189(194), 4-7. https://doi.org/10.1002/hbm.20701
Cruz MD, Fernandes AM, Oliveira CR. Epidemiology of painful procedures performed in neonates: A systematic review of observational studies. Eur J Pain. 2016 Apr;20(4):489-98. doi: 10.1002/ejp.757. Epub 2015 Jul 29.
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
Estabrooks CA, Squires JE, Cummings GG, Birdsell JM, Norton PG. Development and assessment of the Alberta Context Tool. BMC Health Serv Res. 2009 Dec 15;9:234. doi: 10.1186/1472-6963-9-234.
Forman, J., & Damschroder, L. (2007). Qualitative Content Analysis (pp. 39-62). https://doi.org/10.1016/S1479-3709(07)11003-7
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Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
Landsverk, J., Brown, C. H., Smith, J. D., Chamberlain, P., Curran, G. M., Palinkas, L., … McCue Horwitz, S. (2018). Design and Analysis in Dissemination and Implementation Research. In: Lewis, C. C., Proctor, E. K., & Brownson, R. C. (Eds.). Measurement Issues in Dissemination and Implementation Research (pp.201-227). Oxford University Press.
Mayring, P. (2014). Qualitative Content Analysis Theoretical Foundation, Basic Procedures and Software Solution. Retrieved from http://nbn-resolving.de/urn:nbn:de:0168-ssoar-395173
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
Squires, J. E., Hutchinson, A., Hayduk, L., Cranley, L. A., Cummings, G., Norton, P. G., & Estabrooks, C. A. (2014). Alberta Context Tool User Manual 2014.
Stevens BJ, Yamada J, Estabrooks CA, Stinson J, Campbell F, Scott SD, Cummings G; CIHR Team in Children's Pain. Pain in hospitalized children: Effect of a multidimensional knowledge translation strategy on pain process and clinical outcomes. Pain. 2014 Jan;155(1):60-68. doi: 10.1016/j.pain.2013.09.007. Epub 2013 Sep 8.
Stevens BJ, Yamada J, Promislow S, Stinson J, Harrison D, Victor JC; Members of the CIHR Team in Children's Pain. Implementation of multidimensional knowledge translation strategies to improve procedural pain in hospitalized children. Implement Sci. 2014 Nov 25;9:120. doi: 10.1186/s13012-014-0120-1.
Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011 Feb;24(1):53-8. doi: 10.1016/j.apnr.2009.04.003. Epub 2009 Sep 18.
Stevens B, Bueno M, Barwick M, Campbell-Yeo M, Chambers C, Estabrooks C, Flynn R, Gibbins S, Harrison D, Isaranuwatchai W, LeMay S, Noel M, Stinson J, Synnes A, Victor C, Yamada J. The implementation of infant pain practice change resource to improve infant procedural pain practices: a hybrid type 1 effectiveness-implementation study. Pain. 2024 Dec 6;166(7):1587-1596. doi: 10.1097/j.pain.0000000000003496.
Bueno M, Stevens B, Barwick MA, Riahi S, Li SA, Lanese A, Willan AR, Synnes A, Estabrooks CA, Chambers CT, Harrison D, Yamada J, Stinson J, Campbell-Yeo M, Noel M, Gibbins S, LeMay S, Isaranuwatchai W. 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. Trials. 2020 Jan 6;21(1):16. doi: 10.1186/s13063-019-3782-9.
Other Identifiers
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REB1000061599
Identifier Type: -
Identifier Source: org_study_id
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