The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants

NCT03825822 | Completed

• 1 other identifier: REB1000061599
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Hospitalized infants undergo multiple painful procedures daily. Despite generation of a significant amount of evidence, procedural pain assessment and management in infants continues to be suboptimal. Untreated pain at this vital developmental juncture is associated with negative behavioural and neurodevelopmental consequences. To address this knowledge to practice gap, the investigators developed the Implementation of Infant Pain Practice Change (ImPaC) Resource (Resource) to guide change in health care professionals' pain practice behaviour. 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.

Conditions

Pain; Infant

Keywords

Pain; Procedures; Infants; Assessment; Management; Knowledge translation; Context; Implementation

Outcome Measures

Primary Outcomes (3)

• Proportion of infants with procedural pain assessed

  The proportion of infants in the NICU who have procedural pain assessed with a valid pain measure documented on clinical charts over a standardized 24-hour period.

  At 6 months after randomization

• Proportion of infants with procedural pain management

  The proportion of infants in the NICU who have procedural pain managed with evidence-based pharmacological or physical interventions documented on clinical charts over a standardized 24-hour period.

  At 6 months after randomization

• Frequency of painful procedures

  Total number of painful procedures (e.g. heel lance, arterial puncture, eye examination) per infant in the NICU documented in clinical charts over a standardized 24-hour period.

  At 6 months after randomization

Secondary Outcomes (3)

• Use of the Resource (Feasibility/Fidelity)

  At completion of 6-month intervention for INT arm

• Implementation costs

  At completion of 6-month intervention for INT arm

• Integration of the Resource into the practice (Reach)

  At completion of 6-month intervention for INT arm

Other Outcomes (2)

• Context evaluation (ACT)

  Baseline

• Context evaluation (ACT)

  Prior to start of intervention for INT arm

Study Arms (2)

ImPaC Resource Intervention (INT)

EXPERIMENTAL

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.

Behavioral: ImPaC Resource Intervention (INT)

Standard Practice (SP)

OTHER

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).

Other: Standard Practice (SP)

Interventions

ImPaC Resource Intervention (INT) BEHAVIORAL

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.

ImPaC Resource Intervention (INT)

Standard Practice (SP) OTHER

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.

Standard Practice (SP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Staff members of the NICU will be invited to complete the organizational context survey if they:
• have 6 months experience in the NICU, and

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (17)

• Brooke, J. (2013). SUS: A Retrospective. Journal of Usability Studies, 8(2), 29-40. https://doi.org/10.1074/jbc.R115.675280

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26223408 BACKGROUND

• 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.

  PMID: 19664226 BACKGROUND

• 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.

  PMID: 20003531 BACKGROUND

• Forman, J., & Damschroder, L. (2007). Qualitative Content Analysis (pp. 39-62). https://doi.org/10.1016/S1479-3709(07)11003-7

  BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20957426 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24021861 BACKGROUND

• 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.

  PMID: 25928349 BACKGROUND

• 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.

  PMID: 20974066 BACKGROUND

• 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.

  PMID: 39679622 DERIVED

• 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.

  PMID: 31907017 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bonnie Stevens, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will only be possible for the data analysts because no identifiable information about the sites, including the infants in the NICUs, will be available in the database or data extracted from the database. The code associating units with the data will be securely stored by the lead site, kept separate from the data, and only made available to the lead site Research Team for analyses purposes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 31, 2019
• Study Start: April 5, 2019
• Primary Completion: June 24, 2022
• Study Completion: July 4, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)