NCT03825822

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	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.

Timeline

• Start date: 2019-04-05
• Primary completion: 2022-06-24
• Completion: 2023-07-04
• First posted: 2019-01-31
• Last updated: 2023-11-21

Locations

1 site across 1 country: Canada