The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants
- Conditions
- InfantPain
- Interventions
- Behavioral: ImPaC Resource Intervention (INT)Other: Standard Practice (SP)
- Registration Number
- NCT03825822
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ImPaC Resource Intervention (INT) 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. Standard Practice (SP) 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).
- Primary Outcome Measures
Name Time Method Proportion of infants with procedural pain assessed At 6 months after randomization 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.
Frequency of painful procedures At 6 months after randomization 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.
Proportion of infants with procedural pain management At 6 months after randomization 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.
- Secondary Outcome Measures
Name Time Method Use of the Resource (Feasibility/Fidelity) At completion of 6-month intervention for INT arm Feasibility and fidelity will be measured using Resource metrics that address (a) if all 7 steps of the Resource are completed (feasibility) and (b) if all the 7 steps are completed as intended in order (fidelity). Feasibility and fidelity metrics (data captured from the backend of the Resource website) will be electronically collected at the end of the 6-month implementation of the intervention. There is no specific measure to assess feasibility or fidelity.
Implementation costs At completion of 6-month intervention for INT arm Implementation costs will be assessed in terms of (a) incidental costs (Canadian dollars) associated with knowledge translation and implementation activity (e.g., printing posters, refreshments for education sessions) documented in the Resource; and (b) time (hours/minutes) spent by each member of the Change Team in completing each step of the Resource. Time will be converted to actual costs by multiplying hours spent by the hourly wage of the Change Team members. Data will be captured from Resource metrics (data captured from the backend of the website) at the end of the 6-month implementation of the intervention. There is no specific measure to assess reach.
Integration of the Resource into the practice (Reach) At completion of 6-month intervention for INT arm Number of providers in the NICU who receive each knowledge translation and implementation activity that will be documented in the Resource website by the Change Team members. Data will be captured from the Resource website at the end of the 6-month implementation of the intervention. There is no specific measure to assess reach.
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada