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Table 1 Study primary, secondary, and other outcomes

From: 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

Primary outcomesDescriptionMeasure/MetricsTimepoints for data collection
Proportion of infants with procedural pain assessedTotal number of pain assessments performed using a valid pain measure and documented over a 24-h period (i.e. midnight to midnight)Whether or not an infant’s procedural pain was assessed with a valid pain measure [7]T1, T2 (for both groups)
Proportion of infants with procedural pain managementTotal number of pain management interventions (pharmacologic and/or non-pharmacologic) implemented and documented over a 24-h period (i.e. midnight to midnight)Whether or not an infant received pharmacologic (e.g. sucrose, opioids, acetaminophen) and/or non-pharmacologic (e.g. breastfeeding, skin-to-skin contact, non-nutritive sucking) interventions for procedural pain [7]T1, T2 (for both groups)
Frequency of painful proceduresTotal number of painful procedures documented in clinical charts over a 24-h period (i.e. midnight to midnight)Absolute number of painful procedures per infant documented in a 24-h period [7]T1, T2 (for both groups)
Secondary outcomesDescriptionMeasure/MetricsTimepoints for data collection
FeasibilityThe extent to which the Resource was successfully implemented in terms of ease of use and time [10, 15]Focus group. A semi-structured interview guide was developed according to CFIR constructs on intervention characteristics [9] and has been pre-tested in a usability study [12]T2 (for INT group)
Implementation fidelityThe degree to which the Resource is used by a team as prescribed or intended [10, 15]Progression through the Resource, which includes completion of each of the seven steps, completeness of included information will be considered the metric for fidelity. These data will be captured from the backend of the website at completion of using the ResourceT2 and T3 (for INT and SP groups, respectively)
Implementation costsThe financial and time cost to implement the Resource [10]Data on human resources (time spent on orientation session, navigation through the Resource, meeting among team members, implementation of the Resource either individually or in group); space (for meetings and education sessions, for example); equipment (e.g. laptop); materials (e.g. printing materials), and other related expenses. These data will be captured from the backend of the website.T2 and T3 (for INT and SP groups, respectively)
ReachThe integration of a KT strategy within a service setting and its subsystems [15]Proportion (%) of NICU staff who receive a KT strategy (selected from the Resource) divided by the total number of NICU staff expected to receive the service [15]. These data will be captured from the backend of the websiteT2 and T3 (for INT and SP groups, respectively)
SustainabilityThe extent to which the newly implemented Resource is maintained or institutionalized within a service setting’s ongoing, stable operations [10, 15]Maintenance of intervention effectiveness over time. These data will be captured from clinical charts over a 24-h period.
Duration (in months) that NICU continues to use the ImPaC Resource with fidelity. These data will be captured from the backend of the website
T3 (for INT group), and T4 (for both groups)
Other dataDescriptionMeasureTime points for data collection
Context evaluation by [1] staff nurses and [2] change team membersFactors describing the local organizational contextAlberta Context Tool (ACT) [14]. This is a reliable and valid tool that determines which elements of context facilitate and/or hinder successful KT outcomes [16]. It additionally captures a brief section on demographic data in addition to the 56 items and 5-point Likert scale answers for each item)T1 (for staff nurses of both groups) and at commencement of the Resource (for both groups)
  1. CFIR Consolidated Framework for Implementation Research, INT intervention, KT knowledge translation, NICU Neonatal Intensive Care Unit, SP standard practice
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