Table 1 Study primary, secondary, and other outcomes
Primary outcomes | Description | Measure/Metrics | Timepoints for data collection |
|---|---|---|---|
Proportion of infants with procedural pain assessed | Total 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 management | Total 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 procedures | Total 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 outcomes | Description | Measure/Metrics | Timepoints for data collection |
Feasibility | The 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 fidelity | The 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 Resource | T2 and T3 (for INT and SP groups, respectively) |
Implementation costs | The 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) |
Reach | The 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 website | T2 and T3 (for INT and SP groups, respectively) |
Sustainability | The 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 data | Description | Measure | Time points for data collection |
Context evaluation by [1] staff nurses and [2] change team members | Factors describing the local organizational context | Alberta 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) |