Infant, Pain
Conditions
Keywords
Pain, Procedures, Infants, Assessment, Management, Knowledge translation, Context, Implementation
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.
Interventions
BEHAVIORALImPaC 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.
OTHERStandard 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.
Sponsors
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
NICUs in pediatric or general hospitals will be invited to participate in this study if they: * are Level 2 or Level 3 NICUs in Canada, * have at least 15 beds, and * agree to participate for 24 months. Infants' clinical charts data will be collected if infants: • are hospitalized for the designated 24h period for chart review, Infants' charts will be excluded if: * infant leaves the unit at any time (transfer, surgeries, procedures) during the designated 24h period for chart review, * parents request to opt out of the study. Staff members of the NICU will be eligible to participate on the ImPaC change team if they: * are a health care professional, * are English speaking, * have 3+ years of experience in the NICU, * have flexibility within their role to engage in the study, and * have leadership experience (e.g. in an advanced practice or clinical role). There is no
Exclusion criteria
. Staff members of the NICU will be invited to complete the organizational context survey if they: * have 6 months experience in the NICU, and * work 0.5 FTE or above. There is no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Context evaluation (ACT) | Baseline | Local context characteristics will be assessed with the Alberta Context Tool completed by staff nurses. |
Countries
Canada
Outcome results
None listed