The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants
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|ClinicalTrials.gov Identifier: NCT03825822|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : April 12, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Infant||Behavioral: ImPaC Resource Intervention (INT) Other: Standard Practice (SP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Official Title:||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|
|Actual Study Start Date :||April 5, 2019|
|Actual Primary Completion Date :||June 24, 2022|
|Estimated Study Completion Date :||July 5, 2023|
Experimental: 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.
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.
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).
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.
- Proportion of infants with procedural pain assessed [ Time Frame: 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 [ Time Frame: 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.
- Frequency of painful procedures [ Time Frame: 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.
- Use of the Resource (Feasibility/Fidelity) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
- Context evaluation (ACT) [ Time Frame: Baseline ]Local context characteristics will be assessed with the Alberta Context Tool completed by staff nurses.
- Context evaluation (ACT) [ Time Frame: Prior to start of intervention for INT arm ]Local context characteristics will be assessed with the Alberta Context Tool completed by Change Team members.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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 exclusion criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825822
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Bonnie Stevens, PhD||The Hospital for Sick Children|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Bonnie Stevens, Senior Scientist, The Hospital for Sick Children|
|Other Study ID Numbers:||
|First Posted:||January 31, 2019 Key Record Dates|
|Last Update Posted:||April 12, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|