Clinical trial NCT03825822: The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Infant
Keywords: Pain
Procedures
Infants
Assessment
Management
Knowledge translation
Context
Implementation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-01-31
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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 exclusion criteria.

Primary outcomes:
measure: Proportion of infants with procedural pain assessed
timeFrame: At 6 months after randomization
measure: Proportion of infants with procedural pain management
timeFrame: At 6 months after randomization
measure: Frequency of painful procedures
timeFrame: At 6 months after randomization
Secondary outcomes:
measure: Use of the Resource (Feasibility/Fidelity)
timeFrame: At completion of 6-month intervention for INT arm
measure: Implementation costs
timeFrame: At completion of 6-month intervention for INT arm
measure: Integration of the Resource into the practice (Reach)
timeFrame: At completion of 6-month intervention for INT arm
Other outcomes:
measure: Context evaluation (ACT)
timeFrame: Baseline
measure: Context evaluation (ACT)
timeFrame: Prior to start of intervention for INT arm
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Bonnie Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
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