The Effectiveness of a Multifaceted Knowledge Translation Intervention on Pain in Hospitalized Infants

The Hospital for Sick Children

Status: Completed

Conditions: Infant; Pain

Treatments: Behavioral: ImPaC Resource Intervention (INT); Other: Standard Practice (SP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03825822

REB1000061599

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

ImPaC Resource Intervention (INT)

Experimental group

Description:

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.

Treatment:

Behavioral: ImPaC Resource Intervention (INT)

Standard Practice (SP)

Other group

Description:

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).

Treatment:

Other: Standard Practice (SP)