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Completed

NCT Number: NCT03825822

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

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.

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Key information

Conditions

Pain Infant Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ImPaC Resource Intervention (INT)

Behavioral

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)

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Context evaluation (ACT)

    Time frame: Baseline

    Local context characteristics will be assessed with the Alberta Context Tool completed by staff nurses.

  2. 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 31, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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