BACKGROUND: Many children with brain-based developmental disorders and their families,
specifically those with SNI, experience on-going and difficult-to-treat PIUO. However,
currently, no consensus exists among healthcare providers about how to best approach
PIUO, which likely exacerbates the challenges in faced by parents in taking care of their
children with SNI experiencing PIUO. The PIUO Pathway was developed to streamline pain
management and care for these children, who are among the most vulnerable seen in any
hospital or clinic. To-date, the PIUO Pathway has only been used by expert clinicians in
complex care, palliative medicine, and pain medicine, and in tertiary pediatric care
settings. Community pediatricians are not yet trained to use this tool, which limits
access of such care to the tertiary care level and/or through access to specialist
supports. Training front-line clinicians, specifically community pediatricians, to use
the PIUO Pathway holds the potential to delivering sustained, effective, and quality
community care that can better serve and reach this vulnerable population of Canadian
children and families.
AIMS: To advance the assessment and treatment of PIUO in children with SNI and their
families, the primary aims and respective research questions of this hybrid
implementation-effectiveness study are:
Primary Implementation Aim 1: To determine the feasibility and effectiveness of, and
factors that influence implementing the Pain Pathway. Specifically, do the implementation
strategies show promise in facilitating the implementation of the Pain Pathway in
community practice?
Primary Intervention Aim 2: To assess the effectiveness of the Pain Pathway intervention
on relevant outcomes of children with SNI and their families. Specifically, does the Pain
Pathway work to help manage PIUO for children with SNI presenting and their families when
seen in a community practice?
METHODS
Study Design
The investigators will conduct a hybrid implementation-effectiveness feasibility study
using a pre-post, quasi-experimental design. The study will run from 2023 to 2025. Since
the Pain Pathway's effectiveness has not been tested previously in a community pediatric
practice setting, the investigators selected a Type 2 hybrid effectiveness-implementation
design to determine if the Pain Pathway can be feasibly implemented in a real-world
(community-based) setting, while further testing the effectiveness of the intervention
under a different condition. A hybrid design can offer a more rapid and efficient means
to gather information on the effectiveness of the implementation and intervention, as
well as to translate knowledge to practice.
Implementation will be guided by the National Implementation Research Network (NIRN)'s
Active Implementation Frameworks. The Active Implementation Frameworks (AIF) is an
evidence-based set of process frameworks used to facilitate the successful implementation
of innovation into practice, including the delivery of evidence-based health services.
The investigators will also refer to the NIRN Implementation Stages Planning Tool to
support implementation development. Implementation will be conducted in an integrated,
non-linear process across the four stages of the AIF: Stage 1 - Exploration; Stage 2 -
Installation; Stage 3 - Initial Implementation; and Stage 4 - Full Implementation.
Conducting implementation activities in a stepwise manner will allow the investigators to
study the implementation in its entirety, including planning, preparing, training,
evaluation, and sustainability.
The investigators will use the Theoretical Domains Framework (TDF) to identify barriers
and facilitators to implementation. The investigators will also refer to the Behavioural
Change Wheel (BCW) to identify priority mechanisms of action that underlie the selection
of implementation strategies, which will target the priority barriers and facilitators
that the investigators identify.
The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework
will be used to evaluation implementation processes and outcomes. RE-AIM is an integrated
framework developed to support the adoption and sustainable implementation of
evidence-based interventions in a wide range of health, public health, and community
settings.
Intervention Components
The intervention being implemented consists of two components:
Pain Pathway: The Pain Pathway targets PIUO in an intentional, focused, timely,
sequential order of standardized steps to support best outcomes for children with
SNI and families. It is comprised of 2 steps. Step 1 asks the pediatrician to
conduct a thorough history that includes a pain history to identify known and
unknown sources of past and current pain, and a physical examination. Step 2
involves carrying out a series of screening tests to explore any potential
underlying disease or injury, if not apparent based on Step 1. These tests may
include urinalysis, ultrasound, gastric pH, and bloodwork. Each child proceeds
through the Pain Pathway as long as their pain persists, but may not go through all
steps if their pain source is identified or pain resolves at any stage. The steps of
the Pain Pathway may be refined by the study team based on the results of Phase 1
study analysis (NCT03464773), which is underway.
Nursing Support: An observation made in the pilot and again in the Phase 1 RCT was
that the nurse-family interaction that was provided was perceived to be therapeutic
both in cases where a treatable pain source was identified, and in cases when they
were not. Therefore, elucidating the impact of nursing support and the nurse-family
interaction on patient and family outcomes will be an important intervention
evaluation component of this study. A central study nurse will be available to work
closely with and consult with community pediatricians at each clinic. Nursing
support will be defined as any contact or interaction with families in the context
of delivering the Pain Pathway, including communication, consultation, psychosocial
support, and service and resource coordination, and quality of and satisfaction with
nurse-family interaction as reported by parents of children with SNI partaking in
the Pain Pathway.
Hypothesized Mechanisms of Change and Implementation Strategies
The implementation strategies will be developed based on the results of the TDF-guided
barrier and facilitator assessment of BC community paediatricians. The investigators will
select empirically supported implementation strategies to fulfill each mechanism of
action identified as relevant through the BCW, while targeting priority barriers and
facilitators. The investigators hypothesize that the intervention functions of education,
training, and modeling will likely form the foundation of the implementation strategies
because the investigators anticipate that barriers to implementation will include a lack
of knowledge of the Pain Pathway (knowledge - education) and how to apply it to practice
(training), as well as the limited number of pediatricians with expertise in complex
care, pediatric pain, and palliative medicine (lack of confidence in managing complex
pain - modelling).