The cost-effectiveness of screening tools used in the diagnosis of fetal alcohol spectrum disorder: a modelled analysis.

BACKGROUND: Fetal Alcohol Spectrum Disorder (FASD) is characterized by physical and neurological abnormalities resulting from prenatal alcohol exposure. Though diagnosis may help improve patient outcomes, the diagnostic process can be costly. Subsequently, screening children suspected of FASD prior to diagnostic testing has been suggested, to avoid administering testing to children who are unlikely to receive a diagnosis. The present study set out to assess the cost-effectiveness of currently recommended FASD screening tools. METHODS: The screenings tools evaluated were chosen from Children's Healthcare Canada's National Screening Toolkit for Children and Youth Identified and Potentially Affected by FASD and include meconium testing of fatty acid ethyl esters (meconium testing) and the neurobehavioral screening tool (NST). An economic model was constructed to assess cost-effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the robustness of findings. Costs reflect 2017 Canadian dollars and the perspective is the public healthcare system. RESULTS: Both screening tools evaluated resulted in reduced costs and fewer diagnosed years of life than a no screening strategy in which all children suspected of FASD receive diagnostic testing. The model predicts that screening newborns with meconium testing results in a reduced cost of $89,186 per 100 individuals screened and 38 fewer diagnosed years of life by age 18, corresponding to an incremental cost-effectiveness ratio (ICER) of $2359. Screening children with the NST resulted in a reduced cost of $183,895 per 100 individuals screened and 77 fewer diagnosed years of life by age 18, corresponding to an ICER of $2390. CONCLUSION: Findings suggest that screening is associated with less use of healthcare recourses but also fewer years of life with an FASD diagnosis over a no screening strategy. Since diagnosis can be key to children receiving timely and appropriate health and educational services, cost-savings must be weighed against the fewer years of life with a diagnosis associated with screening.

Health care stakeholder perspectives regarding the role of a patient navigator during transition to adult care.

BACKGROUND: Transition to adult care represents a vulnerable period for young people with special health care needs as they navigate multiple life transitions and developmental issues. Patient navigators are a promising intervention designed to facilitate the transfer from pediatric to adult care. However, consistent definitions, key tasks, roles and responsibilities are lacking in guiding the scope of practice and the implementation of patient navigators. METHODS: Fundamental qualitative description was utilized in this study to identify perceptions from health care providers about implementing a patient navigator service for young people with special health care needs in transition to adult care. A purposive sample of health care providers with a variety of backgrounds within pediatric and adult systems in Alberta, Canada were recruited. Semi-structured interviews with participants were analyzed using thematic analysis to inductively identify perceptions regarding the role of patient navigators. RESULTS: A total of 43 health care providers highlighted the need for a patient navigator service to encompass 4 key stages for young people with special health care needs transitioning from pediatric to adult services: (1) identification of young people with special health care needs and families requiring support, (2) preparation for transfer, (3) health system navigation and, (4) post-transfer support. CONCLUSIONS: The results of this qualitative study provide guidance for the development of patient navigator interventions for young people with special health care needs, as well as provide support for current transition services offered across Canada.

Preserved cortical asymmetry despite thinner cortex in children and adolescents with prenatal alcohol exposure and associated conditions.

Prenatal alcohol exposure (PAE) is associated with reduced overall brain volume. Although this has been reported consistently across studies, the status of cortical thickness after PAE is more variable. The cortex is asymmetric in typical controls, but it is unclear whether the left and right counter parts of the cortical gray matter are unevenly influenced in postpartum brain development after PAE. Brain MRI was acquired in a newly recruited sample of 157 participants (PAE: N = 78, 5.5-18.9 years, 40 females and controls: N = 79, 5.8-18.5 years, 44 females) across four Canadian sites in the NeuroDevNet project. The PAE group had other confounds such as psychiatric co-morbidity, different living environment, and so on, not present in the control group. In agreement with previous studies, the volumes of all brain structures were reduced in PAE compared to controls, including gray and white matter of cerebrum and cerebellum, and all deep gray matter including the hippocampus, amygdala, thalamus, caudate, putamen, and pallidum. The PAE group showed reductions in global and regional cortical thickness, while the pattern and degree of cortical thickness asymmetry were preserved in PAE participants with the greatest rightward asymmetry in the lateral parietal lobe and the greatest leftward asymmetry in the lateral frontal cortex. This persistent asymmetry reflects that the homologous left and right cortical regions followed typical relative developmental patterns in the PAE group despite being thinner bilaterally than controls. Hum Brain Mapp 39:72-88, 2018. © 2017 Wiley Periodicals, Inc.

Longitudinal MRI reveals altered trajectory of brain development during childhood and adolescence in fetal alcohol spectrum disorders.

Diffusion tensor imaging (DTI) of brain development in fetal alcohol spectrum disorders (FASD) has revealed structural abnormalities, but studies have been limited by the use of cross-sectional designs. Longitudinal scans can provide key insights into trajectories of neurodevelopment within individuals with this common developmental disorder. Here we evaluate serial DTI and T1-weighted volumetric MRI in a human sample of 17 participants with FASD and 27 controls aged 5-15 years who underwent 2-3 scans each, ∼2-4 years apart (92 scans total). Increases of fractional anisotropy and decreases of mean diffusivity (MD) were observed between scans for both groups, in keeping with changes expected of typical development, but mixed-models analysis revealed significant age-by-group interactions for three major white matter tracts: superior longitudinal fasciculus and superior and inferior fronto-occipital fasciculus. These findings indicate altered developmental progression in these frontal-association tracts, with the FASD group notably showing greater reduction of MD between scans. ΔMD is shown to correlate with reading and receptive vocabulary in the FASD group, with steeper decreases of MD in the superior fronto-occipital fasciculus and superior longitudinal fasciculus between scans correlating with greater improvement in language scores. Volumetric analysis revealed reduced total brain, white, cortical gray, and deep gray matter volumes and fewer significant age-related volume increases in the FASD group, although age-by-group interactions were not significant. Longitudinal DTI indicates delayed white matter development during childhood and adolescence in FASD, which may underlie persistent or worsening behavioral and cognitive deficits during this critical period.

Longitudinal MRI reveals impaired cortical thinning in children and adolescents prenatally exposed to alcohol.

Brain imaging studies suggest that cortical thickness decreases during childhood and adolescence, in concert with underlying structural and synaptic changes required for cognitive maturation and regional specialization of function. Abnormalities of this protracted developmental process may provide key insights into the cognitive and behavioral deficits that emerge in individuals with fetal alcohol spectrum disorders (FASD). Several studies have demonstrated cortical thickness differences in children and adolescents who were prenatally exposed to alcohol, though all have been cross sectional, limiting conclusions about cortical development with age. In this study, we analyze serially collected T1 -weighted MRI from 11 children with FASD and 21 controls, scanned twice each ∼2 to 4 years apart. Mixed-models analysis of cortical thickness measurements revealed age-by-group interactions in cortical thinning, with FASD participants undergoing less developmental thinning than controls across many regions of the cortex, particularly in medial frontal and parietal areas. These results provide further longitudinal evidence in humans that prenatal alcohol exposure is associated with altered patterns of brain development that persist during childhood and adolescence.

Math Abilities Among Children with Neurodevelopmental Difficulties: Understanding Cognitive Factors and Evaluating a Pilot Intervention.

Math development in children relies on several underlying cognitive functions, including executive functions (EF), working memory (WM), and visual-motor abilities, such as visual-motor integration (VMI). Understanding how these cognitive factors contribute to children's math performance is critical to supporting math learning and long-term math success. The present quasi-experimental waitlist control study (N = 28) aimed to (a) examine the unique contributions of EF, WM, and VMI to math abilities among children ages 5-8 years old with neurodevelopmental difficulties; (b) determine whether a math intervention (the Mathematics Interactive Learning Experience; MILE) that supports these cognitive processes was effective when modified to be delivered to small groups in a school setting, and (c) examine whether any participant characteristics, such as age or IQ, were correlated with post-intervention math score changes. At baseline, participants' math scores were significantly below the normative mean in all math content areas (ps < .01). EF, WM, and VMI were highly correlated with math ability; however, verbal WM was the only unique predictor of math ability in regressions analysis. Compared to a waitlist control group, children in the immediate MILE intervention group achieved significantly greater math gains overall. When all children who ultimately completed the intervention were considered together, significant improvement was observed in more than half of math content areas. Furthermore, at the individual level, 85.7% of participants showed reliable change in at least one math content area. Implications for supporting math learning in children with neurodevelopmental difficulties are discussed.

Adaptive behavior, sleep, and physical activity in adolescents with fetal alcohol spectrum disorder.

BACKGROUND: Fetal alcohol spectrum disorder (FASD) is broadly associated with impairments to adaptive behavior and dysfunctional sleep. Associations between sleep, adaptive behavior, and physical activity are frequently drawn in discussions of typical development and other clinical conditions. AIMS: In this study, we sought to characterize patterns of sleep, adaptive behavior, and physical activity in adolescents with FASD. We also investigated the associations between sleep, adaptive behavior, and physical activity within this population. METHODS AND PROCEDURES: Twenty-seven adolescents aged 11- to 17-years with a diagnosis of FASD and their caregivers participated in this study. All participants completed parent and youth questionnaires on adaptive behavior, sleep, and physical activity. OUTCOMES AND RESULTS: Adolescents with FASD displayed significant impairments to all domains of adaptive behavior and considerable sleep disturbance. Worse sleep was associated with older age and sleep-related breathing disturbances were associated with poorer social adaptive behavior. Participation in physical activity, particularly organized sport, was strongly associated with better adaptive behavior. CONCLUSIONS AND IMPLICATIONS: Adolescents with FASD experience considerable challenges with regards to sleep and adaptive behavior. Physical activity, particularly organized sport, may provide opportunities for the improvement of adaptive behavior in this population.

Developmental cortical thinning in fetal alcohol spectrum disorders.

Regional cortical thickness was evaluated using CIVET processing of 3D T1-weighted images (i) to compare the variation in cortical thickness between 33 participants with fetal alcohol spectrum disorders (FASD) aged 6-30 years (mean age 12.3 years) versus 33 age/sex/hand-matched controls, and (ii) to examine developmental changes in cortical thickness with age from children to young adults in both groups. Significant cortical thinning was found in the participants with FASD in large areas of the bilateral middle frontal lobe, pre- and post- central areas, lateral and inferior temporal and occipital lobes compared to controls. No significant cortical thickness increases were observed for the FASD group. Cortical thinning with age in a linear model was observed in both groups, but the locations were different for each group. FASD participants showed thinning with age in the left middle frontal, bilateral precentral, bilateral precuneus and paracingulate, left inferior occipital and bilateral fusiform gyri; while controls showed decreases with age in the bilateral middle frontal gyrus, right inferior frontal gyrus, bilateral precuneus gyrus, and bilateral occipital gyrus. A battery of cognitive assessments of memory, attention, motor, and verbal abilities was conducted with many of the FASD participants, but no significant correlations were found between these cognitive scores and regional cortical thickness. Non-invasive measurements of cortical thickness in children to young adults with FASD have identified both key regions of cortex that may be more deleteriously affected by prenatal alcohol exposure as well as cortical changes with age that differ from normal developmental thinning.

Extensive deep gray matter volume reductions in children and adolescents with fetal alcohol spectrum disorders.

BACKGROUND: The link between the numerous cognitive, motor, and behavioral difficulties of individuals with fetal alcohol spectrum disorders (FASD) and underlying specific structural brain injuries can be investigated using high-resolution imaging. Differential sensitivity of the brain's "relay" stations, namely the deep gray matter structures, may play a key factor given their multifaceted role in brain function. The purpose of our study was to analyze differences in deep gray matter volumes of children and adolescents with FASD relative to age/sex-matched controls and to examine whether any volume differences were consistent across the age range of neurodevelopment. METHODS: Children and adolescents (N = 28, 6 to 17 years) diagnosed with FASD and 56 age- and sex-matched healthy controls (i.e., 2 matched controls per FASD subject) underwent 3-dimensional T1-weighted MRI scans that were used for the automated volume measurement (FreeSurfer) of the intracranial space, total white matter, cortical gray matter, and 6 deep gray matter structures, namely the hippocampus, amygdala, thalamus, caudate, putamen, and globus pallidus, with left and right measured separately. Volumes were compared between FASD and controls, as well as changes with age. RESULTS: Significant reductions of volume in FASD were observed for the intracranial vault (7.6%), total white matter (8.6%), total cortical gray matter (7.8%), and total deep gray matter (13.1%). All 6 deep gray matter structures showed significant volume reductions bilaterally with the caudate (approximately 16%) and globus pallidus (approximately 18%) being most affected. The hippocampus, thalamus, and globus pallidus showed reductions in all 3 age subgroups (6 to 9, 10 to 13, and 14 to 17 years) but the caudate and putamen had smaller volumes for FASD only within the 2 youngest subgroups; the amygdala was only smaller for FASD in the 2 oldest subgroups. CONCLUSIONS: Significant, but variable, volume reductions throughout the deep gray matter are observed over a wide age range of 6 to 17 years in FASD.

Characterizing adverse childhood experiences among children and adolescents with prenatal alcohol exposure and Fetal Alcohol Spectrum Disorder.

BACKGROUND: Individuals with Fetal Alcohol Spectrum Disorder (FASD) and prenatal alcohol exposure (PAE) face elevated rates of postnatal environmental adversity across the lifespan. OBJECTIVE: We explored early adversity among children and adolescents with PAE. PARTICIPANTS AND SETTING: Our sample included 333 children and adolescents with PAE assessed at a Canadian FASD diagnostic clinic, 66% of whom were diagnosed with FASD. METHODS: Data were collected retrospectively via record review, and adversity was measured using the Adverse Childhood Experiences Questionnaire (ACE-Q). RESULTS: Participants experienced high levels of adversity (mean ACE score of 3.4), which increased with age, mental health comorbidity, and number of living placements. Common ACEs included: not being raised by both biological parents (97.3%), caregiver disruption (88.5%), and exposure to household substance use (69.7%). Females had significantly higher rates of sexual abuse than males (p < .001, ø = -0.18). There was no difference in total ACE scores between participants diagnosed with FASD versus those not diagnosed, but participants with FASD were less likely to live with both biological parents (p < .001, ø = .19) or to have been exposed to household mental health problems (p = .007, ø = -0.15). CONCLUSIONS: Children and adolescents with PAE experience high rates of early adversity. Practice and policy initiatives are needed to improve early detection of ACEs among children with PAE, and of PAE among children with ACEs. Targeted supports are needed to strengthen the early caregiving environment and mitigate the risks of adversity to support healthy outcomes for individuals with PAE and FASD.

Prioritizing a Research Agenda of Transitional Care Interventions for Childhood-Onset Disabilities.

Transitional care interventions have the potential to optimize continuity of care, improve health outcomes and enhance quality of life for adolescents and young adults living with chronic childhood-onset disabilities, including neurodevelopmental disorders, as they transition to adult health and social care services. The paucity of research in this area poses challenges in identifying and implementing interventions for research, evaluation and implementation. The purpose of this project was to advance this research agenda by identifying the transitional care interventions from the scientific literature and prioritize interventions for study. A modified-Delphi approach involving two rounds of online surveys followed by a face-to-face consensus meeting with knowledge users, researchers and clinician experts in transitional care (n = 19) was used. A subsequent virtual meeting concluded the formulation of next steps. Experts rated 16 categories of interventions, derived from a systematic review, on importance, impact, and feasibility. Seven of the 16 interventions categories received a mean score rating of ≥7 (out of 10) on all three rating categories. Participants then rank ordered the reduced list of seven interventions in order of priority and the top four ranked interventions advanced for further discussion at a consensus meeting. Using the Template for Intervention Description and Replication (TIDieR) checklist as a guide, the participants identified that a study of a peer system navigator was worthy of future evaluation. This study highlighted that transitional care interventions are complex and multifaceted. However, the presence of a peer to support system navigation, advocacy and individual and family education was considered the most ideal intervention addressing the current gap in care. Future research, which aims to engage patients and families in a co-design approach, is recommended to further develop this intervention.

Brain microstructure is related to math ability in children with fetal alcohol spectrum disorder.

BACKGROUND: Children with fetal alcohol spectrum disorder (FASD) often demonstrate a variety of cognitive deficits, but mathematical ability seems to be particularly affected by prenatal alcohol exposure. Parietal brain regions have been implicated in both functional and structural studies of mathematical ability in healthy individuals, but little is known about the brain structure underlying mathematical deficits in children with FASD. The goal of this study was to use diffusion tensor imaging (DTI) to investigate the relationship between mathematical skill and brain white matter structure in children with FASD. METHODS: Twenty-one children aged 5 to 13 years diagnosed with FASD underwent DTI on a 1.5-T MRI scanner and cognitive assessments including the Woodcock-Johnson Quantitative Concepts test. Voxel-based analysis was conducted by normalizing subject images to a template and correlating fractional anisotropy (FA) values across the brain white matter with age-standardized math scores. RESULTS: Voxel-based analysis revealed 4 clusters with significant correlations between FA and math scores: 2 positively-correlated clusters in the left parietal region, 1 positively-correlated cluster in the left cerebellum, and 1 negatively-correlated cluster in the bilateral brainstem. Diffusion tractography identified the specific white matter tracts passing through these clusters, namely the left superior longitudinal fasciculus, left corticospinal tract and body of the corpus callosum, middle cerebellar peduncle, and bilateral projection fibers including the anterior and posterior limbs of the internal capsule. CONCLUSIONS: These results identify 4 key regions related to mathematical ability and provide a link between brain microstructure and cognitive skills in children with FASD. Given previous findings in typically developing children and those with other abnormal conditions, our results highlight the consistent importance of the left parietal area for mathematical tasks across various populations, and also demonstrate other regions that may be specific to mathematical processing in children with FASD.

The remarkably high prevalence of epilepsy and seizure history in fetal alcohol spectrum disorders.

BACKGROUND: Fetal alcohol spectrum disorder (FASD) is the umbrella term that describes the range of adverse developmental outcomes that may occur in the offspring of mothers who drink alcohol during pregnancy. FASD is associated with several comorbidities including epilepsy. The objective of the study was to evaluate the prevalence of epilepsy or a history of seizures in subjects with FASD and the contribution of relevant risk factors. METHODS: A retrospective chart review was conducted on all active charts (N = 1063) at two FASD clinics. After exclusion of subjects without a confirmed diagnosis, a total of 425 subjects between the ages of 2-49 were included in the analysis. The relationships between FASD diagnosis and other risk factors for co-occurrence of epilepsy or a seizure disorder (e.g., extent of exposure to alcohol and other drugs, type of birth, and trauma) were examined using chi-square and multivariate multinomial logistic regression. RESULTS: Twenty-five (5.9%) individuals in the study population had a confirmed diagnosis of epilepsy, and 50 (11.8%) had at least one documented seizure episode, yielding an overall prevalence of 17.7% in this population. Importantly, a history of epilepsy or seizures was not different across the three diagnostic subgroups. In those subjects with available maternal drinking histories, first trimester exposure or drinking throughout all three trimesters were the predominant forms of fetal exposure. None of the other risk factors were associated with a greater prevalence of epilepsy or seizures. CONCLUSIONS: There is a remarkably high prevalence of epilepsy/seizures in the FASD population.

Current Socioeconomic Status Correlates With Brain Volumes in Healthy Children and Adolescents but Not in Children With Prenatal Alcohol Exposure.

Individuals with prenatal alcohol exposure (PAE) exhibit neurological deficits associated with brain injury including smaller brain volumes. Additional risk factors such as lower socioeconomic status (SES) may also have an impact on brain development for this population. This study examined how brain volumes are related to SES in both neurotypically developing children and adolescents, and those with PAE. 3D T1-weighted MPRAGE images were acquired from 69 participants with PAE (13.0 ± 3.2 years, range 7.1-18.8 years, 49% female) and 70 neurotypical controls (12.4 ± 2.9 years, range 7.0-18.5 years, 60% female) from four scanning sites in Canada. SES scores calculated using Hollingshead's Four-Factor Index of Social Status from current caregiver placement were not significantly different between groups, though more children with PAE had lower SES scores compared to controls. Psychometric data comprised 14 cognitive measures, including executive functioning, attention and working memory, memory, math/numerical ability, and word reading. All cognitive scores were significantly worse in children with PAE compared to controls, though SES was not correlated with cognitive scores in either group after correction for multiple comparisons. All 13 brain volumes were smaller in children with PAE compared to children in the control group. Higher SES was associated with larger hippocampus and amygdala volumes in controls, but there were no such associations in children with PAE. Direct evaluation of the interaction between SES and diagnostic group did not show a significant differential impact of SES on these structures. These findings support previous links between SES and brain volumes in neurotypically developing children, but the lack of such a relationship with SES in children with PAE may be due to the markedly smaller brain volumes resulting from the initial brain injury and postpartum brain development, regardless of later SES.

Transitional Care Interventions for Youth With Disabilities: A Systematic Review.

CONTEXT: Transition from the pediatric to the adult health care system is a complex process that should include medical, psychosocial, educational, recreational, and vocational considerations. OBJECTIVE: In this systematic review, we aim to synthesize the evidence on transitional care interventions (TCIs) to improve the quality of life (QoL) for adolescents and young adults with childhood-onset disabilities, including neurodevelopmental disorders. DATA SOURCES: Four electronic databases (Medline, Embase, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature) were searched. STUDY SELECTION: In the included studies, researchers examined TCIs for adolescents and young adults (12-24 years of age) with childhood-onset disabilities. Studies were experimental, quasi-experimental, and observational studies published in the last 26 years. DATA EXTRACTION: Two reviewers independently completed study screening, data extraction, and risk-of-bias assessment. RESULTS: Fifty-two studies were included. Five studies reported on QoL, but statistically significant improvements were noted in only 1 of these studies. Significant improvements were also found in secondary outcomes including disability-related knowledge and transitional readiness. TCIs targeted patients, families and/or caregivers, and health care providers and exhibited great heterogeneity in their characteristics and components. LIMITATIONS: Inconsistent reporting on interventions between studies hindered synthesis of the relationships between specific intervention characteristics and outcomes. CONCLUSIONS: Although there is limited evidence on the impact of TCIs on the QoL for youth with childhood-onset disabilities, there is indication that they can be effective in improving patient and provider outcomes. The initiation of transition-focused care at an early age may contribute to improved long-term health outcomes in this population.

Deferred diagnosis in children assessed for fetal alcohol spectrum disorder.

Early intervention for individuals with FASD is paramount, thus exploring factors that affect the diagnostic process is critical. This process can be complicated by challenges gathering background information, accurately evaluating higher-level cognitive skills across ages, and teasing apart the impact of life adversities from the effects of prenatal alcohol exposure. This study is a retrospective file review of 154 children (44% female; mean age 8.4 years, range 1.0 to 16.9) deferred at their first FASD assessment, and 51 (43% female; mean 9.9 years, range 2.7 to 17.2) who returned for a second assessment. Data was collected from three Canadian FASD clinics to explore reasons for deferral, the clinical profile of deferred children, why some returning children were diagnosed while others were not, and changes between assessments. Results suggest that deferred children initially lacked evidence of abnormalities sufficient for a diagnosis, presented with areas of relative neurobehavioral strength and difficulty, and children eventually diagnosed with FASD showed significantly more impaired brain function (p < 0.001, ηp2 = 0.547), postnatal risk (p = 0.021, ηp2 = 0.121), and comorbidities (p = 0.038, ηp2 = 0.085) than undiagnosed children. These findings provide important insights into the process of clinical assessment for FASD.

Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.

INTRODUCTION: Transition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care. METHODS AND ANALYSIS: Pragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with usual care. Unit of randomisation is the patient. Treatment assignment will not be blinded. Embedded qualitative study to understand navigator's role and cost analysis attributable to the intervention will be performed. Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals. Sample size will be 300 in each arm. Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management. Primary outcome is ER visit rate during observation period. Secondary outcomes are ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score at 6 and 18 months post-randomisation. Poisson regression will compare rates of ER/urgent care visits between navigator and control participants, using intention to treat principle. Cost analysis of the intervention will be conducted. Thematic analysis will be used to identify perceptions of stakeholders regarding the role of navigators. ETHICS AND DISSEMINATION: Ethics approval was obtained from the University of Calgary Conjoint Health Research Ethics Board (REB #162561) and the University of Alberta Health Research Ethics Board (Pro00077325). Our team is composed of diverse stakeholders who are committed to improving transition of care who will assist with dissemination of results. TRIAL REGISTRATION NUMBER: NCT03342495.