Mental Health Experiences of Adolescents and Young Adults with Inflammatory Bowel Disease During Transition to Adult Care: A Qualitative Descriptive Study.

OBJECTIVE: To explore the mental health experiences of adolescents and young adults (AYA) with inflammatory bowel disease (IBD) enrolled in a randomized controlled trial evaluating the impact of a multimodal transition intervention. STUDY DESIGN: Virtual semistructured interviews were held with 21 AYA aged 16 through 18 years with IBD. Guided by qualitative description, interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive approach to reflexive thematic analysis. RESULTS: Three themes were generated from the data: (1) a continuum of integration between IBD and personal identity in adolescence and young adulthood; (2) manifestations of the mind-gut connection among AYA with IBD; and (3) hopes and priorities for addressing mental health in IBD care. CONCLUSIONS: AYA with IBD endorsed the criticality of incorporating mental health discussions into routine care during the transition to adult care, given the co-occurrence of psychosocial stressors throughout this period. A series of factors promoting and hindering the integration of IBD into one's identity were identified and could be explored in clinical encounters.

An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial.

INTRODUCTION: Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information 'Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings. METHODS AND ANALYSIS: We will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13-18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale-Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness. ETHICS AND DISSEMINATION: Research ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated.

A randomized sham-controlled trial of high-dosage accelerated intermittent theta burst rTMS in major depression: study protocol.

BACKGROUND: Intermittent theta burst stimulation (iTBS), a novel form of repetitive transcranial magnetic stimulation (rTMS), can be administered in 1/10th of the time of standard rTMS (~ 3 min vs. 37.5 min) yet achieves similar outcomes in depression. The brief nature of the iTBS protocol allows for the administration of multiple iTBS sessions per day, thus reducing the overall course length to days rather than weeks. This study aims to compare the efficacy and tolerability of active versus sham iTBS using an accelerated regimen in patients with treatment-resistant depression (TRD). As a secondary objective, we aim to assess the safety, tolerability, and treatment response to open-label low-frequency right-sided (1 Hz) stimulation using an accelerated regimen in those who do not respond to the initial week of treatment. METHODS: Over three years, approximately 230 outpatients at the Centre for Addiction and Mental Health and University of British Columbia Hospital, meeting diagnostic criteria for unipolar MDD, will be recruited and randomized to a triple blind sham-controlled trial. Patients will receive five consecutive days of active or sham iTBS, administered eight times daily at 1-hour intervals, with each session delivering 600 pulses of iTBS. Those who have not achieved response by the week four follow-up visit will be offered a second course of treatment, regardless of whether they initially received active or sham stimulation. DISCUSSION: Broader implementation of conventional iTBS is limited by the logistical demands of the current standard course consisting of 4-6 weeks of daily treatment. If our proposed accelerated iTBS protocol enables patients to achieve remission more rapidly, this would offer major benefits in terms of cost and capacity as well as the time required to achieve clinical response. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04255784.

Evaluation of the implementation and clinical effects of an intervention to improve medical follow-up and health outcomes for Aboriginal children hospitalised with chest infections.

Background: Aboriginal children hospitalised with acute lower respiratory infections (ALRIs) are at-risk of developing bronchiectasis, which can progress from untreated protracted bacterial bronchitis, often evidenced by a chronic (>4 weeks) wet cough following discharge. We aimed to facilitate follow-up for Aboriginal children hospitalised with ALRIs to provide optimal management and improve their respiratory health outcomes. Methods: We implemented an intervention to facilitate medical follow-up four weeks after hospital discharge from a paediatric hospital in Western Australia. The intervention included six-core components that focused on parents, hospital staff and hospital processes. Both health and implementation outcomes were measured for children grouped by three distinct temporal periods of recruitment: (i) nil-intervention, recruited after hospital admission; (ii) health-information only, received during recruitment at hospital admission, pre-intervention; (iii) post-intervention. The primary outcome was the cough-specific quality-of-life score (PC-QoL) in children with a chronic wet cough following discharge. Findings: Of the 214 patients that were recruited, 181 completed the study. Follow-up rates one-month post-discharge were higher in the post-intervention (50.7%) than the nil-intervention (13.6%) and health-information (17.1%) groups. PC-QoL in children with a chronic wet cough was also improved in the post-intervention group compared the health information and nil-intervention groups (difference in means between nil-intervention and post-intervention groups = 1.83, 95% CI: 0.75, 2.92, p = 0.002), aligning with an increase in the percentage who received evidence-based treatment, namely antibiotics at one-month post-discharge (57.9% versus 13.3%). Interpretation: Implementation of our co-designed intervention to facilitate effective and timely medical follow-up for Aboriginal children hospitalised with ALRIs improved their respiratory health outcomes. Funding: State, national grants and fellowships.

Translating Precision Health for Pediatrics: A Scoping Review.

Precision health aims to personalize treatment and prevention strategies based on individual genetic differences. While it has significantly improved healthcare for specific patient groups, broader translation faces challenges with evidence development, evidence appraisal, and implementation. These challenges are compounded in child health as existing methods fail to incorporate the physiology and socio-biology unique to childhood. This scoping review synthesizes the existing literature on evidence development, appraisal, prioritization, and implementation of precision child health. PubMed, Scopus, Web of Science, and Embase were searched. The included articles were related to pediatrics, precision health, and the translational pathway. Articles were excluded if they were too narrow in scope. In total, 74 articles identified challenges and solutions for putting pediatric precision health interventions into practice. The literature reinforced the unique attributes of children and their implications for study design and identified major themes for the value assessment of precision health interventions for children, including clinical benefit, cost-effectiveness, stakeholder values and preferences, and ethics and equity. Tackling these identified challenges will require developing international data networks and guidelines, re-thinking methods for value assessment, and broadening stakeholder support for the effective implementation of precision health within healthcare organizations. This research was funded by the SickKids Precision Child Health Catalyst Grant.

The Implementation Playbook: study protocol for the development and feasibility evaluation of a digital tool for effective implementation of evidence-based innovations.

BACKGROUND: Evidence-based innovations can improve health outcomes, but only if successfully implemented. Implementation can be complex, highly susceptible to failure, costly and resource intensive. Internationally, there is an urgent need to improve the implementation of effective innovations. Successful implementation is best guided by implementation science, but organizations lack implementation know-how and have difficulty applying it. Implementation support is typically shared in static, non-interactive, overly academic guides and is rarely evaluated. In-person implementation facilitation is often soft-funded, costly, and scarce. This study seeks to improve effective implementation by (1) developing a first-in-kind digital tool to guide pragmatic, empirically based and self-directed implementation planning in real-time; and (2) exploring the tool's feasibility in six health organizations implementing different innovations. METHODS: Ideation emerged from a paper-based resource, The Implementation Game©, and a revision called The Implementation Roadmap©; both integrate core implementation components from evidence, models and frameworks to guide structured, explicit, and pragmatic planning. Prior funding also generated user personas and high-level product requirements. This study will design, develop, and evaluate the feasibility of a digital tool called The Implementation Playbook©. In Phase 1, user-centred design and usability testing will inform tool content, visual interface, and functions to produce a minimum viable product. Phase 2 will explore the Playbook's feasibility in six purposefully selected health organizations sampled for maximum variation. Organizations will use the Playbook for up to 24 months to implement an innovation of their choosing. Mixed methods will gather: (i) field notes from implementation team check-in meetings; (ii) interviews with implementation teams about their experience using the tool; (iii) user free-form content entered into the tool as teams work through implementation planning; (iv) Organizational Readiness for Implementing Change questionnaire; (v) System Usability Scale; and (vi) tool metrics on how users progressed through activities and the time required to do so. DISCUSSION: Effective implementation of evidence-based innovations is essential for optimal health. We seek to develop a prototype digital tool and demonstrate its feasibility and usefulness across organizations implementing different innovations. This technology could fill a significant need globally, be highly scalable, and potentially valid for diverse organizations implementing various innovations.

Randomized controlled trial evaluating a virtual parenting intervention for young children at risk of obesity: study protocol for Parenting Addressing Early Years Intervention with Coaching Visits in Toronto (PARENT) trial.

BACKGROUND: The prevalence of overweight (15%) and obesity (6%) in children under 5 years of age in Canada are high, and young children with overweight and obesity are at increased risk of the development of chronic disease(s) in adulthood. Prior research has demonstrated very few published trials on effective obesity prevention interventions in young children at risk of obesity, within primary healthcare settings. The aim of this study is to determine if 18-48-month-old children at risk for obesity, who are randomized to receive the Parents Together program (i.e., intervention group), have reduced body mass index z-score (zBMI), compared to those not receiving the intervention, at a 12-month follow-up. Secondary clinical outcomes between the intervention and control groups will be compared at 12 months. METHODS: A pragmatic, parallel group, 1:1, superiority, randomized control trial (RCT) through the TARGetKids! Practice Based Research Network will be conducted. Young children (ages 18-48 months) who are at increased risk for childhood obesity will be invited to participate. Parents who are enrolled in the intervention group will participate in eight weekly group sessions and 4-5 coaching visits, facilitated by a trained public health nurse. Children and parents who are enrolled in the control group will receive the usual health care. The primary outcome will be compared between intervention arms using an analysis of covariance (ANCOVA). Feasibility and acceptability will be assessed by parent focus groups and interviews, and fidelity to the intervention will be measured using nurse-completed checklists. A cost-effectiveness analysis (CEA) will be conducted. DISCUSSION: This study will aim to reflect the social, cultural, and geographic diversity of children in primary care in Toronto, Ontario, represented by an innovative collaboration among applied child health researchers, community health researchers, and primary care providers (i.e., pediatricians and family physicians in three different models of primary care). Clinical and implementation outcomes will be used to inform future research to test this intervention in a larger number, and diverse practices across diverse geographic settings in Ontario. TRIAL REGISTRATION: ClinicalTrials.gov NCT03219697. Registered on June 27, 2017.

Multidisciplinary implementation of family-based treatment delivered by videoconferencing (FBT-V) for adolescent anorexia nervosa during the COVID-19 pandemic.

Family-Based Treatment (FBT)-the most widely supported treatment for pediatric eating disorders-transitioned to virtual delivery in many programs due to COVID-19. Using a blended implementation approach, we systematically examined therapist adherence to key components of FBT and fidelity to FBT by videoconferencing (FBT-V), preliminary patient outcomes, and team experiences with our FBT-V implementation approach as well as familial perceptions of FBT-V effectiveness. We examined our implementation approach across four pediatric eating disorder programs in Ontario, Canada, using mixed methods. Participants included therapists (n = 8), medical practitioners (n = 4), administrators (n = 6), and families (n = 5; 21 family members in total). We developed implementation teams at each site, provided FBT-V training, and offered clinical and implementation consultation. Therapists submitted video recordings of their first four FBT-V sessions for fidelity rating, and patient outcomes. Therapists self-reported readiness, attitudes, confidence, and adherence to FBT-V. Focus groups were conducted with each team and family after the first four sessions of FBT-V. Quantitative data were analyzed using repeated measures ANOVA. Qualitative data were analyzed using directed and summative content analysis. Therapists adhered to key FBT components and maintained FBT-V fidelity. Changes in therapists' readiness, attitudes, and confidence in FBT-V over time were not significant. All patients gained weight. Focus groups revealed implementation facilitators/barriers, positives/negatives surrounding FBT-V training and consultation, suggestions for improvement, and effectiveness attributed to FBT-V. Our implementation approach appeared to be feasible and acceptable. Future research with a larger sample is required, furthering our understanding of this approach and exploring how organizational factors influence treatment fidelity.

We qualitatively and quantitatively examined the initial implementation (the first four sessions) of Family-Based Treatment (FBT) delivered by videoconferencing (FBT-V) during the COVID-19 pandemic using an evidence-based implementation approach. This included developing implementation teams (consisting of a lead therapist, medical practitioner, and program administrator) at each site, providing FBT-V training to all participants, and offering clinical consultation to all participating therapists and implementation consultation to implementation teams. Therapists were required to submit video recordings of their first four FBT-V sessions. Therapist adherence to key components of FBT as well as fidelity to the FBT-V model, team and family experiences with FBT-V, and preliminary patient outcomes (e.g., weight gain) were examined. Our findings suggest that our implementation approach was feasible and acceptable; therapists adhered to key FBT components and maintained FBT-V fidelity, patients gained weight, and teams and families expressed satisfaction with our intervention. Further research is needed with a larger sample and for a longer duration.

Translation and cross-cultural adaptation of the knowledge translation planning template for the brazilian context / Traducción y adaptación intercultural de la plantilla de planificación para la traducción de conocimiento al contexto brasileño / Tradução e adaptação transcultural da ferramenta knowledge translation planning template para o contexto brasileiro

ABSTRACT Objective: to translate, cross-culturally adapt, and validate the content of the Knowledge Translation Planning Template, a research dissemination planning tool, into Brazilian Portuguese. Method: this is a methodological study, sequentially divided into six stages: initial translation, translation synthesis, back-translation, judges' committee, pre-test, and approval of the adapted version by the instrument author. The judge's committee assessed content validity using the modified Kappa and Content Validity Index. The test was conducted with teachers and students from a Federal University of Santa Catarina graduate program. Results: the process of translating and back-translating the tool showed no discrepancies in terms of meaning. The committee was composed of seven judges who carried out semantic, cultural, and conceptual evaluations and made notes on the translation of the content. At this stage, the content validity showed excellent values for the Content Validity Index and modified Kappa, with 0.99 and 0.816, respectively. The tool was tested with 30 teachers and postgraduate students, where 90% of the respondents considered the tool to be sufficiently comprehensive and that all the items were relevant to the purpose of the instrument. In the last stage, the documents were analyzed together with the author of the original tool and the final version was approved. Conclusion: the Modelo de Planejamento de Tradução do Conhecimento results from a careful translation process, cross-cultural adaptation, and tool content validation. This has resulted in a tool that is applicable and understood by the target audience, which shows consistency in the equivalence of translation and cross-cultural adaptation for Brazil.

RESUMEN Objetivo: realizar la traducción, adaptación transcultural y validar el contenido de la Plantilla de Planificación para la Traducción del Conocimiento para el idioma portugués de Brasil. Método: estudio metodológico que siguió seis etapas: traducción inicial, síntesis de la traducción, retrotraducción, comité de expertos, pretest y aprobación de la versión adaptada por la autora de la herramienta. Em el comité de expertos, la validez del contenido se calculó mediante el índice de validez de contenido y el Kappa modificado. El pre-test se realizó con profesores y estudiantes de un programa de postgrado en la Universidad Federal de Santa Catarina. Resultados: el proceso de traducción y retrotraducción de la herramienta no mostró discrepancias en términos de significado. El comité estuvo formado por siete expertos que evaluaron los aspectos semánticos, culturales y conceptuales y realizaron observaciones sobre la traducción del contenido. En esta etapa, la validez de contenido mostró valores excelentes para el Índice de Validez de Contenido y el Kappa modificado, con 0,99 y 0,816 respectivamente. La herramienta se probó con 30 profesores y estudiantes de posgrado, donde el 90% de los encuestados consideraron que la herramienta era lo suficientemente completa y que todos los elementos eran pertinentes para el propósito de la herramienta. En la fase final, se analizaron los documentos junto con la autora de la herramienta original y se aprobó la versión final. Conclusión: el "Modelo de Planejamento de Tradução do Conhecimento" es el resultado de un proceso riguroso de traducción, adaptación transcultural y validación de contenido de la herramienta. El resultado fue una herramienta aplicable y comprensible para el público destinatario, y que muestra coherencia en la equivalencia de la traducción y la adaptación transcultural para Brasil.

RESUMO Objetivo: realizar a tradução, adaptação transcultural e validar o conteúdo da Knowledge Translation Planning Template para língua portuguesa do Brasil. Método: estudo metodológico, que seguiu seis etapas: tradução inicial, síntese da tradução, retrotradução, comitê de juízes, pré-teste e aprovação da versão adaptada pela autora da ferramenta. No comitê de juízes a validade do conteúdo foi calculada por meio do Índice de Validade de Conteúdo e Kappa modificado. O pré-teste foi realizado com docentes e discentes de um programa de pós-graduação da Universidade Federal de Santa Catarina. Resultados: o processo de tradução e retrotradução da ferramenta não apresentou discrepâncias em termos de significado. O comitê foi composto por sete juízes que realizaram avaliação semântica, cultural, conceitual e realizaram apontamentos quanto à tradução do conteúdo. Nesta etapa, a validade de conteúdo apresentou valores excelentes de Índice de Validade de Conteúdo e Kappa modificado, com 0,99 e 0,816 respectivamente. A ferramenta foi testada com 30 docentes e discentes de pós-graduação, onde 90% dos respondentes consideraram a ferramenta suficientemente abrangente, e que todos os itens são relevantes ao propósito da ferramenta. Na última etapa, os documentos foram analisados em conjunto com a autora da ferramenta original e a versão final foi aprovada. Conclusão: o Modelo de Planejamento de Tradução do Conhecimento é resultado de um processo criterioso de tradução, adaptação transcultural e validação de conteúdo da ferramenta. Isso gerou uma ferramenta aplicável e compreendida pelo público-alvo, a qual apresenta consistência na equivalência da tradução e adaptação transcultural para o Brasil.

Change in health outcomes for First Nations children with chronic wet cough: rationale and study protocol for a multi-centre implementation science study.

BACKGROUND: In children, chronic wet cough may be a sign of underlying lung disease, including protracted bacterial bronchitis (PBB) and bronchiectasis. Chronic (> 4 weeks in duration) wet cough (without indicators pointing to alternative causes) that responds to antibiotic treatment is diagnostic of PBB. Timely recognition and management of PBB can prevent disease progression to irreversible bronchiectasis with lifelong consequences. However, detection and management require timely health-seeking by carers and effective management by clinicians. We aim to improve (a) carer health-seeking for chronic wet cough in their child and (b) management of chronic wet cough in children by clinicians. We hypothesise that implementing a culturally integrated program, which is informed by barriers and facilitators identified by carers and health practitioners, will result in improved lung health of First Nations children, and in the future, a reduced the burden of bronchiectasis through the prevention of the progression of protracted bacterial bronchitis to bronchiectasis. METHODS: This study is a multi-centre, pseudorandomised, stepped wedge design. The intervention is the implementation of a program. The program has two components: a knowledge dissemination component and an implementation component. The implementation is adapted to each study site using a combined Aboriginal Participatory Action Research and an Implementation Science approach, guided by the Consolidated Framework of Implementation Research. There are three categories of outcome measures related to (i) health (ii) cost, and (iii) implementation. We will measure health-seeking as the proportion of parents seeking help for their child in a 6-month period before the intervention and the same 6-month period (i.e., the same six calendar months) thereafter. The parent-proxy, Cough-specific Quality of Life (PC-QoL) will be the primary health-related outcome measure. DISCUSSION: We hypothesise that a tailored intervention at each site will result in improved health-seeking for carers of children with a chronic wet cough and improved clinician management of chronic wet cough. In addition, we expect this will result in improved lung health outcomes for children with a chronic wet cough. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry; ACTRN12622000430730 , registered 16 March 2022, Retrospectively registered.

Evaluation of pediatric-specific resources to support utilization of the Wheelchair Skills Training Program by the users of the resources: a descriptive qualitative study.

BACKGROUND: Children's ability to engage in meaningful activities is positively influenced by their ability to move independently. Preliminary evidence in children suggests that wheelchair skills training improves wheelchair skills, which are important for independent mobility. The Wheelchair Skills Training Program is a standardized program to teach wheelchair skills. However, it is underutilized in pediatric rehabilitation settings. To increase its utilization, 3 pediatric-specific Wheelchair Skills Training Program resources related to indoor skills were developed (i.e., a storybook, four instructional posters, and a training workbook). This study aimed to describe occupational therapists' (OTs) and pediatric manual wheelchair users' (PMWUs) perceived satisfaction with the storybook, instructional posters and training workbook, and to explore their perceptions regarding the usability, relevance, and feasibility of these resources in pediatric rehabilitation settings. METHODS: A descriptive qualitative design was used. Convenience samples of OTs and PMWUs were recruited in a rehabilitation center and affiliated schools. A focus group with OTs and semi-structured interviews with PMWUs were conducted by videoconference to obtain participants' feedback on the resource prototypes and suggestions for improvement. Data were deductively analyzed using the Framework method. RESULTS: Eight OTs and 5 PMWUs expressed general satisfaction with the resources, describing them as usable, relevant, and feasible to integrate into wheelchair skills training with novice wheelchair users and younger children. All OTs and 3 PMWUs expressed the desire to use the resources for wheelchair skills training. Two PMWUs perceived the resources were not relevant to them because they already mastered the skills. The participants suggested minor modifications for improving the resources (e.g., more action in the story, increased precision of illustrations related to the characters' position in the wheelchair). CONCLUSION: OTs and PMWUs were satisfied with the resources, perceiving them to be applicable for training wheelchair skills among young children and novice wheelchair users. The resources represent a concrete solution to facilitate the use of the Wheelchair Skills Training Program in pediatric rehabilitation settings. Additional resources are needed to better reach older and more experienced PMWUs (i.e., of intermediate and advanced skill levels).

A qualitative evaluation of team and family perceptions of family-based treatment delivered by videoconferencing (FBT-V) for adolescent Anorexia Nervosa during the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, outpatient eating disorder care, including Family-Based Treatment (FBT), rapidly transitioned from in-person to virtual delivery in many programs. This paper reports on the experiences of teams and families with FBT delivered by videoconferencing (FBT-V) who were part of a larger implementation study. METHODS: Four pediatric eating disorder programs in Ontario, Canada, including their therapists (n = 8), medical practitioners (n = 4), administrators (n = 6), and families (n = 5), participated in our study. We provided FBT-V training and delivered clinical consultation. Therapists recorded and submitted their first four FBT-V sessions. Focus groups were conducted with teams and families at each site after the first four FBT-V sessions. Focus group transcripts were transcribed verbatim and key concepts were identified through line-by-line reading and categorizing of the text. All transcripts were double-coded. Focus group data were analyzed using directed and summative qualitative content analysis. RESULTS: Analysis of focus group data from teams and families revealed four overarching categories-pros of FBT-V, cons of FBT-V, FBT-V process, and suggestions for enhancing and improving FBT-V. Pros included being able to treat more patients and developing a better understanding of family dynamics by being virtually invited into the family's home (identified by teams), as well as convenience and comfort (identified by families). Both teams and families recognized technical difficulties as a potential con of FBT-V, yet teams also commented on distractions in family homes as a con, while families expressed difficulties in developing therapeutic rapport. Regarding FBT-V process, teams and families discussed the importance and challenge of patient weighing at home. In terms of suggestions for improvement, teams proposed assessing a family's suitability or motivation for FBT-V to ensure it would be appropriate, while families strongly suggested implementing hybrid models of FBT in the future which would include some in-person and some virtual sessions. CONCLUSION: Team and family perceptions of FBT-V were generally positive, indicating acceptability and feasibility of this treatment. Suggestions for improved FBT-V practices were made by both groups, and require future investigation, such as examining hybrid models of FBT that involve in-person and virtual elements. Trial registration ClinicalTrials.gov NCT04678843 .

Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial.

BACKGROUND: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there are no Level 1 evidence-based interventions to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the clinical and implementation effectiveness of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. METHODS: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0-17.5 years. The intervention program consists of 4 core components: (1) individualized assessment, (2) transition navigator, (3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and (4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness and success, anxiety and depression scales, and health service utilization rates. Additionally, we will measure implementation outcomes and related barriers and facilitators for the intervention program. DISCUSSION: The type 1 hybrid effectiveness-implementation design will allow for the development of a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will allow centralization of interventions and funding in order to minimize the impact on local clinical practice or hospital resources. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach. TRIAL REGISTRATION: NCT05221281. Registry: ClinicalTrials.gov. Date of registration: February 2, 2022. https://clinicaltrials.gov/ct2/show/NCT05221281 .

Implementation of a strategy to facilitate effective medical follow-up for Australian First Nations children hospitalised with lower respiratory tract infections: study protocol.

BACKGROUND: First Nations children hospitalised with acute lower respiratory infections (ALRIs) are at increased risk of future bronchiectasis (up to 15-19%) within 24-months post-hospitalisation. An identified predictive factor is persistent wet cough a month after hospitalisation and this is likely related to protracted bacterial bronchitis which can progress to bronchiectasis, if untreated. Thus, screening for, and optimally managing, persistent wet cough one-month post-hospitalisation potentially prevents bronchiectasis in First Nations' children. Our study aims to improve the post-hospitalisation medical follow-up for First Nations children hospitalised with ALRIs and thus lead to improved respiratory health. We hypothesize that implementation of a strategy, conducted in a culturally secure manner, that is informed by barriers and facilitators identified by both parents and health care providers, will improve medical follow-up and management of First Nations children hospitalized with ALRIs. METHODS: Our trial is a multi-centre, pseudo-randomized stepped wedge design where the implementation of the strategy is tailored for each study site through a combined Participatory Action Research and implementation science approach informed by the Consolidated Framework of Implementation Research. Outcome measures will consist of three categories related to (i) health, (ii) economics and (iii) implementation. The primary outcome measure will be Cough-specific Quality of Life (PC-QoL). Outcomes will be measures at each study site/cluster in three different stages i.e., (i) nil-intervention control group, (ii) health information only control group and (iii) post-intervention group. DISCUSSION: If our hypothesis is correct, our study findings will translate to improved health outcomes (cough related quality of life) in children who have persistent wet cough a month after hospitalization for an ALRI. Trial registration ACTRN12622000224729, prospectively registered 8 February 2022, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382886&isReview=true .

Managing Obesity in Young Children: A Multiple Methods Study Assessing Feasibility, Acceptability, and Implementation of a Multicomponent, Family-Based Intervention.

Background: We developed a multicomponent, family-based intervention for young children with obesity consisting of parent group sessions, home nursing visits, and multidisciplinary clinical encounters. Our objective was to assess intervention feasibility, acceptability, and implementation. Methods: From 2017 to 2020, we conducted a multiple methods study in the obesity management clinic at a tertiary children's hospital (Toronto, Canada). We included 1-6 year olds with a body mass index ≥97th percentile and their parents; we also included health care providers (HCPs) who delivered the intervention. To assess feasibility, we performed a pilot randomized controlled trial (RCT) comparing the intervention to usual care. To explore acceptability, we conducted parent focus groups. To explore implementation, we examined contextual factors with HCPs using the Consolidated Framework for Implementation Research. Results: There was a high level of ineligibility (n = 34/61) for the pilot RCT. Over 21 months, 11 parent-child dyads were recruited; of 6 randomized to the intervention, 3 did not participate in group sessions or home visits. In focus groups, themes identified by parents (n = 8) related to information provided at referral; fit between the intervention and patient needs; parental gains from participating in the intervention; and feasibility of group sessions. HCPs (n = 10) identified contextual factors that were positively and negatively associated with intervention implementation. Conclusions: We encountered challenges related to intervention feasibility, acceptability, and implementation. Lessons learned from this study will inform the next iteration of our intervention and are relevant to intervention development and implementation for young children with obesity. Clinical Trial Registration number: NCT03219658.

The quick pivot: Capturing real world modifications for the re-implementation of an early psychosis program transitioning to virtual delivery.

Background: Team-based Early Psychosis Intervention (EPI) services is standard of care for youth with psychosis. The COVID-19 pandemic required most EPI services to mount an unplanned, rapid pivot to virtual delivery, with limited guidance on how to deliver virtual clinical services or whether quality of re-implementation and treatment outcomes would be impacted. We used a structured approach to identify essential modifications for the delivery of core components and explored facilitators and barriers for re-implementation and fidelity of a virtually delivered EPI intervention. Materials and methods: NAVIGATE is a structured approach to team-based EPI. It provides detailed modules to guide delivery of core components including medication management, psychoeducation and psychotherapies, supported employment/education, and family education. Having initially implemented NAVIGATE at the Centre for Addiction and Mental Health (CAMH) in 2017, the EPI service transitioned to virtual delivery amid the COVID pandemic. Using a practice profile developed to support implementation, we detailed how core components of NAVIGATE were rapidly modified for virtual delivery as reported in structured group meetings with clinicians. The Framework for Reporting Adaptations and Modifications for Evidence-Based Interventions (FRAME) was used to describe modifications. Fidelity to the EPI standards of care was assessed by the First Episode Psychosis Fidelity Scale (FEPS-FS). Re-implementation barriers and facilitators and subsequent mitigation strategies were explored using structured clinician interviews guided by the Consolidated Framework for Implementation Research (CFIR). Results: Identified modifications related to the intervention process, context, and training. We identified contextual factors affecting the re-implementation of virtually delivered NAVIGATE and then documented mitigating strategies that addressed these barriers. Findings can inform the implementation of virtual EPI services elsewhere, including guidance on processes, training and technology, and approaches to providing care virtually. Discussion: This study identified modifications, impacts and mitigations to barriers emerging from rapid, unplanned virtual delivery of EPI services. These findings can support delivery of high-quality virtual services to youth with psychosis when virtual care is indicated.

Adapting Evidence-Based Early Psychosis Intervention Services for Virtual Delivery: Protocol for a Pragmatic Mixed Methods Implementation and Evaluation Study.

BACKGROUND: Timely and comprehensive treatment in the form of early psychosis intervention (EPI) has become the standard of care for youth with psychosis. While EPI services were designed to be delivered in person, the COVID-19 pandemic required many EPI programs to rapidly transition to virtual delivery, with little evidence to guide intervention adaptations or to support the effectiveness and satisfaction with virtual EPI services. OBJECTIVE: This study aims to explore the adaptations required to deliver NAVIGATE, a model of coordinated specialty care used in EPI, in a virtual format. This study will evaluate implementation of the NAVIGATE model delivered virtually by describing the nature of the adaptations to the intervention, assessing fidelity to the EPI model and the satisfaction of clients, family members, and care providers. We will investigate barriers and facilitators to virtual NAVIGATE implementation, service engagement, and health equity impacts of this work. METHODS: The Centre for Addiction and Mental Health (Toronto, Ontario, Canada) transitioned to delivering NAVIGATE virtually early in the COVID-19 pandemic. The Framework for Reporting Adaptations and Modifications for Evidence-Based Interventions will be used to describe the adaptations required to deliver NAVIGATE virtually. Fidelity to the EPI model will be measured using the First Episode Psychosis Services Fidelity Scale and fidelity to NAVIGATE will be assessed by investigating adherence to its core components. Implementation facilitators and barriers will be explored using semistructured interviews with providers informed by the Consolidated Framework for Implementation Research. Satisfaction with virtually delivered NAVIGATE will be assessed with virtual client and provider experience surveys and qualitative interviews with clients, family members, and providers. Service engagement data will be collected through review of medical records, and potential impacts of virtually delivered NAVIGATE on different population groups will be assessed with the Health Equity Impact Assessment. RESULTS: Virtual clinical delivery of NAVIGATE started in March 2020 with additional adaptations and data collection is ongoing. Data will be analyzed using descriptive statistics and survival analysis for quantitative data. Qualitative data will be analyzed using thematic content analysis. Integration of qualitative and quantitative data will occur at the data collection, interpretation, and reporting levels following a convergent design. CONCLUSIONS: This study will provide information regarding the type of intervention adaptations required for virtual delivery of NAVIGATE for youth with early psychosis, ensuring access to high-quality care for this population during the pandemic and beyond by guiding future implementation in similar contexts. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34591.

Creation of an electronic patient-reported outcome measure platform Voxe: a mixed methods study protocol in paediatric solid organ transplantation.

INTRODUCTION: Patient-reported outcome measures (PROMs) provide an opportunity for meaningful patient engagement and shared decision-making. The objective of this research programme is to improve health outcomes for paediatric solid organ transplant patients by implementing PROMs into clinical care. The current study aims to create Voxe, a paediatric user-centred electronic PROM platform, by engaging patients and healthcare providers throughout the design and development process. METHODS AND ANALYSIS: The creation of Voxe will occur over two phases that build on previous research. The user interface design phase employs a 'user-centric' approach to identify end-users' needs and iteratively refine the look and layout of Voxe to meet these needs. Transplant recipients, aged 10-17, and healthcare providers will participate in three rounds of testing (24 participants total). Participants will: (1) complete task-based activities (outcomes-effectiveness and efficiency), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. The following phase involves software development and Voxe usability testing. Transplant recipients, aged 8-17, and healthcare providers will participate in four rounds of iterative testing (24-40 participants total). The think-aloud technique will be employed, and participants will describe their thoughts and feelings while interacting with a Voxe prototype. Participants will: (1) log into Voxe and complete tasks (outcomes-time on task, successful task completion, frequency of critical and non-critical errors and error-free rate), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. Findings will result in the creation and launch of a user-centred electronic PROM platform. ETHICS AND DISSEMINATION: Research ethics board approval has been provided by The Hospital for Sick Children. This research is critical to answering methodological and operational questions to inform Voxe implementation in paediatric clinical settings and facilitate PROM data collection. Future investigations will include an implementation-effectiveness evaluation.

Exploration of Barriers and Facilitators to Implementing Best Practice in Exercise Medicine in Primary Pediatric Care-Pediatrician Perspectives.

PURPOSE: Despite the known health benefits of physical activity (PA), few primary care pediatricians discuss, evaluate, or prescribe PA for children. The goal of this study was to examine pediatricians' thoughts and practices related to child PA and the perceived facilitators and barriers to implementing PA evaluation and prescription in pediatric primary care clinics. METHODS: The Consolidated Framework for Implementation Research was used to explore implementation barriers and facilitators. A mixed-method design combined questionnaires and focus groups with 27 pediatricians. RESULTS: Despite the pediatricians' beliefs that PA is important for patients, there was wide practice variability in their approaches to discussing PA. Several perceived barriers to implementing PA evaluation and prescription were identified, including lack of knowledge and training, managing time for PA with multiple demands, the need for a team approach and simple PA tools and resources, support for patient tailoring of PA messaging, and a need for PA best practice champions. CONCLUSION: The identified barriers to implementing evidence in PA suggest several directions for improvement, including a care-team approach; quick, inexpensive, and simple PA tools; community PA partnerships; PA training in medical education; evidence-based strategies; and PA directories for families. These efforts could facilitate the implementation of PA best practices in pediatrics.