Browsing by Author "Mrklas, Kelly"
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Item Open Access A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol(2022-06-29) Pritchard-Wiart, Lesley; Thompson-Hodgetts, Sandy; McKillop, Ashley B.; Rosychuk, Rhonda; Mrklas, Kelly; Zwaigenbaum, Lonnie; Zwicker, Jennifer; Andersen, John; King, Gillian; Firouzeh, PegahAbstract Background Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to therapy, and service delivery efficiency. The primary objective of this trial is to determine the effectiveness of a principles-driven, child-focused approach to goal-setting, Enhancing Child Engagement in Goal-Setting (ENGAGE), on pediatric rehabilitation outcomes compared to usual practice. The three secondary objectives are to 1) compare costs and secondary outcomes of the ENGAGE approach to usual practice, 2) determine the influence of child, parent and therapist characteristics on child engagement in therapy and rehabilitation outcomes, and 3) identify barriers and facilitators to the implementation of ENGAGE. Methods This research protocol describes a pragmatic, multi-site, cluster, effectiveness-implementation (hybrid type 1 design) randomized controlled trial. Therapists (n = 12 clusters of two therapists) at participating sites (n = 6) will be randomized to 1) the ENGAGE intervention group, or 2) usual care (control) using a computer-generated, permuted-block randomization sequence with site as a stratification variable designed by a statistician (RR). Each therapist will recruit four children 5–12 years old with neurodevelopmental conditions (n = 96), who will receive ENGAGE or usual care, according to therapist group allocation. ENGAGE therapists will be trained to use a 'toolbox' of evidence-driven, theory-informed principles to optimize child and parent motivation, engagement in the goal-setting process, and performance feedback strategies. Outcomes include goal performance (primary outcome), engagement in therapy, functional abilities, participation, and parent and child quality of life. Qualitative interviews with children, parents, ENGAGE therapists, and managers will explore challenges to implementation and potential mitigation strategies. Mixed effects multiple linear regression models will be developed for each outcome to assess group differences adjusted for clustering. A cost-effectiveness analysis will combine cost and a measure of effectiveness into an incremental cost-effectiveness ratio. Qualitative data on implementation will be analyzed inductively (thematic analysis) and deductively using established implementation science frameworks. Discussion This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal-setting practices. Trial Registration NCT05017363 (registered August 23, 2021 on ClinicalTrials.gov).Item Open Access Advancing Concussion Assessment in Pediatrics (A-CAP): a prospective, concurrent cohort, longitudinal study of mild traumatic brain injury in children: protocol study(BMJ, 2017-07-01) Yeates, Keith O.; Beauchamp, Miriam; Craig, William; Doan, Quynh; Zemek, Roger; Bjornson, Bruce H.; Gravel, Jocelyn; Mikrogianakis, Angelo; Goodyear, Bradley; Abdeen, Nishard; Beaulieu, Christian; Dehaes, Mathieu; Deschenes, Sylvain; Harris, Ashley D.; Lebel, Catherine; Lamont, Ryan; Williamson, Tyler; Barlow, Karen M.; Bernier, Francois; Brooks, Brian L.; Emery, Carolyn; Freedman, Stephen B.; Kowalski, Kristina; Mrklas, Kelly; Tomfohr-Madsen, Lianne; Schneider, Kathryn J.Introduction Paediatric mild traumatic brain injury (mTBI) is a public health burden. Clinicians urgently need evidence-based guidance to manage mTBI, but gold standards for diagnosing and predicting the outcomes of mTBI are lacking. The objective of the Advancing Concussion Assessment in Pediatrics (A-CAP) study is to assess a broad pool of neurobiological and psychosocial markers to examine associations with postinjury outcomes in a large sample of children with either mTBI or orthopaedic injury (OI), with the goal of improving the diagnosis and prognostication of outcomes of paediatric mTBI. Methods and analysis A-CAP is a prospective, longitudinal cohort study of children aged 8.00-16.99 years with either mTBI or OI, recruited during acute emergency department (ED) visits at five sites from the Pediatric Emergency Research Canada network. Injury information is collected in the ED; follow-up assessments at 10 days and 3 and 6 months postinjury measure a variety of neurobiological and psychosocial markers, covariates/confounders and outcomes. Weekly postconcussive symptom ratings are obtained electronically. Recruitment began in September 2016 and will occur for approximately 24 months. Analyses will test the major hypotheses that neurobiological and psychosocial markers can: (1) differentiate mTBI from OI and (2) predict outcomes of mTBI. Models initially will focus within domains (eg, genes, imaging biomarkers, psychosocial markers), followed by multivariable modelling across domains. The planned sample size (700 mTBI, 300 OI) provides adequate statistical power and allows for internal cross-validation of some analyses. Ethics and dissemination The ethics boards at all participating institutions have approved the study and all participants and their parents will provide informed consent or assent. Dissemination will follow an integrated knowledge translation plan, with study findings presented at scientific conferences and in multiple manuscripts in peer-reviewed journals.Item Open Access Contextual factors and mechanisms that influence sustainability: a realist evaluation of two scaled, multi-component interventions(2021-11-04) Flynn, Rachel; Mrklas, Kelly; Campbell, Alyson; Wasylak, Tracy; Scott, Shannon D.Abstract Background In 2012, Alberta Health Services created Strategic Clinical NetworksTM (SCNs) to develop and implement evidence-informed, clinician-led and team-delivered health system improvement in Alberta, Canada. SCNs have had several provincial successes in improving health outcomes. Little research has been done on the sustainability of these evidence-based implementation efforts. Methods We conducted a qualitative realist evaluation using a case study approach to identify and explain the contextual factors and mechanisms perceived to influence the sustainability of two provincial SCN evidence-based interventions, a delirium intervention for Critical Care and an Appropriate Use of Antipsychotics (AUA) intervention for Senior’s Health. The context (C) + mechanism (M) = outcome (O) configurations (CMOcs) heuristic guided our research. Results We conducted thirty realist interviews in two cases and found four important strategies that facilitated sustainability: Learning collaboratives, audit & feedback, the informal leadership role, and patient stories. These strategies triggered certain mechanisms such as sense-making, understanding value and impact of the intervention, empowerment, and motivation that increased the likelihood of sustainability. For example, informal leaders were often hands-on and influential to front-line staff. Learning collaboratives broke down professional and organizational silos and encouraged collective sharing and learning, motivating participants to continue with the intervention. Continual audit-feedback interventions motivated participants to want to perform and improve on a long-term basis, increasing the likelihood of sustainability of the two multi-component interventions. Patient stories demonstrated the interventions’ impact on patient outcomes, motivating staff to want to continue doing the intervention, and increasing the likelihood of its sustainability. Conclusions This research contributes to the field of implementation science, providing evidence on key strategies for sustainability and the underlying causal mechanisms of these strategies that increases the likelihood of sustainability. Identifying causal mechanisms provides evidence on the processes by which implementation strategies operate and lead to sustainability. Future work is needed to evaluate the impact of informal leadership, learning collaboratives, audit-feedback, and patient stories as strategies for sustainability, to generate better guidance on planning sustainable improvements with long term impact.Item Open Access Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial(2020-03-19) Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, AbhayAfter publication of our article [1], the authors have reported mathematical errors made in the sample size calculation for this cluster randomized controlled trial (cRCT) (Benzies et al. 2017).Item Open Access Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial(2017-10-10) Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, AbhayAbstract Background Every year, about 15 million of the world’s infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [320/7] to 336/7 weeks) and late preterm (340/7 to 366/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. Methods We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. Discussion Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. Trial registration ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.Item Open Access How do stakeholders from multiple hierarchical levels of a large provincial health system define engagement? A qualitative study(2017-08-01) Norris, Jill M; White, Deborah E; Nowell, Lorelli; Mrklas, Kelly; Stelfox, Henry TAbstract Background Engaging stakeholders from varied organizational levels is essential to successful healthcare quality improvement. However, engagement has been hard to achieve and to measure across diverse stakeholders. Further, current implementation science models provide little clarity about what engagement means, despite its importance. The aim of this study was to understand how stakeholders of healthcare improvement initiatives defined engagement. Methods Participants (n = 86) in this qualitative thematic study were purposively sampled for individual interviews. Participants included leaders, core members, frontline clinicians, support personnel, and other stakeholders of Strategic Clinical Networks in Alberta Health Services, a Canadian provincial health system with over 108,000 employees. We used an iterative thematic approach to analyze participants’ responses to the question, “How do you define engagement?” Results Regardless of their organizational role, participants defined engagement through three interrelated themes. First, engagement was active participation from willing and committed stakeholders, with levels that ranged from information sharing to full decision-making. Second, engagement centered on a shared decision-making process about meaningful change for everyone “around the table,” those who are most impacted. Third, engagement was two-way interactions that began early in the change process, where exchanges were respectful and all stakeholders felt heard and understood. Conclusions This study highlights the commonalities of how stakeholders in a large healthcare system defined engagement—a shared understanding and terminology—to guide and improve stakeholder engagement. Overall, engagement was an active and committed decision-making about a meaningful problem through respectful interactions and dialog where everyone’s voice is considered. Our results may be used in conjunction with current implementation models to provide clarity about what engagement means and how to engage various stakeholders.Item Open Access Impact of an addiction medicine consult team intervention in a Canadian inner city hospital on acute care utilization: a pragmatic quasi-experimental study(2022-03-12) Salvalaggio, Ginetta; Dong, Kathryn A.; Hyshka, Elaine; McCabe, Christopher; Nixon, Lara; Rosychuk, Rhonda J.; Dmitrienko, Klaudia; Krajnak, Judith; Mrklas, Kelly; Wild, T. C.Abstract Background Inner city patients have a higher illness burden and need for care, but experience more unmet care needs. Hospital Addiction Medicine Consult Teams (AMCTs) are a promising emerging intervention. The objective of this study was to assess the impact of a Canadian AMCT-like intervention for inner city patients on reduction in high emergency department (ED) use, hospital admission, and inpatient length of stay. Methods Using a community-engaged, two-arm, pre-post, longitudinal quasi-experimental study design, 572 patients reporting active substance use, unstable housing, unstable income, or a combination thereof (302 at intervention site, 270 at control sites) were enrolled. Survey and administrative health service data were collected at baseline, six months post-enrolment, and 12 months post-enrolment. Multivariable regression models tested the intervention effect, adjusting for clinically important covariables (inpatient status at enrolment, medical complexity, age, gender, Indigenous identity, shelter use, opioid use). Results Initial bivariable analyses demonstrated an intervention effect on reduction in admissions and length of stay, however, this effect was no longer significant after adjusting for covariables. There was no evidence of reduction in high ED use on either bivariable or subsequent multivariable analysis. Conclusions After adjusting for covariables, no AMCT intervention effect was detected for reduction in high ED use, inpatient admission, or hospital length of stay. Further research is recommended to assess other patient-oriented intervention outcomes.Item Open Access Randomized controlled pilot trial of supportive text messages for patients with depression(2017-08-02) Agyapong, Vincent I O; Juhás, Michal; Ohinmaa, Arto; Omeje, Joy; Mrklas, Kelly; Suen, Victoria Y M; Dursun, Serdar M; Greenshaw, Andrew JAbstract Background Depression is projected to be the primary cause of disability worldwide by 2030. In a recent survey, the most commonly cited unmet need among 42.4% of depressed Albertans was the lack of sufficient, accessible, and affordable counselling. Our aim was to test the efficacy of a supportive text messaging mobile health intervention in improving treatment outcomes in depressed patients. Methods We performed a single-rater-blinded randomized trial involving 73 patients with Major Depressive Disorder. Patients in the intervention group (n = 35) received twice-daily supportive text messages for 3 months while those in the control group (n = 38) received a single text message every fortnight thanking them for participating in the study. The primary outcome of this study was: “Mean changes in the BDI scores from baseline“. Results After adjusting for baseline BDI scores, a significant difference remained in the 3 month mean BDI scores between the intervention and control groups: (20.8 (SD = 11.7) vs. 24.9 (SD = 11.5), F (1, 60) = 4.83, p = 0.03, ηp2 = 0.07). The mean difference in the BDI scores change was significant with an effect size (Cohen’s d) of 0.67. Furthermore, after adjusting for baseline scores, a significant difference remained in the 3 month mean self-rated VAS scores (EQ-5D-5 L scale) between the intervention and control groups, 65.7 (SD = 15.3) vs. 57.4 (SD = 22.9), F (1, 60) =4.16, p = 0.05, ηp2 = 0.065. The mean difference in change mean self-rated VAS scores was also statistically significant with an effect size (Cohen’s d) of 0.51. Conclusions Our findings suggest that supportive text messages are a potentially useful psychological intervention for depression, especially in underserved populations. Further studies are needed to explore the implications of our findings in larger clinical samples. Trial registration ClinicalTrials.gov NCT02327858 . Registered 24 December 2014.Item Open Access Towards the Development of Valid, Reliable, and Acceptable Tools for Assessing the Outcomes and Impacts of Health Research Partnerships(2022-07-05) Mrklas, Kelly; Hill, Michael D; Graham, Ian D; Raffin Bouchal, Shelley; Tonelli, Marcello; Job McIntosh, Christiane; Lockwood, CraigBackground Researchers and their partners need access to high quality assessment tools to demonstrate the tangible outcomes and impacts of their work. As health research partnership approaches grow in popularity and mandated use, so too will the demand for tools to systematically measure their effects. This thesis surveyed literature spanning partnership traditions to locate and examine the globally available tools for assessing health research partnership outcomes and impacts. It systematically identified and assessed tools and tool characteristics (conceptual, psychometric, pragmatic), terminology, use of theories, models and frameworks, and examined the nature of outcomes and impacts arising from studies using tools with known characteristics. Methods We searched four electronic databases (Ovid MEDLINE, Embase, CINAHL+, PsychINFO) from inception to June 2021 without limits, and guided by an a priori protocol and search strategy. We retained studies involving a health research partnership, the development, use, and/or assessment of tools to evaluate partnership outcomes and impacts as a study aim, studies that reported empirical psychometric evidence (manuscript 2), and those with explicit conceptual foundations, empirical psychometric evidence, and pragmatic characteristics (manuscript 3). Study quality was assessed in both systematic reviews. Results Of 56123 total citations, we screened 36027 de-duplicated records, yielding 2784 full text records, ultimately retaining 169, 49, and 37 eligible studies, respectively. Studies were largely North America-centric, and published in English, after 2010. The tools we located were mostly bespoke (205); few had distinguishing conceptual, psychometric, and pragmatic features (58). The research revealed persistent measurement challenges across partnership traditions, including non-standard terminology, inconsistent reporting and use of term definitions, insufficient psychometric/pragmatic tools and a lack of quantitative methods and deliberate focus on tool development, testing, and use, among others. As compared with other historical reviews, very few of the identified studies and tools overlapped; yet the key messages regarding the need to evolve measurement and tool development were the same. Conclusions Dedicated, collaborative efforts among research partnership traditions are required to coordinate the advancement of partnership measurement and science, and to tackle complex outcomes and impacts measurement challenges in this rapidly expanding research field.Item Open Access Trainee-led research using an integrated knowledge translation or other research partnership approaches: a scoping reviews(2021-11-02) Cassidy, Christine E.; Shin, Hwayeon D.; Ramage, Emily; Conway, Aislinn; Mrklas, Kelly; Laur, Celia; Beck, Amy; Varin, Melissa D.; Steinwender, Sandy; Nguyen, Tram; Langley, Jodi; Dorey, Rachel; Donnelly, Lauren; Ormel, IljaAbstract Background There are increasing expectations for researchers and knowledge users in the health system to use a research partnership approach, such as integrated knowledge translation, to increase the relevance and use of research findings in health practice, programmes and policies. However, little is known about how health research trainees engage in research partnership approaches such as IKT. In response, the purpose of this scoping review was to map and characterize the evidence related to using an IKT or other research partnership approach from the perspective of health research trainees in thesis and/or postdoctoral work. Methods We conducted this scoping review following the Joanna Briggs Institute methodology and Arksey and O’Malley’s framework. We searched the following databases in June 2020: MEDLINE, Embase, CINAHL and PsycINFO. We also searched sources of unpublished studies and grey literature. We reported our findings in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Results We included 74 records that described trainees’ experiences using an IKT or other research partnership approach to health research. The majority of studies involved collaboration with knowledge users in the research question development, recruitment and data collection stages of the research process. Intersecting barriers to IKT or other research partnerships at the individual, interpersonal and organizational levels were reported, including lack of skills in partnership research, competing priorities and trainees’ “outsider” status. We also identified studies that evaluated their IKT approach and reported impacts on partnership formation, such as valuing different perspectives, and enhanced relevance of research. Conclusion Our review provides insights for trainees interested in IKT or other research partnership approaches and offers guidance on how to apply an IKT approach to their research. The review findings can serve as a basis for future reviews and primary research focused on IKT principles, strategies and evaluation. The findings can also inform IKT training efforts such as guideline development and academic programme development.