A data-driven approach to implementing the HPTN 094 complex intervention INTEGRA in local communities.

BACKGROUND: HIV burden in the US among people who inject drugs (PWID) is driven by overlapping syndemic factors such as co-occurring health needs and environmental factors that synergize to produce worse health outcomes among PWID. This includes stigma, poverty, and limited healthcare access (e.g. medication to treat/prevent HIV and for opioid use disorder [MOUD]). Health services to address these complex needs, when they exist, are rarely located in proximity to each other or to the PWID who need them. Given the shifting drug use landscapes and geographic heterogeneity in the US, we evaluate a data-driven approach to guide the delivery of such services to PWID in local communities. METHODS: We used a hybrid, type I, embedded, mixed method, data-driven approach to identify and characterize viable implementation neighborhoods for the HPTN 094 complex intervention, delivering integrated MOUD and HIV treatment/prevention through a mobile unit to PWID across five US cities. Applying the PRISM framework, we triangulated geographic and observational pre-implementation phase data (epidemiological overdose and HIV surveillance data) with two years of implementation phase data (weekly ecological assessments, study protocol meetings) to characterize environmental factors that affected the viability of implementation neighborhoods over time and across diverse settings. RESULTS: Neighborhood-level drug use and geographic diversity alongside shifting socio-political factors (policing, surveillance, gentrification) differentially affected the utility of epidemiological data in identifying viable implementation neighborhoods across sites. In sites where PWID are more geographically dispersed, proximity to structural factors such as public transportation and spaces where PWID reside played a role in determining suitable implementation sites. The utility of leveraging additional data from local overdose and housing response systems to identify viable implementation neighborhoods was mixed. CONCLUSIONS: Our findings suggest that data-driven approaches provide a contextually relevant pragmatic strategy to guide the real-time implementation of integrated care models to better meet the needs of PWID and help inform the scale-up of such complex interventions. This work highlights the utility of implementation science methods that attend to the impact of local community environmental factors on the implementation of complex interventions to PWID across diverse drug use, sociopolitical, and geographic landscapes in the US. TRIAL REGISTRATION: ClincalTrials.gov, Registration Number: NCT04804072 . Registered 18 February 2021.

Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians' perceived barriers and facilitators.

BACKGROUND: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. RESULTS: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. CONCLUSIONS: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.

Pressure Injury Prevention in Adult Critically Ill Patients: A Best Practice Implementation Project.

Implementation science is the process of integrating an intervention into practice within an organization or health system and is a useful strategy to improve practice, affect patient outcomes, and promote practice sustainability. In this series, AJN and the journal JBI Evidence Implementation have partnered to deliver examples of how health care facilities from around the world have worked to solve common patient care problems. Through this partnership, we strive to create awareness and share knowledge and experiences by publishing summaries of studies that have appeared in JBI Evidence Implementation. These summaries are designed to provide nursing teams with an overview of the barriers faced and the strategies and resources needed to improve practice and drive change at the unit level. Our goal is to ensure that AJN readers have access to important evidence-based information designed to influence patient outcomes and nursing practice.-Carl A. Kirton, DNP, MBA, RN, ANP, FAAN.

The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial.

BACKGROUND: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. METHODS: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. DISCUSSION: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.

Supporting Implementation Through Online Learning Communities: Lessons Learned From a National Training and Technical Assistance Network.

Recent implementation science frameworks highlight the role of training and technical assistance (TTA) in building workforce capacity to implement evidence-based practices (EBPs). However, evaluation of TTA is limited. We describe three case examples that highlight TTA by three regional centers in the national Mental Health Technology Transfer Center (MHTTC) network. Each MHTTC formed Learning Communities (LCs) to facilitate connections among behavioral health professionals with the goals of sharing implementation strategies, discussing best-practices, and developing problem solving techniques. Data on outcomes were collected through a combination of self-report surveys and qualitative interviews. LC participants reported strong connectedness, gains in knowledge and skills, improvements in implementation capacity, and intentions to advocate for organizational and systems-level change. Furthermore, across the case examples, we identified LC characteristics that are associated with participant perceptions of outcomes, including tailoring LC content to workforce needs, providing culturally relevant information, engaging leaders, forming connections among participants and trainers, and challenging participants' current workplace practices. These findings are interpreted through the lens of the Interactive Systems Framework, which focuses on how TTA, such as LCs, can facilitate connections between the theoretical and empirical foundations of interventions and the practices of implementing interventions in real-world settings to advance workforce capacity.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

BACKGROUND: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

Implementation science in humanitarian assistance: applying a novel approach for humanitarian care optimization.

Humanitarian assistance is hindered by a lack of strategies to optimize care delivery through research and organized networks. Distinct from global health, humanitarian assistance struggles to address its multifaceted challenges, including duplicative resources, uncoordinated communication, unregulated staff expertise and safety, financial waste, and poor-quality metrics and care delivery. Implementation science provides an exciting and underutilized approach that can be applied to address these challenges, by studying how to effectively design, implement, optimize, and scale evidence-based interventions. Though successful in well-resourced and global health systems, implementation science approaches are rare in humanitarian assistance. Adopting implementation science approaches including identifying determinants, creating accessible evidence-based intervention bundles, adapting study methodologies for the humanitarian context, and partnering with implementation experts could make these promising approaches more accessible for thousands of humanitarian actors delivering healthcare for millions of vulnerable patients worldwide.

Exploring the content and delivery of feedback facilitation co-interventions: a systematic review.

BACKGROUND: Policymakers and researchers recommend supporting the capabilities of feedback recipients to increase the quality of care. There are different ways to support capabilities. We aimed to describe the content and delivery of feedback facilitation interventions delivered alongside audit and feedback within randomised controlled trials. METHODS: We included papers describing feedback facilitation identified by the latest Cochrane review of audit and feedback. The piloted extraction proforma was based upon a framework to describe intervention content, with additional prompts relating to the identification of influences, selection of improvement actions and consideration of priorities and implications. We describe the content and delivery graphically, statistically and narratively. RESULTS: We reviewed 146 papers describing 104 feedback facilitation interventions. Across included studies, feedback facilitation contained 26 different implementation strategies. There was a median of three implementation strategies per intervention and evidence that the number of strategies per intervention is increasing. Theory was used in 35 trials, although the precise role of theory was poorly described. Ten studies provided a logic model and six of these described their mechanisms of action. Both the exploration of influences and the selection of improvement actions were described in 46 of the feedback facilitation interventions; we describe who undertook this tailoring work. Exploring dose, there was large variation in duration (15-1800 min), frequency (1 to 42 times) and number of recipients per site (1 to 135). There were important gaps in reporting, but some evidence that reporting is improving over time. CONCLUSIONS: Heterogeneity in the design of feedback facilitation needs to be considered when assessing the intervention's effectiveness. We describe explicit feedback facilitation choices for future intervention developers based upon choices made to date. We found the Expert Recommendations for Implementing Change to be valuable when describing intervention components, with the potential for some minor clarifications in terms and for greater specificity by intervention providers. Reporting demonstrated extensive gaps which hinder both replication and learning. Feedback facilitation providers are recommended to close reporting gaps that hinder replication. Future work should seek to address the 'opportunity' for improvement activity, defined as factors that lie outside the individual that make care or improvement behaviour possible. REVIEW REGISTRATION: The study protocol was published at: https://www.protocols.io/private/4DA5DE33B68E11ED9EF70A58A9FEAC02 .

Leveraging systems science and design thinking to advance implementation science: moving toward a solution-oriented paradigm.

Many public health challenges are characterized by complexity that reflects the dynamic systems in which they occur. Such systems involve multiple interdependent factors, actors, and sectors that influence health, and are a primary driver of challenges of insufficient implementation, sustainment, and scale of evidence-based public health interventions. Implementation science frameworks have been developed to help embed evidence-based interventions in diverse settings and identify key factors that facilitate or hinder implementation. These frameworks are largely static in that they do not explain the nature and dynamics of interrelationships among the identified determinants, nor how those determinants might change over time. Furthermore, most implementation science frameworks are top-down, deterministic, and linear, leaving critical gaps in understanding of both how to intervene on determinants of successful implementation and how to scale evidence-based solutions. Design thinking and systems science offer methods for transforming this problem-oriented paradigm into one that is solution-oriented. This article describes these two approaches and how they can be integrated into implementation science strategies to promote implementation, sustainment, and scaling of public health innovation, ultimately resulting in transformative systems changes that improve population health.

Ultrasound in Cardiopulmonary Arrest and Resuscitation: Constructing Comprehensive Implementation Frameworks in High-Risk Settings.

OBJECTIVES: Information obtained from point-of-care ultrasound during cardiopulmonary arrest and resuscitation (POCUS-CA) can be used to identify underlying pathophysiology and provide life-sustaining interventions. However, integration of POCUS-CA into resuscitation care is inconsistent. We used expert consensus building methodology to help identify discrete barriers to clinical integration. We subsequently applied implementation science frameworks to generate generalizable strategies to overcome these barriers. MEASURES AND MAIN RESULTS: Two multidisciplinary expert working groups used KJ Reverse-Merlin consensus building method to identify and characterize barriers contributing to failed POCUS-CA utilization in a hypothetical future state. Identified barriers were organized into affinity groups. The Center for Implementation Research (CFIR) framework and Expert Recommendations for Implementing Change (CFIR-ERIC) tool were used to identify strategies to guide POCUS-US implementation. RESULTS: Sixteen multidisciplinary resuscitation content experts participated in the working groups and identified individual barriers, consolidated into 19 unique affinity groups that mapped 12 separate CFIR constructs, representing all 5 CFIR domains. The CFIR-ERIC tool identified the following strategies as most impactful to address barriers described in the affinity groups: identify and prepare champions, conduct local needs assessment, conduct local consensus discussions, and conduct educational meetings. CONCLUSIONS: KJ Reverse-Merlin consensus building identified multiple barriers to implementing POCUS-CA. Implementation science methodologies identified and prioritized strategies to overcome barriers and guide POCUS-CA implementation across diverse clinical settings.

Understanding pathways from implementation to sustainment: a longitudinal, mixed methods analysis of promising practices implemented in the Veterans Health Administration.

BACKGROUND: The Veterans Health Administration (VHA) is the United States largest learning health system. The Diffusion of Excellence (DoE) program is a large-scale model of diffusion that identifies and diffuses evidence-informed practices across VHA. During the period of 2016-2021, 57 evidence-informed practices were implemented across 82 VHA facilities. This setting provides a unique opportunity to understand sustainment determinants and pathways. Our objective was to characterize the longitudinal pathways of practices as they transition from initial implementation to long-term sustainment at each facility. METHODS: A longitudinal, mixed-methods evaluation of 82 VHA facilities. Eighty-two facility representatives, chosen by leadership as points-of-contact for 57 DoE practices, were eligible for post-implementation interviews and annual sustainment surveys. Primary outcomes (implementation, sustainment), and secondary outcomes (institutionalization, effectiveness, anticipated sustainment) at four time-points were collected. We performed descriptive statistics and directed content analysis using Hailemariam et al.'s factors influencing sustainment. RESULTS: After approximately five years post-implementation (e.g., 2021 sustainment outcomes), of the 82 facilities, about one-third fully sustained their practice compared to one-third that did not fully sustain their practice because it was in a "liminal" stage (neither sustained nor discontinued) or permanently discontinued. The remaining one-third of facilities had missing 2021 sustainment outcomes. A higher percentage of facilities (70%) had inconsistent primary outcomes (changing over time) compared to facilities (30%) with consistent primary outcomes (same over time). Thirty-four percent of facilities with sustained practices reported resilience since they overcame implementation and sustainment barriers. Facilities with sustained practices reported more positive secondary outcomes compared to those that did not sustain their practice. Key factors facilitating practice sustainment included: demonstrating practice effectiveness/benefit, sufficient organizational leadership, sufficient workforce, and adaptation/alignment with local context. Key factors hindering practice sustainment included: insufficient workforce, not able to maintain practice fidelity/integrity, critical incidents related to the COVID-19 pandemic, organizational leadership did not support sustainment of practice, and no ongoing support. CONCLUSIONS: We identified diverse pathways from implementation to sustainment, and our data underscore that initial implementation outcomes may not determine long-term sustainment outcomes. This longitudinal evaluation contributes to understanding impacts of the DoE program, including return on investment, achieving learning health system goals, and insights into achieving high-quality healthcare in VHA.

A Narrative Review of NICU Implementation of Evidence-Based Early Relational Health Interventions.

BACKGROUND: Early relational health (ERH) interventions in the neonatal intensive care unit (NICU) buffer infants from toxic stress effects. Implementation science (IS) can guide successful uptake of evidence-based practice (EBP) ERH interventions. It is unknown if implementors of ERH interventions currently use the resources of IS to improve implementation. PURPOSE: A narrative review of recent literature on implementation of ERH EBPs was completed to understand (a) which ERH interventions are currently being implemented in NICUs globally, (b) whether clinical implementors of ERH interventions have adopted the resources of IS, (c) existence of implementation gaps, and (d) implementation outcomes of ERH interventions in contemporary literature. DATA SOURCES: Scopus, PubMed, and CINHAL were searched for original research regarding implementation of dyadic ERH interventions using key words related to IS and ERH. STUDY SELECTION: For inclusion, ERH EBPs had to have been implemented exclusively in NICU settings, contained data addressing an IS domain, printed in English within the last 5 years. Twenty-four studies met inclusion criteria. DATA EXTRACTION: Studies were distilled for intervention, IS domains addressed, location, aims, design, sample, and outcomes. RESULTS: Eleven ERH interventions were described in the literature. Few studies utilized the resources of IS, indicating variable degrees of success in implementation. Discussions of implementation cost were notably missing. IMPLICATIONS FOR PRACTICE AND RESEARCH: Implementors of ERH interventions appear to be largely unfamiliar with IS resources. More work is needed to reach clinicians with the tools and resources of IS to improve implementation outcomes.

Inter-organizational alignment and implementation outcomes in integrated mental healthcare for children and adolescents: a cross-sectional observational study.

BACKGROUND: Integrated care involves care provided by a team of professionals, often in non-traditional settings. A common example worldwide is integrated school-based mental health (SBMH), which involves externally employed clinicians providing care at schools. Integrated mental healthcare can improve the accessibility and efficiency of evidence-based practices (EBPs) for vulnerable populations suffering from fragmented traditional care. However, integration can complicate EBP implementation due to overlapping organizational contexts, diminishing the public health impact. Emerging literature suggests that EBP implementation may benefit from the similarities in the implementation context factors between the different organizations in integrated care, which we termed inter-organizational alignment (IOA). This study quantitatively explored whether and how IOA in general and implementation context factors are associated with implementation outcomes in integrated SBMH. METHODS: SBMH clinicians from community-based organizations (CBOs; nclinician = 27) and their proximal student-support school staff (nschool = 99) rated their schools and CBOs (clinician only) regarding general (organizational culture and molar climate) and implementation context factors (Implementation Climate and Leadership), and nine common implementation outcomes (e.g., treatment integrity, service access, acceptability). The levels of IOA were estimated by intra-class correlations (ICCs). We fitted multilevel models to estimate the standalone effects of context factors from CBOs and schools on implementation outcomes. We also estimated the 2-way interaction effects between CBO and school context factors (i.e., between-setting interdependence) on implementation outcomes. RESULTS: The IOA in general context factors exceeded those of implementation context factors. The standalone effects of implementation context factors on most implementation outcomes were larger than those of general context factors. Similarly, implementation context factors between CBOs and schools showed larger 2-way interaction effects on implementation outcomes than general context factors. CONCLUSIONS: This study preliminarily supported the importance of IOA in context factors for integrated SBMH. The findings shed light on how IOA in implementation and general context factors may be differentially associated with implementation outcomes across a broad array of integrated mental healthcare settings.

Advancing Translation of Clinical Research Into Practice and Population Health Impact Through Implementation Science.

Translational and implementation sciences aim to prioritize and guide efforts to create greater efficiency and speed of scientific innovation across the translational science continuum to improve patient and population health. Key principles and practices rooted in translational and implementation science may be incorporated into clinical trials research, particularly pragmatic trials, to improve the relevance and impact of scientific innovation. This thematic review intends to raise awareness on the value of translational and implementation science in clinical research and to encourage its use in designing and implementing clinical trials across the translational research continuum. Herein, we describe the gap in translating research findings into clinical practice, introduce translational and implementation science, and describe the principles and practices from implementation science that can be used in clinical trial research across the translational continuum to inform clinical practice, to improve population health impact, and to address health care inequities.

Effectiveness and Implementation of a Text Messaging mHealth Intervention to Prevent Childhood Obesity in Mexico in the COVID-19 Context: Mixed Methods Study.

BACKGROUND: Promoting physical activity (PA) and healthy feeding (HF) is crucial to address the alarming increase in obesity rates in developing countries. Leveraging mobile phones for behavior change communication to encourage infant PA and promote HF is particularly significant within the Mexican context. OBJECTIVE: This study aims to explore the effectiveness and feasibility of mHealth interventions aimed at promoting PA and HF among primary caregivers (PCs) of Mexican children under the age of 5 years. Additionally, the study aims to disseminate insights gained from intervention implementation amidst the COVID-19 pandemic and assess the potential of behavior change mHealth interventions on a broader population scale. METHODS: NUTRES, an mHealth intervention, underwent an effectiveness-implementation hybrid trial. Over 36 weeks, participants in the intervention group (IG), totaling 230 individuals, received approximately 108 SMS text messages tailored to their children's age. These messages covered topics such as PA and HF and emphasized the significance of proper child nutrition amidst the COVID-19 pandemic. NUTRES participants were recruited from both urban and rural health units across 2 states in Mexico. Given the COVID-19 context, both baseline and follow-up surveys were conducted via mobile or fixed telephone. The evaluation of effectiveness and implementation used a mixed methods approach. Qualitative analysis delved into participants' experiences with NUTRES and various implementation indicators, including acceptance, relevance, and coverage. Grounded theory was used for coding and analysis. Furthermore, difference-in-differences regression models were used to discern disparities between groups (comparison group [CG] versus IG) concerning knowledge and practices pertaining to infant PA and HF. RESULTS: Of the total 494 PCs enrolled in NUTRES, 334 persisted until the end of the study, accounting for 67.6% (334/494) participation across both groups. A majority of PCs (43/141, 30.5%, always; and 97/141, 68.8%, sometimes) used the SMS text message information. Satisfaction and acceptability toward NUTRES were notably high, reaching 98% (96/98), with respondents expressing that NUTRES was "good," "useful," and "helpful" for enhancing child nutrition. Significant differences after the intervention were observed in PA knowledge, with social interaction favored (CG: 8/135, 5.9% vs IG: 20/137, 14.6%; P=.048), as well as in HF practice knowledge. Notably, sweetened beverage consumption, associated with the development of chronic diseases, showed divergence (CG: 92/157, 58.6% vs IG: 110/145, 75.9%; P=.003). In the difference-in-differences model, a notable increase of 0.03 in knowledge regarding the benefits of PA was observed (CG: mean 0.13, SD 0.10 vs IG: mean 0.16, SD 0.11; P=.02). PCs expressed feeling accompanied and supported, particularly amidst the disruption of routine health care services during the COVID-19 pandemic. CONCLUSIONS: While NUTRES exhibited a restricted impact on targeted knowledge and behaviors, the SMS text messages functioned effectively as both a reminder and a source of new knowledge for PCs of Mexican children under 5 years of age. The key lessons learned were as follows: mHealth intervention strategies can effectively maintain communication with individuals during emergencies, such as the COVID-19 pandemic; methodological and implementation barriers can constrain the effectiveness of mHealth interventions; and using mixed methods approaches ensures the complementary nature of results. The findings contribute valuable evidence regarding the opportunities and constraints associated with using mobile phones to enhance knowledge and practices concerning PA and HF among PCs of children under 5 years old. TRIAL REGISTRATION: ClinicalTrials.gov NCT04250896; https://clinicaltrials.gov/ct2/show/NCT04250896.

Building CapaCITY/É for sustainable transportation: protocol for an implementation science research program in healthy cities.

INTRODUCTION: Improving sustainable transportation options will help cities tackle growing challenges related to population health, congestion, climate change and inequity. Interventions supporting active transportation face many practical and political hurdles. Implementation science aims to understand how interventions or policies arise, how they can be translated to new contexts or scales and who benefits. Sustainable transportation interventions are complex, and existing implementation science frameworks may not be suitable. To apply and adapt implementation science for healthy cities, we have launched our mixed-methods research programme, CapaCITY/É. We aim to understand how, why and for whom sustainable transportation interventions are successful and when they are not. METHODS AND ANALYSIS: Across nine Canadian municipalities and the State of Victoria (Australia), our research will focus on two types of sustainable transportation interventions: all ages and abilities bicycle networks and motor vehicle speed management interventions. We will (1) document the implementation process and outcomes of both types of sustainable transportation interventions; (2) examine equity, health and mobility impacts of these interventions; (3) advance implementation science by developing a novel sustainable transportation implementation science framework and (4) develop tools for scaling up and scaling out sustainable transportation interventions. Training activities will develop interdisciplinary scholars and practitioners able to work at the nexus of academia and sustainable cities. ETHICS AND DISSEMINATION: This study received approval from the Simon Fraser University Office of Ethics Research (H22-03469). A Knowledge Mobilization Hub will coordinate dissemination of findings via a website; presentations to academic, community organisations and practitioner audiences; and through peer-reviewed articles.

Patient and healthcare professional perspectives on the Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC): analysis of open-ended responses from patients and healthcare professionals.

IMPORTANCE: Several international calls have been made for evidence-based patient-reported outcome measure (PROM) implementation for gender-affirming care. The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is a resource which can help guide PROM implementation efforts, developed using a three-phase participatory research approach with transgender and gender-diverse (TGD) patients and gender-affirming healthcare professionals. However, thoughts and perspectives from TGD patients and gender-affirming healthcare professionals on the PG-PROM-GAC need to be investigated. OBJECTIVE: Investigate patient and healthcare professional perspectives on the PG-PROM-GAC through analysis of open-ended survey results. DESIGN: Qualitative study analysing open-ended responses from TGD patients and gender-affirming healthcare professionals. SETTING: Participants were recruited from a UK National Health System (NHS) gender clinic. PARTICIPANTS: Patients receiving care at an NHS gender clinic and healthcare professionals working at an NHS gender clinic were eligible for participation. Eligible participants were invited to participate in this study via email. INTERVENTION: Participants were sent an open-ended survey to collect responses on the PG-PROM-GAC. MAIN OUTCOMES AND MEASURES: Data were thematically analysed by two independent researchers and interpreted following guidance from established methods in implementation science. RESULTS: A total of 64 TGD patients and 9 gender-affirming healthcare professionals responded to the open-ended survey (mean (SD) age: 35 (16) and 48 (8), respectively). Four main themes emerged from the data: overall opinions and support for the PG-PROM-GAC, presentation of the PG-PROM-GAC, impact of gender clinic resources on PROM implementation and impact of PROM selection on implementation. Data were used to iterate the PG-PROM-GAC in response to participant feedback. CONCLUSIONS AND RELEVANCE: The PG-PROM-GAC is an acceptable and feasible resource that can be used by clinicians, researchers and policymakers to guide PROM implementation for gender-affirming care settings, helping to align gender-affirming care with patient needs.

Implementation Science to Achieve Equity in Heart Failure Care: A Scientific Statement From the American Heart Association.

Guideline-directed medical therapies and guideline-directed nonpharmacological therapies improve quality of life and survival in patients with heart failure (HF), but eligible patients, particularly women and individuals from underrepresented racial and ethnic groups, are often not treated with these therapies. Implementation science uses evidence-based theories and frameworks to identify strategies that facilitate uptake of evidence to improve health. In this scientific statement, we provide an overview of implementation trials in HF, assess their use of conceptual frameworks and health equity principles, and provide pragmatic guidance for equity in HF. Overall, behavioral nudges, multidisciplinary care, and digital health strategies increased uptake of therapies in HF effectively but did not include equity goals. Few HF studies focused on achieving equity in HF by engaging stakeholders, quantifying barriers and facilitators to HF therapies, developing strategies for equity informed by theory or frameworks, evaluating implementation measures for equity, and titrating strategies for equity. Among these HF equity studies, feasibility was established in using various educational strategies to promote organizational change and equitable care. A couple include ongoing randomized controlled pragmatic trials for HF equity. There is great need for additional HF implementation trials designed to promote delivery of equitable guideline-directed therapy.

Practice-Oriented Research: An Introduction to New Developments and Future Directions.

Aimed at understanding and improving psychological therapies as they are conducted in clinical routine, practice-oriented research (POR) is now a well-established approach to the scientific foundations of mental health care services. Resting on the accumulation of a wide range of practice-based evidence related to treatment outcome and process, as well as factors associated with the participants of psychotherapy and its context, POR is ripe for new developments - regarding what to investigate and how to investigate it. This paper is the introduction of a series devoted to recent advances and future directions of POR as their pertained to routine outcome monitoring, technologies and artificial intelligence, the integration of constructs and methods from program evaluation and implementation science, and the investigation of populations with limited financial resources across various regions of the world. The series also includes commentaries from two leaders of POR.