Results Of Implementation Research Articles

Innovations in primary healthcare in Slovenia 2011-2020: Exploring the stepwise process behind effective implementation.

Countries worldwide seek to strengthen their primary healthcare systems often through introducing health promotion and disease prevention, multidisciplinary teams, group practices and community approaches to advance universal health coverage. These strategies are underpinned by scientific evidence and international standards. Slovenia's primary healthcare system reflects many of these features, with universally accessible, multidisciplinary, and integrated health services, emphasizing health promotion, disease prevention, and equity. Municipal primary healthcare centres serve as hubs within local communities. Slovenia's efforts to strengthen the delivery model are continuous and follow a controlled stepwise implementation process. This approach has strong policy support and organizational and implementation capacities. This paper describes Slovenia's primary healthcare model and three innovations between 2011 and 2020: (1) family medicine model practices, (2) health promotion centres, and (3) mental health centres. These innovations are used both to showcase the efforts of Slovenia to enhance primary healthcare and as a lens to explore Slovenia's established primary healthcare innovation implementation approach. The three innovations have had a positive impact on health outcomes in the short- to medium-term, but mixed health system and implementation outcomes. Slovenia's experience can inspire other countries looking to sustainably integrate primary healthcare fully or effectively introduce single innovations in their primary healthcare systems.

Early implementation of an electronic measurement-based care tool in substance use disorder treatment clinics.

Measurement-based care (MBC), routinely measuring and reviewing treatment progress with a standardized tool, can inform clinical decision making and improve patient outcomes. Despite potential benefits, implementation of MBC in SUD treatment settings has been limited and little is known about its implementation in SUD settings. The goal of this convergent parallel mixed methods study was to understand staff experiences during early implementation of MBC in SUD treatment clinics. The Treatment Progress Assessment-8 (TPA8) is an 8-item measure that supports MBC with an electronic system (eTPA8) allowing client completion on electronic devices and providing staff reports. The study introduced the eTPA8 into 13 clinics using external practice facilitation and implementation teams. Quantitative data examining implementation included eTPA8 system data (1672 administrations) and staff surveys (n = 70) using feasibility, acceptability, and appropriateness measures. Semi-structured interviews (n = 34) were conducted with clinic staff. To analyze data, we classified clinics into adopters, non-adopters, and sustainers using eTPA8 system data. One-way ANOVA compared these classifications on the three implementation outcome measures. Rapid qualitative analysis was used for the interviews. There were significant differences between staff in sustainer (M = 3.90) and non-adopter (M = 3.21) clinics on the feasibility measure (F(2, 68) = [4.28], p = 0.018). SUD program staff found the eTPA8 to be user-friendly, appropriate, and acceptable. There was some variation in perceived feasibility of regular use of the eTPA8, especially given competing demands and time constraints. Staff found the eTPA8 useful to support clinical interactions but varied in embracing new technology and the overall MBC concept. The inner and outer contexts influenced implementation and required attention by clinic champions and implementation teams. External practice facilitators were key to addressing barriers in an ongoing and flexible manner. Implementing MBC using the eTPA8 showed promise. Staff felt the TPA8 was generally clinically useful, appropriate, and acceptable; yet feasibility was variable. Adoption of MBC faced barriers (e.g., competing demands). Implementation required relatively intensive implementation supports that were dynamic, proactive, and responsive. Findings have implications for guiding development and refinement of responsive, theory-driven implementation strategies to support MBC in SUD treatment settings, with a particular focus on addressing feasibility.

Early detection and a treatment bundle strategy for postpartum haemorrhage: a mixed-methods process evaluation.

Postpartum haemorrhage is a leading cause of maternal mortality. A multicountry, cluster-randomised trial (E-MOTIVE) demonstrated a 60% reduction in adverse postpartum haemorrhage outcomes. The E-MOTIVE intervention included early postpartum haemorrhage detection using calibrated blood-collection drapes, followed by a postpartum haemorrhage treatment bundle (ie, uterine massage, oxytocics, tranexamic acid, intravenous fluids, examination and escalation [MOTIVE]), supported by implementation strategies. We report a mixed-methods process evaluation assessing the implementation of the E-MOTIVE intervention in Kenya, Nigeria, South Africa, and Tanzania. In this mixed-methods process evaluation, data sources were observations of health workers providing clinical care to pregnant women and pregnant people during vaginal birth and postpartum haemorrhage at intervention sites, and surveys and qualitative interviews with health workers at intervention and control sites. Intervention sites received the calibrated drapes, MOTIVE bundle, and implementation strategies and control sites used uncalibrated drapes. Primary implementation outcomes included fidelity, adoption, adaptation, acceptability, feasibility, and contamination to the calibrated drape, MOTIVE bundle, and implementation strategies. Between June 1, 2022, and Jan 31, 2023, 2578 births were observed, 295 pregnant women and people had postpartum haemorrhage, 47 qualitative interviews were done, and 889 surveys were completed. Fidelity to calibrated drape use was high (birth observations 2578 [100%] of 2578; survey 451 [98·3%] of 459). Among health workers, calibrated drape acceptability was high; however, they reported barriers to pregnant women's and people's acceptability. Fidelity to postpartum haemorrhage treatment bundle delivery was high (birth observations 286 [96·9%] of 295), with moderate to high fidelity in median time from postpartum haemorrhage diagnosis to final treatment initiation (≤15 min initiation time in 191 [66·8%] of 295 birth observations, 16-20 min in 42 [14·7%] birth observations), and high acceptability and feasibility. Research midwives participated in clinical assessments after birth and bundle delivery in some sites (mixed fidelity). This process evaluation shows generally high levels of fidelity, feasibility, and acceptability of the calibrated drape and treatment bundle across evaluation methods and countries. The E-MOTIVE intervention should be included in national policies, with consideration for health workforce, supplies, and medication issues, which might need addressing for successful implementation. The Bill and Melinda Gates Foundation and the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction, a co-sponsored programme of WHO. For the Swahili translation of the abstract see Supplementary Materials section.

Study protocol: type II hybrid effectiveness-implementation study of routine functional status screening in VA primary care

BackgroundMaintaining functional status, defined as the ability to perform daily activities such as bathing, dressing, and preparing meals, is central to older adults’ quality of life, health, and ability to remain independent. Identifying functional impairments – defined as having difficulty or needing help performing these activities – is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into routine patient care has been slow and inconsistent due to the burden posed by current tools. The goal of the Patient-Aligned Care Team (PACT) Functional Status Screening Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve identification and management of functional impairment among older veterans in Veterans Health Administration (VHA) primary care settings.MethodsWe will conduct a hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial at 8 VHA sites using the Practical, Robust Implementation and Sustainability Model (PRISM) to guide implementation and evaluation. During a Pre-Implementation phase, we will engage clinical partners and develop local adaptations to maximize intervention-setting fit. During an Implementation phase, we will launch a standard bundle of implementation strategies (coalition building, champions, technical assistance) and system-level audit and feedback, identify sites with low uptake, and randomize those sites to receive continued standard vs. enhanced strategies (standard strategies plus clinician-level audit and feedback). The primary implementation outcome is reach (proportion of eligible patients at each site who receive screening/assessment) and the primary effectiveness outcome is appropriate management of impairment (proportion of patients with identified impairments who receive related referrals).DiscussionImplementing routine measurement of functional status in primary care has the potential to improve identification and management of functional impairment for older veterans. Improved management includes increasing access to services and supports for veterans and family caregivers, reducing potentially preventable acute care utilization, and allowing veterans to live in the least restrictive setting for as long as possible. Implementation will also provide data to inform the delivery of proactive interventions to prevent and delay development of functional impairment and improve quality of life, health, and independence.Trial registrationRegistered at ClinicalTrials.gov on May 7, 2024, at NCT06404970 (https://clinicaltrials.gov/).Reporting guidelinesStandards for Reporting Implementation Studies (Additional file 1).

Implementation of rural provider-to-provider telehealth in country Western Australia: a retrospective observational analysis via the RE-AIM framework

BackgroundRural provider-to-provider telehealth is growing globally. It is used to both facilitate equitable access to specialist healthcare services for those living in rural and remote areas and provide support to place-based providers. There is limited research on the implementation of these services, especially in an emergency or inpatient hospital setting. The Western Australia Country Health Service (WACHS) Command Centre is one such example. First implemented in 2012, the Command Centre services a geographical area covering 2.55 million square kilometres, a population of approximately 550,000, and provides five clinical streams including Emergency, Mental Health Emergency, Midwifery and Obstetrics Emergency, Inpatient, and Palliative Care Afterhours Telehealth Services.ObjectivesThis study aimed to evaluate the implementation and access of rural provider-to-provider telehealth in country Western Australia, for the years 2012 to 2023.MethodsA retrospective observational analysis was conducted of all patient contacts managed by clinical telehealth streams of the Command Centre, between 31 August 2012 and 31 December 2023. Utilising descriptive statistics, analyses was informed by the expanded Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Framework and Implementation Outcomes Framework (IOF) definitions.ResultsOver the near 12-year period, a total of 215,965 service contacts were analysed from the five Command Centre clinical streams. There was large variation in the reach and adoption of services across regions, sites, and health facility types, however service scope and activity has increased steadily over time (maintenance). 95 of the 103 WACHS-managed sites had utilised Command Centre clinical telehealth services. The Command Centre has seen an increase in the proportion of clinical telehealth services provided to the most disadvantaged populations, demonstrating improved equity of access (effectiveness) over time.ConclusionThere is a steady expansion in the availability of provider-to-provider clinical telehealth services delivered by the WACHS Command Centre across country WA, but with wide variability of usage depending on region, site, and health facility type. The results of this study show there is a need to understand the contextual factors influencing the adoption, implementation, and sustainability of the service.

Siyakhana: A hybrid type 2 effectiveness-implementation stepped-wedge trial to reduce stigma towards substance use and depression among community health workers in HIV/TB care in South Africa.

Substance use (SU) and other mental health conditions, such as depression, contribute to poor engagement in HIV and TB care in South Africa, a country with the highest global prevalence of HIV and a significant TB burden. Yet, community health workers (CHWs)-frontline lay health workers who play a central role in re-engaging patients in HIV/TB care-receive little-to-no training on supporting patients with SU or other mental health concerns. CHWs also display stigma towards patients with SU and depression, which may contribute to HIV/TB care disengagement. We developed and tested a CHW training ("Siyakhana") to reduce CHW stigma towards SU and depression in HIV/TB care. A cluster randomized, stepped-wedge hybrid type 2 effectiveness-implementation trial (N = 82 CHWs) evaluated Siyakhana across six clinics in a low-resource area of Cape Town, SA. The three-day Siyakhana training included psychoeducation, self-care strategies, non-judgmental communication, problem solving, and contact-based stigma reduction using lived experience narratives. Pre-training and three- and six-months post-training assessments were conducted. Primary effectiveness outcomes were CHW stigma towards SU and depression, assessed using the Social Distance Scale. Primary implementation outcomes were guided by Proctor's model, including fidelity, acceptability, appropriateness, and feasibility, assessed using structured coding of role plays and a validated quantitative measure for assessing implementation outcomes in low- and middle-income countries. Participants were on average 46.8 years old (SD = 8.9), 99 % female, and 100 % Black African. Ninety-five percent of CHWs completed the Siyakhana training, with approximately 90 % retention over six months. A linear mixed effects model showed a significant effect of the Siyakhana training on reducing SU stigma over six months after adjusting for time (β = -1.46, SE = 0.67, p < 0.05), but no effect on depression stigma (β = -0.20, SE = 0.57, p > 0.05). CHW fidelity was 89.4 % (SD = 11.3 %) at six-months. Quantitative implementation outcomes indicated high acceptability (M = 2.85, SD = 0.27), appropriateness (M = 2.77, SD = 0.31), and feasibility (M = 2.41, SD = 0.38). Siyakhana was associated with reductions in CHW SU stigma in the context of HIV/TB care, with promising implementation outcomes. Findings will inform a larger randomized trial evaluating the effectiveness and implementation of Siyakhana and examine whether shifting CHW stigma improves patient-level health outcomes. ClinicalTrials.gov: NCT05282173. Registered on 7 March 2022.

AI-Driven Transport and Distribution Optimization Model (TDOM) for the downstream petroleum sector: enhancing sme supply chains and sustainability

The downstream petroleum sector faces significant challenges in transport and distribution logistics, particularly for small and medium enterprises (SMEs) that rely on efficient supply chains to remain competitive. Inefficiencies such as fluctuating demand, fuel shortages, and route optimization hurdles contribute to increased operational costs and environmental impact. Addressing these persistent issues requires innovative solutions that balance efficiency, cost reduction, and sustainability. This study introduces the AI-Driven Transport and Distribution Optimization Model (TDOM), a transformative approach designed to revolutionize logistics in the downstream petroleum sector. TDOM leverages advanced machine learning algorithms and predictive analytics to optimize delivery routes, reduce fuel consumption, and ensure real-time adaptability to market demands. By integrating data from diverse sources, including traffic patterns, fuel station inventories, and weather conditions, TDOM provides SMEs with actionable insights for enhanced decision-making. The primary objectives of this research are threefold: to improve supply chain efficiency for SMEs in the downstream petroleum sector, to minimize environmental impacts through reduced carbon emissions, and to ensure cost-effective transport and distribution processes. The methodology includes developing a robust AI-driven model utilizing supervised and unsupervised learning techniques, followed by simulation testing on real-world logistics data. Key performance metrics such as delivery time, cost savings, and carbon footprint reduction will be analyzed to validate the model's efficacy. Anticipated outcomes of the TDOM implementation include a 20-30% reduction in transport costs, a significant decrease in fuel consumption, and improved supply chain resilience for SMEs. Furthermore, the model is expected to enhance sustainability by promoting eco-friendly logistics practices, thereby aligning with global environmental standards. By addressing inefficiencies in downstream petroleum logistics and supporting SMEs, the AI-driven TDOM represents a paradigm shift in how the industry approaches transport and distribution challenges. This innovative solution underscores the potential of artificial intelligence to transform traditional industries and foster a more sustainable future.

The evolution of subscription models in agriculture and construction: A technical analysis

The integration of subscription-based business models into traditional agriculture and construction sectors represents a paradigm shift in how capital-intensive industries approach technology adoption and service delivery. This technical article examines the transformative impact of subscription models on both end-users and service providers, exploring the evolution of financial architectures, technical scalability frameworks, revenue stream engineering, and data analytics infrastructure. The article delves into the mechanics of market expansion, competitive differentiation architecture, and future technical considerations, highlighting how these models have revolutionized operational efficiency, customer engagement, and value creation across the industry spectrum. Through comprehensive examination of implementation strategies and outcomes, this article demonstrates how subscription models are reshaping traditional business approaches while enabling unprecedented levels of innovation and growth.

Strategies for Implementing Integrated Behavioral Health into Health Centers.

Integrated behavioral health (IBH) is a promising approach which embeds behavioral health services into primary care. Yet, IBH has had limited implementation. Our objective was to identify strategies to successfully implement the "Cherokee" IBH model by examining a 2013 to 2019 IBH demonstration project in New Jersey that included Federally Qualified Health Centers (FQHCs) and Community Health Centers (CHCs). We conducted qualitative semistructured interviews of 18 primary care and behavioral health clinicians from 10 FQHCs/CHCs in 2022. Interview guide questions drew on the Proctor Implementation Outcomes Framework to capture strategies to optimize acceptability, appropriateness, feasibility, fidelity, penetration, and sustainability of IBH implementations. A template approach was used to code data and identify themes. All participating FQHCs/CHCs were still offering IBH services 3 years after the demonstration project, suggesting that strategies were successful in implementing and sustaining IBH. Strategies these FQHCs/CHCs employed included: (1) select champions with experience leading organizational change; (2) provide training that emphasizes how brief behavioral health interventions differ from traditional therapy; (3) develop on-going IBH training procedures for new staff; (4) create physical spaces for behavioral health consultants; (5) establish scheduling systems; and (6) identify local IBH billing codes, policies, and procedures. Change management approaches can help in the implementation of IBH; however, additional strategies unique to IBH may be needed to address the attitudinal, organizational, and financial challenges inherent to IBH. Future implementations should apply multi-faceted approaches that address persistent and seemingly intractable barriers that have inhibited IBH integration.

Barriers, Facilitators, and a Proposed Model of Care for Implementation of Upper Limb Distributed Practice Approaches for Children with Unilateral Cerebral Palsy

Background/Objectives: There is high-level research evidence supporting task-focused upper limb therapy models for children with unilateral cerebral palsy (CP). However, a knowledge gap exists in understanding how to effectively implement distributed practice approaches in clinical practice and the effect on the development of bimanual performance. This study aims to evaluate clinical outcomes, examine key considerations for implementation outcomes, and propose a Model of Care for children with unilateral CP. Methods: A mixed-methods approach was applied, including a retrospective case series with an observational descriptive design. A convenience sample of nine children (&lt;5 years of age) with unilateral CP who received multiple blocks of distributed, evidence-based upper limb therapy approaches between 2014 and 2020 were included. Outcomes were evaluated using the Assisting Hand Assessment family of assessments. A Model of Care framework was informed by the Updated Consolidated Framework for Implementation Research and the Conceptual Model for Implementation Research. Results: A total of 59 blocks of upper limb therapy (10 mCIMT and 49 bimanual therapy) were delivered, ranging from two to nine blocks (mean = 6.6) for each child. All children demonstrated improved outcomes in bimanual performance with an average change of 14 AHA units (range 1–22). Barriers to implementation included complexity and cost. Facilitators included the evidence base and adaptability of the approaches that allowed clinicians to respond to an individual child and family’s needs. Informed by evidence-based protocols and visual analysis of data, and in consideration of the barriers and/or facilitators to implementation from this study, a Model of Care for implementation of upper limb distributed practice approaches for children with unilateral CP in clinical practice is proposed. Conclusions: Implementing repeated, distributed blocks of evidence-based upper limb therapy in a clinical setting for children with unilateral CP led to incremental improvements in bimanual performance. There are a range of barriers and facilitators to the implementation of distributed practice approaches in clinical practice. The Model of Care outlines best practice care and service delivery for children with unilateral CP and their families and aims to support clinical practice and the future examination of implementation-effectiveness in practice.

P-1804. Evaluating Implementation Outcomes of Stewardship Interventions for Rapid Blood Culture Diagnostics

Abstract Background Rapid diagnostic testing for bloodstream infections, when coupled with antimicrobial stewardship (AS) intervention, has demonstrated improved clinical outcomes. Yet, data regarding implementation outcomes and the necessary strategies for these interventions are limited.Table 1:Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) results Pre-intervention and During the Intervention Frequency and percentage of BC-GP results during the pre-intervention phase and intervention phases are reported. Coagulase negative staphylococci includes Staphylococcus species, Staphylococcus epidermidis, methicillin susceptible Staphylococcus epidermidis, and methicillin resistant Staphylococcus epidermidis BC-GP results. Methods A pre-post quasi-experimental design was used to compare children with positive blood culture results. Pre-intervention causative organisms were identified using the Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) and reported to clinicians by a microbiology technologist. Post-intervention organisms were identified and reported similarly, in addition to 24 hours a day/7 days a week (24/7) AS intervention. AS members received BC-GP notifications and communicated antibiotic recommendations to the primary team. Hospital stakeholders were identified in the pre-intervention phase to assess divisional needs. The primary outcome was time to targeted therapy (TTT), calculated as time from BC-GP result to order of predetermined narrowest antibiotic regimen or discontinuation of therapy. TTT was compared by time-series analyses. Secondary outcomes included acceptability, appropriateness, and feasibility, assessed using validated surveys completed by pediatric infectious diseases (ID) clinicians and non-ID clinicians who received the AS intervention. Proportion of Patients Receiving Targeted Antibiotic Therapy Over Time A Kaplan-Meier analysis with a hazard function for time to targeted therapy (TTT) in children with positive blood cultures. Cases in the intervention phase (11/2023-04/2024) are represented in blue, and preintervention (10/2022-10/2023) controls are represented in orange. Censored cases included patients who did not receive targeted antibiotic therapy within their hospital admission. Log rank test demonstrated a statistically significant reduction in TTT in the intervention group versus the pre-intervention group, with a larger proportion of patients in the intervention group receiving targeted antibiotic therapy more rapidly than patients in the pre-intervention group (P-value of 0.013). Results The median TTT decreased from 15.9 hours before intervention to 0.9 hours with AS intervention (P=0.013). Validated surveys were completed by 23 ID and 38 non-ID clinicians. Over 80% of ID and non-ID clinicians agreed or strongly agreed that the intervention was acceptable and appropriate. However, significant differences were noted in all feasibility domains, including “doable,” “easy to apply,” “implementable,” and “possible" measures. Specifically, 39% of ID clinicians reported the intervention was “easy” or “very easy” to apply, as compared to 84% of non-ID clinicians (P &amp;lt; 0.0001). Infectious diseases (ID) respondents categorized by their role within the medical team. APRNs: Advanced Practice Registered Nurses, RPh: Registered Pharmacist. Non-infectious diseases (ID) respondents categorized by their role within the medical team. APRNs: Advanced Practice Registered Nurses, ICU: Intensive Care Unit. Conclusion 24/7 AS intervention paired with rapid blood culture diagnostics is associated with reduced TTT and is deemed appropriate and acceptable by ID and non-ID clinicians. The difference in feasibility perception by ID and non-ID clinicians highlights implementation challenges, and warrants evaluation of future strategies. Frequency and percentage of responses from infectious diseases (ID) clinicians in comparison to non-ID clinicians for the three domains of successful implementation outcomes including 1) acceptability, 2) appropriateness, and 3) feasibility. Agreement on the acceptability and appropriateness for the AS intervention was observed among ID and non-ID clinicians with no significant difference between the two groups. Statistically significant differences were noted among responses between ID and non-ID clinicians in the feasibility domain. Table 2: Frequency and percentage of responses on a Likert scale from ID clinicians (n=23) in comparison to non-ID clinicians (n=38) in the feasibility domain. Chi-Square or Fisher's Exact tests demonstrated significant differences in responses when comparing ID to non-ID clinician’s perception of “doable”, “easy to apply”, “implementable”, and “possible” measures for AS interventions on the BC-GP. Disclosures Jason G. Newland, MD, MEd, Moderna: Grant/Research Support|Pfizer: Grant/Research Support

Harnessing Human-Centered Design for Evidence-Based Psychosocial Interventions and Implementation Strategies in Community Settings: Protocol for Redesign to Improve Usability, Engagement, and Appropriateness.

Although substantial progress has been made in establishing evidence-based psychosocial clinical interventions and implementation strategies for mental health, translating research into practice-particularly in more accessible, community settings-has been slow. This protocol outlines the renewal of the National Institute of Mental Health-funded University of Washington Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness Center, which draws from human-centered design (HCD) and implementation science to improve clinical interventions and implementation strategies. The Center's second round of funding (2023-2028) focuses on using the Discover, Design and Build, and Test (DDBT) framework to address 3 priority clinical intervention and implementation strategy mechanisms (ie, usability, engagement, and appropriateness), which we identified as challenges to implementation and scalability during the first iteration of the center. Local redesign teams work collaboratively and share decision-making to carry out DDBT. All 4 core studies received institutional review board approval by June 2024, and each pilot project will pursue institutional review board approval when awarded. We will provide research infrastructure to 1 large effectiveness study and 3 exploratory pilot studies as part of the center grant. At least 4 additional small pilot studies will be solicited and funded by the center. All studies will explore the use of DDBT for clinical interventions and implementation strategies to identify modification targets to improve usability, engagement, and appropriateness in accessible nonspecialty settings (Discover phase); develop redesign solutions with local teams to address modification targets (Design and Build phase); and determine if redesign improves usability, engagement, and appropriateness (Test phase), as well as implementation outcomes. Center staff will collaborate with local redesign teams to develop and test clinical interventions and implementation strategies for community settings. We will collaborate with teams to use methods and centerwide measures that facilitate cross-project analysis of the effects of DDBT-driven redesign on outcomes of interest. As of January 2025, three of the 4 core studies are underway. We will generate additional evidence on the robustness of DDBT and whether combining HCD and implementation science is an asset for improving clinical interventions and implementation strategies. During the first round of the center, we established that DDBT is a useful approach to systematically identify and address chronic challenges of implementing clinical interventions and implementation strategies. In this subsequent grant, we expect to increase evidence of DDBT's impact on clinical interventions and implementation strategies by expanding a list of common challenges that could benefit from modification, a list of exemplary solutions to address these challenges, and guidance on using the DDBT framework. These resources will contribute to broader discourse on how to enhance implementation of clinical interventions and implementation strategies that integrate HCD and implementation science. PRR1-10.2196/65446.

P-1424. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US

Abstract Background Little is known outside of registrational clinical trials about patient experiences on CAB LA, the first long-acting injectable regimen for HIV prevention. We report real-world experiences and outcomes of men at month 6 (M6) after initiating CAB LA in the US. Methods PILLAR is a Phase 4 gender-concordant implementation science trial assessing integrating CAB LA at 17 clinics for men who have sex with men (MSM) and transgender men (TGM). MSM and TGM completed surveys at baseline (BL) and M6 on experiences and implementation outcomes. A purposeful sample of men completed interviews about their experiences. Results 201 men enrolled and initiated CAB LA from May 2022-August 2023, 186 (93%) and 159 (79%) completed BL and M6 surveys, respectively; of these, 45 men completed interviews at M6. Table 1 presents BL demographics. At BL,15-29% of men reported experiencing stigma and anxiety on oral PrEP (Table 2). At M6, 0-1% of CAB LA users reported stigma and anxiety concerns. At BL, 53-54% oral PrEP users reported concerns about forgetting to take and running out of PrEP. At M6, 2-7% of CAB LA users concerns were forgetting or missing injection visits. Interviewees noted CAB LA reduced stress and fear of missing PrEP, while offering confidence of protection. High acceptability of CAB LA increased from BL to M6 [mean acceptability: 4.4 (SD:0.69) vs. 4.6 (SD:0.61)] and feasibility remained high [mean feasibility: 4.4 (SD:0.74) vs 4.4 (SD:0.75)]. Interviewees noted CAB LA was convenient for their life. Though 45% reported injection site reactions, majority (86%) returned to daily activities the same day. Few were bothered by injection pain (8%) and reported that pain decreased over subsequent injections. At M6, 80-92% of survey respondents reported flexible scheduling by clinics as useful to supporting CAB LA use, which was also expressed by most interviewees. Among men who received transportation to visits, had injection reminders and had virtual appointments, over 80% rated them useful. Conclusion M6 results show that MSM and TGM report no to little PrEP stigma and anxiety concerns while on CAB LA and that it is feasible and acceptable in their lives. Flexible and virtual appointments and transportation support are helpful while on injectable PrEP. Disclosures Nanlesta Pilgrim, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee William M. Valenti, MD, FIDSA, Gilead Sciences: Grant/Research Support|Gilead Sciences: Stocks/Bonds (Public Company)|ViiV Healthcare: Grant/Research Support Bo Li, PhD, GSK: Employee Alison Gaudion, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Deanna Merrill, PharmD, MBA, AAHIVP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Patrick Daniele, MS, GSK: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant Larissa Stassek, MPH, ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Travel support Riya Moodley, FCP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Toyin Nwafor, MD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Katherine L. Nelson, PhD, MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Kimberley Brown, PharmD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Maggie Czarnogorski, MD MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee

Clinical effectiveness and implementation outcomes of pMDI-to-DPI switch in children between 5 and 12 years of age: a scoping review protocol

IntroductionInhalers are critical in asthma treatment, and inappropriate inhaler use leads to poor asthma outcomes. In adults and adolescents, dry powder inhalers (DPIs) are safe and effective alternatives to mainstay...

Solving unknown primary cancer with earlier diagnosis - the SUPER-ED trial: study protocol for a stepped-wedge cluster randomised controlled trial to support earlier diagnosis for people presenting with malignancy of undefined primary origin

BackgroundPeople with malignancy of undefined primary origin (MUO) have a poor prognosis and may undergo a protracted diagnostic workup causing patient distress and high cancer related costs. Not having a primary diagnosis limits timely site-specific treatment and access to precision medicine. There is a need to improve the diagnostic process, and healthcare delivery and support for these patients. This trial aims to implement and evaluate an optimal model of care for people presenting with MUO to reduce time to diagnosis, improve patient experiences and reduce healthcare costs.Methods/designThis is a pragmatic stepped-wedge cluster randomised trial comparing a control phase of standard practice with an intervention phase. Patient inclusion criteria are: 1) age 18 years or older, 2) presenting with suspected metastatic malignancy without an obvious primary site on imaging, 3) clinically appropriate to undergo diagnostic work-up and 4) able to provide written or verbal consent. The intervention is a new model of care comprising four key components: standardised diagnostic workup, dedicated cancer care coordinators, virtual multidisciplinary meetings and a website resource for patients, carers and clinicians. The primary endpoint is the time to completion of minimum diagnostic workup. Secondary outcomes are whether the type of tumour is diagnosed, clinical trial participation, referral to palliative care, patient-reported physical, social and mental health, patient-reported understanding and uncertainty. Implementation outcomes include acceptability, feasibility, fidelity and adoption and health care use and costs. Intervention implementation will be supported using clinical leadership, education and reinforcement. Patients who consent to having their data collected will receive the model of care active at the site at the time of recruitment. Patients will complete a patient-reported outcomes questionnaire four months after study enrolment. A health economic analysis will be included. Across 15 hospitals, a total sample size of 240 is planned.DiscussionThere is a lack of intervention research for people presenting with MUO. The stepped-wedge design seeks to mitigate the potential challenge of enrolling people with a poor prognosis and high symptom burden in trials. This research will generate important evidence with scalability for future research at trial completion.Trial registrationACTRN12622001504707

Considerations for establishment of a private virtual hospital identified using an implementation science approach

Virtual hospitals are rapidly being implemented internationally. Research has predominantly focused on clinical outcomes not implementation. We aimed to identify pre-implementation determinants to enable health services to tailor virtual hospital models, increasing likelihood of suitability, acceptability, uptake, clinical effectiveness, and sustainability. We aimed to inform the design and implementation of a private Australian virtual hospital by identifying contextual barriers, enablers, and considerations. We conducted a qualitative pre-implementation determinant study using snowball sampling and semi-structured interviews (n = 37) between February and July 2023 with consumers/carers/both (n = 11), clinicians (doctors/allied health/nursing/personal carers), hospital, health service and aged care leadership (n = 22), and public health stakeholders (n=4). Deductive framework analysis based on the PERCS implementation science framework was used. The following key determinants were identified: Enablers – strong executive leadership support; enthusiasm for expanding rural and remote services; need for a clear vision; strong tension for change; commitment to high-quality healthcare. Major barrier: restrictive funding models that stifle opportunities for innovation. Other barriers: technological limitations; communication challenges; workforce issues; clinicians’ opinions varied on safety and suitability of virtual healthcare. This implementation science approach enabled identification of a broad set of determinants not previously reported, relevant locally and for an international audience. Evaluation of implementation outcomes is necessary.

P-1899. Improvement in Provider Experiences from Baseline to Month 12 with Integrating Cabotegravir Long-Acting (CAB LA) for PrEP into Care in an Implementation Science Trial (PILLAR)

Abstract Background Real world clinical experience with CAB LA, the first long-acting injectable medication for HIV prevention, might be helpful to alleviate provider implementation concerns. We evaluate changes in healthcare providers (HCPs) CAB LA implementation outcomes over 12 months. Methods PILLAR (ClinicalTrials.gov # NCT05374525) is a Phase IV randomized controlled trial conducted at 17 sites in the US. Sites were randomized 2:1 to dynamic (standard + enhanced support) and routine implementation (standard support). HCPs providing PrEP services were enrolled and completed surveys at month (M) 1, M4, and M12. Change across six CAB LA domains was assessed: 1) acceptability (4 items); 2) feasibility (4 items); 3) resources needed to implement (4 items); 4) fidelity to dosing and administration (6 items); 5) scheduling and patient management (5 items); and 6) patient adoption and adherence (6 items). Results 86 HCPs enrolled between April-October 2022 completed M1 surveys; 80 and 81 HCPs completed M4 and M12 surveys, respectively. HCPs reported high levels of acceptability and feasibility of CAB LA at M1 (mean scale scores≥4.4), M4 (mean scale scores≥4.1), and M12 (mean scale scores≥4.3) across both arms; change from BL to M12 between arms was not significant. Across timepoints, HCPs reported reduced concerns in implementing CAB LA except risk of drug resistance due to non-adherence (Table 1). Concerns related to resources needed to implement CAB LA reduced by an average of 51% between M1 and M12. Staff needed per week to implement CAB LA reduced (M1: 4.4 vs. M12: 3.8) while the number of CAB LA patients clinics could manage per week increased (M1: &amp;gt;25=22% vs. M12: &amp;gt;25=63%) (Table 2). Concerns about scheduling and managing patients, fidelity to dosing and administration, and patients’ adoption and adherence reduced by an average of 42%, 46% and 32%, respectively, between M1 and M12. Drug resistance concerns rose by 7%. A higher proportion of HCPs in the dynamic arm reported less concerns about resourcing and fidelity to dosing and administration than HCPs in the routine arm. Conclusion HCPs confidence delivering CAB LA improved as early as M4 and continued through M12. Use of available implementation tools (e.g., guidance documents) support CAB LA implementation. Disclosures Taimur H. Khan, MD MPH, ViiV Healthcare/GSK: Grant/Research Support Linda Mercado, PA-C, Gilead: Advisor/Consultant|Gilead: Grant/Research Support|Gilead: Honoraria|Gilead: Institution-samples; lunches for staff; travel support|Janssen: Institution-samples, lunches for staff|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria|ViiV Healthcare: Institution-samples; lunches for staff; travel support Bo Li, PhD, GSK: Employee Katherine L. Nelson, PhD, MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Lisa Petty, MT(ASCP), GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Michael Acquadro, PhD, GSK: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant Nicola Barnes, MA, GSK: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant William Lenderking, PhD, Gilead: Advisor/Consultant Neelima Jain, PhD, GSK: Employee|GSK: Stocks/Bonds (Public Company) Heidi Swygard, MD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Todd McKeon, PharmD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Annemiek de Ruiter, MBBS FRCP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Maggie Czarnogorski, MD MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Nanlesta Pilgrim, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee

Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial

IntroductionTraditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice...

Implementing psychosocial interventions for teachers' mental health: Protocol for integrating scoping review with teachers lived experiences in LMICs.

Teachers are pivotal in shaping educational environments and student development but face significant occupational stress and high rates of mental problems. Despite the availability of various psychosocial interventions, comprehensive evidence of their effectiveness and implementation is limited for this occupational group, especially in low- and middle-income countries (LMICs). This mixed methods study aims to conduct a scoping review of characteristics, effectiveness, and implementation outcomes of psychosocial interventions for teachers' mental health and mental problems, integrating these with teachers' lived experiences to inform the implementation of mental health interventions in LMICs. The study combines a scoping review with insights from an advisory group of teaching professionals with relevant lived experiences (PWLEs). The review will focus on examining psychosocial interventions studies promoting mental health or addressing mental problems among grade 1-12 school teachers of all genders, ages and contexts, except those working in specialized settings, such as special education centers, or disaster- or crisis-stricken zones. Intervention studies exclusively focusing on physical health or job-related outcomes will be excluded. Using pre-defined search terms, quantitative and qualitative research studies, including unpublished literature, will be searched across multiple databases. Titles and abstracts of identified studies will be screened against inclusion criteria, and the potentially relevant sources will be retrieved in full. Data will be extracted using a data extraction sheet developed for the study covering variables related to participant characteristics, intervention characteristics, study context, effectiveness and implementation outcomes. A purposively selected sample of 10 PWLEs will form the study advisory group and participate in four online workshop-group discussions. The meetings will include a presentation of the scoping review findings, followed by discussions on the relevance of these intervention packages for LMICs, adaptations needed to make them acceptable among school teachers and feasible for delivery in low-resourced settings like India. The synthesis of the data will employ narrative and thematic approaches to generate actionable insights for implementing psychosocial interventions in LMICs. This study will provide comprehensive evidence on the characteristics and outcomes of psychosocial interventions for teachers' mental health and mental problems. By integrating insights from teachers with relevant lived experiences, the study will provide practical guidelines for adapting and implementing psychosocial interventions among school teachers in LMICs. Review registration number: Open Science Framework, doi.org/10.17605/OSF.IO/GF59J.

AdvantAGE: Implementation and Evaluation of an Interprofessional Transitional Care Model for Frail Older Adults-Protocol of an Effectiveness-Implementation Hybrid Study.

To implement and evaluate an Advanced Practice Nurse-led transitional care model (AdvantAGE) to reduce rehospitalisation rates in frail older adults discharged from a Swiss geriatric hospital. The study adopts an effectiveness-implementation hybrid design (Type 1) to simultaneously evaluate the effectiveness of the care model and explore the implementation process. The primary outcome, the 90-day rehospitalisation rate, will be evaluated using a matched-cohort design with a prospective intervention group and a retrospective control group. Secondary outcomes include the number of emergency department visits, health-related quality of life and intervention costs. The care model was developed through comprehensive contextual analysis and pilot testing in an iterative approach. It comprises five core elements: continuous support, care coordination, comprehensive health management at home, medication and self-management and advance care planning. Data collection includes both quantitative and qualitative methods, utilising routine hospital data, structured and semi-structured interviews and observations. Qualitative data will provide insights into implementation outcomes, potential barriers and facilitators. Additionally, a process evaluation will offer an in-depth understanding of individual intervention effects and reasons for rehospitalisation. The AdvantAGE project, grounded in implementation science methodology, aims to significantly improve transitional care outcomes for frail older adults. The results are expected to provide essential recommendations for scaling up the model to other settings. The study addresses the issue of frequent rehospitalisations in older adults, which carry risks of functional and cognitive decline. By implementing a comprehensive transitional care model, the study aims to improve continuity of care, reduce readmissions and enable frail older adults to remain in the community longer. The project highlights the importance of contextually adapted intervention and implementation strategies to bridge the gap between research and real-world healthcare practice. The project employs a participatory approach, engaging representatives from the hospital and primary care settings, the cantonal health department and older people and their caregivers. This study has been registered at clinicaltrials.gov on 5 January 2024 (Identifier: NCT06190288).