Exploration, Preparation, Implementation, Sustainment Research Articles

An effectiveness-implementation hybrid trial of phone-based tobacco cessation interventions in the Lebanese primary healthcare system: protocol for project PHOENICS

BackgroundTobacco use remains the leading cause of preventable disease, disability, and death in the world. Lebanon has an exceptionally high tobacco use burden. The World Health Organization endorses smoking cessation advice integrated into primary care settings as well as easily accessible and free phone-based counseling and low-cost pharmacotherapy as standard of practice for population-level tobacco dependence treatment. Although these interventions can increase access to tobacco treatment and are highly cost-effective compared with other interventions, their evidence base comes primarily from high-income countries, and they have rarely been evaluated in low- and middle-income countries. Recommended interventions are not integrated as a routine part of primary care in Lebanon, as in other low-resource settings. Addressing this evidence-to-practice gap requires research on multi-level interventions and contextual factors for implementing integrated, scalable, and sustainable cessation treatment within low-resource settings.MethodsThe objective of this study is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based tobacco treatment in primary healthcare centers within the Lebanese National Primary Healthcare Network. We will adapt and tailor an existing in-person smoking cessation program to deliver phone-based counseling to smokers in Lebanon. We will then conduct a three-arm group-randomized trial of 1500 patients across 24 clinics comparing (1) ask about tobacco use; advise to quit; assist with brief counseling (AAA) as standard care; (2) ask; advise; connect to phone-based counseling (AAC); and (3) AAC + nicotine replacement therapy (NRT). We will also evaluate the implementation process to measure factors that influence implementation. Our central hypothesis is that connecting patients to phone-based counseling with NRT is the most effective alternative. This study will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, supported by Proctor’s framework for implementation outcomes.DiscussionThe project addresses the evidence-to-practice gap in the provision of tobacco dependence treatment within low-resource settings by developing and testing contextually tailored multi-level interventions while optimizing implementation success and sustainability. This research is significant for its potential to guide the large-scale adoption of cost-effective strategies for implementing tobacco dependence treatment in low-resource settings, thereby reducing tobacco-related morbidity and mortality.Trial registrationClinicalTrials.gov, NCT05628389, Registered 16 November 2022.

Facilitators of and Barriers to Integrating Digital Mental Health Into County Mental Health Services: Qualitative Interview Analyses

Digital mental health interventions (DMHIs) represent a promising solution to address the growing unmet mental health needs and increase access to care. Integrating DMHIs into clinical and community settings is challenging and complex. Frameworks that explore a wide range of factors, such as the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, can be useful for examining multilevel factors related to DMHI implementation efforts. This paper aimed to identify the barriers to, facilitators of, and best practice recommendations for implementing DMHIs across similar organizational settings, according to the EPIS domains of inner context, outer context, innovation factors, and bridging factors. This study stems from a large state-funded project in which 6 county behavioral health departments in California explored the use of DMHIs as part of county mental health services. Our team conducted interviews with clinical staff, peer support specialists, county leaders, project leaders, and clinic leaders using a semistructured interview guide. The development of the semistructured interview guide was informed by expert input regarding relevant inner context, outer context, innovation factors, and bridging factors in the exploration, preparation, and implementation phases of the EPIS framework. We followed a recursive 6-step process to conduct qualitative analyses using inductive and deductive components guided by the EPIS framework. On the basis of 69 interviews, we identified 3 main themes that aligned with the EPIS framework: readiness of individuals, readiness of innovations, and readiness of organizations and systems. Individual-level readiness referred to the extent to which clients had the necessary technological tools (eg, smartphones) and knowledge (digital literacy) to support the DMHI. Innovation-level readiness pertained to the accessibility, usefulness, safety, and fit of the DMHI. Organization- and system-level readiness concerned the extent to which providers and leadership collectively held positive views about DMHIs as well as the extent to which infrastructure (eg, staffing and payment model) was appropriate. The successful implementation of DMHIs requires readiness at the individual, innovation, and organization and system levels. To improve individual-level readiness, we recommend equitable device distribution and digital literacy training. To improve innovation readiness, we recommend making DMHIs easier to use and introduce, clinically useful, and safe and adapting them to fit into the existing client needs and clinical workflow. To improve organization- and system-level readiness, we recommend supporting providers and local behavioral health departments with adequate technology and training and exploring potential system transformations (eg, integrated care model). Conceptualizing DMHIs as services allows the consideration of both the innovation characteristics of DMHIs (eg, efficacy, safety, and clinical usefulness) and the ecosystem around DMHIs, such as individual and organizational characteristics (inner context), purveyors and intermediaries (bridging factor), client characteristics (outer context), as well as the fit between the innovation and implementation settings (innovation factor).

An Implementation of a Community-Engaged, Group-Level Mental Health Pilot for Black and Latina Transgender Women.

The primary aim is to assess the implementation of an eight-session, group therapy pilot for Black and Latina transgender women in Chicago in terms of implementation outcomes regarding intervention effectiveness, acceptability, appropriateness, and feasibility. The Exploration Preparation Implementation Sustainment (EPIS) framework guided implementation processes, including community engagement as an implementation strategy, and an implementation taxonomy was used to evaluate outcomes of acceptability, appropriateness, and feasibility, in addition to intervention effectiveness regarding anxiety and community connectedness. Two rounds of the pilot were completed in 2020, during the COVID-19 pandemic, at a community-based organization serving LGBTQ+ (lesbian, gay, bisexual, transgender, queer/questioning) youth on Chicago's West Side. Participants (N = 14) completed a baseline and postintervention assessment and evaluations after each of eight intervention modules. Descriptive statistics show improvement across measures of anxiety and community connectedness, and high mean scores across domains of acceptability, appropriateness, and feasibility. Pilot findings indicate intervention effectiveness, acceptability, appropriateness, and feasibility to address mental health and social support of Black and Latina transgender women. Additional resources are needed for transgender community-engaged mental health programs and research to establish core and adaptable intervention elements, scaled-up evidence for clinical effectiveness, and, most importantly, to improve mental health outcomes and the sustainability of such interventions.

Intervening on women's health for rural young breast cancer survivors: A study protocol

IntroductionFrom diagnosis to post-treatment, many young breast cancer survivors (YBCS) experience infertility, limited contraception choices, concern about pregnancy safety, and menopausal symptoms. Clinical guidelines recommend oncofertility care (counseling and/or clinical services that meet fertility, contraception, pregnancy health and/or menopausal symptom management needs) throughout the cancer care continuum. However, significant oncofertility care gaps exist in rural, community oncology settings. Materials and methodsWe describe the design of an interrupted time series, effectiveness-implementation hybrid clinical trial that evaluates a multi-component intervention to improve YBCS engagement in oncofertility care. The intervention is comprised of 1) oncology clinic-based oncofertility needs screen; 2) a women's health survivorship care plan in Spanish and English; 3) remote patient navigation; and 4) telehealth oncofertility consultation. During the pre-intervention period (12 months), usual care will be delivered. During the intervention period (15 months), the multi-component intervention will be implemented at two rural oncology clinics with largely Latina, Spanish-speaking populations. The primary outcome of YBCS (n = 135) engagement in oncofertility care will be collected from medical record review. We will also collect validated patient-reported outcomes. Informed by the Exploration Preparation Implementation Sustainment (EPIS) implementation science framework, we will integrate qualitative and quantitative data to explore whether and how the intervention was effective, acceptable, appropriate, and delivered with fidelity. DiscussionOur overall goal is to speed implementation of a scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life. Trial registrationClinicaltrials.gov Identifier: NCT05414812

Systems Approach to Suicide Prevention: Strengthening Culture, Practice, and Education.

Contemporary approaches to suicide prevention extend beyond an individual's interactions with care providers to seek opportunities for improvement in the wider care system. A systems-based analysis can yield opportunities to improve prevention and recovery across the care continuum. This article uses an example of an individual seeking care in an emergency department to show how a traditional clinical case formulation can be framed in terms of the outer and inner contexts of the EPIS (Exploration, Preparation, Implementation, Sustainment) framework to illuminate the impact of systemic factors on outcomes and to identify opportunities for improvement. Three mutually reinforcing domains (a culture of safety and prevention; best practices, policies, and pathways; and workforce education and development) of a systems approach to suicide prevention are outlined, along with their defining characteristics. A culture of safety and prevention requires engaged, informed leaders who prioritize prevention; lived experience integrated into leadership teams; and adverse events review in a Restorative Just Culture focused on healing and improvement. Best practices, policies, and pathways that promote safety, recovery, and health require codesign of processes and services and evolve through continuous measurement and improvement. To support a culture of safety and prevention, and caring, competent application of policy, organizations benefit from a longitudinal approach to workforce education. This includes a common framework and language; models clinical and lived experience collaboration; and supports continuous learning, as well as onboarding of new staff, rather than following a "one-and-done" approach, so that suicide prevention training remains top of mind across the workforce.

A policy implementation study of earmarked taxes for mental health services: study protocol

BackgroundInsufficient funding is frequently identified as a critical barrier to the implementation and sustainment of evidence-based practices (EBPs). Thus, increasing access to funding is recognized as an implementation strategy. Policies that create earmarked taxes—defined as taxes for which revenue can only be spent on specific activities—are an increasingly common mental health financing strategy that could improve the reach of EBPs. This project’s specific aims are to (1) identify all jurisdictions in the USA that have implemented earmarked taxes for mental health and catalogue information about tax design; (2) characterize experiences implementing earmarked taxes among local (e.g., county, city) mental health agency leaders and other government and community organization officials and assess their perceptions of the acceptability and feasibility of different types of policy implementation strategies; and (3) develop a framework to guide effect earmarked tax designs, inform the selection of implementation strategies, and disseminate the framework to policy audiences.MethodsThe project uses the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to inform data collection about the determinants and processes of tax implementation and Leeman’s typology of implementation strategies to examine the acceptability and feasibility strategies which could support earmarked tax policy implementation. A legal mapping will be conducted to achieve aim 1. To achieve aim 2, a survey will be conducted of 300 local mental health agency leaders and other government and community organization officials involved with the implementation of earmarked taxes for mental health. The survey will be followed by approximately 50 interviews with these officials. To achieve aim 3, quantitative and qualitative data will be integrated through a systematic framework development and dissemination process.DiscussionThis exploratory policy implementation process study will build the evidence base for outer-context implementation determinants and strategies by focusing on policies that earmarked taxes for mental health services.

Implementation and outcomes of an ambulatory care pharmacist service: Application of an implementation science framework.

As teams work to optimize the pharmacist's role on care teams, it is important to be proactive and strategic during the service creation process. Implementation science frameworks can help guide pharmacists as they work to translate evidence-based interventions into practice. When a care gap in respiratory chronic disease state management in the primary care setting was identified, a team was created to investigate whether an ambulatory care pharmacist service would be a valuable way to address the care gap. This paper outlines the steps taken to scope and implement a new pharmacist service. An implementation science framework, the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, was used to guide the service implementation process. Postimplementation data were collected to assess the impact of the service. A total of 56 patients were managed by the pharmacist in the first year following implementation. Data suggested that the pharmacist service has clinical value based on an improvement in chronic obstructive pulmonary disease (COPD) symptom control, rescue inhaler use, adherence, and inhaler technique. The data also informed postimplementation changes for continuous quality improvement. The use of an implementation science framework to implement a new pharmacist service proved valuable. Although this project focused on addressing a care gap in COPD, implementation science frameworks can and should be used to guide the implementation of a variety of new clinical services to enhance impact and sustainability.

Integrating HPV Vaccination Within PrEP care Delivery for Underserved Populations: A Mixed Methods Feasibility Study.

Human Papillomavirus (HPV) vaccination is effective at preventing anal cancer, which disproportionally impacts gay/bisexual men (GBM) and transgender women (TGW). Vaccine coverage among GBM/TGW is insufficient to reduce anal cancer disparities. Federally qualified health centers (FQHCs) can increase reach and uptake of HPV vaccination by integrating and promoting HPV vaccination in ongoing HIV preventive care (e.g., Pre-exposure Prophylaxis [PrEP]). The purpose of the current study was to assess the feasibility and potential impact of integrating HPV vaccination with PrEP care. We conducted a mixed methods study of PrEP providers and staff (qualitative interviews, N = 9) and PrEP patients (quantitative survey, N = 88) at an FQHC in Philadelphia, Pennsylvania. Qualitative thematic analysis of PrEP provider/staff interviews was informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to identify and describe barriers and facilitators to HPV vaccination implementation. Quantitative analysis of PrEP patient survey was informed by the Information-Motivation-Behavioral Skills Model. Quantitative interviews resulted in 16 themes related to characteristics of the inner and outer clinic context. Barriers among providers included lack of focus on HPV in PrEP management guidelines, in metrics mandated by funding agencies, and in electronic medical record templates. Lack of anal cancer specific knowledge and motivation was identified in both PrEP patients and providers/staff. Providing HPV vaccination during routine PrEP visits was highly acceptable to both patients and providers. Based on these findings, we recommend several multi-level strategies to increase HPV vaccine uptake among PrEP patients.

Developing an Implementation Model for ADHD Intervention in Community Clinics: Leveraging Artificial Intelligence and Digital Technology

Implementation of behavior therapy for ADHD faces challenges in community settings. We describe development of a community-based implementation model for adolescent ADHD behavior therapy (Supporting Teens’ Autonomy Daily; STAND) blended with Motivational Interviewing (MI). A stakeholder-engaged development approach is used based on the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. Resulting model features include: (a) task-shifting supervision from experts to agency supervisors, (b) holding bi-weekly technical assistance drop-ins to provide training and implementation supports, (c) MI integrity monitoring and feedback by artificial intelligence (AI), (d) AI-generated metrics for STAND content fidelity, (e) digitizing resources (manual, worksheets, tips, videos) on a clinician dashboard, (f) creating visual displays of feedback using badges and graphs, and (g) adding a rapport-building session prior to manualized content. We conducted stakeholder focus groups (N = 32) and two pilot studies to evaluate the new STAND AI measurement tool and revised service-delivery model (N = 6 therapists, 7 youth and parents, 3 agency supervisors). Results revealed advantages and disadvantages of the model, supported the promise of a STAND AI fidelity measurement tool, and indicated initial feasibility, acceptability, and agency engagement in STAND’s community-based implementation model. We discuss future directions for continued iterative development and testing. Video examples are included as supplementary material.

A Novel Policy Alignment and Enhancement Process to Improve Sustainment of School-Based Physical Activity Programming.

The purpose of the current study was twofold: (1) to evaluate the strength and comprehensiveness of district wellness policies in one central Michigan intermediate school district (ISD; 16 districts), and (2) to pilot a novel policy alignment and enhancement process in one district within the ISD to improve sustainment of district-wide physical activity (PA) programming. Policy evaluation and alignment were determined using WellSAT 3.0. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework was used to guide a seven-step policy alignment and enhancement process. Initial evaluation of the PA policy for the ISD revealed a strength score of 19/100 (i.e., included weak and non-specific language) and 31/100 for comprehensiveness (i.e., mentioned few components of the Comprehensive School Physical Activity Program). For the pilot school district, initial strength scores were 19/100 and 38/100 for comprehensiveness (exploration). An alignment of the tailored PA policy with current practices resulted in a 100% increase in strength (score of 38/100), and 132% increase in comprehensiveness (score of 88/100; preparation). However, district administrators encountered barriers to adopting the tailored policy and subsequently integrated the PA requirements into their curriculum guide and school improvement plan (implementation and sustainment). Future research should examine the effectiveness of our EPIS-informed policy evaluation, alignment, and enhancement process to promote widespread increases in student PA.

Advancing research on teams and team effectiveness in implementation science: An application of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.

Effective teams are essential to high-quality healthcare. However, teams, team-level constructs, and team effectiveness strategies are poorly delineated in implementation science theories, models, and frameworks (TMFs), hindering our understanding of how teams may influence implementation. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework is a flexible and accommodating framework that can facilitate the application of team effectiveness approaches in implementation science. We define teams and provide an overview of key constructs in team effectiveness research. We describe ways to conceptualize different types of teams and team constructs relevant to implementation within the EPIS framework. Three case examples illustrate the application of EPIS to implementation studies involving teams. Within each study, we describe the structure of the team and how team constructs influenced implementation processes and outcomes. Integrating teams and team constructs into the EPIS framework demonstrates how TMFs can be applied to advance our understanding of teams and implementation. Implementation strategies that target team effectiveness may improve implementation outcomes in team-based settings. Incorporation of teams into implementation TMFs is necessary to facilitate application of team effectiveness research in implementation science.

The comparative effectiveness of Core versus Core+Enhanced implementation strategies in a randomized controlled trial to improve substance use treatment receipt among justice-involved youth

BackgroundMost justice-involved youth are supervised in community settings, where assessment and linkage to substance use (SU) treatment services are inconsistent and fragmented. Only 1/3 of youth with an identified SU need receive a treatment referral and even fewer initiate services. Thus, improving identification and linkage to treatment requires coordination across juvenile justice (JJ) and behavioral health (BH) agencies. The current study examines the comparative effectiveness of two bundled implementation intervention strategies for improving SU treatment initiation, engagement, and continuing care among justice-involved youth supervised in community settings. Exploration, Preparation, Implementation, Sustainment (EPIS) served as the conceptual framework for study design and selection/timing of implementation intervention components, and the BH Services Cascade served as the conceptual and measurement framework for identifying and addressing gaps in service receipt.MethodsPart of a larger Juvenile-Justice Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) Cooperative, this study involved a multisite, cluster-randomized control trial where sites were paired then randomly assigned to receive Core (training teams on the BH Services Cascade and data-driven decision making; supporting goal selection) or Core+Enhanced (external facilitation of implementation teams) intervention components. Youth service records were collected from 20 JJ community supervision agencies (in five states) across five study phases (baseline, pre-randomization, early experiment, late experiment, maintenance). Implementation teams comprised of JJ and BH staff collaboratively identified goals along the BH Cascade and used data-driven decision-making to implement change.ResultsResults suggest that Core intervention components were effective at increasing service receipt over time relative to baseline, but differences between Core and Core+Enhanced conditions were non-significant. Time to service initiation was shorter among Core+Enhanced sites, and deeper Cascade penetration occurred when external facilitation (of implementation teams) was provided. Wide variation existed in the degree and nature of change across service systems.ConclusionsFindings demonstrate the criticality of early EPIS phases, demonstrating that strategies provided during the formative exploration and preparation phases produced some improvement in service receipt, whereas implementation-focused activities produced incremental improvement in moving youth farther along the Cascade.

Integrating Adolescent Mental Health into HIV Prevention and Treatment Programs: Can Implementation Science Pave the Path Forward?

Adolescent mental health (AMH) is a critical driver of HIV outcomes, but is often overlooked in HIV research and programming. The implementation science Exploration, Preparation, Implementation, Sustainment (EPIS) framework informed development of a questionnaire that was sent to a global alliance of adolescent HIV researchers, providers, and implementors working in sub-Saharan Africa with the aim to (1) describe current AMH outcomes incorporated into HIV research within the alliance; (2) identify determinants (barriers/gaps) of integrating AMH into HIV research and care; and (3) describe current AMH screening and referral systems in adolescent HIV programs in sub-Saharan Africa. Respondents reported on fourteen named studies that included AMH outcomes in HIV research. Barriers to AMH integration in HIV research and care programs were explored with suggested implementation science strategies to achieve the goal of integrated and sustained mental health services within adolescent HIV programs.

Understanding implementation research collaborations from a co-creation lens: Recommendations for a path forward.

Increasing calls within the field of implementation science (IS) research seek to promote active engagement of diverse and often disenfranchised stakeholder voices to increase buy-in, fidelity, outcome relevance, and sustainment of evidence-based practices (EBPs). Including such voices requires cultural humility and the integration of multiple perspectives and values among organizations, groups, and individuals. However, the IS field lacks guidance for researchers on structuring collaborative approaches to promote a co-created process (i.e., synergistic approach to goal attainment). We contend that improved operationalization of co-created implementation collaborations is critical to sparking synergy and addressing differentials based on power, privilege, knowledge, and access to resources among stakeholders. These differentials can undermine future implementation and sustainment efforts if not addressed early in the research effort. An insufficient understanding of the guiding principles of co-created implementation collaborations may limit the scientific value of evaluation processes, and researchers' ability to replicate outcomes. We propose a perspective foregrounded in the concept of co-creation to guide the structuring of implementation collaboratives through five principles. We offer three case examples informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework to illustrate the application of these co-creation principles. Lastly, we offer recommendations for promoting co-creation in IS research moving forward.

Using the Exploration-Preparation-Implementation-Sustainment (EPIS) Framework to prepare for the implementation of evidence-based practices into adolescent HIV settings.

Despite advances in evidence-based practices (EBP) to support HIV prevention and treatment, youth ages 13-24 experience significant disparities in HIV risk and outcomes. An important factor in this disparity is poor EBP implementation, yet implementation research is limited, particularly in youth-serving settings. This study used the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to guide the implementation of four Motivational Interviewing (MI) and MI-framed interventions into youth-serving HIV prevention and treatment settings. Key stakeholders (n = 153) across 13 sites completed pre-implementation interviews. Stakeholders' comments identified two critical factors for effective implementation: fit with the patient population and provider receptivity, including concerns about scope of practice, buy-in, and time. Stakeholders recommended strategies for structuring training, fidelity monitoring, and facilitating implementation including engaging informal leaders, collaboratively developing the implementation strategy, and site-wide implementation. Results highlight the importance of pre-implementation contextual assessment and strategic planning for identifying provider concerns and developing responsive implementation strategies.

Supporting immigrant caregivers during the COVID-19 pandemic: Continuous adaptation and implementation of an early childhood digital engagement program.

Digital messaging programs have the potential to be a powerful, low‐cost, technological tool to support multiple facets of caregivers' knowledge, and implementation of developmentally appropriate caregiver‐child activities among diverse immigrant populations. However, involving caregivers and community stakeholders in the cultural and linguistic tailoring of interventions to optimize utilization and engagement may be critical to ensuring messaging programs' usability and acceptability. The purpose of this mixed‐method study was to use the dynamic adaptation process (DAP) within an Exploration, Preparation, Implementation, Sustainment (EPIS) framework to examine the implementation of a digital messaging program, developed at the beginning of the COVID‐19 pandemic, aimed at providing Spanish‐, English‐, and Mandarin‐speaking immigrant caregivers with caregiver‐child activities that supported children's development and caregivers' knowledge. Building upon the EPIS framework, using DAP, we assessed the feasibility and acceptability of a messaging program via short message service or multimedia message service, WeChat, and Remind and webinar program during the COVID‐19 pandemic. The study illustrated how a digital messaging program is a feasible mechanism for sharing developmentally and culturally appropriate information with immigrant caregivers. In addition, the use of the DAP and the EPIS framework allowed us to continuously track the process of cultural adaptation, identify barriers and facilitators of the outreach program, and examine how implementation unfolded across all three groups of caregivers.

Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care

BackgroundThe US continues to face public health crises related to both chronic pain and opioid overdoses. Thirty percent of Americans suffer from chronic noncancer pain at an estimated yearly cost of over $600 billion. Most patients with chronic pain turn to primary care clinicians who must choose from myriad treatment options based on relative risks and benefits, patient history, available resources, symptoms, and goals. Recently, with attention to opioid-related risks, prescribing has declined. However, clinical experts have countered with concerns that some patients for whom opioid-related benefits outweigh risks may be inappropriately discontinued from opioids. Unfortunately, primary care clinicians lack usable tools to help them partner with their patients in choosing pain treatment options that best balance risks and benefits in the context of patient history, resources, symptoms, and goals. Thus, primary care clinicians and patients would benefit from patient-centered clinical decision support (CDS) for this shared decision-making process.MethodsThe objective of this 3-year project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in new clinical settings in the OneFlorida Clinical Research Consortium. Our central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making. We further hypothesize that increases in shared decision making will lead to improved patient outcomes, specifically pain and physical function. The CDS implementation will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. The evaluation will be organized by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. We will adapt and tailor PainManager, an open source interoperable CDS tool, for implementation in primary care clinics affiliated with the OneFlorida Clinical Research Consortium. We will evaluate the effect of tailored implementation support on PainManager’s adoption for pain treatment shared decision making. This evaluation will establish the feasibility and obtain preliminary data in preparation for a multi-site pragmatic trial targeting the effectiveness of PainManager and tailored implementation support on shared decision making and patient-reported pain and physical function.DiscussionThis research will generate evidence on strategies for implementing interoperable CDS in new clinical settings across different types of electronic health records (EHRs). The study will also inform tailored implementation strategies to be further tested in a subsequent hybrid effectiveness-implementation trial. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions.Trial registrationClinicalTrials.gov, NCT05256394, Registered 25 February 2022.

Implementation and sustainability of safe consumption sites: a qualitative systematic review and thematic synthesis

BackgroundSafe consumption sites (SCSs) serve diverse populations of people who use drugs (PWUD) and public health objectives. SCS implementation began in the 1980s, and today, there are at least 200 known SCSs operating in over twelve countries. While a growing literature supports their effectiveness as a harm reduction strategy, there is limited information on contextual factors that may support or hinder SCS implementation and sustainability. We aimed to fill this gap in knowledge by reviewing existing qualitative studies on SCSs.MethodsWe conducted a systematic review and thematic synthesis of qualitative studies. We identified all peer-reviewed, English-language qualitative studies on SCSs containing original data in PubMed, Web of Science, Google Scholar, and Science Direct as of September 23, 2019. Two authors independently screened, abstracted, and coded content relating to SCS implementation and sustainment aligned with the Exploration, Preparation, Implementation, Sustainment (EPIS) implementation science framework.ResultsAfter removing duplicates, we identified 765 unique records, of which ten qualitative studies met inclusion criteria for our synthesis. Across these ten studies, 236 total interviews were conducted. Overall, studies described how SCSs can (1) keep drug use out of public view while fostering a sense of inclusion for participants, (2) support sustainment by enhancing external communities’ acceptability of SCSs, and (3) encourage PWUD utilization. Most studies also described how involving PWUD and peer workers (i.e., those with lived experience) in SCS operation supported implementation and sustainability.DiscussionOur thematic synthesis of qualitative literature identified engagement of PWUD and additional factors that appear to support SCS planning and operations and are critical to implementation success. However, the existing qualitative literature largely lacked perspectives of SCS staff and other community members who might be able to provide additional insight into factors influencing the implementation and sustainability of this promising public health intervention.

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing DPYD and UGT1A1 Screening to Guide Chemotherapy Dosing.

BackgroundFluoropyrimidines (fluorouracil [5-FU], capecitabine) and irinotecan are commonly prescribed chemotherapy agents for gastrointestinal (GI) malignancies. Pharmacogenetic (PGx) testing for germline DPYD and UGT1A1 variants associated with reduced enzyme activity holds the potential to identify patients at high risk for severe chemotherapy-induced toxicity. Slow adoption of PGx testing in routine clinical care is due to implementation barriers, including long test turnaround times, lack of integration in the electronic health record (EHR), and ambiguity in test cost coverage. We sought to establish PGx testing in our health system following the Exploration, Preparation, Implementation, Sustainment (EPIS) framework as a guide. Our implementation study aims to address barriers to PGx testing.MethodsThe Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI) study is a non-randomized, pragmatic, open-label implementation study at three sites within a major academic health system. Eligible patients with a GI malignancy indicated for treatment with 5-FU, capecitabine, or irinotecan will undergo PGx testing prior to chemotherapy initiation. Specimens will be sent to an academic clinical laboratory followed by return of results in the EHR with appropriate clinical decision support for the care team. We hypothesize that the availability of a rapid turnaround PGx test with specific dosing recommendations will increase PGx test utilization to guide pharmacotherapy decisions and improve patient safety outcomes. Primary implementation endpoints are feasibility, fidelity, and penetrance. Exploratory analyses for clinical effectiveness of genotyping will include assessing grade ≥3 treatment-related toxicity using available clinical data, patient-reported outcomes, and quality of life measures.ConclusionWe describe the formative work conducted to prepare our health system for DPYD and UGT1A1 testing. Our prospective implementation study will evaluate the clinical implementation of this testing program and create the infrastructure necessary to ensure sustainability of PGx testing in our health system. The results of this study may help other institutions interested in implementing PGx testing in oncology care.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT04736472, identifier [NCT04736472].

Profile of the Portfolio of NIH-Funded HIV Implementation Research Projects to Inform Ending the HIV Epidemic Strategies.

The US government created an initiative to end the HIV epidemic in the United States by the year 2030 (EHE). This multiagency initiative was structured around four pillars: Prevent, Diagnose, Treat, and Respond to improve HIV programs, resources, and service delivery infrastructure. In support of its research mission, the National Institutes of Health (NIH) has funded implementation research (IR) projects by addressing the four pillars and encouraging investigators to collaborate with local partners and Health and Human Services (HHS) grantees in 57 priority jurisdictions. This paper analyzed data from the NIH funded CFAR/ARC supplement projects from 2019 to 2021. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework was used to characterize projects by stage of implementation. The Prevent pillar was most frequently studied, with Pre-Exposure Prophylaxis (PrEP) being the most studied intervention. The most common partners were health departments, community-based organizations (CBOs), and Federally Qualified Health Centers (FQHCs). The Consolidated Framework for Implementation Research (CFIR) framework was the most utilized to investigate implementation determinants, followed by the RE-AIM framework and Proctor model to assess implementation outcomes. Monitoring the projects resulting from NIH investments is fundamental to understanding the response to EHE, and achieving these results requires systematic and continuous effort that can support the generalizable implementation knowledge emerging from individual studies. There are some remaining gaps in the project portfolio, including geographical coverage, range of implementation outcomes being measured, and interventions still requiring further research to ensure equitable scale-up of evidence based interventions and achieve EHE goals.