Study protocol: the ILANA study - exploring optimal implementation strategies for long-acting antiretroviral therapy to ensure equity in clinical care and policy for women, racially minoritised people and older people living with HIV in the UK - a qualitative multiphase longitudinal study design.

INTRODUCTION: Cabotegravir and rilpivirine (CAB+RPV long-acting (LA)) is recommended as a treatment for HIV-1 allowing people living with HIV to receive 2 monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage study participants on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within constrained health economies with capacity limitations. In this pragmatic multicentre study, we aim to understand the implementation of CAB-RPV-LA administration in two settings via mixed methods to explore perspectives of participants and the clinical team delivering CAB+RPV LA. METHODS AND ANALYSIS: Women, racially minoritised people and older people are chronically under-represented in HIV clinical trials so the ILANA trial has set recruitment caps to ensure recruitment of 50% women, 50% ethnically diverse people and 30% over 50 years of age to include a more representative study population. Using a mixed-methods approach, the primary objective is to identify and evaluate the critical implementation strategies for CAB+RPV LA in both hospital and community settings. Secondary objectives include evaluating feasibility and acceptability of CAB+RPV LA administration at UK clinics and community settings from the perspective of HIV care providers, nurses and representatives at community sites, evaluating barriers to implementation, the utility of implementation strategies and adherence. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Health Research Authority Research Ethics Committee (REC reference: 22/PR/0318). The dissemination strategy has been formulated with the SHARE Collaborative Community Advisory Board to maximise the impact of this work on clinical care and policy. This strategy draws on and leverages existing resources within the participating organisations, such as their academic infrastructure, professional relationships and community networks. The strategy will leverage the Public Engagement Team and press office to support dissemination of findings. TRIAL REGISTRATION NUMBER: NCT05294159.

Patient Preferences for Discussing and Acting on Health-Related Needs in Primary Care.

BACKGROUND: Addressing social needs, health behaviors, and mental health may help patients more than traditional medical care. However, these root causes of poor health are difficult to address and the role of primary care is unclear. This qualitative study assesses patient's willingness and motivations to discuss and accept assistance for these needs from their primary care team. METHODS: In July and August of 2020, semi-structured virtual interviews were conducted with family medicine patients (n = 6) and residents of low resource neighborhoods (n = 11) in Richmond, Virginia. Interviews were conducted over Zoom. We conducted a qualitative analysis of patient and resident interview transcripts. A rapid qualitative analysis approach and immersion-crystallization processes were used to identify themes and categories. RESULTS: Interviewees reported varying degrees of comfort discussing topics with their health care team. They were less comfortable discussing needs they considered outside the realm of "traditional primary care" including finances, transportation, and housing, but interviewees expressed willingness to discuss these needs under certain conditions. Important factors were a strong patient-clinician relationship to create a trusted and safe space for discussion, adequate time for discussion during visits, communication of practices' ability to provide resources to help patients, and ensuring appropriate high quality referrals. CONCLUSIONS: Primary care provides opportunity for identifying and addressing needs that adversely impact health. Some needs are more sensitive for patients to work with their care team on, though, there was willingness to work on any need when a strong provider relationship and clinic structure for providing support were in place. This study highlights critical care delivery factors which may be used to enhance patient comfort accepting support for their needs and ultimately improve clinical care and chronic disease management.

Implementation of social needs screening in primary care: a qualitative study using the health equity implementation framework.

BACKGROUND: Screening in primary care for unmet individual social needs (e.g., housing instability, food insecurity, unemployment, social isolation) is critical to addressing their deleterious effects on patients' health outcomes. To our knowledge, this is the first study to apply an implementation science framework to identify implementation factors and best practices for social needs screening and response. METHODS: Guided by the Health Equity Implementation Framework (HEIF), we collected qualitative data from clinicians and patients to evaluate barriers and facilitators to implementing the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), a standardized social needs screening and response protocol, in a federally qualified health center. Eligible patients who received the PRAPARE as a standard of care were invited to participate in semi-structured interviews. We also obtained front-line clinician perspectives in a semi-structured focus group. HEIF domains informed a directed content analysis. RESULTS: Patients and clinicians (i.e., case managers) reported implementation barriers and facilitators across multiple domains (e.g., clinical encounters, patient and provider factors, inner context, outer context, and societal influence). Implementation barriers included structural and policy level determinants related to resource availability, discrimination, and administrative burden. Facilitators included evidence-based clinical techniques for shared decision making (e.g., motivational interviewing), team-based staffing models, and beliefs related to alignment of the PRAPARE with patient-centered care. We found high levels of patient acceptability and opportunities for adaptation to increase equitable adoption and reach. CONCLUSION: Our results provide practical insight into the implementation of the PRAPARE or similar social needs screening and response protocols in primary care at the individual encounter, organizational, community, and societal levels. Future research should focus on developing discrete implementation strategies to promote social needs screening and response, and associated multisector care coordination to improve health outcomes and equity for vulnerable and marginalized patient populations.

Strengthening methods for tracking adaptations and modifications to implementation strategies.

BACKGROUND: Developing effective implementation strategies requires adequate tracking and reporting on their application. Guidelines exist for defining and reporting on implementation strategy characteristics, but not for describing how strategies are adapted and modified in practice. We built on existing implementation science methods to provide novel methods for tracking strategy modifications. METHODS: These methods were developed within a stepped-wedge trial of an implementation strategy package designed to help community clinics adopt social determinants of health-related activities: in brief, an 'Implementation Support Team' supports clinics through a multi-step process. These methods involve five components: 1) describe planned strategy; 2) track its use; 3) monitor barriers; 4) describe modifications; and 5) identify / describe new strategies. We used the Expert Recommendations for Implementing Change taxonomy to categorize strategies, Proctor et al.'s reporting framework to describe them, the Consolidated Framework for Implementation Research to code barriers / contextual factors necessitating modifications, and elements of the Framework for Reporting Adaptations and Modifications-Enhanced to describe strategy modifications. RESULTS: We present three examples of the use of these methods: 1) modifications made to a facilitation-focused strategy (clinics reported that certain meetings were too frequent, so their frequency was reduced in subsequent wedges); 2) a clinic-level strategy addition which involved connecting one study clinic seeking help with community health worker-related workflows to another that already had such a workflow in place; 3) a study-level strategy addition which involved providing assistance in overcoming previously encountered (rather than de novo) challenges. CONCLUSIONS: These methods for tracking modifications made to implementation strategies build on existing methods, frameworks, and guidelines; however, as none of these were a perfect fit, we made additions to several frameworks as indicated, and used certain frameworks' components selectively. While these methods are time-intensive, and more work is needed to streamline them, they are among the first such methods presented to implementation science. As such, they may be used in research on assessing effective strategy modifications and for replication and scale-up of effective strategies. We present these methods to guide others seeking to document implementation strategies and modifications to their studies. TRIAL REGISTRATION: clinicaltrials.gov ID: NCT03607617 (first posted 31/07/2018).

A scoping review of the use of ethnographic approaches in implementation research and recommendations for reporting.

BACKGROUND: Researchers have argued for the value of ethnographic approaches to implementation science (IS). The contested meanings of ethnography pose challenges and possibilities to its use in IS. The goal of this study was to identify sources of commonality and variation, and to distill a set of recommendations for reporting ethnographic approaches in IS. METHODS: We included in our scoping review English-language academic journal articles meeting two criteria: (1) IS articles in the healthcare field and (2) articles that described their approach as ethnographic. In March 2019, we implemented our search criteria in four academic databases and one academic journal. Abstracts were screened for inclusion by at least two authors. We iteratively develop a codebook for full-text analysis and double-coded included articles. We summarized the findings and developed reporting recommendations through discussion. RESULTS: Of the 210 articles whose abstracts were screened, 73 were included in full-text analysis. The number of articles increased in recent years. Ethnographic approaches were used within a wide variety of theoretical approaches and research designs. Articles primarily described using interviews and observational methods as part of their ethnographic approaches, though numerous other methods were also employed. The most cited rationales for using ethnographic approaches were to capture context-specific phenomena, understand insiders' perspective, and study complex interactions. In reporting on ethnographic approaches, we recommend that researchers provide information on researcher training and position, reflect on researchers' positionality, describe observational methods in detail, and report results from all the methods used. CONCLUSION: The number of IS studies using ethnography has increased in recent years. Ethnography holds great potential for contributing further to IS, particularly to studying implementation strategy mechanisms and understanding complex adaptive systems.

Engaging with the Richmond Community to Reduce Pediatric Asthma Disparities: Findings from a Community-engaged Needs Assessment.

Childhood asthma disparities persist, with children living in low-income areas experiencing worse morbidity. We partnered with a community-academic research team and stakeholders to conduct a needs assessment to understand barriers and supports to asthma treatment. We convened a community advisory board, comprised of parents of children with asthma, youth with asthma, and members of key community organizations. Two focus groups with parents of children with asthma and four focus groups with youth with asthma were conducted, and a survey was administered to 100 parents. A visual mapping process was used to gather qualitative data about barriers, strategies, and outcomes, and allowed advisory board members to interpret focus group and survey data within the lived experiences of families. Focus group themes included parent stress/anxiety, concerns about school nurses, and lack of trust in providers. Findings from focus groups and surveys suggested that emergency department visits were not perceived negatively by families, although health providers and researchers generally view them as such. Public health implications include systemic changes that allow the healthcare system to address families' acute needs and worry. A community program focused on education and coordination among families, schools, and medical homes might improve asthma outcomes at the population level.

Improving the implementation and sustainment of evidence-based practices in community mental health organizations: a study protocol for a matched-pair cluster randomized pilot study of the Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS).

BACKGROUND: Implementing and sustaining evidence-based programs with fidelity may require multiple implementation strategies tailored to address multi-level, context-specific barriers and facilitators. Ideally, selecting and tailoring implementation strategies should be guided by theory, evidence, and input from relevant stakeholders; however, methods to guide the selection and tailoring of strategies are not well-developed. There is a need for more rigorous methods for assessing and prioritizing implementation determinants (barriers and facilitators) and linking implementation strategies to determinants. The Collaborative Organizational Approach to Selecting and Tailoring Implementation Strategies (COAST-IS) is an intervention designed to increase the effectiveness of evidence-based practice implementation and sustainment. COAST-IS will enable organizational leaders and clinicians to use Intervention Mapping to select and tailor implementation strategies to address their site-specific needs. Intervention Mapping is a multi-step process that incorporates theory, evidence, and stakeholder perspectives to ensure that implementation strategies effectively address key determinants of change. METHODS: COAST-IS will be piloted with community mental health organizations that are working to address the needs of children and youth who experience trauma-related emotional or behavioral difficulties by engaging in a learning collaborative to implement an evidence-based psychosocial intervention (trauma-focused cognitive behavioral therapy). Organizations will be matched and then randomized to participate in the learning collaborative only (control) or to receive additional support through COAST-IS. The primary aims of this study are to (1) assess the acceptability, appropriateness, feasibility, and perceived utility of COAST-IS; (2) evaluate the organizational stakeholders' fidelity to the core elements of COAST-IS; and (3) demonstrate the feasibility of testing COAST-IS in a larger effectiveness trial. DISCUSSION: COAST-IS is a systematic method that integrates theory, evidence, and stakeholder perspectives to improve the effectiveness and precision of implementation strategies. If effective, COAST-IS has the potential to improve the implementation and sustainment of a wide range of evidence-based practices in mental health and other sectors. TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov (NCT03799432) on January 10, 2019 (last updated August 5, 2019).

Determinants of Implementing Evidence-Based Trauma-Focused Interventions for Children and Youth: A Systematic Review.

A systematic review was conducted to identify determinants (barriers and facilitators) of implementing evidence-based psychosocial interventions for children and youth who experience emotional or behavioral difficulties due to trauma exposure. Determinants were coded, abstracted, and synthesized using the Exploration, Preparation, Implementation, and Sustainment framework. Twenty-three articles were included, all of which examined implementation of Trauma-Focused Cognitive Behavioral Therapy or Cognitive-Behavioral Intervention for Trauma in Schools. This review identified multilevel and multiphase determinants that can be addressed by implementation strategies to improve implementation and clinical outcomes, and suggests how future studies might address gaps in the evidence base.

Assessing the Impacts and Ripple Effects of a Community-University Partnership: A Retrospective Roadmap.

Each community-based participatory research (CBPR) partnership may incur "ripple effects" - impacts that happen outside the scope of planned projects. We used brainstorming and interviewing to create a roadmap that incorporated input from nine CBPR participants and five community/academic partners to retrospectively assess the ripple effects observed after five years of participatory research in one urban community. The resulting roadmap reflected a range of community impacts which we then divided into four key areas: impacts in the community (i.e., strategies, programs, and policies implemented by community partners), impacts on the CBPR team, impacts on individuals (participants and community members), and contributions to the field and the university. Our approach focused on observing what happened in the community that was directly or indirectly related to our partnership, process, products, and relationships. Much of the impact we observed reflected the synergy of sharing our research and community voice with responsive partners and stakeholders.

A Patient and Provider Research Agenda on Diabetes and Hypertension Management.

INTRODUCTION: A demonstration project in Richmond, Virginia involved patients and other stakeholders in the creation of a research agenda on dietary and behavioral management of diabetes and hypertension. Given the impact of these diseases on morbidity and mortality, considerable research has been directed at the challenges patients face in chronic disease management. The continuing need to understand disparities and find evidence-based interventions to improve outcomes has been fruitful, but disparities and unmet needs persist. METHODS: The Stakeholder Engagement in Question Development (SEED) method is a stakeholder engagement methodology that combines engagement with a review of available evidence to generate research questions that address current research gaps and are important to patients and other stakeholders. Using the SEED method, patients and other stakeholders participated in research question development through a combination of collaborative, participatory, and consultative engagement. Steps in the process included: (1) identifying the topic and recruiting participants; (2) conducting focus groups and interviews; (3) developing conceptual models; (4) developing research questions; and (5) prioritizing research questions. RESULTS: Stakeholders were involved in the SEED process from February to August 2015. Eighteen questions were prioritized for inclusion in the research agenda, covering diverse domains, from healthcare provision to social and environmental factors. Data analysis took place September to May 2016. During this time, researchers conducted a literature review to target research gaps. CONCLUSIONS: The stakeholder-prioritized, novel research questions developed through the SEED process can directly inform future research and guide the development of evidence that translates more directly to clinical practice.

Authentic Engagement Of Patients And Communities Can Transform Research, Practice, And Policy.

The engagement of patients and the public is increasingly important in the design and conduct of research. Some researchers still cling to the outdated notion that laypeople cannot contribute meaningfully to science; for some, "community engagement" is another term for recruiting patients for trials. Authentic engagement encompasses far more, involving stakeholders as full partners in all phases of research, as research funders increasingly require. Such engagement, although challenging, can enhance the quality and impact of studies on many levels, from ensuring that data are relevant to users' needs to elevating the moral plane of research by showing respect to patients and vulnerable populations. We share examples from our work, including the engagement of patients in a study of cancer screening decisions and the engagement of inner-city residents in addressing social determinants of health. These engagement principles are of growing relevance to health systems and policy makers responsible for population health.

Translating Research into Action: A Framework for Research That Supports Advances In Population Health.

The research community faces a growing need to deliver useful data and actionable evidence to support health systems and policymakers on ways to optimize the health of populations. Translating science into policy has not been the traditional strong suit of investigators, who typically view a journal publication as the endpoint of their work. They are less accustomed to seeing their data as an input to the work of communities and policymakers to improve population health. This article offers four suggestions as potential solutions: (1) shaping a research portfolio around user needs, (2) understanding the decision-making environment, (3) engaging stakeholders, and (4) strategic communication.

Translating evidence into population health improvement: strategies and barriers.

Among the challenges facing research translation-the effort to move evidence into policy and practice-is that key questions chosen by investigators and funders may not always align with the information priorities of decision makers, nor are the findings always presented in a form that is useful for or relevant to the decisions at hand. This disconnect is a problem particularly for population health, where the change agents who can make the biggest difference in improving health behaviors and social and environmental conditions are generally nonscientists outside of the health professions. To persuade an audience that does not read scientific journals, strong science may not be enough to elicit change. Achieving influence in population health often requires four ingredients for success: research that is responsive to user needs, an understanding of the decision-making environment, effective stakeholder engagement, and strategic communication. This article reviews the principles and provides examples from a national and local initiative.