Search

Abstract Background Increased engagement with community-based practices is a promising strategy for increasing clinical trials access of diverse patient populations. In this study we assessed the ability to utilize a patient-advocacy organization led clinical network to engage diverse practices as field sites for clinical research. Methods GO2 for Lung Cancer led recruitment efforts of 17 field sites from their Centers of Excellence in Lung Cancer Screening Network for participation in an implementation-effectiveness trial focused on smoking cessation integration into screening programs for lung cancer. Sites were engaged by one of three methods: 1) Pre-Grant submission of letters of support, 2) a non-targeted study information dissemination campaign to network members, and 3) proactive, targeted outreach to specific centers informed by previously submitted network member data. Detailed self-reported information on barriers to participation was collected from centers that declined to join the study. Results Of 17 total field sites, 16 were recruited via the targeted outreach campaign and 1 via pre-grant letter of support submission. The sites covered 13 states and 4 United States geographic regions, were varied in annual screening volumes and years of screening program experience and were predominantly community-based practices (10 of 17 sites). The most reported reason (by 33% of sites) for declining to participate as a field site was inadequate staffing bandwidth for trial activities. This was especially true in community-based programs among which it was reported by 45% as a reason for declining. Conclusions Our results suggest that this model of field site recruitment leveraging an existing partnership between an academic research team and an informal clinical network maintained by a disease-specific patient advocacy organization can result in engagement of diverse, community-based field sites. Additionally, reported barriers to participation by sites indicate that solutions centered around providing additional resources to enable greater capacity for site staff may increase community-practice participation in research.

Abstract Background Policy is receiving increasing attention in the field of implementation science. However, there remains a lack of clear, concise guidance about how policy can be conceptualized in implementation science research. Building on Curran’s article “Implementation science made too simple”—which defines “the thing” as the intervention, practice, or innovation in need of implementation support—we offer a typology of four very basic ways to conceptualize policy in implementation science research. We provide examples of studies that have conceptualized policy in these different ways and connect aspects of the typology to established frameworks in the field. The typology simplifies and refines related typologies in the field. Four very basic ways to think about policy in implementation science research. 1) Policy as something to adopt: an evidence-supported policy proposal is conceptualized as “the thing” and the goal of research is to understand how policymaking processes can be modified to increase adoption, and thus reach, of the evidence-supported policy. Policy-focused dissemination research is well-suited to achieve this goal. 2) Policy as something to implement: a policy, evidence-supported or not, is conceptualized as “the thing” and the goal of research is to generate knowledge about how policy rollout (or policy de-implementation) can be optimized to maximize benefits for population health and health equity. Policy-focused implementation research is well-suited to achieve this goal. 3) Policy as context to understand: an evidence-supported intervention is “the thing” and policies are conceptualized as a fixed determinant of implementation outcomes. The goal of research is to understand the mechanisms through which policies affect implementation of the evidence-supported intervention. 4) Policy as strategy to use: an evidence-supported intervention is “the thing” and policy is conceptualized as a strategy to affect implementation outcomes. The goal of research is to understand, and ideally test, how policy strategies affect implementation outcomes related to the evidence-supported intervention. Conclusion Policy can be conceptualized in multiple, non-mutually exclusive ways in implementation science. Clear conceptualizations of these distinctions are important to advancing the field of policy-focused implementation science and promoting the integration of policy into the field more broadly.

Abstract Background Tobacco 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. Methods The 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. Discussion The 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 registration ClinicalTrials.gov, NCT05628389, Registered 16 November 2022.

Abstract Background Permanent supportive housing (PSH)—subsidized housing paired with support services such as case management—is a key part of national strategic plans to end homelessness. PSH tenants face high overdose risk due to a confluence of individual and environmental risk factors, yet little research has examined overdose prevention in PSH. Methods We describe the protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial (RCT) of overdose prevention practice implementation in PSH. We adapted evidence-based overdose prevention practices and implementation strategies for PSH using input from stakeholder focus groups. The trial will include 20 PSH buildings (with building size ranging from 20 to over 150 tenants) across New York City and New York’s Capital Region. Buildings will be randomized to one of four 6-month intervention waves during which they will receive a package of implementation support including training in using a PSH Overdose Prevention (POP) Toolkit, time-limited practice facilitation, and learning collaboratives delivered to staff and tenant implementation champions appointed by each building. The primary outcome is building-level fidelity to a defined list of overdose prevention practices. Secondary and exploratory implementation and effectiveness outcomes will be examined using PSH staff and tenant survey questionnaires, and analysis of tenant Medicaid data. We will explore factors related to implementation success, including barriers and facilitators, using qualitative interviews with key stakeholders. The project is being conducted through an academic-community partnership, and an Advisory Board including PSH tenants and other key stakeholders will be engaged in all stages of the project. Discussion We describe the protocol for a hybrid type 3 stepped-wedge cluster RCT of overdose prevention practice implementation in PSH. This study will be the first controlled trial of overdose prevention implementation in PSH settings. The research will make a significant impact by testing and informing future implementation strategies to prevent overdose for a population at particularly high risk for overdose mortality. Findings from this PSH-focused research are expected to be broadly applicable to other housing settings and settings serving people experiencing homelessness. Trial registration ClinicalTrials.gov, NCT05786222 , registered 27 March 2023.

Abstract Background Healthcare facilitation, an implementation strategy designed to improve the uptake of effective clinical innovations in routine practice, has produced promising yet mixed results in randomized implementation trials and has not been fully researched across different contexts. Objective Using mechanism mapping, which applies directed acyclic graphs that decompose an effect of interest into hypothesized causal steps and mechanisms, we propose a more concrete description of how healthcare facilitation works to inform its further study as a meta-implementation strategy. Methods Using a modified Delphi consensus process, co-authors developed the mechanistic map based on a three-step process. First, they developed an initial logic model by collectively reviewing the literature and identifying the most relevant studies of healthcare facilitation components and mechanisms to date. Second, they applied the logic model to write vignettes describing how facilitation worked (or did not) based on recent empirical trials that were selected via consensus for inclusion and diversity in contextual settings (US, international sites). Finally, the mechanistic map was created based on the collective findings from the vignettes. Findings Theory-based healthcare facilitation components informing the mechanistic map included staff engagement, role clarification, coalition-building through peer experiences and identifying champions, capacity-building through problem solving barriers, and organizational ownership of the implementation process. Across the vignettes, engagement of leaders and practitioners led to increased socialization of the facilitator’s role in the organization. This in turn led to clarifying of roles and responsibilities among practitioners and identifying peer experiences led to increased coherence and sense-making of the value of adopting effective innovations. Increased trust develops across leadership and practitioners through expanded capacity in adoption of the effective innovation by identifying opportunities that mitigated barriers to practice change. Finally, these mechanisms led to eventual normalization and ownership of the effective innovation and healthcare facilitation process. Impact Mapping methodology provides a novel perspective of mechanisms of healthcare facilitation, notably how sensemaking, trust, and normalization contribute to quality improvement. This method may also enable more efficient and impactful hypothesis-testing and application of complex implementation strategies, with high relevance for lower-resourced settings, to inform effective innovation uptake.

Abstract Background The Cancer Center Cessation Initiative (C3I) is a National Cancer Institute (NCI) Cancer Moonshot Program that supports NCI-designated cancer centers developing tobacco treatment programs for oncology patients who smoke. C3I-funded centers implement evidence-based programs that offer various smoking cessation treatment components (e.g., counseling, Quitline referrals, access to medications). While evaluation of implementation outcomes in C3I is guided by evaluation of reach and effectiveness (via RE-AIM), little is known about technical efficiency—i.e., how inputs (e.g., program costs, staff time) influence implementation outcomes (e.g., reach, effectiveness). This study demonstrates the application of data envelopment analysis (DEA) as an implementation science tool to evaluate technical efficiency of C3I programs and advance prioritization of implementation resources. Methods DEA is a linear programming technique widely used in economics and engineering for assessing relative performance of production units. Using data from 16 C3I-funded centers reported in 2020, we applied input-oriented DEA to model technical efficiency (i.e., proportion of observed outcomes to benchmarked outcomes for given input levels). The primary models used the constant returns-to-scale specification and featured cost-per-participant, total full-time equivalent (FTE) effort, and tobacco treatment specialist effort as model inputs and reach and effectiveness (quit rates) as outcomes. Results In the DEA model featuring cost-per-participant (input) and reach/effectiveness (outcomes), average constant returns-to-scale technical efficiency was 25.66 (SD = 24.56). When stratified by program characteristics, technical efficiency was higher among programs in cohort 1 (M = 29.15, SD = 28.65, n = 11) vs. cohort 2 (M = 17.99, SD = 10.16, n = 5), with point-of-care (M = 33.90, SD = 28.63, n = 9) vs. no point-of-care services (M = 15.59, SD = 14.31, n = 7), larger (M = 33.63, SD = 30.38, n = 8) vs. smaller center size (M = 17.70, SD = 15.00, n = 8), and higher (M = 29.65, SD = 30.99, n = 8) vs. lower smoking prevalence (M = 21.67, SD = 17.21, n = 8). Conclusion Most C3I programs assessed were technically inefficient relative to the most efficient center benchmark and may be improved by optimizing the use of inputs (e.g., cost-per-participant) relative to program outcomes (e.g., reach, effectiveness). This study demonstrates the appropriateness and feasibility of using DEA to evaluate the relative performance of evidence-based programs.

Abstract Background Smoking rates remain high in Vietnam, particularly among people living with HIV/AIDS (PLWH), but tobacco cessation services are not available in outpatient HIV clinics (OPCs). The research team is conducting a type II hybrid randomized controlled trial (RCT) comparing the cost-effectiveness of three tobacco cessation interventions among PLWH receiving care in HIV clinics in Vietnam. The study is simultaneously evaluating the implementation processes and outcomes of strategies aimed at increasing the implementation of tobacco dependence treatment (TDT) in the context of HIV care. This paper describes the systematic, theory-driven process of adapting intervention components and implementation strategies with demonstrated effectiveness in high-income countries, and more recently in Vietnam, to a new population (i.e., PLWH) and new clinical setting, prior to launching the trial. Methods Data collection and analyses were guided by two implementation science frameworks and the socio-ecological model. Qualitative interviews were conducted with 13 health care providers and 24 patients in three OPCs. Workflow analyses were conducted in each OPC. Qualitative data were analyzed using rapid qualitative analysis procedures. Based on findings, components of the intervention and implementation strategies were adapted, followed by a 3-month pilot study in one OPC with 16 patients randomized to one of two intervention arms. Results The primary adaptations included modifying the TDT intervention counseling content to address barriers to quitting among PLWH and Vietnamese sociocultural norms that support smoking cessation. Implementation strategies (i.e., training and system changes) were adapted to respond to provider- and clinic-level determinants of implementation effectiveness (e.g., knowledge gaps, OPC resource constraints, staffing structure, compatibility). Conclusions Adaptations were facilitated through a mixed method, stakeholder (patient and health care provider, district health leader)-engaged evaluation of context-specific influences on intervention and implementation effectiveness. This data-driven approach to refining and adapting components aimed to optimize intervention effectiveness and implementation in the context of HIV care. Balancing pragmatism with rigor through the use of rapid analysis procedures and multiple methods increased the feasibility of the adaptation process. Trial registration ClinicalTrials.gov NCT05162911 . Registered on December 16, 2021.

Abstract Background Several tools to improve reporting of implementation studies for evidence-based decision making have been created; however, no tool for critical appraisal of implementation outcomes exists. Researchers, practitioners, and policy makers lack tools to support the concurrent synthesis and critical assessment of outcomes for implementation research. Our objectives were to develop a comprehensive tool to (1) describe studies focused on implementation that use qualitative, quantitative, and/or mixed methodologies and (2) assess risk of bias of implementation outcomes. Methods A hybrid consensus-building approach combining Delphi Group and Nominal Group techniques (NGT) was modeled after comparative methodologies for developing health research reporting guidelines and critical appraisal tools. First, an online modified NGT occurred among a small expert panel (n = 5), consisting of literature review, item generation, round robin with clarification, application of the tool to various study types, voting, and discussion. This was followed by a larger e-consensus meeting and modified Delphi process with implementers and implementation scientists (n = 32). New elements and elements of various existing tools, frameworks, and taxonomies were combined to produce the ASSESS tool. Results The 24-item tool is applicable to a broad range of study designs employed in implementation science, including qualitative studies, randomized-control trials, non-randomized quantitative studies, and mixed methods studies. Two key features are a section for assessing bias of the implementation outcomes and sections for describing the implementation strategy and intervention implemented. An accompanying explanation and elaboration document that identifies and describes each of the items, explains the rationale, and provides examples of reporting and appraising practice, as well as templates to allow synthesis of extracted data across studies and an instructional video, has been prepared. Conclusions The comprehensive, adaptable tool to support both reporting and critical appraisal of implementation science studies including quantitative, qualitative, and mixed methods assessment of intervention and implementation outcomes has been developed. This tool can be applied to a methodologically diverse and growing body of implementation science literature to support reviews or meta-analyses that inform evidence-based decision-making regarding processes and strategies for implementation.

Abstract Background A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. Methods The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. Discussion Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. Trial registration This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

Abstract Background Most hookah use studies have not included racial and ethnic minorities which limits our understanding of its use among these growing populations. This study aimed to investigate the individual characteristics of hookah use patterns and associated risk behaviors among an ethnically diverse sample of college students. Methods A cross-sectional survey of 2460 students (aged 18–25) was conducted in 2015, and data was analyzed in 2017. Descriptive statistics were used to present the sociodemographic characteristics, hookah use-related behavior, and binge drinking and marijuana use according to the current hookah use group, including never, exclusive, dual/poly hookah use. Multivariate logistic regression was conducted to examine how hookah related behavior and other risk behaviors varied by sociodemographics and hookah use patterns. Results Among current hookah users (n = 312), 70% were exclusive hookah users and 30% were dual/poly hookah users. There were no statistically significant differences in sociodemographic characteristics except for race/ethnicity (p

Abstract Background Implementation science (IS) has the potential to serve an important role in encouraging the successful uptake of evidence-based interventions. The current state of IS awareness and engagement among health researchers, however, is relatively unknown. Methods To determine IS awareness and engagement among health researchers, we performed an online survey of health researchers in the USA in 2018. Basic science researchers were excluded from the sample. Engagement in and awareness of IS were measured with multiple questionnaire items that both directly and indirectly ask about IS methods used. Unrecognized IS engagement was defined as participating in research using IS elements and not indicating IS as a research method used. We performed simple logistic regressions and tested multivariable logistic regression models of researcher characteristics as predictors of IS engagement. Results Of the 1767 health researchers who completed the survey, 68% stated they would be able to describe IS. Only 12.7% of the population self-identified as using IS methods. Of the researchers not self-identifying as using IS methods, 86.4% reported using the IS elements “at least some of the time.” Nearly half (47.9%) reported using process/implementation evaluation, 89.2% use IS measures, 27.3% use IS frameworks, and 75.6% investigate or examine ways to integrate interventions into routine health settings. IS awareness significantly reduced the likelihood of all measures of unrecognized IS engagement (aOR 0.13, 95% CI 0.07 to 0.27, p < 0.001). Conclusion Overall, awareness of IS is high among health researchers, yet there is also a high prevalence of unrecognized IS engagement. Efforts are needed to further disseminate what constitutes IS research and increase IS awareness among health researchers.

Abstract Background Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes. Methods/design The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (≥ 5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss. Discussion This study will be the first to test the efficacy of an integrated EHR–CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study’s implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways. Trial registration This study protocol has been approved and is made available on ClinicalTrials.gov by NCT 03188094 as of 15 June 2017.

Abstract Background Tobacco remains a leading cause of preventable death in the U.S., responsible for more than 440,000 deaths each year. Approximately 10% of these deaths are attributable to exposure of non-smokers to secondhand smoke (SHS). Residents living in public multi-unit housing (MUH) are at excess risk for SHS exposure compared to the general population. On November 30, 2016, the U.S. Department of Housing and Urban Development (HUD) passed a rule requiring all public housing agencies to implement smoke-free housing (SFH) policies in their housing developments by July 30, 2018. Methods As part of a larger natural experiment study, we designed a protocol to evaluate indoor SHS levels before and after policy implementation through collection of repeat indoor air samples in non-smoking apartments and common areas of select high-rise NYCHA buildings subject to the HUD SFH rule, and also from socio-demographically matched private-sector high-rise control buildings not subject to the rule. A baseline telephone survey was conducted in all selected buildings to facilitate rapid recruitment into the longitudinal study and assess smoking prevalence, behaviors, and attitudes regarding the SFH policy prior to implementation. Data collection began in early 2018 and will continue through 2021. Discussion The baseline survey was completed by 559 NYCHA residents and 471 comparison building residents (response rates, 35, and 32%, respectively). Smoking prevalence was comparable between study arms (15.7% among NYCHA residents and 15.2% among comparison residents). The majority of residents reported supporting a building-wide smoke-free policy (63.0 and 59.9%, respectively). We enrolled 157 NYCHA and 118 comparison non-smoking households into the longitudinal air monitoring study and performed air monitoring in common areas. Follow up surveys and air monitoring in participant households occur every 6 months for 2.5 years. Capitalizing on the opportunity of this federal policy rollout, the large and diverse public housing population in NYC, and robust municipal data sources, this study offers a unique opportunity to evaluate the policy’s direct impacts on SHS exposure. Methods in this protocol can inform similar SFH policy evaluations elsewhere.

Abstract Background Treatment for opioid use disorder (OUD) is highly effective, yet it remains dramatically underutilized. Individuals with OUD have disproportionately high rates of hospitalization and low rates of addiction treatment. Hospital-based addiction consult services offer a potential solution by using multidisciplinary teams to evaluate patients, initiate medication for addiction treatment (MAT) in the hospital, and connect patients to post-discharge care. We are studying the effectiveness of an addiction consult model [Consult for Addiction Treatment and Care in Hospitals (CATCH)] as a strategy for engaging patients with OUD in treatment as the program rolls out in the largest municipal hospital system in the US. The primary aim is to evaluate the effectiveness of CATCH in increasing post-discharge initiation and engagement in MAT. Secondary aims are to assess treatment retention, frequency of acute care utilization and overdose deaths and their associated costs, and implementation outcomes. Methods A pragmatic trial at six hospitals, conducted in collaboration with the municipal hospital system and department of health, will be implemented to study the CATCH intervention. Guided by the RE-AIM evaluation framework, this hybrid effectiveness-implementation study (Type 1) focuses primarily on effectiveness and also measures implementation outcomes to inform the intervention’s adoption and sustainability. A stepped-wedge cluster randomized trial design will determine the impact of CATCH on treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a 6- to 18-month maintenance period at each hospital. A mixed methods approach will primarily utilize administrative data to measure outcomes, while interviews and focus groups with staff and patients will provide additional information on implementation fidelity and barriers to delivering MAT to patients with OUD. Discussion Because of their great potential to reduce the negative health and economic consequences of untreated OUD, addiction consult models are proliferating in response to the opioid epidemic, despite the absence of a strong evidence base. This study will provide the first known rigorous evaluation of an addiction consult model in a large multi-site trial and promises to generate knowledge that can rapidly transform practice and inform the potential for widespread dissemination of these services. Trial registration: NCT03611335

An amendment to this paper has been published and can be accessed via the original article.