The Tennessee Heart Health Network effectiveness study: A stepped wedge cluster randomized controlled trial to assess the effectiveness of statewide quality improvement cooperative participation on cardiovascular outcomes.

BACKGROUND: Cardiovascular disease (CVD) is the primary cause of premature morbidity and mortality in the United States and Tennessee ranks among the highest in CVD events. While patient-centered outcomes research (PCOR) evidence-based approaches that reach beyond the traditional doctor-patient visit hold promise to improve CVD care and prevent serious complications, most primary care providers lack time, knowledge, and infrastructure to implement these proven approaches. Statewide primary care quality improvement (QI) collaboratives hold potential to help address primary care needs, however, little is known regarding their effectiveness in improving uptake of PCOR evidence-based population health approaches and improving CVD outcomes. This study describes the design and implementation of a stepped-wedge cluster randomized controlled trial to assess the effectiveness of participation in a statewide quality improvement cooperative (The Tennessee Heart Health Network [TN-HHN]) on cardiovascular outcomes. METHODS/DESIGN: The TN-HHN Effectiveness Study randomized 77 practices to 4 waves (i.e., clusters), with each wave beginning three months after the start of the prior wave and lasting for 18 months. All practice clusters received one of three Network interventions, and outcomes are measured for each three months both in the control phase and the intervention phase. Primary outcomes include Center for Medicare and Medicaid Services measures for aspirin use, blood pressure control, cholesterol control, and smoking cessation (ABCS). CONCLUSIONS: This trial, upon its conclusion, will allow us to assess the effect of participation in a statewide quality improvement cooperative on cardiovascular outcomes as well as key contributors to successful practice transformation.

"Hypertension is such a difficult disease to manage": federally qualified health center staff- and leadership-perceived readiness to implement a technology-facilitated team-based hypertension model.

BACKGROUND: Despite decades of evidence demonstrating the efficacy of hypertension care delivery in reducing morbidity and mortality, a majority of hypertension cases remain uncontrolled. There is an urgent need to elucidate and address multilevel facilitators and barriers clinical staff face in delivering evidence-based hypertension care, patients face in accessing it, and clinical systems face in sustaining it. Through a rigorous pre-implementation evaluation, we aimed to identify facilitators and barriers bearing the potential to affect the planned implementation of a multilevel technology-facilitated hypertension management trial across six primary care sites in a large federally qualified health center (FQHC) in New York City. METHODS: During a dedicated pre-implementation period (3-9 months/site, 2021-2022), a capacity assessment was conducted by trained practice facilitators, including (1) online anonymous surveys (n = 124; 70.5% of eligible), (2) hypertension training analytics (n = 69; 94.5% of assigned), and (3) audio-recorded semi-structured interviews (n = 67; 48.6% of eligible) with FQHC leadership and staff. Surveys measured staff sociodemographic characteristics, adaptive reserve, evidence-based practice attitudes, and implementation leadership scores via validated scales. Training analytics, derived from end-of-course quizzes, included mean score and number attempts needed to pass. Interviews assessed staff-reported facilitators and barriers to current hypertension care delivery and uptake; following audio transcription, trained qualitative researchers employed a deductive coding approach, informed by the Consolidated Framework for Implementation Research (CFIR). RESULTS: Most survey respondents reported moderate adaptive reserve (mean = 0.7, range = 0-1), evidence-based practice attitudes (mean = 2.7, range = 0-4), and implementation leadership (mean = 2.5, range = 0-4). Most staff passed training courses on first attempt and demonstrated high scores (means > 80%). Findings from interviews identified potential facilitators and barriers to implementation; specifically, staff reported that complex barriers to hypertension care, control, and clinical communication exist; there is a recognized need to improve hypertension care; in-clinic challenges with digital tool access imposes workflow delays; and despite high patient loads, staff are motivated to provide high-quality cares. CONCLUSIONS: This study serves as one of the first to apply the CFIR to a rigorous pre-implementation evaluation within the understudied context of a FQHC and can serve as a model for similar trials seeking to identify and address contextual factors known to impact implementation success. TRIAL REGISTRATION: ClinicalTrials.gov NCT03713515 , date of registration: October 19, 2018.

Application of the FRAME-IS to a multifaceted implementation strategy.

BACKGROUND: Research demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation. In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC). METHODS: Three data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation. RESULTS: We modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process. CONCLUSION: With modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations. TRIAL REGISTRATION: Clinicaltrials.gov NCT03713515, Registration date: October 19, 2018.

Building a sharable literature collection to advance the science and practice of implementation facilitation.

Background: Implementation science seeks to produce generalizable knowledge on strategies that promote the adoption and sustained use of evidence-based innovations. Literature reviews on specific implementation strategies can help us understand how they are conceptualized and applied, synthesize findings, and identify knowledge gaps. Although rigorous literature reviews can advance scientific knowledge and facilitate theory development, they are time-consuming and costly to produce. Improving the efficiency of literature review processes and reducing redundancy of effort is especially important for this rapidly developing field. We sought to amass relevant literature on one increasingly used evidence-based strategy, implementation facilitation (IF), as a publicly available resource. Methods: We conducted a rigorous systematic search of PubMed, CINAHL, and Web of Science citation databases for peer-reviewed, English-language articles with "facilitation" and a combination of other terms published from January 1996 to December 2021. We searched bibliographies of articles published from 1996 to 2015 and identified articles during the full text review that reported on the same study. Two authors screened 3,168 abstracts. After establishing inter-rater reliability, they individually conducted full-text review of 786 relevant articles. A multidisciplinary team of investigators provided recommendations for preparing and disseminating the literature collection. Findings: The literature collection is comprised of 510 articles. It includes 277 empirical studies of IF and 77 other articles, including conceptual/theoretical articles, literature reviews, debate papers and descriptions of large-scale clinical initiatives. Over half of the articles were published between 2017 and 2021. The collection is publicly available as an Excel file and as an xml file that can be imported into reference management software. Conclusion: We created a publicly accessible collection of literature about the application of IF to implement evidence-based innovations in healthcare. The comprehensiveness of this collection has the potential to maximize efficiency and minimize redundancy in scientific inquiry about this strategy. Scientists and practitioners can use the collection to more rapidly identify developments in the application of IF and to investigate a wide range of compelling questions on its use within and across different healthcare disciplines/settings, countries, and payer systems. We offer several examples of how this collection has already been used.

Exemplar Hospital initiation trial to Enhance Treatment Engagement (EXHIT ENTRE): protocol for CTN-0098B a randomized implementation study to support hospitals in caring for patients with opioid use disorder.

BACKGROUND: Hospitalizations involving opioid use disorder (OUD) are increasing. Medications for opioid use disorder (MOUD) reduce mortality and acute care utilization. Hospitalization is a reachable moment for initiating MOUD and arranging for ongoing MOUD engagement following hospital discharge. Despite existing quality metrics for MOUD initiation and engagement, few hospitals provide hospital based opioid treatment (HBOT). This protocol describes a cluster-randomized hybrid type-2 implementation study comparing low-intensity and high-intensity implementation support strategies to help community hospitals implement HBOT. METHODS: Four state implementation hubs with expertise in initiating HBOT programs will provide implementation support to 24 community hospitals (6 hospitals/hub) interested in starting HBOT. Community hospitals will be randomized to 24-months of either a low-intensity intervention (distribution of an HBOT best-practice manual, a lecture series based on the manual, referral to publicly available resources, and on-demand technical assistance) or a high-intensity intervention (the low-intensity intervention plus funding for a hospital HBOT champion and regular practice facilitation sessions with an expert hub). The primary efficacy outcome, adapted from the National Committee on Quality Assurance, is the proportion of patients engaged in MOUD 34-days following hospital discharge. Secondary and exploratory outcomes include acute care utilization, non-fatal overdose, death, MOUD engagement at various time points, hospital length of stay, and discharges against medical advice. Primary, secondary, and exploratory outcomes will be derived from state Medicaid data. Implementation outcomes, barriers, and facilitators are assessed via longitudinal surveys, qualitative interviews, practice facilitation contact logs, and HBOT sustainability metrics. We hypothesize that the proportion of patients receiving care at hospitals randomized to the high-intensity arm will have greater MOUD engagement following hospital discharge. DISCUSSION: Initiation of MOUD during hospitalization improves MOUD engagement post hospitalization. Few studies, however, have tested different implementation strategies on HBOT uptake, outcome, and sustainability and only one to date has tested implementation of a specific type of HBOT (addiction consultation services). This cluster-randomized study comparing different intensities of HBOT implementation support will inform hospitals and policymakers in identifying effective strategies for promoting HBOT dissemination and adoption in community hospitals. TRIAL REGISTRATION: NCT04921787.

What AHRQ Learned While Working to Transform Primary Care.

Building on previous efforts to transform primary care, the Agency for Healthcare Research and Quality (AHRQ) launched EvidenceNOW: Advancing Heart Health in 2015. This 3-year initiative provided external quality improvement support to small and medium-size primary care practices to implement evidence-based cardiovascular care. Despite challenges, results from an independent national evaluation demonstrated that the EvidenceNOW model successfully boosted the capacity of primary care practices to improve quality of care, while helping to advance heart health. Reflecting on AHRQ's own learnings as the funder of this work, 3 key lessons emerged: (1) there will always be surprises that will require flexibility and real-time adaptation; (2) primary care transformation is about more than technology; and (3) it takes time and experience to improve care delivery and health outcomes. EvidenceNOW taught us that lasting practice transformation efforts need to be responsive to anticipated and unanticipated changes, relationship-oriented, and not tied to a specific disease or initiative. We believe these lessons argue for a national primary care extension service that provides ongoing support for practice transformation.

An age-friendly approach to primary care in an academic health system.

BACKGROUND: Age-friendly care, addressing what matters most, medications, mentation, and mobility, is a successful model for improving older adult care. We describe the initial outcomes of age-friendly care implementation in five primary care clinics in an academic health system. METHODS: In partnership with a regional quality improvement (QI) organization, we used practice facilitation to implement age-friendly care from July 2020 to June 2023. Clinic workflows and electronic health record (EHR) templates were modified to capture six QI measures for patients ≥65 years: Documenting what matters most to patients Advance care planning (ACP) Annual cognitive screening Caregiver referral to dementia community resources Fall-risk screening Co-prescription of opioid and sedative-hypnotic drugs Providers were alerted if patients had positive screens and given support tools for clinical decision-making. QI measures from January-June 2023 were compared to the year prior to implementation. Providers and staff were interviewed about implementation barriers and facilitators. RESULTS: All six measures improved in Geriatrics and and other clinics showed improvement in ACP and cognitive screening. All clinics had high fall-risk screening rates (≥85%). The least improved measure was co-prescription of opioids and sedative-hypnotics with co-prescription rates ranging from 7% to 39%. Implementation hinged on leadership prioritization, practice facilitator guidance, clinical team buy-in, EHR functionality, and clinical performance review. Three clinics received Age-Friendly Health System recognition. CONCLUSIONS: A QI approach using practice facilitation and EHR templates improved some but not all age-friendly care measures. Future interventions will focus on training in high-risk medication tapering and elicitation of health goals.

Improving Guideline-Recommended Colorectal Cancer Screening in a Federally Qualified Health Center (FQHC): Implementing a Patient Navigation and Practice Facilitation Intervention to Promote Health Equity.

BACKGROUND: Colorectal cancer (CRC) screening is effective in the prevention and early detection of cancer. Implementing evidence-based screening guidelines remains a challenge, especially in Federally Qualified Health Centers (FQHCs), where current rates (43%) are lower than national goals (80%), and even lower in populations with limited English proficiency (LEP) who experience increased barriers to care related to systemic inequities. METHODS: This quality improvement (QI) initiative began in 2016, focused on utilizing patient navigation and practice facilitation to addressing systemic inequities and barriers to care to increase CRC screening rates at an urban FQHC, with two clinical locations (the intervention and control sites) serving a diverse population through culturally tailored education and navigation. RESULTS: Between August 2016 and December 2018, CRC screening rates increased significantly from 31% to 59% at the intervention site (p < 0.001), with the most notable change in patients with LEP. Since 2018 through December 2022, navigation and practice facilitation expanded to all clinics, and the overall CRC screening rates continued to increase from 43% to 50%, demonstrating the effectiveness of patient navigation to address systemic inequities. CONCLUSIONS: This multilevel intervention addressed structural inequities and barriers to care by implementing evidence-based guidelines into practice, and combining patient navigation and practice facilitation to successfully increase the CRC screening rates at this FQHC.

Virtual facilitation best practices and research priorities: a scoping review.

BACKGROUND: Facilitation is an implementation strategy that supports the uptake of evidence-based practices. Recently, use of virtual facilitation (VF), or the application of facilitation using primarily video-based conferencing technologies, has become more common, especially since the COVID-19 pandemic. Thorough assessment of the literature on VF, however, is lacking. This scoping review aimed to identify and describe conceptual definitions of VF, evaluate the consistency of terminology, and recommend "best" practices for its use as an implementation strategy. METHODS: We conducted a scoping review to identify literature on VF following the PRISMA-ScR guidance. A search of PubMed, Embase, Web of Science, and CINAHL databases was conducted in June 2022 for English language articles published from January 2012 through May 2022 and repeated in May 2023 for articles published from January 2012 through April 2023. Identified articles, including studies and conference abstracts describing VF, were uploaded into Covidence and screened independently by two reviewers. Data extraction was done by two reviewers in Microsoft Excel; additionally, studies were evaluated based on the Proctor et al. (2013) reporting guidelines for specifying details of implementation strategies. RESULTS: The search strategy identified 19 articles. After abstract and full-text screening, eight studies described by 10 articles/abstracts were included in analysis. Best practices summarized across studies included (1) stakeholder engagement, (2) understanding the recipient's organization, (3) facilitator training, (4) piloting, (5) evaluating facilitation, (6) use of group facilitation to encourage learning, and (7) integrating novel tools for virtual interaction. Three papers reported all or nearly all components of the Proctor et al. reporting guidelines; justification for use of VF was the most frequently omitted. CONCLUSIONS: This scoping review evaluated available literature on use of VF as a primary implementation strategy and identified significant variability on how VF is reported, including inconsistent terminology, lack of details about how and why it was conducted, and limited adherence to published reporting guidelines. These inconsistencies impact generalizability of these methods by preventing replicability and full understanding of this emerging methodology. More work is needed to develop and evaluate best practices for effective VF to promote uptake of evidence-based interventions. TRIAL REGISTRATION: N/A.

Application of the FRAME-IS to a Multifaceted Implementation Strategy.

Background: Research demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation (PF). In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC). Methods: Three data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation. Results: We modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process. Conclusion: With modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations. Trial Registration: clinicaltrials.gov NCT03713515, Registration date: October 19, 2018.

Perspectives of clinical stakeholders and patients from four VA liver clinics to tailor practice facilitation for implementing evidence-based alcohol-related care.

BACKGROUND: Unhealthy alcohol use (UAU) is particularly dangerous for people with chronic liver disease. Liver clinics may be an important setting in which to provide effective alcohol-related care by integrating evidence-based strategies, such as brief intervention and medications for alcohol use disorder. We conducted qualitative interviews with clinical stakeholders and patients at liver clinics in four Veterans Health Administration (VA) medical centers to understand barriers and facilitators of integrating alcohol-related care and to support tailoring of a practice facilitation implementation intervention. METHODS: Data collection and analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Interviews were transcribed and qualitatively analyzed using a Rapid Assessment Process (RAP) guided by the CFIR. RESULTS: We interviewed 46 clinical stakeholders and 41 patient participants and analyzed findings based on the CFIR. Clinical stakeholders described barriers and facilitators that ranged from operations/clinic resource-based (e.g., time and capacity, desire for additional provider types, referral processes) to individual perspective and preference-based (e.g., supportiveness of leadership, individual experiences/beliefs). Patient participants shared barriers and facilitators that ranged from relationship-based (e.g., trusting the provider and feeling judged) to resource and education-based (e.g., connection to a range of treatment options, education about impact of alcohol). Many barriers and facilitators to integrating alcohol-related care in liver clinics were similar to those identified in other clinical settings (e.g., time, resources, role clarity, stigmatizing beliefs). However, some barriers (e.g., fellow-led care and lack of integration of liver clinics with addictions specialists) and facilitators (e.g., presence of quality improvement staff in clinics and integrated pharmacists and behavioral health specialists) were more unique to liver clinics. CONCLUSIONS: These findings support the possibility of integrating alcohol-related care into liver clinics but highlight the importance of tailoring efforts to account for variation in provider beliefs and experiences and clinic resources. The barriers and facilitators identified in these interviews were used to tailor a practice facilitation implementation intervention in each clinic setting.