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.

"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 (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.

Key Principles Underlying a Research-Practice Alignment in a Federally Qualified Health Center.

Context: Minoritized populations such as racial and ethnic minorities and individuals of less privileged socioeconomic status experience a disproportionate burden of poor hypertension (HTN) control in the United States. Multilevel systems interventions have been shown to improve patient-level outcomes in minoritized populations; however, there remains a large translational gap in implementing these approaches into federally qualified health centers (FQHC), which serve those at highest risk of HTN-related morbidity and mortality. The paucity of purposeful collaborations between academic researchers and practice staff throughout the research process remains a significant roadblock to the timely translation of evidence to practice. Design: This commentary describes the key principles and best practices that underlie the development and sustainment of an equitable research-practice alignment, which is supporting the implementation of multilevel systems intervention for improved HTN care in a large FQHC in Brooklyn, New York. The key principles, which are derived from the central tenants of relationship development and maintenance in community-engaged participatory research, patient-centered outcomes research, and organizational alignment theory include (1) cocreation of a shared mental model, (2) bridging multilevel communication, (3) ensuring mutual accountability, and (4) creating a culture of continuous improvement. Conclusions: Together, the principles guide how the research and practice teams work together to achieve a shared goal of improving the health and well-being of minoritized patients through the provision of high quality, community-oriented HTN care. Best practices to sustain our alignment require an ongoing and deliberate investment in honest and transparent communication by all members.

The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.