Assessing the implementation of a multi-component hypertension program in a Guatemalan under-resourced dynamic context: an application of the RE-AIM/PRISM extension for sustainability and health equity.

BACKGROUND: The COVID-19 pandemic necessitated rapid changes in healthcare delivery in Guatemala's public primary care settings. A new hypertension program, implemented as part of a type 2 hybrid trial since 2019, exemplifies an implementation effort amidst a changing context in an under-resourced setting. We assessed the implementation of an evidence-based intervention (EBI; protocol-based hypertension treatment) and one of its main implementation strategies (team-based collaborative care), raising implications for health equity and sustainability. We present innovative application of systems thinking visuals. METHODS: Conducting a convergent mixed methods analysis, we assessed implementation in response to contextual changes across five Ministry of Health (MoH) districts at the pandemic's onset. Utilizing quantitative programmatic data and qualitative interviews with stakeholders (n=18; health providers, administrators, study staff), we evaluated dimensions of "Reach, Effectiveness, Adoption, Implementation and Maintenance," RE-AIM (Reach, Implementation delivery + adaptations), and "Practical Robust Implementation and Sustainability Model," PRISM (Organizational perspective on the EBI, Fit, Implementation and sustainability infrastructure) frameworks. We assessed representativeness by comparing participants to census data. To assess implementation delivery, we built behavior-over-time (BOT) graphs with quantitative programmatic data (July 2019-July 2021). To assess adaptations and contextual changes, we performed matrix-based thematic qualitative analysis. We converged quantitative implementation delivery data + qualitative adaptations data in joint displays. Finally, we analyzed qualitative and quantitative results across RE-AIM/PRISM and health districts to identify equity and sustainability considerations. RESULTS: Contextual factors that facilitated program delivery included the perception that the EBI was beneficial, program champions, and staff communication. Key barriers to implementation delivery included competition with other primary care activities and limited implementation infrastructure (e.g., equipment, medications). Contextual changes related to COVID-19 hindered implementation delivery, threatened sustainability, and may have exacerbated inequities. However, adaptations that were planned enhanced implementation delivery and may have supported improved equity and sustainability. CONCLUSIONS: Recognition of an EBI's benefits and program champions are important for supporting initial uptake. The ability to plan adaptations amid rapid contextual changes has potential advantages for sustainability and equitable delivery. Systems thinking tools and mixed methods approaches may shed light on the relations between context, adaptations, and equitable and sustainable implementation. TRIAL REGISTRATION: NCT03504124.

Aligning the planning, development, and implementation of complex interventions to local contexts with an equity focus: application of the PRISM/RE-AIM Framework.

For the fields of implementation science and health equity, understanding and being responsive to local contexts is of utmost importance to better inform the development, implementation, and evaluation of healthcare and public health interventions to increase their uptake and sustainment. Contexts are multi-level and include political, historical, economic, and social factors that influence health, as well as organizational characteristics, reflecting the richness of members' views, resources, values, and needs. Poor alignment between solutions and those contextual characteristics could have an impact on inequities. The PRISM (Practical Robust Implementation and Sustainability Model) is a context-based implementation science framework that incorporates RE-AIM outcomes (Reach, Effectiveness, Adoption, Implementation, Maintenance) and offers guidance to researchers, practitioners, and their patient and community partners on how to conceptualize, assess, and address contextual domains with a focus on health equity. Drawing from systems thinking, participatory engagement, and health equity principles, this commentary expands on previous work to 1) offer a novel perspective on how to align an intervention's core functions and forms with the PRISM's contextual domains, and 2) foster an ongoing and iterative engagement process with diverse partners throughout the research and practice process using a co-creation approach. We recommend intervention-to-context alignment through iterative cycles. To that end, we present the RE-AIM Framework's 'outcomes cascade' to illustrate touch points of opportunity and gaps within and across each of the five RE-AIM outcomes to illustrate 'where things go wrong'. We present a case study to illustrate and offer recommendations for research and practice efforts to increase contextual responsiveness, and enhance alignment with context before, during, and after implementation efforts and to ensure equity is being addressed. We strive to make a conceptual contribution to advance the field of pragmatic research and implementation of evidence-based practices through the application of the contextually-based PRISM framework with a focus on health equity.

Impact of COVID-19 on diabetes care: mixed methods study in an Indigenous area of Guatemala.

INTRODUCTION: SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K'iche' ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic. METHODS: We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach. RESULTS: Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased -3.54 points (95% CI, -4.56 to -2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care. CONCLUSIONS: The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.

The iPRISM webtool: an interactive tool to pragmatically guide the iterative use of the Practical, Robust Implementation and Sustainability Model in public health and clinical settings.

BACKGROUND: To increase uptake of implementation science (IS) methods by researchers and implementers, many have called for ways to make it more accessible and intuitive. The purpose of this paper is to describe the iPRISM webtool (Iterative, Practical, Robust Implementation and Sustainability Model) and how this interactive tool operationalizes PRISM to assess and guide a program's (a) alignment with context, (b) progress on pragmatic outcomes, (c) potential adaptations, and (d) future sustainability across the stages of the implementation lifecycle. METHODS: We used an iterative human-centered design process to develop the iPRISM webtool. RESULTS: We conducted user-testing with 28 potential individual and team-based users who were English and Spanish speaking from diverse settings in various stages of implementing different types of programs. Users provided input on all aspects of the webtool including its purpose, content, assessment items, visual feedback displays, navigation, and potential application. Participants generally expressed interest in using the webtool and high likelihood of recommending it to others. The iPRISM webtool guides English and Spanish-speaking users through the process of iteratively applying PRISM across the lifecycle of a program to facilitate systematic assessment and alignment with context. The webtool summarizes assessment responses in graphical and tabular displays and then guides users to develop feasible and impactful adaptations and corresponding action plans. Equity considerations are integrated throughout. CONCLUSIONS: The iPRISM webtool can intuitively guide individuals and teams from diverse settings through the process of using IS methods to iteratively assess and adapt different types of programs to align with the context across the implementation lifecycle. Future research and application will continue to develop and evaluate this IS resource.

Global implementation research capacity building to address cardiovascular disease: An assessment of efforts in eight countries.

Cardiovascular diseases are the leading causes of morbidity and mortality worldwide, but implementation of evidence-based interventions for risk factors such as hypertension is lacking, particularly in low and middle income countries (LMICs). Building implementation research capacity in LMICs is required to overcome this gap. Members of the Global Research on Implementation and Translation Science (GRIT) Consortium have been collaborating in recent years to establish a research and training infrastructure in dissemination and implementation to improve hypertension care. GRIT includes projects in Ghana, Guatemala, India, Kenya, Malawi, Nepal, Rwanda, and Vietnam. We collected data from each site on capacity building activities using the Potter and Brough (2004) model, mapping formal and informal activities to develop (a) structures, systems and roles, (b) staff and infrastructure, (c) skills, and (d) tools. We captured information about sites' needs assessments and metrics plus program adaptations due to the COVID-19 pandemic. All sites reported capacity building activities in each layer of the Capacity Pyramid, with the largest number of activities in the Skills and Tools categories, the more technical and easier to implement categories. All sites included formal and informal training to build Skills. All sites included a baseline needs assessment to guide capacity building activities or assess context and inform intervention design. Sites implementing evidence-based hypertension interventions used common implementation science frameworks to evaluate implementation outcomes. Although the COVID-19 pandemic affected timelines and in-person events, all projects were able to pivot and carry out planned activities. Although variability in the activities and methods used existed, GRIT programs used needs assessments to guide locally appropriate design and implementation of capacity building activities. COVID-19 related changes were necessary, but strong collaborations and relationships with health ministries were maintained. The GRIT Consortium is a model for planning capacity building in LMICs.

Increasing use of systems science in cardiovascular disease prevention to understand how to address geographic health disparities in communities with a disproportionate burden of risk.

Objective: Marginalized communities shoulder a disproportionate burden of cardiovascular disease (CVD) driven by concentrated neighborhood social risk factors. We provide a case study of systems science application to address geographic CVD health disparities at the community level - informing the science of CVD health disparities research. Methods: We conducted a two-phased, multi-methods needs assessment in the Denver, Colorado area. Phase I consisted of a social network analysis to map a two-mode network of existing CVD prevention interventions and their implementing organizations. In Phase II, group model building (GMB) sessions with key community, public health, and healthcare provider stakeholders, were utilized to identify and visualize community factors contributing to disparities in CVD risk, producing a consensus-based causal loop diagram. Results: Between May 2021 and June 2022, we conducted 24 virtual, semi-structured interviews in Phase I to describe CVD prevention interventions, and 7 virtual GMB sessions in Phase II to describe experiences of disparities in CVD risk. For the purposes of this paper, we focus on a subset of results for both phases. In Phase I we identified 89 active CVD prevention interventions, 29 of which addressed tobacco use. In Phase II, causal loop diagrams revealed root causes of disparities in CVD risk. We provide an example of a causal loop diagram that focuses on the community prevalence of tobacco use, identifying stress as a key underlying factor driving disparities. The integration of findings from both phases highlighted the alignment and misalignment between quit tobacco intervention goals and how they are being experienced in marginalized communities. Conclusion: Systems science methods were useful to organize a large number of CVD prevention efforts, and evaluate the root causes of CVD health disparities in a high risk community. By integrating these two aspects, interventions may be reoriented to more effectively address the root causes of CVD health disparities.

Applying an equity lens to assess context and implementation in public health and health services research and practice using the PRISM framework.

Dissemination and implementation science seeks to enhance the uptake, successful implementation, and sustainment of evidence-based programs and policies. While a focus on health equity is implicit in many efforts to increase access to and coverage of evidence-based programs and policies, most implementation frameworks and models do not explicitly address it. Disparities may in fact be increased by emphasizing high intensity interventions or ease of delivery over meeting need within the population, addressing deep-rooted structural inequities, and adapting to local context and priorities. PRISM (Practical, Robust Implementation and Sustainability Model), the contextual expansion of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework has several elements that address health equity, but these have not been explicated, integrated, or illustrated in one place. We present guidance for applying PRISM with an equity lens across its four context domains (external environment; multi-level perspectives on the intervention; characteristics of implementers and intended audience; and the implementation and sustainability infrastructure-as well as the five RE-AIM outcome dimensions. We then present an example with health equity considerations and discuss issues of representation and participation, representativeness and the importance of ongoing, iterative assessment of dynamic context and structural drivers of inequity. We also elaborate on the importance of a continuous process that requires addressing community priorities and responding to capacity and infrastructure needs and changes. We conclude with research and practice recommendations for applying PRISM with an increased emphasis on equity.

Protocol for a scoping review of health equity frameworks and models applied in empirical studies of chronic disease prevention and control.

BACKGROUND: Chronic diseases, such as cancers and cardiovascular diseases, present the greatest burden of morbidity and mortality worldwide. This burden disproportionately affects historically marginalized populations. Health equity is rapidly gaining increased attention in public health, health services, and implementation research, though many health inequities persist. Health equity frameworks and models (FM) have been called upon to guide equity-focused chronic disease and implementation research. However, there is no clear synthesis of the health equity FM used in chronic disease research or how these are applied in empirical studies. This scoping review seeks to fill this gap by identifying and characterizing health equity FM applied in empirical studies along the chronic disease prevention and control continuum, describing how these FM are used, and exploring potential applications to the field of implementation science. METHODS: We follow established guidance for conducting scoping reviews, which includes six stages: (1) identify the research question; (2) identify relevant studies; (3) select studies for inclusion; (4) data extraction; (5) collating, summarizing, and reporting the results; and (6) consultation. This protocol presents the iterative, collaborative approach taken to conceptualize this study and develop the search strategy. We describe the criteria for inclusion in this review, methods for conducting two phases of screening (title and abstract, full text), data extraction procedures, and quality assurance approaches taken throughout the project. DISCUSSION: The findings from this review will inform health-equity focused chronic disease prevention and control research. FM identified through this review will be added to an existing website summarizing dissemination and implementation science frameworks, and we will offer case examples and recommendations for utilizing a health equity FM in empirical studies. Our search strategy and review methodology may serve as an example for scholars seeking to conduct reviews of health equity FM in other health disciplines. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework Registration https://doi.org/10.17605/OSF.IO/SFVE6.

Assessing the implementation of a multi-component hypertension program in a Guatemalan under-resourced dynamic context: An application of the RE-AIM/PRISM extension for sustainability and health equity.

Background: The COVID-19 pandemic necessitated rapid changes in the delivery of care across public primary care settings in rural Guatemala in 2020. In response, a hypertension program implemented within the public primary care system required multiple adaptations, providing an illustrative example of dynamic implementation amidst changing context in an under-resourced setting. This study describes the evolvability of an evidence-based intervention (EBI; protocol-based hypertension treatment) and one of its main implementation strategies (team-based collaborative care) during the COVID-19 pandemic and discusses implications for health equity and sustainability. Methods: This convergent mixed methods analysis assessed implementation across five Ministry of Health districts during the initial phase of the pandemic. Qualitative and quantitative data were collected, analyzed, and integrated, informed by the RE-AIM (Reach, Effectiveness, Adoption, Implementation Maintenance) Framework's extension for sustainability, and its contextual enhancement, PRISM (Pragmatic, Robust, Implementation and Sustainability Model). For RE-AIM, we focused on the "Implementation" domain, operationalizing it qualitatively as continued delivery and adaptations to the EBI and implementation strategy, and quantitatively as the extent of delivery over time. We conducted 18 in-depth interviews with health providers / administrators (n=8) and study staff (n=10) and performed a matrix-based thematic-analysis. Qualitative results informed the selection of quantitative implementation summarized as behavior over time graphs. Quantitative implementation data and illustrative quotes are presented as joint displays. Results: In relation to implementation, several organic adaptations hindered delivery, threatened sustainability, and may have exacerbated health inequities. Planned adaptations enhanced program delivery and may have supported improved equity and sustainability. Salient PRISM factors that influenced implementation included "Organizational perspective of the EBI", "Fit" and "Implementation and sustainability infrastructure". Facilitators to continued delivery included the perception that the EBI is beneficial, program champions, and healthcare team organization. Barriers included the perception that the EBI is complicated, competition with other primary care activities, and temporary suspension of services due to COVID-19. Conclusions: Multi-level contextual changes led to numerous adaptations of the EBI and implementation strategy. Systems thinking approaches may shed light on how a program's sustainability and its equitable delivery are influenced by adaptations over time in response to dynamic, multi-level contextual factors. Trial registration: NCT03504124.

Training in eight low-and middle-income countries: lessons learned from a pilot study using the WHO-TDR dissemination and implementation massive open online course.

Introduction: Non-communicable diseases (NCDs) are a leading cause of morbidity and mortality in low-and middle- income countries (LMICs). Despite this, a lack of funding, training and mentorship for NCD investigators in LMICs exists. In an effort to gain knowledge and skills to address these gaps, participants from the Global Research on Implementation and Translation Science (GRIT), a consortium of studies in eight LMICs and their networks, attended the dissemination and implementation (D&I) massive open online course (MOOC) developed by the Special Programme for Research and Training in Tropical Diseases at the World Health Organization to strengthen D&I capacity building. Here, we report on the pilot of this MOOC, which was implemented during the SARS COVID-19 pandemic from April- November 2020. Methods: Participants completed pre-and post-training questionnaires to assess self-reported D&I competencies, general research skills, and research mentor access and quality. D&I competencies were measured by use of a scale developed for a US-based training program, with change in competency scores assessed by paired t test. We used univariate statistics to analyze the data for all other outcomes. Results: Of the 247 participants enrolled, 32 (13%) completed all course requirements, 21 (9%) completed the pre-and post-surveys and are included in the analysis. D&I competency scores suggest improvement for those who had complete pre- and post-assessments. Trainee's average score on the full competency scale improved 1.45 points (0-5 scale) from pre- to post-test; all four subscales also showed evidence of improvements. There were small but not significant increases in competencies for grant writing, proposal/ manuscript writing and presentations from pre- to post-test assessment. 40% of trainees reported access to a research mentor and 12% reported access to a D&I specific mentor. Participants reported barriers (e.g., unstable internet access and challenges due to COVID-19) and facilitators (e.g., topical interests, collaboration with colleagues) to completing the MOOC. Conclusions: Although COVID-19 affected program usage and completion, the MOOC was feasible. We also had signals of effectiveness, meaning among LMIC participants completing the course, there was improvement in self-report D&I competency scores. Recommendations for future D&I trainings in LMICs include (1) adding more topic specific modules (i.e., NCD research, general research skills) for scalability; (2) fostering more collaboration with participants across LMICs; and (3) establishing partnerships with D&I mentors for course participants.

Explanatory models of hypertension in Guatemala: recognizing the perspectives of patients, family members, health care providers and administrators, and national-level health system stakeholders.

BACKGROUND: Uncontrolled hypertension is a major public health burden and the most common preventable risk factor for cardiovascular diseases in Guatemala and other low- and middle-income countries. Prior to an initial trial that evaluated a hypertension intervention in rural Guatemala, we collected qualitative information on the needs and knowledge gaps of hypertension care within Guatemala's public healthcare system. This analysis applied Kleinman's Explanatory Models of Illness to capture how patients, family members, community-, district-, and provincial-level health care providers and administrators, and national-level health system stakeholders understand hypertension.  METHODS: We conducted in-depth interviews with three types of participants: 1) national-level health system stakeholders (n = 17), 2) local health providers and administrators from district, and health post levels (25), and 3) patients and family members (19) in the departments of Sololá and Zacapa in Guatemala. All interviews were conducted in Spanish except for 6 Maya-Kaqchikel interviews. We also conducted focus group discussions with auxiliary nurses (3) and patients (3), one in Maya-Tz'utujil and the rest in Spanish. Through framework and matrix analysis, we compared understandings of hypertension by participant type using the Explanatory Model of Illness domains -etiology, symptoms, pathophysiology, course of illness, and treatment. RESULTS: Health providers and administrators, and patients described hypertension as an illness that spurs from emotional states like sadness, anger, and worry; is inherited and related to advanced age; and produces symptoms that include a weakened body, nerves, pain, and headaches. Patients expressed concerns about hypertension treatment's long-term consequences, despite trying to comply with treatment. Patients stated that they combine biomedical treatment (when available) with natural remedies (teas and plants). Health providers and administrators and family members stated that once patients feel better, they often disengage from treatment. National-level health system stakeholders referred to lifestyle factors as important causes, considered patients to typically be non-compliant, and identified budget limitations as a key barrier to hypertension care. The three groups of participants identified structural barriers to limited hypertension care (e.g., limited access to healthy food and unaffordability of medications). CONCLUSION: As understandings of hypertension vary between types of participants, it is important to describe their similarities and differences considering the role each has in the health system. Considering different perceptions of hypertension will enable better informed program planning and implementation efforts.

Use of the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to guide iterative adaptations: Applications, lessons learned, and future directions.

Introduction: Implementation science frameworks have been used widely for planning and evaluation, but seldom to guide adaptations during program implementation. There is great potential for these frameworks to be used to inform conceptual and data-driven decisions about adaptations. Methods: We summarize recent applications using Iterative RE-AIM to capture and guide adaptations. Iterative RE-AIM can be repeated at multiple time points customized to each project and involves the following activities: identification of key implementation partners; rating importance of and progress on each RE-AIM dimension (reach, effectiveness, adoption, implementation, and maintenance); use of summary data on ratings to identify one or two RE-AIM dimensions for adaptations and implementation strategies; and evaluation of progress and impact of adaptations. We summarize recent and ongoing Iterative RE-AIM applications across multiple care coordination and pain management projects within the Veterans Health Administration, a hypertension control trial in Guatemala, a hospital-based lung ultrasound implementation pilot, and a colorectal cancer screening program in underserved communities. Results: Iterative RE-AIM appears feasible, helpful, and broadly applicable across diverse health care issues, interventions, contexts, and populations. In general, the RE-AIM dimension showing the largest gap between importance and progress has been Reach. The dimensions most frequently selected for improvement have been Reach and Implementation. We discuss commonalities, differences and lessons learned across these various applications of Iterative RE-AIM. Challenges include having objective real time data on which to make decisions, having key implementation staff available for all assessments, and rapidly scoring and providing actionable feedback. We discuss print and online resources and materials to support Iterative RE-AIM. Conclusions: The use of Iterative RE-AIM to guide and support understanding of adaptations has proven feasible across diverse projects and in multiple case studies, but there are still questions about its strengths, limitations, essential components, efficiency, comparative effectiveness, and delivery details. Future directions include investigating the optimal frequency and timing for iterative applications; adding contextual assessments; developing more continuous and rapid data on which to make adaptation decisions; identifying opportunities to enhance health equity; and determining the level of facilitation that is most cost-effective.

Monitoring Study Participants and Implementation with Phone Calls to Support Hypertension Control During the COVID-19 Pandemic: The Case of a Multicomponent Intervention Trial in Guatemala.

Background: The COVID-19 pandemic presents a challenge to health care for patients with chronic diseases, especially hypertension, because of the important association and increased risk of these patients with a severe presentation of COVID-19 disease. The Guatemalan Ministry of Health has been implementing a multi-component program aimed at improving hypertension control in rural communities since 2019 as a part of an intervention research cluster randomized trial. When the first cases of COVID-19 were reported (March 13, 2020) in Guatemala, our study paused all study field activities, and began monitoring participants through phone calls. The objective of this paper is to describe the approach used to monitor study participants during the COVID-19 pandemic and compare data obtained during phone calls for intervention and control group participants. Methods: We developed a cross-sectional study within the HyTREC (Hypertension Outcomes for T4 Research within Lower Middle-Income Countries) project 'Multicomponent Intervention to Improve Hypertension Control in Central America: Guatemala' in which phone calls were made to participants from both intervention and control groups to monitor measures important to the study: delivery of antihypertensive medications in both groups, receipt of coaching sessions and use of a home blood pressure monitor by intervention group participants, as well as reasons that they were not implemented. Results: Regarding the delivery of antihypertensive drugs by the MoH to participants, those in the intervention group had a higher level of medication delivery (73%) than the control group (51%), p<0.001. Of the total participants in the intervention group, 62% had received at least one health coaching session in the previous three months and 81% used a digital home blood pressure monitor at least twice a week. Intervention activities were lower than expected due to restricted public transportation on top of decreased availability of health providers. Conclusion: In Guatemala, specifically in rural settings, access to antihypertensive medications and health services during pandemic times was impaired and less than expected, even after accounting for the program's implementation activities and actions.

Diabetes Prevention and Care Capacity at Urban Indian Health Organizations.

American Indian and Alaska Native (AI/AN) people suffer a disproportionate burden of diabetes and cardiovascular disease. Urban Indian Health Organizations (UIHOs) are an important source of diabetes services for urban AI/AN people. Two evidence-based interventions-diabetes prevention (DP) and healthy heart (HH)-have been implemented and evaluated primarily in rural, reservation settings. This work examines the capacity, challenges and strengths of UIHOs in implementing diabetes programs. Methods: We applied an original survey, supplemented with publicly-available data, to assess eight organizational capacity domains, strengths and challenges of UIHOs with respect to diabetes prevention and care. We summarized and compared (Fisher's and Kruskal-Wallis exact tests) items in each organizational capacity domain for DP and HH implementers vs. non-implementers and conducted a thematic analysis of strengths and challenges. Results: Of the 33 UIHOs providing services in 2017, individuals from 30 sites (91% of UIHOs) replied to the survey. Eight UIHOs (27%) had participated in either DP (n = 6) or HH (n = 2). Implementers reported having more staff than non-implementers (117.0 vs. 53.5; p = 0.02). Implementers had larger budgets, ~$10 million of total revenue compared to $2.5 million for non-implementers (p = 0.01). UIHO strengths included: physical infrastructure, dedicated leadership and staff, and community relationships. Areas to strengthen included: staff training and retention, ensuring sufficient and consistent funding, and data infrastructure. Conclusions: Strengthening UIHOs across organizational capacity domains will be important for implementing evidence-based diabetes interventions, increasing their uptake, and sustaining these interventions for AI/AN people living in urban areas of the U.S.

Implementation of a Diabetes Self-Management Education and Support Intervention in Rural Guatemala: A Mixed-Methods Evaluation Using the RE-AIM Framework.

INTRODUCTION: To address the global diabetes epidemic, lifestyle counseling on diet, physical activity, and weight loss is essential. This study assessed the implementation of a diabetes self-management education and support (DSMES) intervention using a mixed-methods evaluation framework. METHODS: We implemented a culturally adapted, home-based DSMES intervention in rural Indigenous Maya towns in Guatemala from 2018 through 2020. We used a pretest-posttest design and a mixed-methods evaluation approach guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative data included baseline characteristics, implementation metrics, effectiveness outcomes, and costs. Qualitative data consisted of semistructured interviews with 3 groups of stakeholders. RESULTS: Of 738 participants screened, 627 participants were enrolled, and 478 participants completed the study. Adjusted mean change in glycated hemoglobin A1c was -0.4% (95% CI, -0.6% to -0.3%; P < .001), change in systolic blood pressure was -5.0 mm Hg (95% CI, -6.4 to -3.7 mm Hg; P < .001), change in diastolic blood pressure was -2.6 mm Hg (95% CI, -3.4 to -1.9 mm Hg; P < .001), and change in body mass index was 0.5 (95% CI, 0.3 to 0.6; P < .001). We observed improvements in diabetes knowledge, distress, and most self-care activities. Key implementation factors included 1) recruitment barriers for men, 2) importance of patient-centered care, 3) role of research staff in catalyzing health worker involvement, 4) tradeoffs between home and telephone visits, and 5) sustainability challenges. CONCLUSION: A community health worker-led DSMES intervention was successfully implemented in the public health system in rural Guatemala and resulted in significant improvements in most clinical and psychometric outcomes. Scaling up sustainable DSMES in health systems in rural settings requires careful consideration of local barriers and facilitators.

Hypertension in Guatemala's Public Primary Care System: A Needs Assessment Using the Health System Building Blocks Framework.

BACKGROUND: Uncontrolled hypertension represents a substantial and growing burden in Guatemala and other low and middle-income countries. As a part of the formative phase of an implementation research study, we conducted a needs assessment to define short- and long-term needs and opportunities for hypertension services within the public health system. METHODS: We conducted a multi-method, multi-level assessment of needs related to hypertension within Guatemala's public system using the World Health Organization's health system building blocks framework. We conducted semi-structured interviews with stakeholders at national (n = 17), departmental (n = 7), district (n = 25), and community (n = 30) levels and focus groups with patients (3) and frontline auxiliary nurses (3). We visited and captured data about infrastructure, accessibility, human resources, reporting, medications and supplies at 124 health posts and 53 health centers in five departments of Guatemala. We conducted a thematic analysis of transcribed interviews and focus group discussions supported by matrix analysis. We summarized quantitative data observed during visits to health posts and centers. RESULTS: Major challenges for hypertension service delivery included: gaps in infrastructure, insufficient staffing and high turnover, limited training, inconsistent supply of medications, lack of reporting, low prioritization of hypertension, and a low level of funding in the public health system overall. Key opportunities included: prior experience caring for patients with chronic conditions, eagerness from providers to learn, and interest from patients to be involved in managing their health. The 5 departments differ in population served per health facility, accessibility, and staffing. All but 7 health posts had basic infrastructure in place. Enalapril was available in 74% of health posts whereas hydrochlorothiazide was available in only 1 of the 124 health posts. With the exception of one department, over 90% of health posts had a blood pressure monitor. CONCLUSIONS: This multi-level multi-method needs assessment using the building blocks framework highlights contextual factors in Guatemala's public health system that have been important in informing the implementation of a hypertension control trial. Long-term needs that are not addressed within the scope of this study will be important to address to enable sustained implementation and scale-up of the hypertension control approach.

A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension.

Interactive voice response and text message (IVR-T) technology may improve hypertension control in under-resourced settings. We conducted a randomized clinical trial to determine whether an IVR-T intervention would improve blood pressure (BP), medication adherence and visit keeping among adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico. Two hundred and ninety-five participants were randomly assigned to IVR-T (N = 148) or to usual care (N = 147). The IVR-T arm received reminders for clinic visits, messages to reschedule missed clinic visits, monthly medication refill reminders, weekly motivational messages, and a blood pressure cuff. The usual care arm received no messages. The primary outcome was change in systolic BP (SBP) between baseline and 12 months. Secondary outcomes included change in SBP between baseline and 6 months, change in diastolic BP (DBP) at 6 and 12 months, self-reported adherence at 6 months, and the proportion of missed primary care clinic appointments. The intervention did not affect SBP or DBP at 6 or 12 months. The 12-month change in SBP/DBP was 1.66/1.10 mm Hg in usual care and 0.23/1.34 mm Hg in the intervention group (P values = .57 and .88, respectively). Self-reported medication adherence improved comparably in both groups, and there was no difference in percentage of kept visits. Several features of study design, clinic operations, and data transfer were barriers to demonstrating effectiveness.

Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial.

BACKGROUND: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. METHODS: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness. DISCUSSION: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.

Opportunities, Challenges, and Strategies for Engaging Family in Diabetes and Hypertension Management: A Qualitative Study.

Family engagement may improve disease management, yet little is known about this topic as it relates to underrepresented minorities who receive care in low-resource primary care settings. This study aimed to explore family engagement in diabetes and hypertension management at an Urban Indian Health Organization to identify opportunities and challenges, and inform care strategies. We employed semi-structured interviews, genograms, eco-maps, and timelines, among 23 English- and Spanish-speaking American Indian and Latino adults with a dual diagnosis of type 2 diabetes and hypertension and 13 family members. Using thematic analysis, we found that family support is not always available, patients have difficulty sharing medical information, and family often live far away. Conversely, opportunities to leverage included a desire for increased engagement, motivation from the younger generation, prevention within the family, outreach to family members with the same conditions, and learning from elders and ancestors. Implications for programs, clinical care, and research are discussed.

Stakeholder Perceptions of Point-of-Care Ultrasound Implementation in Resource-Limited Settings.

BACKGROUND: Nearly half of the world lacks access to diagnostic imaging. Point of care ultrasound (POCUS) is a versatile and relatively affordable imaging modality that offers promise as a means of bridging the radiology gap and improving care in low resource settings. METHODS: We performed semi-structured interviews of key stakeholders at two diverse hospitals where POCUS implementation programs had recently been conducted: one in a rural private hospital in Haiti and the other in a public referral hospital in Malawi. Questions regarding the clinical utility of POCUS, as well as barriers and facilitators of its implementation, were asked of study participants. Using the Framework Method, analysis of interview transcripts was guided by the WHO ASSURED criteria for point of care diagnostics. RESULTS: Fifteen stakeholders with diverse roles in POCUS implementation were interviewed. Interviewees from both sites considered POCUS a valuable diagnostic tool that improved clinical decisions. They perceived barriers to adequate training as one of the most important remaining barriers to POCUS implementation. CONCLUSIONS: In spite of the increasing affordability and portability of ultrasounds devices, there are still important barriers to the implementation of POCUS in resource-limited settings.