Quality improvement lessons learned from National Implementation of the "Patient Safety Events in Community Care: Reporting, Investigation, and Improvement Guidebook".

OBJECTIVE: To evaluate nationwide implementation of a Guidebook designed to standardize safety practices across VA-delivered and VA-purchased care (i.e., Community Care) and identify lessons learned and strategies to improve them. DATA SOURCES AND STUDY SETTING: Qualitative data collected from key informants at 18 geographically diverse VA facilities across 17 Veterans Integrated Services Networks (VISNs). STUDY DESIGN: We conducted semi-structured interviews from 2019 to 2022 with VISN Patient Safety Officers (PSOs) and VA facility patient safety and quality managers (PSMs and QMs) and VA Facility Community Care (CC) staff to assess lessons learned by examining organizational contextual factors affecting Guidebook implementation based on the Consolidated Framework for Implementation Research (CFIR). DATA COLLECTION/EXTRACTION METHODS: Interviews were conducted virtually with 45 facility staff and 10 VISN PSOs. Using directed content analysis, we identified CFIR factors affecting implementation. These factors were mapped to the Expert Recommendations for Implementing Change (ERIC) strategy compilation to identify lessons learned that could be useful to our operational partners in improving implementation processes. We met frequently with our partners to discuss findings and plan next steps. PRINCIPAL FINDINGS: Six CFIR constructs were identified as both facilitators and barriers to Guidebook implementation: (1) planning for implementation; (2) engaging key knowledge holders; (3) available resources; (4) networks and communications; (5) culture; and (6) external policies. The two CFIR constructs that were only barriers included: (1) cosmopolitanism and (2) executing implementation. CONCLUSIONS: Our findings suggest several important lessons: (1) engage all collaborators involved in implementation; (2) ensure end-users have opportunities to provide feedback; (3) describe collaborators' purpose and roles/responsibilities clearly at the start; (4) communicate information widely and repeatedly; and (5) identify how multiple high priorities can be synergistic. This evaluation will help our partners and key VA leadership to determine next steps and future strategies for improving Guidebook implementation through collaboration with VA staff.

Coming back for more: factors linked to higher participation among Veterans with chronic pain in an innovative VA-YMCA wellness clinic.

In 2019, the Indianapolis VA developed a Wellness Clinic in partnership with the Young Men's Christian Associations (YMCA) to comprehensively address Veterans' chronic pain. Our specific aims were twofold: (1) to evaluate the implementation of the Veterans Health Indiana (VHI) Wellness Clinic on patient utilisation and (2) to evaluate patient functioning.We conducted a mixed-methods evaluation, which included the extraction of VA administrative data to identify a patient cohort; the conduct of chart review to extract clinic utilisation, clinical outcomes collected during pain-related healthcare services and comorbidities; and semistructured interviews with Veteran patients who used the VHI Wellness Clinic in different patterns to identify challenges and facilitators to clinic utilisation. We applied configurational analysis to a Veteran sample who had their first visit to the VHI Wellness Clinic in March/April 2019 to pinpoint difference-making factors linked to Veterans' successful participation.The cohort included 312 Veterans (83% male), mean age of 55.4 years. The configurational model included six factors: participation in physical therapy, pain psychology or pain education sessions (22%); presence of any 'no-shows' (57% had 0); history of depression (39%) and clinic referral source (51% self-referred from primary care). The model consisted of four different pathways to successful participation, explaining 60% of cases in the higher-participation group with 86% consistency. Patient outcomes after clinic utilisation demonstrated a significant reduction in self-reported pain and pain catastrophising across time. Moreover, patients reported distance to clinic as both a facilitator and challenge.This mixed-methods analysis identified specific biopsychosocial factors and clinical services directly linked to higher Veteran participation in a new VA-YMCA Wellness Clinic. The VHI Wellness Clinic embedded within a YMCA facility is a feasible and efficacious healthcare delivery model for primary care patients experiencing chronic pain. Additional marketing to clinical providers for referrals and to patients to extend its reach is needed.

Standardizing Patient Safety Event Reporting between Care Delivered or Purchased by the Veterans Health Administration (VHA).

BACKGROUND: Increasing community care (CC) use by veterans has introduced new challenges in providing integrated care across the Veterans Health Administration (VHA) and CC. VHA's well-recognized patient safety program has been particularly challenging for CC staff to adopt and implement. To standardize VHA safety practices across both settings, VHA implemented the Patient Safety Guidebook in 2018. The authors compared national- and facility-level trends in VHA and CC safety event reporting post-Guidebook implementation. METHODS: In this retrospective study using patient safety event data from VHA's event reporting system (2020-2022), the research team examined trends in patient safety events, adverse events, close calls (near misses), and recovery rates (ratio of close calls to adverse events plus close calls) in VHA and CC using linear regression models to determine whether the average changes in VHA and CC safety events at the national and facility levels per quarter were significant. RESULTS: A total of 499,332 safety events were reported in VHA and CC. Although VHA patient safety event trends were not significant (p > 0.05), there was a significant negative trend for adverse events (p = 0.02) and positive trends for close calls (p = 0.003) and recovery rates (p = 0.004). In CC there were significant negative trends for patient safety events and adverse events (p = 0.02) and a significant positive trend for recovery rates (p = 0.03). There was less variation in VHA than in CC facilities with significant decreases (for example, interquartile ranges in VHA and CC were 0.03 vs. 0.05, respectively). CONCLUSION: Fluctuations in different safety events over time were likely due to the disruption of care caused by COVID-19 as well as organizational factors. Notably, the increases in recovery rates reflect less staff focus on harmful events and more attention to close calls (preventable events). Although safety practice adoption from VHA to CC was feasible, additional implementation strategies are needed to sustain standardized safety reporting across settings.

The role of organizational capacity in intervention efficacy in a church-based cancer education program: A configurational analysis.

It is well-established in the field of implementation science that the context in which an intervention is delivered can play a crucial role in how well it is implemented. However, less is known about how organizational context or capacity relates to efficacy outcomes, particularly with health promotion interventions delivered outside of healthcare settings. The present study examined whether organizational capacity indicators were linked to key efficacy outcomes in an evidence-based cancer control intervention delivered in 13 African American churches in Maryland. Outcomes included increases in colorectal cancer knowledge and self-report colonoscopy screening behavior from baseline to follow-up. We used Coincidence Analysis to identify features of organizational capacity that uniquely distinguished churches with varying levels of cancer knowledge and screening. Indicators of organizational capacity (e.g., congregation size, prior health promotion experience) were from an existing measure of church organizational capacity for health promotion. A single solution pathway accounted for greater increases in colorectal cancer knowledge over 12 months, a combination of two conditions: conducting 3 or more health promotion activities in the prior 2 years together with not receiving any technical assistance from outside partners in the prior 2 years. A single condition accounted for greater increases in colonoscopy screening over 24 months: churches that had conducted health promotion activities in 1-4 different topical areas in the prior 2 years. Findings highlight aspects of organizational capacity (e.g., prior experience in health promotion) that may facilitate intervention efficacy and can help practitioners identify organizational settings most promising for intervention impact.

The VA National TeleNeurology Program implementation: a mixed-methods evaluation guided by RE-AIM framework.

Introduction: The Veteran Affairs (VA) Office of Rural Health (ORH) funded the Veterans Health Administration (VHA) National TeleNeurology Program (NTNP) as an Enterprise-Wide Initiative (EWI). NTNP is an innovative healthcare delivery model designed to fill the patient access gap for outpatient neurological care especially for Veterans residing in rural communities. The specific aim was to apply the RE-AIM framework in a pragmatic evaluation of NTNP services. Materials and methods: We conducted a prospective implementation evaluation. Guided by the pragmatic application of the RE-AIM framework, we conceptualized a mixed-methods evaluation for key metrics: (1) reach into the Veteran patient population assessed as total NTNP new patient consult volume and total NTNP clinical encounters (new and return); (2) effectiveness through configurational analysis of conditions leading to high Veteran satisfaction and referring providers perceived effectiveness; (3) adoption and implementation by VA sites through site staff and NTNP interviews; (4) implementation success through perceived management, implementation barriers, facilitators, and adaptations and through rapid qualitative analysis of multiple stakeholders' assessments; and (5) maintenance of NTNP through monitoring quarterly TeleNeurology consultation volume. Results: NTNP was successfully implemented in 13 VA Medical Centers over 2 years. The total NTNP new patient consult volume in fiscal year 2021 (FY21) was 836 (58% rurally residing); this increased to 1,706 in fiscal year 2022 (FY22) (55% rurally residing). Total (new and follow-up) NTNP clinical encounters were 1,306 in FY21 and 3,730 in FY22. Overall, the sites reported positive experiences with program implementation and perceived that the program was serving Veterans with little access to neurological care. Veterans also reported high satisfaction with the NTNP program. We identified the patient level of perceived excellent teleneurologist-patient communications, reduced need to drive to get care, and that NTNP provided care that the Veteran otherwise could not access as key factors related to high Veteran satisfaction. Conclusions: The VA NTNP demonstrated substantial reach, adoption, effectiveness, implementation success, and maintenance over the first 2 years of the program. The NTNP was highly acceptable to both the clinical providers making the referrals and the Veterans receiving the referred video care. The pragmatic application of the RE-AIM framework to guide implementation evaluations is appropriate, comprehensive, and recommended for future applications.

Impact of the coronavirus disease-2019 pandemic on Veterans Health Administration Sleep Services.

Objectives: To understand the impact of the coronavirus disease-2019 pandemic on sleep services within the United States Department of Veterans Affairs using separate surveys from "pre-COVID" and pandemic periods. Methods: Data from a pre-pandemic survey (September to November 2019) were combined with data from a pandemic-period survey (August to November 2020) to Veterans Affairs sleep medicine providers about their local sleep services within 140 Veterans Affairs facilities). Results: A total of 67 (47.9%) facilities responded to the pandemic online survey. In-lab diagnostic and titration sleep studies were stopped at 91.1% of facilities during the pandemic; 76.5% of facilities resumed diagnostic studies and 60.8% resumed titration studies by the time of the second survey. Half of the facilities suspended home sleep testing; all facilities resumed these services. In-person positive airway pressure clinics were stopped at 76.3% of facilities; 46.7% resumed these clinics. Video telehealth was either available or in development at 86.6% of facilities and was considered a lasting addition to sleep services. Coronavirus disease-2019 transmission precautions occurred at high rates. Sleep personnel experienced high levels of stress, anxiety, fear, and burnout because of the pandemic and in response to unexpected changes in sleep medicine care delivery. Conclusions: Sleep medicine services within the Veterans Affairs evolved during the pandemic with many key services being interrupted, including in-lab studies and in-person positive airway pressure clinics. Expansion and initiation of telehealth sleep services occurred commonly. The pandemic adversely affected sleep medicine personnel as they sought to maintain access to care.

The impact of the COVID-19 pandemic on blood pressure control after a stroke or transient ischemic attack among patients at VA medical centers.

OBJECTIVE: To study factors associated with systolic blood pressure(SBP) control for patients post-discharge from an ischemic stroke or transient ischemic attack(TIA) during the early months of the COVID-19 pandemic compared to pre-pandemic periods within the Veterans Health Administration(VHA). MATERIALS AND METHODS: We analyzed retrospective data from patients discharged from Emergency Departments or inpatient admissions after an ischemic stroke or TIA. Cohorts consisted of 2,816 patients during March-September 2020 and 11,900 during the same months in 2017-2019. Outcomes included primary care or neurology clinic visits, recorded blood pressure readings and average blood pressure control in the 90-days post-discharge. Random effect logit models were used to compare clinical characteristics of the cohorts and relationships between patient characteristics and outcomes. RESULTS: The majority (73%) of patients with recorded readings during the COVID-19 period had a mean post-discharge SBP within goal (<140 mmHg); this was slightly lower than the pre-COVID-19 period (78%; p=0.001). Only 38% of the COVID-19 cohort had a recorded SBP in the 90-days post-discharge compared with 83% of patients during the pre-pandemic period (p=0.001). During the pandemic period, 29% did not have follow-up primary care or neurologist visits, and 33% had a phone or video visit without a recorded SBP reading. CONCLUSIONS: Patients with an acute cerebrovascular event during the initial COVID-19 period were less likely to have outpatient visits or blood pressure measurements than during the pre-pandemic period; patients with uncontrolled SBP should be targeted for follow-up hypertension management.

The role of secondary traumatic stress breakthrough champions in reducing worker trauma and improving organizational health using a configurational analysis approach.

Background: Emerging research has demonstrated that organizational efforts at becoming secondary traumatic stress (STS)-informed can improve the overall well-being of the workforce, especially when implementation activity by a champion team is high. Questions remain, however, regarding the mechanisms that enable these improvements. Method: This study uses configurational analysis to determine necessary and sufficient conditions to produce reductions in STS symptoms in workers as well as organizational improvements toward being more STS-informed in a cohort survey of 6,033 professionals working with individuals exposed to trauma representing 52 organizations. The Secondary Traumatic Stress Informed Organizational Assessment (STSI-OA) was used to measure professional's perceptions of how well the unit addressed secondary trauma in the workplace, and the Secondary Traumatic Stress Scale (STSS) assessed traumatic stress symptoms in respondents. Champions' activity was scored using the categories suggested by Shea. Results: For the STSS outcome, either a STSI-OA positive increase of 10 or more points or high levels of champion problem-solving were independently sufficient for an improvement in the outcome. The STSI-OA model had two pathways: high levels of peer engagement via the scaling up of innovations using PDSAs or the combination of facilitation of peer knowledge and skills together with working in a child welfare organization. Either pathway was sufficient by itself to yield the STSI-OA outcome. Conclusions: Identifying and cultivating the champions' use of problem-solving and peer engagement strategies can transform the threat posed by indirect trauma exposure into an opportunity for shared experience and healing. Plain Language Summary: Organizational champions are individuals or teams that strive to promote change within their workplace. These champions are integral to spreading innovative ideas and strategies and creating organization-wide changes ( Powell et al., 2015). However, little is known about the processes or specific strategies that make champions successful. One area in which champions are needed is in improving organizations' response to and understanding of secondary traumatic stress (STS), among those in helping professions that are indirectly exposed to trauma through the traumatic stories of those they work with. In fact, research has shown that organizational efforts to address STS improve the well-being of individual professionals within that organization ( Sprang et al., 2021). The present study sought to better understand what champion-related processes or conditions led to organizational change in addressing the effects of indirect exposure and improving symptoms related to STS. Results showed that organizational change in addressing STS and champions' problem-solving strategies resulted in reductions in individual professionals' STS symptoms. Furthermore, champions' use of peer engagement or sharing of knowledge among peers in child welfare settings led to improvements at an organizational level. These results show that organization-level change can have a direct impact on individual well-being and there are specific champion activities that can promote this change. Specifically, results demonstrate a need to identify and support champions' use of problem-solving and peer engagement strategies to turn the individual and organizational threat posed by indirect trauma into an opportunity for shared healing.

Modeling Contingency in Veteran Community Reintegration: A Mixed Methods Approach.

Researchers need approaches for analyzing complex phenomena when assessing contingency relationships where specific conditions explain an outcome only when combined with other conditions. Using a mixed methods design, we paired configurational methods and qualitative thematic analysis to model contingency in veteran community reintegration outcomes, identifying combinations of conditions that led to success or lack of success in community reintegration among US military veterans. This pairing allowed for modeling contingency at a detailed level beyond the capabilities of either approach alone. Our analysis revealed multiple contingent relationships at work in explaining reintegration, including social support, purpose, cultural adjustment, and military separation experiences. This study contributes to the field of mixed methods by pairing a mathematical cross-case method with a qualitative method to model contingency.

Facility-level program components leading to population impact: a coincidence analysis of obesity treatment options within the Veterans Health Administration.

Obesity is a well-established risk factor for increased morbidity and mortality. Comprehensive lifestyle interventions, pharmacotherapy, and bariatric surgery are three effective treatment approaches for obesity. The Veterans Health Administration (VHA) offers all three domains but in different configurations across medical facilities. Study aim was to explore the relationship between configurations of three types of obesity treatments, context, and population impact across VHA using coincidence analysis. This was a cross-sectional analysis of survey data describing weight management treatment components linked with administrative data to compute population impact for each facility. Coincidence analysis was used to identify combinations of treatment components that led to higher population impact. Facilities with higher impact were in the top two quintiles for (1) reach to eligible patients and (2) weight outcomes. Sixty-nine facilities were included in the analyses. The final model explained 88% (29/33) of the higher-impact facilities with 91% consistency (29/32) and was comprised of five distinct pathways. Each of the five pathways depended on facility complexity-level plus factors from one or more of the three domains of weight management: comprehensive lifestyle interventions, pharmacotherapy, and/or bariatric surgery. Three pathways include components from multiple treatment domains. Combinations of conditions formed "recipes" that lead to higher population impact. Our coincidence analyses highlighted both the importance of local context and how combinations of specific conditions consistently and uniquely distinguished higher impact facilities from lower impact facilities for weight management.

Obesity can contribute to increased rates of ill health and earlier death. Proven treatments for obesity include programs that help people improve lifestyle behaviors (e.g., being physically active), medications, and/or bariatric surgery. In the Veterans Health Administration (VHA), all three types of treatments are offered, but not at every medical center­in practice, individual medical centers offer different combinations of treatment options to their patients. VHA medical centers also have a wide range of population impact. We identified high-impact medical centers (centers with the most patients participating in obesity treatment who would benefit from treatment AND that reported the most weight loss for their patients) and examined which treatment configurations led to better population-level outcomes (i.e., higher population impact). We used a novel analysis approach that allows us to compare combinations of treatment components, instead of analyzing them one-by-one. We found that optimal combinations are context-sensitive and depend on the type of center (e.g., large centers affiliated with a university vs. smaller rural centers). We list five different "recipes" of treatment combinations leading to higher population-level impact. This information can be used by clinical leaders to design treatment programs to maximize benefits for their patients.

Scaling Interventions to Manage Chronic Disease: Innovative Methods at the Intersection of Health Policy Research and Implementation Science.

Policy implementation is a key component of scaling effective chronic disease prevention and management interventions. Policy can support scale-up by mandating or incentivizing intervention adoption, but enacting a policy is only the first step. Fully implementing a policy designed to facilitate implementation of health interventions often requires a range of accompanying implementation structures, like health IT systems, and implementation strategies, like training. Decision makers need to know what policies can support intervention adoption and how to implement those policies, but to date research on policy implementation is limited and innovative methodological approaches are needed. In December 2021, the Johns Hopkins ALACRITY Center for Health and Longevity in Mental Illness and the Johns Hopkins Center for Mental Health and Addiction Policy convened a forum of research experts to discuss approaches for studying policy implementation. In this report, we summarize the ideas that came out of the forum. First, we describe a motivating example focused on an Affordable Care Act Medicaid health home waiver policy used by some US states to support scale-up of an evidence-based integrated care model shown in clinical trials to improve cardiovascular care for people with serious mental illness. Second, we define key policy implementation components including structures, strategies, and outcomes. Third, we provide an overview of descriptive, predictive and associational, and causal approaches that can be used to study policy implementation. We conclude with discussion of priorities for methodological innovations in policy implementation research, with three key areas identified by forum experts: effect modification methods for making causal inferences about how policies' effects on outcomes vary based on implementation structures/strategies; causal mediation approaches for studying policy implementation mechanisms; and characterizing uncertainty in systems science models. We conclude with discussion of overarching methods considerations for studying policy implementation, including measurement of policy implementation, strategies for studying the role of context in policy implementation, and the importance of considering when establishing causality is the goal of policy implementation research.

Determinants of inter-organizational implementation success: A mixed-methods evaluation of Veteran Directed Care.

BACKGROUND: Veteran Directed Care (VDC) aims to keep Veterans at risk for nursing home placement in their communities. VA medical centers (VAMCs) purchase VDC from third-party organizational providers who then partner with them during implementation. Experiences with VDC implementation have varied. OBJECTIVES: We sought to identify conditions differentiating partnerships with higher enrollment (implementation success). METHODS: We conducted a case-based study with: qualitative data on implementation determinants two and eight months after program start, directed content analysis to assign numerical scores (-2 strong barrier to +2 strong facilitator), and mathematical modeling using Coincidence Analysis (CNA) to identify key determinants of implementation success. Cases consisted of VAMCs and partnering non-VAMC organizations who started VDC during 2017 or 2018. The Consolidated Framework for Implementation Research (CFIR) guided analysis. RESULTS: Eleven individual organizations within five partnerships constituted our sample. Two CFIR determinants- Networks & Communication and External Change Agent-uniquely and consistently identified implementation success. At an inter-organizational partnership level, Networks & Communications and External Change Agent +2 (i.e., present as strong facilitators) were both necessary and sufficient. At a within-organization level, Networks & Communication +2 was necessary but not sufficient for the non-VAMC providers, whereas External Change Agent +2 was necessary and sufficient for VAMCs. CONCLUSION: Networks & Communication and External Change Agent played difference-making roles in inter-organizational implementation success, which differ by type of organization and level of analysis. IMPLICATIONS: This multi-level approach identified crucial difference-making conditions for inter-organizational implementation success when putting a program into practice requires partnerships across multiple organizations.

Coincidence Analysis: A Novel Approach to Modeling Nurses' Workplace Experience.

OBJECTIVES: The purpose of this study is to identify combinations of workplace conditions that uniquely differentiate high, medium, and low registered nurse (RN) ratings of appropriateness of patient assignment during daytime intensive care unit (ICU) work shifts. METHODS: A collective case study design and coincidence analysis were employed to identify combinations of workplace conditions that link directly to high, medium, and low RN perception of appropriateness of patient assignment at a mid-shift time point. RN members of the study team hypothesized a set of 55 workplace conditions as potential difference makers through the application of theoretical and empirical knowledge. Conditions were derived from data exported from electronic systems commonly used in nursing care. RESULTS: Analysis of 64 cases (25 high, 24 medium, and 15 low) produced three models, one for each level of the outcome. Each model contained multiple pathways to the same outcome. The model for "high" appropriateness was the simplest model with two paths to the outcome and a shared condition across pathways. The first path comprised of the absence of overtime and a before-noon patient discharge or transfer, and the second path comprised of the absence of overtime and RN assignment to a single ICU patient. CONCLUSION: Specific combinations of workplace conditions uniquely distinguish RN perception of appropriateness of patient assignment at a mid-shift time point, and these difference-making conditions provide a foundation for enhanced observability of nurses' work experience during hospital work shifts. This study illuminates the complexity of assessing nursing work system status by revealing that multiple paths, comprised of multiple conditions, can lead to the same outcome. Operational decision support tools may best reflect the complex adaptive nature of the work systems they intend to support by utilizing methods that accommodate both causal complexity and equifinality.

The Perils of a "My Work Here is Done" perspective: a mixed methods evaluation of sustainment of an evidence-based intervention for transient ischemic attack.

BACKGROUND: To evaluate quality improvement sustainment for Transient Ischemic Attack (TIA) and identify factors influencing sustainment, which is a challenge for Learning Healthcare Systems. METHODS: Mixed methods were used to assess changes in care quality across periods (baseline, implementation, sustainment) and identify factors promoting or hindering sustainment of care quality. PREVENT was a stepped-wedge trial at six US Department of Veterans Affairs implementation sites and 36 control sites (August 2015-September 2019). Quality of care was measured by the without-fail rate: proportion of TIA patients who received all of the care for which they were eligible among brain imaging, carotid artery imaging, neurology consultation, hypertension control, anticoagulation for atrial fibrillation, antithrombotics, and high/moderate potency statins. Key informant interviews were used to identify factors associated with sustainment. RESULTS: The without-fail rate at PREVENT sites improved from 36.7% (baseline, 58/158) to 54.0% (implementation, 95/176) and settled at 48.3% (sustainment, 56/116). At control sites, the without-fail rate improved from 38.6% (baseline, 345/893) to 41.8% (implementation, 363/869) and remained at 43.0% (sustainment, 293/681). After adjustment, no statistically significant difference in sustainment quality between intervention and control sites was identified. Among PREVENT facilities, the without-fail rate improved ≥2% at 3 sites, declined ≥2% at two sites, and remained unchanged at one site during sustainment. Factors promoting sustainment were planning, motivation to sustain, integration of processes into routine practice, leadership engagement, and establishing systems for reflecting and evaluating on performance data. The only factor that was sufficient for improving quality of care during sustainment was the presence of a champion with plans for sustainment. Challenges during sustainment included competing demands, low volume, and potential problems with medical coding impairing use of performance data. Four factors were sufficient for declining quality of care during sustainment: low motivation, champion inactivity, no reflecting and evaluating on performance data, and absence of leadership engagement. CONCLUSIONS: Although the intervention improved care quality during implementation; performance during sustainment was heterogeneous across intervention sites and not different from control sites. Learning Healthcare Systems seeking to sustain evidence-based practices should embed processes within routine care and establish systems for reviewing and reflecting upon performance. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT02769338 ).

Pairing regression and configurational analysis in health services research: modelling outcomes in an observational cohort using a split-sample design.

BACKGROUND: Configurational methods are increasingly being used in health services research. OBJECTIVES: To use configurational analysis and logistic regression within a single data set to compare results from the two methods. DESIGN: Secondary analysis of an observational cohort; a split-sample design involved randomly dividing patients into training and validation samples. PARTICIPANTS AND SETTING: Patients who had a transient ischaemic attack (TIA) in US Department of Veterans Affairs hospitals. MEASURES: The patient outcome was the combined endpoint of all-cause mortality or recurrent ischaemic stroke within 1 year post-TIA. The quality-of-care outcome was the without-fail rate (proportion of patients who received all processes for which they were eligible, among seven processes). RESULTS: For the recurrent stroke or death outcome, configurational analysis yielded a three-pathway model identifying a set of (validation sample) patients where the prevalence was 15.0% (83/552), substantially higher than the overall sample prevalence of 11.0% (relative difference, 36%). The configurational model had a sensitivity (coverage) of 84.7% and specificity of 40.6%. The logistic regression model identified six factors associated with the combined endpoint (c-statistic, 0.632; sensitivity, 63.3%; specificity, 63.1%). None of these factors were elements of the configurational model. For the quality outcome, configurational analysis yielded a single-pathway model identifying a set of (validation sample) patients where the without-fail rate was 64.3% (231/359), nearly twice the overall sample prevalence (33.7%). The configurational model had a sensitivity (coverage) of 77.3% and specificity of 78.2%. The logistic regression model identified seven factors associated with the without-fail rate (c-statistic, 0.822; sensitivity, 80.3%; specificity, 84.2%). Two of these factors were also identified in the configurational analysis. CONCLUSIONS: Configurational analysis and logistic regression represent different methods that can enhance our understanding of a data set when paired together. Configurational models optimise sensitivity with relatively few conditions. Logistic regression models discriminate cases from controls and provided inferential relationships between outcomes and independent variables.

Defining optimal implementation packages for delivering community-wide mass drug administration for soil-transmitted helminths with high coverage.

BACKGROUND: Recent evidence suggests that community-wide mass drug administration (MDA) may interrupt the transmission of soil-transmitted helminths (STH), a group of intestinal worms that infect 1.5 billion individuals globally. Although current operational guidelines provide best practices for effective MDA delivery, they do not describe which activities are most essential for achieving high coverage or how they work together to produce effective intervention delivery. We aimed to identify the various packages of influential intervention delivery activities that result in high coverage of community-wide MDA for STH in Benin, India, and Malawi. METHODS: We applied coincidence analysis (CNA), a novel cross-case analytical method, to process mapping data as part of the implementation science research of the DeWorm3 Project, a Hybrid Type 1 cluster randomized controlled trial assessing the feasibility of interrupting the transmission of STH using bi-annual community-wide MDA in Benin, India, and Malawi. Our analysis aimed to identify any necessary and/or sufficient combinations of intervention delivery activities (i.e., implementation pathways) that resulted in high MDA coverage. Activities were related to drug supply chain, implementer training, community sensitization strategy, intervention duration, and implementation context. We used pooled implementation data from three sites and six intervention rounds, with study clusters serving as analytical cases (N = 360). Secondary analyses assessed differences in pathways across sites and over intervention rounds. RESULTS: Across all three sites and six intervention rounds, efficient duration of MDA delivery (within ten days) singularly emerged as a common and fundamental component for achieving high MDA coverage when combined with other particular activities, including a conducive implementation context, early arrival of albendazole before the planned start of MDA, or a flexible community sensitization strategy. No individual activity proved sufficient by itself for producing high MDA coverage. We observed four possible overall models that could explain effective MDA delivery strategies, all which included efficient duration of MDA delivery as an integral component. CONCLUSION: Efficient duration of MDA delivery uniquely stood out as a highly influential implementation activity for producing high coverage of community-wide MDA for STH. Effective MDA delivery can be achieved with flexible implementation strategies that include various combinations of influential intervention components.

How education and racial segregation intersect in neighborhoods with persistently low COVID-19 vaccination rates in Philadelphia.

BACKGROUND: COVID-19 infection has disproportionately affected socially disadvantaged neighborhoods. Despite this disproportionate burden of infection, these neighborhoods have also lagged in COVID-19 vaccinations. To date, we have little understanding of the ways that various types of social conditions intersect to explain the complex causes of lower COVID-19 vaccination rates in neighborhoods. METHODS: We used configurational comparative methods (CCMs) to study COVID-19 vaccination rates in Philadelphia by neighborhood (proxied by zip code tabulation areas). Specifically, we identified neighborhoods where COVID-19 vaccination rates (per 10,000) were persistently low from March 2021 - May 2021. We then assessed how different combinations of social conditions (pathways) uniquely distinguished neighborhoods with persistently low vaccination rates from the other neighborhoods in the city. Social conditions included measures of economic inequities, racial segregation, education, overcrowding, service employment, public transit use, health insurance and limited English proficiency. RESULTS: Two factors consistently distinguished neighborhoods with persistently low COVID-19 vaccination rates from the others: college education and concentrated racial privilege. Two factor values together - low college education AND low/medium concentrated racial privilege - identified persistently low COVID-19 vaccination rates in neighborhoods, with high consistency (0.92) and high coverage (0.86). Different values for education and concentrated racial privilege - medium/high college education OR high concentrated racial privilege - were each sufficient by themselves to explain neighborhoods where COVID-19 vaccination rates were not persistently low, likewise with high consistency (0.93) and high coverage (0.97). CONCLUSIONS: Pairing CCMs with geospatial mapping can help identify complex relationships between social conditions linked to low COVID-19 vaccination rates. Understanding how neighborhood conditions combine to create inequities in communities could inform the design of interventions tailored to address COVID-19 vaccination disparities.

Factors influencing primary care organization commitment to technical assistance for pharmacist clinical services integration.

BACKGROUND: While technical assistance (TA) has been utilized by primary care organizations (PCOs) for electronic health record installation and medical home recognition, little is known about PCOs' use of TA to optimize pharmacist clinical services and integration in team-based care or population health programs. In 2019, the Connecticut Office of Health Strategy's State Innovation Model Program funded a no-cost TA initiative for 9 PCOs to initiate and/or advance pharmacist clinical services. OBJECTIVE: To assess organizational, operational, and pharmacist factors that influenced PCO commitment to the TA program. METHODS: During the TA program, data were collected from multiple sources including PCO demographic data; discussions and meetings with PCO medical, pharmacy, and administrative leaders; on-site workflow observations; and pharmacist coaching sessions. Configurational comparative methods were applied using the data collected during the TA program. Candidate factors were identified and calibrated on the basis of the researchers' knowledge of the TA program, organizational readiness for change models, implementation science frameworks, and published literature. Each candidate factor was iteratively assessed until 13 factors were selected and calibrated by independently assigning each factor a dichotomous value across PCOs. Calibration differences between the researchers were discussed until consensus was reached. Solutions were modeled using the Coincidence Analysis (cna) package in R and RStudio (RStudio, PBC). RESULTS: Of the 9 PCOs, 4 committed to participating in the TA program. Only 1 factor, the presence of a hired pharmacist, consistently distinguished PCOs that committed from those that did not, with 100% coverage and 80% consistency. CONCLUSION: PCO commitment to participate in the TA program was best explained by the factor of already having hired a pharmacist. These results can inform future efforts to engage PCOs in TA, primary care policy initiatives, and future research to understand factors influencing PCO success with pharmacist clinical services integration.

Evaluation of organizational capacity in the implementation of a church-based cancer education program.

Implementation evaluations have increasingly taken into account how features of local context help determine implementation outcomes. The purpose of this study was to determine which contextual features of organizational capacity led directly to the RE-AIM Framework implementation outcomes of intervention reach and number of days taken to implement, in an implementation trial of a series of cancer education workshops conducted across 13 African American churches in Maryland. We used a configurational approach with Coincidence Analysis to identify specific features of organizational capacity that uniquely distinguished churches with implementation success from those that were less successful. Aspects of organizational capacity (e.g., congregation size, staffing/volunteers, health ministry experience) were drawn from an existing measure of church organizational capacity for health promotion. Solution pathways leading to higher intervention reach included: having a health ministry in place for 1-4 years; or having fewer than 100 members; or mid-size churches that had conducted health promotion activities in 1-4 different topics in the past 2 years. Solution pathways to implementing the intervention in fewer number of days included: having conducted 1-2 health promotion activities in the past 2 years; or having 1-5 part-time staff and a pastor without additional outside employment; or churches with a doctorally prepared pastor and a weekly attendance of 101-249 members. Study findings can inform future theory, research, and practice in implementation of evidence-based health promotion interventions delivered in faith-based and other limited-resource community settings. Findings support the important role of organizational capacity in implementation outcomes in these settings.