Investigating the impact of suboptimal prescription of preoperative antiplatelets and statins on race and ethnicity-related disparities in major limb amputation.

BACKGROUND: Non-Hispanic Black and Hispanic patients with symptomatic PAD may receive different treatments than White patients with symptomatic PAD. The delivery of guideline-directed medical treatment may be a modifiable upstream driver of race and ethnicity-related disparities in outcomes such as limb amputation. The purpose of our study was to investigate the prescription of preoperative antiplatelets and statins in producing disparities in the risk of amputation following revascularization for symptomatic peripheral artery disease (PAD). METHODS: We used data from the Vascular Quality Initiative, a vascular procedure-based registry in the United States (2011-2018). We estimated the probability of preoperative antiplatelet and statin prescriptions and 1-year incidence of amputation. We then estimated the amputation risk difference between race/ethnicity groups that could be eliminated under a hypothetical intervention. RESULTS: Across 100,579 revascularizations, the 1-year amputation risk was 2.5% (2.4%, 2.6%) in White patients, 5.3% (4.9%, 5.6%) in Black patients, and 5.3% (4.7%, 5.9%) in Hispanic patients. Black (57.5%) and Hispanic patients (58.7%) were only slightly less likely than White patients (60.9%) to receive antiplatelet and statin therapy. However, the effect of antiplatelets and statins was greater in Black and Hispanic patients such that, had all patients received these medications, the estimated risk difference comparing Black to White patients would have reduced by 8.9% (-2.9%, 21.9%) and the risk difference comparing Hispanic to White patients would have been reduced by 17.6% (-0.7%, 38.6%). CONCLUSION: Even though guideline-directed care appeared evenly distributed by race/ethnicity, increasing access to such care may decrease health care disparities in major limb amputation.

Use of Sociodemographic Information in Clinical Vignettes of Multiple-Choice Questions for Preclinical Medical Students.

Purpose: This paper aims to characterize the use of demographic data in multiple-choice questions from a commercial preclinical question bank and determine if there is appropriate use of different distractors. Background: Multiple-choice questions for medical students often include vignettes describing a patient's presentation to help guide students to a diagnosis, but overall patterns of usage between different types of nonmedical patient information in question stems have yet to be determined. Methods: Three hundred eighty of 453 randomly selected questions were included for analysis after determining they contained a clinical vignette and required a diagnosis. The vignettes and following explanations were then examined for the presence/absence of 11 types of demographic information, including age, sex/gender, and socioeconomic status. We compared both the usage frequency and relevance between the 11 information types. Results: Most information types were present in less than 10% of clinical vignettes, but age and sex/gender were present in over 95% of question stems. Over 50% of questions included irrelevant information about age and sex/gender, but 75% of questions did not include any irrelevant information of other types. Patient weight and environmental exposures were significantly more likely to be relevant than age or sex/gender. Discussion: Students using the questions in this study will frequently gain practice incorporating age and sex/gender into their clinical reasoning while receiving little exposure to other demographic information. Based on our findings, we posit that questions could include more irrelevant information, outside age and sex/gender, to better approximate real clinical scenarios and ensure students do not overvalue certain demographic data. Supplementary Information: The online version contains supplementary material available at 10.1007/s40670-023-01778-z.

Examining ACCURE's Nurse Navigation Through an Antiracist Lens: Transparency and Accountability in Cancer Care.

There are persistent disparities in the delivery of cancer treatment, with Black patients receiving fewer of the recommended cancer treatment cycles than their White counterparts on average. To enhance racial equity in cancer care, innovative methods that apply antiracist principles to health promotion interventions are needed. The parent study for the current analysis, the Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) intervention, was a system-change intervention that successfully eliminated the Black-White disparity in cancer treatment completion among patients with early-stage breast and lung cancer. The intervention included specially trained nurse navigators who leveraged real-time data to follow-up with patients during their treatment journeys. Community and academic research partners conducted thematic analysis on all clinical notes (n = 3,251) written by ACCURE navigators after each contact with patients in the specialized navigation arm (n = 162). Analysis was informed by transparency and accountability, principles adapted from the antiracist resource Undoing Racism and determined as barriers to treatment completion through prior research that informed ACCURE. We identified six themes in the navigator notes that demonstrated enhanced accountability of the care system to patient needs. Underlying these themes was a process of enhanced data transparency that allowed navigators to provide tailored patient support. Themes include (1) patient-centered advocacy, (2) addressing system barriers to care, (3) connection to resources, (4) re-engaging patients after lapsed treatment, (5) addressing symptoms and side effects, and (6) emotional support. Future interventions should incorporate transparency and accountability mechanisms and examine the impact on racial equity in cancer care.

A Path Toward Health Care Equity: System-Based Interventions for Change.

Despite documentation spanning decades, health care disparities across North Carolina have remained persistent for populations of color, especially for Black patients. This commentary reviews recent studies that used system-based interventions to reduce disparities and improve outcomes for everyone, and outlines how clinicians, partnering with NC AHEC, can apply results to practice.

Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study.

PURPOSE: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection.VISUAL ABSTRACT.

Generating and Reporting Electronic Clinical Quality Measures from Electronic Health Records: Strategies from EvidenceNOW Cooperatives.

BACKGROUND: Electronic clinical quality measures (eCQMs) from electronic health records (EHRs) are a key component of quality improvement (QI) initiatives in small-to-medium size primary care practices, but using eCQMs for QI can be challenging. Organizational strategies are needed to effectively operationalize eCQMs for QI in these practice settings. OBJECTIVE: This study aimed to characterize strategies that seven regional cooperatives participating in the EvidenceNOW initiative developed to generate and report EHR-based eCQMs for QI in small-to-medium size practices. METHODS: A qualitative study comprised of 17 interviews with representatives from all seven EvidenceNOW cooperatives was conducted. Interviewees included administrators were with both strategic and cooperative-level operational responsibilities and external practice facilitators were with hands-on experience helping practices use EHRs and eCQMs. A subteam conducted 1-hour semistructured telephone interviews with administrators and practice facilitators, then analyzed interview transcripts using immersion crystallization. The analysis and a conceptual model were vetted and approved by the larger group of coauthors. RESULTS: Cooperative strategies consisted of efforts in four key domains. First, cooperative adaptation shaped overall strategies for calculating eCQMs whether using EHRs, a centralized source, or a "hybrid strategy" of the two. Second, the eCQM generation described how EHR data were extracted, validated, and reported for calculating eCQMs. Third, practice facilitation characterized how facilitators with backgrounds in health information technology (IT) delivered services and solutions for data capture and quality and practice support. Fourth, performance reporting strategies and tools informed QI efforts and how cooperatives could alter their approaches to eCQMs. CONCLUSION: Cooperatives ultimately generated and reported eCQMs using hybrid strategies because they determined neither EHRs alone nor centralized sources alone could operationalize eCQMs for QI. This required cooperatives to devise solutions and utilize resources that often are unavailable to typical small-to-medium-sized practices. The experiences from EvidenceNOW cooperatives provide insights into how organizations can plan for challenges and operationalize EHR-based eCQMs.

A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study.

PURPOSE: To evaluate the implementation and effectiveness of the Carolina Heart Alliance Networking for Greater Equity (CHANGE) Program, an adapted evidence-based cardiovascular disease risk reduction intervention delivered by Community Health Workers (CHW) to rural adults. DESIGN: Hybrid implementation-effectiveness study with a pre-post design. SETTING: North Carolina Federally Qualified Health Center and local health department in a rural, medically underserved area. SAMPLE: Participants (n = 255) included 87% Non-Hispanic Black with a mean age of 57 years; 84% had diagnosed hypertension, 55% had diabetes, and 65% had hypercholesterolemia. INTERVENTION: A CHW-delivered, low-intensity, 4-month behavioral lifestyle intervention promoting a southern-style Mediterranean dietary pattern and physical activity. MEASURES: We measured number and representativeness of participants reached and retained, intervention delivery fidelity, weight, blood pressure, and self-reported dietary and physical activity behaviors. ANALYSIS: Pre-post changes at 4 months were analyzed using paired t-tests. RESULTS: Study participants completed 90% of planned intervention contacts; 87% were retained. Intervention delivery fidelity measures showed participants receiving a mean of 3.5 counseling visits, 2.7 booster calls, and on average completing 1.7 modules, setting 1.8 goals, and receiving 1.3 referrals per visit. There were significant mean reductions in systolic (-2.5 mmHg, P < .05) and diastolic blood pressure (-2.1 mmHg, P < .01); the proportion of participants with systolic blood pressure <130 increased by 7 % points (P = .05), and diastolic pressure <80 by 9 percentage points (P < .01). Dietary behaviors improved significantly with average weekly servings of nuts increased by .5 serving (P < .0001), and fruits and vegetables by .8 daily serving (P < .0001). Physical activity also increased on average by 45 min./week (P < .001). Weight did not change significantly. CONCLUSIONS: The CHANGE program showed both implementation and program effectiveness and adds to the evidence supporting CHW-delivered lifestyle interventions to reduce CVD risk among rural, Non-Hispanic Black, and medically underserved populations.

A Heart Healthy Intervention Improved Tobacco Screening Rates and Cessation Support in Primary Care Practices.

We examined whether an evidence-based cardiovascular disease risk reduction intervention (Heart Health Now) would improve rates for tobacco cessation screening and counseling in small primary care practices in North Carolina. Heart Health Now was a stepped wedge, stratified, cluster randomized trial for primary care practices that were staffed by 10 or fewer clinicians and had an electronic health record. The Heart Health Now intervention consisted of education tools, onsite practice facilitation for one year, and a practice-specific cardiovascular population management dashboard that included monthly, measure-specific run charts to help guide quality improvement. Our primary outcomes were practice-level rates of tobacco screening and tobacco cessation support-extracted from practices' electronic health records-and measured at pre-intervention and 6 months post-intervention. The 28 practices included in our analyses represented 78,120 patients and 17,687 smokers. Significant change occurred in practices' tobacco screening rates and cessation support rates over time. From pre- to post-intervention, screening rates significantly increased from 82.7 to 96.2% (p < 0.001). Similarly, cessation support rates significantly increased from 44.3 to 50.1% (p = 0.03). Several practice-level factors were associated with improvement including being in an academic health center or faculty practice, having more clinicians, and having a lower percentage of White patients. In conclusion, a multi-component intervention focused on multiple cardiovascular disease risk reduction in multiple small primary care practices successfully improved rates of tobacco screening and cessation support.

Development and Validation of the Trust in My Doctor, Trust in Doctors in General, and Trust in the Health Care Team Scales.

RATIONALE: Historic and present-day racism and inequity in the United States (U.S.) have resulted in diminished trust in health care among many populations. A key barrier to improving trust in health care is a dearth of well-validated measures appropriate for diverse populations. Indeed, systematic reviews indicate a need to develop and test updated trust measures that are multidimensional and inclusive of relevant domains (e.g., fairness). OBJECTIVE: We developed three trust measures: the Trust in My Doctor (T-MD), Trust in Doctors in General (T-DiG), and Trust in the Health Care Team (T-HCT) scales. METHODS: After developing an initial item pool, expert reviewers (n = 6) provided feedback on the face validity of each scale. We conducted cognitive interviews (n = 21) with a convenience sample of adults to ensure items were interpreted as intended. In 2020, we administered an online survey to a convenience sample of U.S. adults recruited through the Qualtrics Panel (n = 801) to assess scale reliability and validity. RESULTS: Exploratory and confirmatory factor analyses indicated acceptable model fit for second order latent factor models for each scale (root mean square error of approximation: <0.07, comparative fit index: ≥0.98, and standardized root mean square residual: ≤0.03). The T-MD contained 25 items and six subscales: communication competency, fidelity, systems trust, confidentiality, fairness, and global trust. The T-DiG and T-HCT each contained 29 items and seven subscales (the same subscales in the T-MD plus an additional subscale related to stigma-based discrimination). Each scale was strongly correlated with existing trust measures and perceived racism in health care and was significantly associated with delayed health care seeking and receipt of a routine health exam. CONCLUSIONS: The multidimensional T-MD, T-DiG, and T-HCT scales have sound psychometric properties and may be useful for researchers evaluating trust-related interventions or conducting studies where trust is an important construct or main outcome.

Effect of an Antiracism Intervention on Racial Disparities in Time to Lung Cancer Surgery.

PURPOSE: Timely lung cancer surgery is a metric of high-quality cancer care and improves survival for early-stage non-small-cell lung cancer. Historically, Black patients experience longer delays to surgery than White patients and have lower survival rates. Antiracism interventions have shown benefits in reducing racial disparities in lung cancer treatment. METHODS: We conducted a secondary analysis of Accountability for Cancer Care through Undoing Racism and Equity, an antiracism prospective pragmatic trial, at five cancer centers to assess the impact on overall timeliness of lung cancer surgery and racial disparities in timely surgery. The intervention consisted of (1) a real-time warning system to identify unmet care milestones, (2) race-specific feedback on lung cancer treatment rates, and (3) patient navigation. The primary outcome was surgery within 8 weeks of diagnosis. Risk ratios (RRs) and 95% CIs were estimated using log-binomial regression and adjusted for clinical and demographic factors. RESULTS: A total of 2,363 patients with stage I and II non-small-cell lung cancer were included in the analyses: intervention (n = 263), retrospective control (n = 1,798), and concurrent control (n = 302). 87.1% of Black patients and 85.4% of White patients in the intervention group (P = .13) received surgery within 8 weeks of diagnosis compared with 58.7% of Black patients and 75.0% of White patients in the retrospective group (P < .01) and 64.9% of Black patients and 73.2% of White patients (P = .29) in the concurrent group. Black patients in the intervention group were more likely to receive timely surgery than Black patients in the retrospective group (RR 1.43; 95% CI, 1.26 to 1.64). White patients in the intervention group also had timelier surgery than White patients in the retrospective group (RR 1.10; 95% CI, 1.02 to 1.18). CONCLUSION: Accountability for Cancer Care through Undoing Racism and Equity is associated with timelier lung cancer surgery and reduction of the racial gap in timely surgery.

Non-Hispanic Black and Hispanic Patients Have Worse Outcomes Than White Patients Within Similar Stages of Peripheral Artery Disease.

Background Racial and ethnic disparities in outcomes following lower limb revascularization for peripheral artery disease have been ascribed to disease severity at presentation for surgery. Methods and Results We calculated 1-year risk of major adverse limb events (MALEs), major amputation, and death for patients undergoing elective revascularization for claudication or chronic limb-threatening ischemia in the Vascular Quality Initiative data (2011-2018). We report hazard ratios according to race and ethnicity using Cox (death) or Fine and Gray subdistribution hazards models (MALE and major amputation, treating death as a competing event), adjusted for patient, treatment, and anatomic factors associated with disease severity. Among 88 599 patients (age, 69 years; 37% women), 1-year risk of MALE (major amputation and death) was 12.8% (95% CI, 12.5-13.0) in 67 651 White patients, 16.5% (95% CI, 5.8-7.8) in 15 442 Black patients, and 17.2% (95% CI, 5.6-6.9) in 5506 Hispanic patients. Compared with White patients, we observed an increased hazard of poor limb outcomes among Black (MALE: 1.17; 95% CI, 1.12-1.22; amputation: 1.52; 95% CI, 1.39-1.65) and Hispanic (MALE: 1.22; 95% CI, 1.14-1.31; amputation: 1.45; 95% CI, 1.28-1.64) patients. However, Black and Hispanic patients had a hazard of death of 0.85 (95% CI, 0.79-0.91) and 0.71 (95% CI, 0.63-0.79) times the hazard among White patients, respectively. Worse limb outcomes were observed among Black and Hispanic patients across subcohorts of claudication and chronic limb-threatening ischemia. Conclusions Black and Hispanic patients undergoing infrainguinal revascularization for chronic limb-threatening ischemia and claudication had worse limb outcomes compared with White patients, even with similar disease severity at presentation. Additional investigation aimed at eliminating disparate limb outcomes is needed.

The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care.

BACKGROUND: Unhealthy alcohol use is a leading cause of preventable deaths in the USA and is associated with many societal and health problems. Less than a third of people who visit primary care providers in the USA are asked about or ever discuss alcohol use with a health professional. METHODS/DESIGN: This study is an adaptive, randomized, controlled trial to evaluate the effect of primary care practice facilitation and telehealth services on evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use in small-to-medium-sized primary care practices. Study participants will include primary care practices in North Carolina with 10 or fewer providers. All enrolled practices will receive a practice facilitation intervention that includes quality improvement (QI) coaching, electronic health record (EHR) support, training, and expert consultation. After 6 months, practices in the lower 50th percentile (based on performance) will be randomized to continued practice facilitation or provision of telehealth services plus ongoing facilitation for the next 6 months. Practices in the upper 50th percentile after the initial 6 months of intervention will continue to receive practice facilitation alone. The main outcome measures include the number (and %) of patients in the target population who are screened for unhealthy alcohol use, screen positive, and receive brief counseling. Additional measures include the number (and %) of patients who receive pharmacotherapy for AUD or are referred for AUD services. Sample size calculations determined that 35 practices are needed to detect a 10% increase in the main outcome (percent screened for unhealthy alcohol use) over 6 months. DISCUSSION: A successful intervention would significantly reduce morbidity among adults from unhealthy alcohol use by increasing counseling and other treatment opportunities. The study will produce important evidence about the effect of practice facilitation on uptake of evidence-based screening, counseling, and pharmacotherapy for unhealthy alcohol use when delivered on a large scale to small and medium-sized practices. It will also generate scientific knowledge about whether embedded telehealth services can improve the use of evidence-based screening and interventions for practices with slower uptake. The results of this rigorously conducted evaluation are expected to have a positive impact by accelerating the dissemination and implementation of evidence related to unhealthy alcohol use into primary care practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT04317989 . Registered on March 23, 2020.

A Taxonomy for External Support for Practice Transformation.

BACKGROUND: There is no commonly accepted comprehensive framework for describing the practical specifics of external support for practice change. Our goal was to develop such a taxonomy that could be used by both external groups or researchers and health care leaders. METHODS: The leaders of 8 grants from Agency for Research and Quality for the EvidenceNOW study of improving cardiovascular preventive services in over 1500 primary care practices nationwide worked collaboratively over 18 months to develop descriptions of key domains that might comprehensively characterize any external support intervention. Combining literature reviews with our practical experiences in this initiative and past work, we aimed to define these domains and recommend measures for them. RESULTS: The taxonomy includes 1 domain to specify the conceptual model(s) on which an intervention is built and another to specify the types of support strategies used. Another 5 domains provide specifics about the dose/mode of that support, the types of change process and care process changes that are encouraged, and the degree to which the strategies are prescriptive and standardized. A model was created to illustrate how the domains fit together and how they would respond to practice needs and reactions. CONCLUSIONS: This taxonomy and its use in more consistently documenting and characterizing external support interventions should facilitate communication and synergies between 3 areas (quality improvement, practice change research, and implementation science) that have historically tended to work independently. The taxonomy was designed to be as useful for practices or health systems managing change as it is for research.

A controlled trial of dissemination and implementation of a cardiovascular risk reduction strategy in small primary care practices.

OBJECTIVE: To assess the effect of dissemination and implementation of an intervention consisting of practice facilitation and a risk-stratified, population management dashboard on cardiovascular risk reduction for patients at high risk in small, primary care practices. STUDY SETTING: A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018. STUDY DESIGN: We performed a stepped-wedge, stratified, cluster randomized trial of a one-year intervention consisting of practice facilitation utilizing quality improvement techniques coupled with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79 years and their unmet treatment opportunities. The primary outcome was change in 10-Year ASCVD Risk score among all patients with a baseline score ≥10 percent from baseline to 3 months postintervention. DATA COLLECTION/ EXTRACTION METHODS: Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry. PRINCIPLE FINDINGS: ASCVD risk scores were assessed on 437 556 patients and 146 826 had a calculated 10-year risk ≥10 percent. The mean baseline risk was 23.4 percent (SD ± 12.6 percent). Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4). Models considering calendar time and stepped-wedge controls revealed most of the improvement (4.0 of 6.3 percent) was attributable to the intervention and not secular trends. In multivariate analysis, male gender, age >65 years, low-income (<$40 000), and Black race (P < .001 for all variables) were each associated with greater risk reductions. CONCLUSION: A risk-stratified, population management dashboard combined with practice facilitation led to substantial reductions of 10-year ASCVD risk for patients at high risk. Similar approaches could lead to effective dissemination and implementation of other new evidence, especially in rural and other under-resourced practices. Registration: ClinicalTrials.Gov 15-0479.

Practice level factors associated with enhanced engagement with practice facilitators; findings from the heart health now study.

BACKGROUND: Practice facilitation is a promising strategy to enhance care processes and outcomes in primary care settings. It requires that practices and their facilitators engage as teams to drive improvement. In this analysis, we explored the practice and facilitator factors associated with greater team engagement at the mid-point of a 12-month practice facilitation intervention focused on implementing cardiovascular prevention activities in practice. Understanding factors associated with greater engagement with facilitators in practice-based quality improvement can assist practice facilitation programs with planning and resource allocation. METHODS: One hundred thirty-six ambulatory care small to medium sized primary care practices that participated in the EvidenceNow initiative's NC Cooperative, named Heart Health Now (HHN), fit the eligibility criteria for this analysis. We explored the practice and facilitator factors associated with greater team engagement at the mid-point of a 12-month intervention using a retrospective cohort design that included baseline survey data, monthly practice activity implementation data and information about facilitator's experience. Generalized linear mixed-effects models (GLMMs) identified variables associated with greater odds of team engagement using an ordinal scale for level of team engagement. RESULTS: Among our practice cohort, over half were clinician-owned and 27% were Federally Qualified Health Centers. The mean number of clinicians was 4.9 (SD 4.2) and approximately 40% of practices were in Medically Underserved Areas (MUA). GLMMs identified a best fit model. The Model presented as odd ratios and 95% confidence intervals suggests greater odds ratios of higher team engagement with greater practice QI leadership 17.31 (5.24-57.19), [0.00], and practice location in a MUA 7.25 (1.8-29.20), [0.005]. No facilitator characteristics were independently associated with greater engagement. CONCLUSIONS: Our analysis provides information for practice facilitation stakeholders to consider when considering which practices may be more amendable to embracing facilitation services.

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study.

BACKGROUND: Community Health Workers (CHW) are recommended for delivery of interventions to prevent cardiovascular disease, but there is insufficient evidence to guide implementation of CHW interventions in rural, medically underserved areas. METHODS: Using a hybrid implementation-effectiveness design, we evaluated the implementation and effectiveness of an adapted, evidence-based cardiovascular disease risk reduction intervention among rural high-risk adults. CHWs at a community health center and local health department recruited, enrolled and counseled participants during 4 monthly home visits and 3 brief phone contacts. Participant data collection included pre- and post-intervention measurements of blood pressure, weight, and dietary and physical activity behaviors. We evaluated implementation with measures of intervention reach and delivery fidelity. Statistical analyses included descriptive statistics and paired t-tests. RESULTS: Study participants (n = 105) had a mean age of 62 years and included 88% Non-Hispanic Blacks and 82% females. Recruitment strategies resulted in the enrollment of 38% of interested and eligible participants who received 80% of the planned intervention visits and phone contacts. Mean differences in pre-/post-intervention measures showed significant mean reductions in blood pressure (- 5.4 mmHg systolic, p = .006; - 2.3 mmHg diastolic, p = .04) and body weight (- 3.8 lb., p = .02). Self-reported dietary and physical activity behaviors also improved significantly. CONCLUSION: This feasibility study demonstrated preliminary implementation and program effectiveness of a CHW-delivered intervention to reduce cardiovascular disease risk factors. Additionally, it identified areas for future refinements to strategies that strengthen community-clinical linkages with an integrated role of CHWs in rural health care delivery. If results from this feasibility study can be enhanced in a larger sample, there would be significant potential to positively impact the excess burden of chronic diseases that adversely impact rural, low-income, and medically underserved populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03582696.

A Multi-faceted Intervention Aimed at Black-White Disparities in the Treatment of Early Stage Cancers: The ACCURE Pragmatic Quality Improvement trial.

BACKGROUND: Reports continue to show that Blacks with curable lung or breast cancer complete treatment less often than similar Whites contributing to worse survival. ACCURE is an intervention trial designed to address this problem. PATIENTS AND METHODS: A pragmatic, quality improvement trial comparing an intervention group to retrospective and concurrent controls. Patients with early stage breast or lung cancer aged 18 to 85 were enrolled (N = 302) at 2 cancer centers between April 2013 and March 2015 for the intervention component. Data from patients seen between January 2007 and December 2012 with these diagnoses were obtained to establish control completion rates. Concurrent data for non-study patients were used to identify secular trends. The intervention included: a real time registry derived from electronic health records of participants to signal missed appointments or unmet care milestones, a navigator, and clinical feedback. The primary outcome was "Treatment Complete", a composite variable representing completion of surgery, recommended radiation and chemotherapy for each patient. RESULTS: The mean age in the intervention group was 63.1 years; 37.1% of patients were Black. Treatment completion in retrospective and concurrent controls showed significant Black-White differences (Blacks (B) 79.8% vs. Whites (W) 87.3%, p < 0.001; 83.1% B vs. 90.1% W, p < 0.001, respectively). The disparity lessened within the intervention (B 88.4% and W 89.5%, p = 0.77). Multivariate analyses confirmed disparities reduction. OR for Black-White disparity within the intervention was 0.98 (95% CI 0.46-2.1); Black completion in the intervention compared favorably to Whites in retrospective (OR 1.6; 95% CI 0.90-2.9) and concurrent (OR 1.1; 95% CI 0.59-2.0) controls. CONCLUSION: A real time registry combined with feedback and navigation improved completion of treatment for all breast and lung cancer patients and narrowed disparities. Similar multi-faceted interventions could mitigate disparities in the treatment of other cancers and chronic conditions.

The role of patient-physician relationship on health-related quality of life and pain in cancer patients.

PURPOSE: Health-related quality of life (HRQOL) and pain are important supportive cancer care outcomes. The patient-provider relationship, a modifiable care experience, has been linked to healthcare outcomes; however, less is known about associations between patient-provider relationship and supportive care outcomes in cancer patients. We examined the role of multiple aspects of the patient-provider relationship in explaining patterns of HRQOL and pain among breast and lung cancer patients. METHODS: Our analysis included 283 breast and lung cancer patients from two cancer centers. Clinical data and survey data on patient sociodemographic factors, physical and mental HRQOL, pain, and patient-physician relationship (i.e., doctor's respectfulness, time spent with doctors, patient involvement in decision-making, satisfaction with care, and following doctor's advice/treatment plan) were collected at baseline and during treatment. We estimated adjusted modified Poisson regression models to assess associations between patient-physician relationship factors and physical and mental HRQOL and pain. RESULTS: Compared with patients reporting suboptimal respect from doctors, patients reporting optimal respect were less likely to report below average physical HRQOL (adjusted risk ratio (ARR), 0.73; 95%CI, 0.62-0.86), below average mental HRQOL (ARR, 0.71; 95%CI, 0.54-0.93), and moderate-to-severe pain (ARR, 0.53; 95%CI, 0.35-0.79). Patients reporting optimal involvement in care decision-making and patients who reported following their doctor's advice/treatment plan were less likely to report below average mental HRQOL than their respective counterparts (ARR, 0.64; 95%CI, 0.50-0.83; ARR, 0.65; 95%CI, 0.48-0.86). CONCLUSION: Multiple patient-physician relationship factors account for variations in HRQOL and pain in cancer patients. These findings provide insight into potential targets for improving the patient-provider relationship and supportive cancer care outcomes.

Reducing cardiovascular disease in a rural community.

In this case report, we describe the one-year formative phase of a five-year study to develop, implement, and test a community health worker (CHW)-delivered cardiovascular disease (CVD) prevention intervention. The purpose of the formative phase was to engage community partners in the adaptation of an existing evidence-based CVD prevention intervention to fit the needs and preferences of a rural, predominantly African-American community. The formative work was guided by a framework for adapting evidence-based interventions and involved engaging stakeholders in assessing the intervention's fit with the local context and then applying assessment findings to iteratively adapt the intervention's contents, materials, and delivery methods. Findings from the formative work were then applied to develop CHW position descriptions, workflow diagrams, and a training plan. Findings also were applied to adapt intervention materials and protocols to fit the needs of the community. This case report illustrates how community-engaged formative work can be applied to adapt an evidence-based intervention to fit community needs and resources.