Association of Continuity of Care With Health Care Utilization and Expenditures Among Patients Discharged Home After Stroke or Transient Ischemic Attack.

OBJECTIVES: To examine the association of prestroke continuity of care (COC) with postdischarge health care utilization and expenditures. STUDY POPULATION: The study population included 2233 patients with a diagnosis of stroke or a transient ischemic attack hospitalized in one of 41 hospitals in North Carolina between March 2016 and July 2019 and discharged directly home from acute care. METHODS: COC was assessed from linked Centers for Medicare and Medicaid Services Medicare claims using the Modified, Modified Continuity Index. Logistic regressions and 2-part models were used to examine the association of prestroke primary care COC with postdischarge health care utilization and expenditures. RESULTS: Relative to patients in the first (lowest) COC quartile, patients in the second and third COC quartiles were more likely [21% (95% CI: 8.5%, 33.5%) and 33% (95% CI: 20.5%, 46.1%), respectively] to have an ambulatory care visit within 14 days. Patients in the highest COC quartile were more likely to visit a primary care provider but less likely to see a stroke specialist. Highest as compared with lowest primary care COC quartile was associated with $45 lower (95% CI: $14, $76) average expenditure for ambulatory care visits within 30 days postdischarge. Patients in the highest, as compared with the lowest, primary care COC quartile were 36% less likely (95% CI: 8%, 64%) to be readmitted within 30 days postdischarge and spent $340 less (95% CI: $2, $678) on unplanned readmissions. CONCLUSIONS: These findings underscore the importance of primary care COC received before stroke hospitalization to postdischarge care and expenditures.

Comparative analysis of hospitalization risk for incident heart failure in non-Hispanic Black versus non-Hispanic White individuals with type 2 diabetes on empagliflozin (Empa-AA): Insights from real-world data.

AIM: There are limited data to evaluate hospitalization for heart failure (hHF) in non-Hispanic Black (hereafter Black) or non-Hispanic White (hereafter White) individuals without previous hHF. Our goal was to evaluate the risk of hHF among Black versus White patients with type 2 diabetes (T2DM) who were initially prescribed empagliflozin using real-world data. METHODS: This multicentre retrospective cohort study included participants aged ≥18 years who had T2DM, were either Black or White, had no previous hHF, and were prescribed empagliflozin between August 2014 and December 2019. Our primary outcome was time to first hHF after the initial prescription of empagliflozin. A propensity-score (PS)-weighted analysis was performed to balance characteristics by race. The inverse probability treatment weighting method based on PS was used to make treatment comparisons. To compare Black with White, a PS-weighted Cox's cause-specific hazards model was used. RESULTS: In total, 8789 participants were eligible for inclusion (Black = 3216 vs. White = 5573). The Black cohort was significantly younger, had a higher proportion of females, and had a higher prevalence of chronic kidney disease, hypertension and diabetic retinopathy, while the White cohort had a higher prevalence of coronary artery disease. After adjustment for confounding factors such as age, gender, coronary artery disease, hypertension and diabetic retinopathy, the hazard ratio for first-time hHF was not significantly different between the two racial groups [hazard ratio (95% confidence interval) = 1.09 (0.84-1.42), p = .52]. CONCLUSION: This study showed no significant difference in incident hHF among Black versus White individuals with T2DM following a prescription for empagliflozin.

Postacute Expenditures Among Patients Discharged Home After Stroke or Transient Ischemic Attack: The COMprehensive Post-Acute Stroke Services (COMPASS) Trial.

OBJECTIVES: The COMPASS (COMprehensive Post-Acute Stroke Services) pragmatic trial cluster-randomized 40 hospitals in North Carolina to the COMPASS transitional care (TC) postacute care intervention or usual care. We estimated the difference in healthcare expenditures postdischarge for patients enrolled in the COMPASS-TC model of care compared with usual care. METHODS: We linked data for patients with stroke or transient ischemic attack enrolled in the COMPASS trial with administrative claims from Medicare fee-for-service (n = 2262), Medicaid (n = 341), and a large private insurer (n = 234). The primary outcome was 90-day total expenditures, analyzed separately by payer. Secondary outcomes were total expenditures 30- and 365-days postdischarge and, among Medicare beneficiaries, expenditures by point of service. In addition to intent-to-treat analysis, we conducted a per-protocol analysis to compare Medicare patients who received the intervention with those who did not, using randomization status as an instrumental variable. RESULTS: We found no statistically significant difference in total 90-day postacute expenditures between intervention and usual care; the results were consistent across payers. Medicare beneficiaries enrolled in the COMPASS intervention arm had higher 90-day hospital readmission expenditures ($682, 95% CI $60-$1305), 30-day emergency department expenditures ($132, 95% CI $13-$252), and 30-day ambulatory care expenditures ($67, 95% CI $38-$96) compared with usual care. The per-protocol analysis did not yield a significant difference in 90-day postacute care expenditures for Medicare COMPASS patients. CONCLUSIONS: The COMPASS-TC model did not significantly change patients' total healthcare expenditures for up to 1 year postdischarge.

The Cost of Implementing and Sustaining the COMprehensive Post-Acute Stroke Services Model.

BACKGROUND: The COMprehensive Post-Acute Stroke Services (COMPASS) model, a transitional care intervention for stroke patients discharged home, was tested against status quo postacute stroke care in a cluster-randomized trial in 40 hospitals in North Carolina. This study examined the hospital-level costs associated with implementing and sustaining COMPASS. METHODS: Using an activity-based costing survey, we estimated hospital-level resource costs spent on COMPASS-related activities during approximately 1 year. We identified hospitals that were actively engaged in COMPASS during the year before the survey and collected resource cost estimates from 22 hospitals. We used median wage data from the Bureau of Labor Statistics and COMPASS enrollment data to estimate the hospital-level costs per COMPASS enrollee. RESULTS: Between November 2017 and March 2019, 1582 patients received the COMPASS intervention across the 22 hospitals included in this analysis. Average annual hospital-level COMPASS costs were $2861 per patient (25th percentile: $735; 75th percentile: $3,475). Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016). About half (N=10) of hospitals reported postacute clinic visits as their highest-cost activity, while a third (N=7) reported case ascertainment (ie, identifying eligible patients) as their highest-cost activity. CONCLUSIONS: We found that the costs of implementing COMPASS varied across hospitals. On average, hospitals with higher stroke volume and higher enrollment reported lower costs per patient. Based on average costs of COMPASS and readmissions for stroke patients, COMPASS could lower net costs if the model is able to prevent about 6 readmissions per year.

Hospital to Home Transition for Patients With Stroke Under Bundled Payments.

Bundled payments are a promising alternative payment model for reducing costs and improving the coordination of postacute stroke care, yet there is limited evidence supporting the effectiveness of bundled payments for stroke. This may be due to the lack of effective strategies to address the complex needs of stroke survivors. In this article, we describe COMprehensive Post-Acute Stroke Services (COMPASS), a comprehensive transitional care intervention focused on discharge from the acute care setting to home. COMPASS may serve as a potential care redesign strategy under bundled payments for stroke, such as the Centers for Medicare & Medicaid Innovation Bundled Payment for Care Improvement Initiative. The COMPASS care model is aligned with the incentive structures and essential components of bundled payments in terms of care coordination, patient assessment, patient and family involvement, and continuity of care. Ongoing evaluation will inform the design of incorporating COMPASS-like transitional care interventions into a stroke bundle.

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.

Implementation of a billable transitional care model for stroke patients: the COMPASS study.

BACKGROUND: The COMprehensive Post-Acute Stroke Services (COMPASS) pragmatic trial compared the effectiveness of comprehensive transitional care (COMPASS-TC) versus usual care among stroke and transient ischemic attack (TIA) patients discharged home from North Carolina hospitals. We evaluated implementation of COMPASS-TC in 20 hospitals randomized to the intervention using the RE-AIM framework. METHODS: We evaluated hospital-level Adoption of COMPASS-TC; patient Reach (meeting transitional care management requirements of timely telephone and face-to-face follow-up); Implementation using hospital quality measures (concurrent enrollment, two-day telephone follow-up, 14-day clinic visit scheduling); and hospital-level sustainability (Maintenance). Effectiveness compared 90-day physical function (Stroke Impact Scale-16), between patients receiving COMPASS-TC versus not. Associations between hospital and patient characteristics with Implementation and Reach measures were estimated with mixed logistic regression models. RESULTS: Adoption: Of 95 eligible hospitals, 41 (43%) participated in the trial. Of the 20 hospitals randomized to the intervention, 19 (95%) initiated COMPASS-TC. Reach: A total of 24% (656/2751) of patients enrolled received a billable TC intervention, ranging from 6 to 66% across hospitals. IMPLEMENTATION: Of eligible patients enrolled, 75.9% received two-day calls (or two attempts) and 77.5% were scheduled/offered clinic visits. Most completed visits (78% of 975) occurred within 14 days. Effectiveness: Physical function was better among patients who attended a 14-day visit versus those who did not (adjusted mean difference: 3.84, 95% CI 1.42-6.27, p = 0.002). Maintenance: Of the 19 adopting hospitals, 14 (74%) sustained COMPASS-TC. CONCLUSIONS: COMPASS-TC implementation varied widely. The greatest challenge was reaching patients because of system difficulties maintaining consistent delivery of follow-up visits and patient preferences to pursue alternate post-acute care. Receiving COMPASS-TC was associated with better functional status. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02588664. Registered 28 October 2015.

Optimizing research in symptomatic uterine fibroids with development of a computable phenotype for use with electronic health records.

BACKGROUND: Women with symptomatic uterine fibroids can report a myriad of symptoms, including pain, bleeding, infertility, and psychosocial sequelae. Optimizing fibroid research requires the ability to enroll populations of women with image-confirmed symptomatic uterine fibroids. OBJECTIVE: Our objective was to develop an electronic health record-based algorithm to identify women with symptomatic uterine fibroids for a comparative effectiveness study of medical or surgical treatments on quality-of-life measures. Using an iterative process and text-mining techniques, an effective computable phenotype algorithm, composed of demographics, and clinical and laboratory characteristics, was developed with reasonable performance. Such algorithms provide a feasible, efficient way to identify populations of women with symptomatic uterine fibroids for the conduct of large traditional or pragmatic trials and observational comparative effectiveness studies. Symptomatic uterine fibroids, due to menorrhagia, pelvic pain, bulk symptoms, or infertility, are a source of substantial morbidity for reproductive-age women. Comparing Treatment Options for Uterine Fibroids is a multisite registry study to compare the effectiveness of hormonal or surgical fibroid treatments on women's perceptions of their quality of life. Electronic health record-based algorithms are able to identify large numbers of women with fibroids, but additional work is needed to develop electronic health record algorithms that can identify women with symptomatic fibroids to optimize fibroid research. We sought to develop an efficient electronic health record-based algorithm that can identify women with symptomatic uterine fibroids in a large health care system for recruitment into large-scale observational and interventional research in fibroid management. STUDY DESIGN: We developed and assessed the accuracy of 3 algorithms to identify patients with symptomatic fibroids using an iterative approach. The data source was the Carolina Data Warehouse for Health, a repository for the health system's electronic health record data. In addition to International Classification of Diseases, Ninth Revision diagnosis and procedure codes and clinical characteristics, text data-mining software was used to derive information from imaging reports to confirm the presence of uterine fibroids. Results of each algorithm were compared with expert manual review to calculate the positive predictive values for each algorithm. RESULTS: Algorithm 1 was composed of the following criteria: (1) age 18-54 years; (2) either ≥1 International Classification of Diseases, Ninth Revision diagnosis codes for uterine fibroids or mention of fibroids using text-mined key words in imaging records or documents; and (3) no International Classification of Diseases, Ninth Revision or Current Procedural Terminology codes for hysterectomy and no reported history of hysterectomy. The positive predictive value was 47% (95% confidence interval 39-56%). Algorithm 2 required ≥2 International Classification of Diseases, Ninth Revision diagnosis codes for fibroids and positive text-mined key words and had a positive predictive value of 65% (95% confidence interval 50-79%). In algorithm 3, further refinements included ≥2 International Classification of Diseases, Ninth Revision diagnosis codes for fibroids on separate outpatient visit dates, the exclusion of women who had a positive pregnancy test within 3 months of their fibroid-related visit, and exclusion of incidentally detected fibroids during prenatal or emergency department visits. Algorithm 3 achieved a positive predictive value of 76% (95% confidence interval 71-81%). CONCLUSION: An electronic health record-based algorithm is capable of identifying cases of symptomatic uterine fibroids with moderate positive predictive value and may be an efficient approach for large-scale study recruitment.

A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project.

BACKGROUND: Because residents of the southeastern United States experience disproportionally high rates of cardiovascular disease (CVD), it is important to develop effective lifestyle interventions for this population. METHODS: The primary objective was to develop and evaluate a dietary, physical activity (PA) and weight loss intervention for residents of the southeastern US. The intervention, given in eastern North Carolina, was evaluated in a 2 year prospective cohort study with an embedded randomized controlled trial (RCT) of a weight loss maintenance intervention. The intervention included: Phase I (months 1-6), individually-tailored intervention promoting a Mediterranean-style dietary pattern and increased walking; Phase II (months 7-12), option of a 16-week weight loss intervention for those with BMI ≥ 25 kg/m(2) offered in 2 formats (16 weekly group sessions or 5 group sessions and 10 phone calls) or a lifestyle maintenance intervention; and Phase III (months 13-24), weight loss maintenance RCT for those losing ≥ 8 lb with all other participants receiving a lifestyle maintenance intervention. Change in diet and PA behaviors, CVD risk factors, and weight were assessed at 6, 12, and 24 month follow-up. RESULTS: Baseline characteristics (N = 339) were: 260 (77 %) females, 219 (65 %) African Americans, mean age 56 years, and mean body mass index 36 kg/m(2). In Phase I, among 251 (74 %) that returned for 6 month follow-up, there were substantial improvements in diet score (4.3 units [95 % CI 3.7 to 5.0]), walking (64 min/week [19 to 109]), and systolic blood pressure (-6.4 mmHg [-8.7 to -4.1]) that were generally maintained through 24 month follow-up. In Phase II, 138 (57 group only, 81 group/phone) chose the weight loss intervention and at 12 months, weight change was: -3.1 kg (-4.9 to -1.3) for group (N = 50) and -2.1 kg (-3.2 to -1.0) for group/phone combination (N = 75). In Phase III, 27 participants took part in the RCT. At 24 months, weight loss was -2.1 kg (-4.3 to 0.0) for group (N = 51) and -1.1 kg (-2.7 to 0.4) for combination (N = 72). Outcomes for African American and whites were similar. CONCLUSIONS: The intervention yielded substantial improvement in diet, PA, and blood pressure, but weight loss was modest. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01433484.

Patient perspectives on tobacco use treatment in primary care.

INTRODUCTION: Evidence-based tobacco cessation interventions increase quit rates, yet most smokers do not use them. Every primary care visit offers the potential to discuss such options, but communication can be tricky for patients and provider alike. We explored smokers' personal interactions with health care providers to better understand what it is like to be a smoker in an increasingly smoke-free era and the resources needed to support quit attempts and to better define important patient-centered outcomes. METHODS: Three 90-minute focus groups, involving 33 patients from 3 primary care clinics, were conducted. Participants were current or recent (having quit within 6 months) smokers. Topics included tobacco use, quit attempts, and interactions with providers, followed by more pointed questions exploring actions patients want from providers and outcome measures that would be meaningful to patients. RESULTS: Four themes were identified through inductive coding techniques: 1) the experience of being a tobacco user (inconvenience, shame, isolation, risks, and benefits), 2) the medical encounter (expectations of providers, trust and respect, and positive, targeted messaging), 3) high-value actions (consistent dialogue, the addiction model, point-of-care nicotine patches, educational materials, carbon monoxide monitoring, and infrastructure), and 4) patient-centered outcomes. CONCLUSION: Engaged patient-centered smoking cessation counseling requires seeking the patient voice early in the process. Participants desired honest, consistent, and pro-active discussions and actions. Participants also suggested creative patient-centered outcome measures to consider in future research.

Patient and practice perspectives on strategies for controlling blood pressure, North Carolina, 2010-2012.

INTRODUCTION: Patient and practice perspectives can inform development of team-based approaches to improving blood pressure control in primary care. We used a community-based participatory research approach to assess patient and practice perceptions regarding the value of team-based strategies for controlling blood pressure in a rural North Carolina population from 2010 through 2012. METHODS: In-depth interviews were conducted with 41 adults with hypertension, purposely sampled to include diversity of sex, race, literacy, and blood pressure control, and with key office staff at 5 rural primary care practices in the southeastern US "stroke belt." Interviews explored barriers to controlling blood pressure, the practice's role in controlling blood pressure, and opinions on the use of team care delivery. RESULTS: Patients reported that provider strategies to optimize blood pressure control should include regular visits, medication adjustment, side-effect discussion, and behavioral counseling. When discussing team-based approaches to hypertension care, patients valued verbal encouragement, calls from the doctor's office, and the opportunity to ask questions. However, they voiced concerns about the effect of having too many people involved in their care. Practice staff focused on multiple, broad methods to control blood pressure including counseling, regular office visits, media to improve awareness, and support groups. An explicit focus of delivering care as teams was a newer concept. CONCLUSION: When developing a team approach to hypertension treatment, patients value high-quality communication and not losing their primary relationship with their provider. Practice staff members were open to a team-based approach but had limited knowledge of what such an approach would entail.

Costs and benefits of transforming primary care practices: a qualitative study of North Carolina's Improving Performance in Practice.

Primary care organizations must transform care delivery to realize the Institute for Healthcare Improvement's Triple Aim of better healthcare, better health, and lower healthcare costs. However, few studies have considered the financial implications for primary care practices engaged in transformation. In this qualitative, comparative case study, we examine the practice-level personnel and nonpersonnel costs and the benefits involved in transformational change among 12 primary care practices participating in North Carolina's Improving Performance in Practice (IPIP) program. We found average annual opportunity costs of $21,550 ($6,659 per full-time equivalent provider) for maintaining core IPIP activities (e.g., data management, form development and maintenance, meeting attendance). This average represents the cost of a 50% full-time equivalent registered nurse or licensed practical nurse. Practices were able to limit transformation costs by scheduling meetings during relatively slow patient care periods and by leveraging resources such as the assistance of IPIP practice coaches. Still, the costs of practice transformation were not trivial and would have been much higher in the absence of these efforts. Benefits of transformation included opportunities for enhanced revenue through reimbursement incentives and practice growth, improved efficiency and care quality, and maintenance of certification. Given the potentially high costs for some practices, policy makers may need to consider reimbursement and other strategies to help primary care practices manage the costs of practice redesign.

Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial.

Importance: Rural Black participants need effective intervention to achieve better blood pressure (BP) control. Objective: Among Black rural adults with persistently uncontrolled hypertension attending primary care clinics, to determine whether peer coaching (PC), practice facilitation (PF), or both (PCPF) are superior to enhanced usual care (EUC) in improving BP control. Design, Setting, and Participants: A cluster randomized clinical trial was conducted in 69 rural primary care practices across Alabama and North Carolina between September 23, 2016, and September 26, 2019. The participating practices were randomized to 4 groups: PC plus EUC, PF plus EUC, PCPF plus EUC, and EUC alone. The baseline EUC approach included a laptop for each participating practice with hyperlinks to participant education on hypertension, a binder of practice tips, a poster showing an algorithm for stepped care to improve BP, and 25 home BP monitors. The trial was stopped on February 28, 2021, after final data collection. The study included Black participants with persistently uncontrolled hypertension. Data were analyzed from February 28, 2021, to December 13, 2022. Interventions: Practice facilitators helped practices implement at least 4 quality improvement projects designed to improve BP control throughout 1 year. Peer coaches delivered a structured program via telephone on hypertension self-management throughout 1 year. Main Outcomes and Measures: The primary outcome was the proportion of participants in each trial group with BP values of less than 140/90 mm Hg at 6 months and 12 months. The secondary outcome was a change in the systolic BP of participants at 6 months and 12 months. Results: A total of 69 practices were randomized, and 1209 participants' data were included in the analysis. The mean (SD) age of participants was 58 (12) years, and 748 (62%) were women. In the intention-to-treat analyses, neither intervention alone nor in combination improved BP control or BP levels more than EUC (at 12 months, PF vs EUC odds ratio [OR], 0.94 [95% CI, 0.58-1.52]; PC vs EUC OR, 1.30 [95% CI, 0.83-2.04]; PCPF vs EUC OR, 1.02 [95% CI, 0.64-1.64]). In preplanned subgroup analyses, participants younger than 60 years in the PC and PCPF groups experienced a significant 5 mm Hg greater reduction in systolic BP than participants younger than 60 years in the EUC group at 12 months. Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the trial's participants. Conclusions and Relevance: The results of this cluster randomized clinical trial demonstrated that neither PC nor PF demonstrated a superior improvement in overall BP control compared with EUC. However, PC led to a significant reduction in systolic BP among younger adults. Trial Registration: ClinicalTrials.gov Identifier: NCT02866669.

Facilitators of transforming primary care: a look under the hood at practice leadership.

PURPOSE: This study examined how characteristics of practice leadership affect the change process in a statewide initiative to improve the quality of diabetes and asthma care. METHODS: We used a mixed methods approach, involving analyses of existing quality improvement data on 76 practices with at least 1 year of participation and focus groups with clinicians and staff in a 12-practice subsample. Existing data included monthly diabetes or asthma measures (clinical measures) and monthly practice implementation, leadership, and practice engagement scores rated by an external practice coach. RESULTS: Of the 76 practices, 51 focused on diabetes and 25 on asthma. In aggregate, 50% to 78% made improvements within in each clinical measure in the first year. The odds of making practice changes were greater for practices with higher leadership scores (odds ratios = 2.41-4.20). Among practices focused on diabetes, those with higher leadership scores had higher odds of performing nephropathy screening (odds ratio = 1.37, 95% CI, 1.08-1.74); no significant associations were seen for the intermediate outcome measures of hemoglobin A1c, blood pressure, and cholesterol. Focus groups revealed the importance of a leader, typically a physician, who believed in the transformation work (ie, a visionary leader) and promoted practice engagement through education and cross-training. Practices with greater change implementation also mentioned the importance of a midlevel operational leader who helped to create and sustain practice changes. This person communicated and interacted well with, and was respected by both clinicians and staff. CONCLUSIONS: In the presence of a vision for transformation, operational leaders within practices can facilitate practice changes that are associated with clinical improvement.

Context matters: the experience of 14 research teams in systematically reporting contextual factors important for practice change.

PURPOSE: We aimed to advance the internal and external validity of research by sharing our empirical experience and recommendations for systematically reporting contextual factors. METHODS: Fourteen teams conducting research on primary care practice transformation retrospectively considered contextual factors important to interpreting their findings (internal validity) and transporting or reinventing their findings in other settings/situations (external validity). Each team provided a table or list of important contextual factors and interpretive text included as appendices to the articles in this supplement. Team members identified the most important contextual factors for their studies. We grouped the findings thematically and developed recommendations for reporting context. RESULTS: The most important contextual factors sorted into 5 domains: (1) the practice setting, (2) the larger organization, (3) the external environment, (4) implementation pathway, and (5) the motivation for implementation. To understand context, investigators recommend (1) engaging diverse perspectives and data sources, (2) considering multiple levels, (3) evaluating history and evolution over time, (4) looking at formal and informal systems and culture, and (5) assessing the (often nonlinear) interactions between contextual factors and both the process and outcome of studies. We include a template with tabular and interpretive elements to help study teams engage research participants in reporting relevant context. CONCLUSIONS: These findings demonstrate the feasibility and potential utility of identifying and reporting contextual factors. Involving diverse stakeholders in assessing context at multiple stages of the research process, examining their association with outcomes, and consistently reporting critical contextual factors are important challenges for a field interested in improving the internal and external validity and impact of health care research.

Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension.

BACKGROUND/OBJECTIVE: Because racial disparities in hypertension treatment persist, the objective of the present study was to examine patient vs. practice characteristics that influence antihypertensive selection and treatment intensity for non-Hispanic Black (hereafter "Black") patients with uncontrolled hypertension in the rural southeastern USA. METHODS: We enrolled 25 Black patients from each of 69 rural practices in Alabama and North Carolina with uncontrolled hypertension (systolic blood pressure (BP) ≥ 140 mm Hg) in a 4-arm cluster randomized trial of BP control interventions. Patients' antihypertensive medications were abstracted from medical records and reconciled at the baseline visit. Treatment intensity was computed using the defined daily dose (DDD) method of the World Health Organization. Correlates of greater antihypertensive medication intensity were assessed by linear regression modeling, and antihypertensive medication classes were compared by baseline systolic BP (SBP) level. RESULTS: A total of 1431 patients were enrolled and had complete baseline data. Antihypertensive treatment intensity averaged 3.7 ± 2.6 equivalent medications at usual dosages and was significantly related to higher baseline systolic BP, older age, male sex, insurance availability, higher BMI, and concurrent diabetes, but not to practice type or medication barriers in regression models. Renin-angiotensin system inhibitors were the most commonly used medications, followed by diuretics and calcium channel blockers. CONCLUSION/RELEVANCE: Antihypertensive treatment intensity for Black patients in the rural southeastern USA with a history of uncontrolled hypertension averaged the equivalent of almost four medications at usual dosages and was significantly associated with baseline SBP levels and other patient characteristics, but not clinic type. TRIAL REGISTRATION: ClinicalTrials.gov NCT02866669.

Implementing practice facilitation in research: how facilitators spend their time guiding practices to improve blood pressure control.

BACKGROUND: Practice facilitators (PFs) coach practices through quality improvement (QI) initiatives aimed at enhancing patient outcomes and operational efficiencies. Practice facilitation is a dynamic intervention that, by design, is tailored to practices' unique needs and contexts. Little research has explored the amount of time PFs spend with practices on QI activities. This short report expands on previously published work that detailed a 12-month practice facilitation intervention as part of the Southeastern Collaboration to Improve Blood Pressure Control (SEC) trial, which focused on improving hypertension control among people living in rural settings in the southeastern USA. This report analyzes data on the time PFs spent to guide 32 primary care practices in implementing QI activities to support enhanced outcomes in patients with high blood pressure. METHODS: The SEC trial employed four certified PFs across all practice sites, who documented time spent: (1) driving to support practices; (2) working on-site with staff and clinicians; and (3) communicating remotely (phone, email, or video conference) with practice members. We analyzed the data using descriptive statistics to help understand time devoted to individual and aggregated tasks. Additionally, we explored correlations between practice characteristics and time spent with PFs. RESULTS: In aggregate, the PFs completed 416 visits to practices and spent an average of 130 (SD 65) min per visit driving to and from practices. The average time spent on-site per visit with practices was 87 (SD 37) min, while an average of 17 (SD 12) min was spent on individual remote communications. During the 12-month intervention, 1131 remote communications were conducted with practices. PFs spent most of their time with clinical staff members (n = 886 instances) or with practice managers alone (n = 670 instances) while relatively few on-site visits were conducted with primary care providers alone (n = 15). In 19 practices, no communications were solely with providers. No significant correlations were found between time spent on PF activities and a practices' percent of Medicaid and uninsured patients, staff-provider ratio, or federally qualified health center (FQHC) status. CONCLUSIONS: PFs working with practices serving rural patients with hypertension devote substantial time to driving, highlighting the importance of optimizing a balance between time spent on-site vs. communicating remotely. Most time spent was with clinical staff, not primary care providers. These findings may be useful to researchers and business leaders who design, test, and implement efficient facilitation services. TRIAL REGISTRATION: NIH ClinicalTrials.gov NCT02866669 . Registered on 15 August 2016. NHLBI AWARD number: PCS-1UH3HL130691.

Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control.

Background: Racial disparities related to hypertension prevalence and control persist, with Black persons continuing to have both high prevalence and suboptimal control. The Black Belt region of the US Southeast is characterized by multiple critical priority populations: rural, low-income, and minority (Black). Methods: In a cluster-randomized, controlled, pragmatic implementation trial, the Southeastern Collaboration to Improve Blood Pressure Control evaluated two multi-component, multi-level functional interventions - peer coaching (PC) and practice facilitation (PF) (separately and combined) - as adjuncts to usual care to improve blood pressure control in the Black Belt. The overall goal was to randomize 80 primary care practices (later reduced to 69 practices) in Alabama and North Carolina to one of four interventions: 1) enhanced usual care (EUC); 2) EUC plus PC; 3) EUC plus PF; or 4) EUC plus both PC and PF. Several measures to facilitate recruitment and retention of practices were employed, including practice readiness assessment. Results: Contact was initiated with 248 practices during the study enrollment period. Of these, 99 declined participation, 39 were ineligible, and 41 were being evaluated for inclusion when the target number of practices was reached. The remaining 69 practices eventually were enrolled, with 18 practices randomized to EUC, 19 to PC, 16 to PF, and 16 to PC plus PF. Only two practices (2.9%) were withdrawn during the study. Several facilitators of and barriers to practice recruitment and retention were identified. Conclusion: Our findings underscore the importance of a structured approach to recruiting primary care practices in a pragmatic implementation trial.ClinicalTrials.gov registration number NCT02866669.

Integrating a health-related-quality-of-life module within electronic health records: a comparative case study assessing value added.

BACKGROUND: Health information technology (HIT) applications that incorporate point-of-care use of health-related quality of life (HRQL) assessments are believed to promote patient-centered interactions between seriously ill patients and physicians. However, it is unclear how willing primary care providers are to use such HRQL HIT applications. The specific aim of this study was to explore factors that providers consider when assessing the value added of an HRQL application for their geriatric patients. METHODS: Three case studies were developed using the following data sources: baseline surveys with providers and staff, observations of staff and patients, audio recordings of patient-provider interactions, and semi-structured interviews with providers and staff. RESULTS: The primary factors providers considered when assessing value added were whether the HRQL information from the module was (1) duplicative of information gathered via other means during the encounter; (2) specific enough to be useful and/or acted upon, and; (3) useful for enough patients to warrant time spent reviewing it for all geriatric patients. Secondary considerations included level of integration of the HRQL and EHR, impact on nursing workflow, and patient reluctance to provide HRQL information. CONCLUSIONS: Health-related quality of life modules within electronic health record systems offer the potential benefit of improving patient centeredness and quality of care. However, the modules must provide benefits that are substantial and prominent in order for physicians to decide that they are worthwhile and sustainable. Implications of this study for future research include the identification of perceived "costs" as well as a foundation for operationalizing the concept of "usefulness" in the context of such modules. Finally, developers of these modules may need to make their products customizable for practices to account for variation in EHR capabilities and practice workflows.

A Mixed Methods Approach to Improving Provider Counseling of Patients Who Vape.

Significance: Vaping is an epidemic among young people, but there is little guidance on how medical providers should counsel young adults about vaping. To address this gap, we examined how electronic health record (EHR) systems prompt providers to collect vaping data and interviewed young adults about vaping communications with providers and preferred information sources. Methods: In this mixed methods study, we used survey research methods to explore if prompts exist in EHR systems to guide discussions about vaping with youth seen in primary care. We collected primary care practice information about EHR prompts regarding e-cigarette use from 10 rural North Carolina practices from August 2020 through November 2020 and interviewed 17 young adults (age 18-21 years) who reviewed resources and provided their opinion on the resource's relevance for their age group. Interviews were stratified by vaping status, transcribed, coded, and thematically analyzed. Results: Only 5 of 10 EHR systems included prompts to capture information about vaping and data capture was optional in all 5 cases. Of the 17 interviewees, 10 were female, 14 were White, 3 were non-White and the mean age was 19.6 years. Two central themes emerged. Young adults: 1) were open to confidential, non-confrontational interactions with trusted providers and supported the use of a 2-page resource/discussion guide, questionnaires about vaping, and other waiting room resources, and 2) wanted prevention and cessation resources to be age-appropriate, including medical facts from a trusted source, and to be disseminated via social media platforms used by young adults. Conclusions: We found a lack of EHR functionalities in screening for vaping status hindered patients from receiving counseling on use. Young adults report a willingness to communicate with and learn from trusted providers and to gain understanding from information accessed via social media.