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.

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.

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.

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.

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.

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.

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.

Rural-urban outcome differences associated with COVID-19 hospitalizations in North Carolina.

People living in rural regions in the United States face more health challenges than their non-rural counterparts which could put them at additional risks during the COVID-19 pandemic. Few studies have examined if rurality is associated with additional mortality risk among those hospitalized for COVID-19. We studied a retrospective cohort of 3,991 people hospitalized with SARS-CoV-2 infections discharged between March 1 and September 30, 2020 in one of 17 hospitals in North Carolina that collaborate as a clinical data research network. Patient demographics, comorbidities, symptoms and laboratory data were examined. Logistic regression was used to evaluate associations of rurality with a composite outcome of death/hospice discharge. Comorbidities were more common in the rural patient population as were the number of comorbidities per patient. Overall, 505 patients died prior to discharge and 63 patients were discharged to hospice. Among rural patients, 16.5% died or were discharged to hospice vs. 13.3% in the urban cohort resulting in greater odds of death/hospice discharge (OR 1.3, 95% CI 1.1, 1.6). This estimate decreased minimally when adjusted for age, sex, race/ethnicity, payer, disease comorbidities, presenting oxygen levels and cytokine levels (adjusted model OR 1.2, 95% CI 1.0, 1.5). This analysis demonstrated a higher COVID-19 mortality risk among rural residents of NC. Implementing policy changes may mitigate such disparities going forward.

The Key Driver Implementation Scale (KDIS) for practice facilitators: Psychometric testing in the "Southeastern collaboration to improve blood pressure control" trial.

BACKGROUND: Practice facilitators (PFs) provide tailored support to primary care practices to improve the quality of care delivery. Often used by PFs, the "Key Driver Implementation Scale" (KDIS) measures the degree to which a practice implements quality improvement activities from the Chronic Care Model, but the scale's psychometric properties have not been investigated. We examined construct validity, reliability, floor and ceiling effects, and a longitudinal trend test of the KDIS items in the Southeastern Collaboration to Improve Blood Pressure Control trial. METHODS: The KDIS items assess a practice's progress toward implementing: a clinical information system (using their own data to drive change); standardized care processes; optimized team care; patient self-management support; and leadership support. We assessed construct validity and estimated reliability with a multilevel confirmatory factor analysis (CFA). A trend test examined whether the KDIS items increased over time and estimated the expected number of months needed to move a practice to the highest response options. RESULTS: PFs completed monthly KDIS ratings over 12 months for 32 primary care practices, yielding a total of 384 observations. Data was fitted to a unidimensional CFA model; however, parameter fit was modest and could be improved. Reliability was 0.70. Practices started scoring at the highest levels beginning in month 5, indicating low variability. The KDIS items did show an upward trend over 12 months (all p < .001), indicating that practices were increasingly implementing key activities. The expected time to move a practice to the highest response category was 9.1 months for standardized care processes, 10.2 for clinical information system, 12.6 for self-management support, 13.1 for leadership, and 14.3 months for optimized team care. CONCLUSIONS: The KDIS items showed acceptable reliability, but work is needed in larger sample sizes to determine if two or more groups of implementation activities are being measured rather than one.

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.

Hospital Readmissions and Mortality Among Fee-for-Service Medicare Patients With Minor Stroke or Transient Ischemic Attack: Findings From the COMPASS Cluster-Randomized Pragmatic Trial.

Background Mortality and hospital readmission rates may reflect the quality of acute and postacute stroke care. Our aim was to investigate if, compared with usual care (UC), the COMPASS-TC (Comprehensive Post-Acute Stroke Services Transitional Care) intervention (INV) resulted in lower all-cause and stroke-specific readmissions and mortality among patients with minor stroke and transient ischemic attack discharged from 40 diverse North Carolina hospitals from 2016 to 2018. Methods and Results Using Medicare fee-for-service claims linked with COMPASS cluster-randomized trial data, we performed intention-to-treat analyses for 30-day, 90-day, and 1-year unplanned all-cause and stroke-specific readmissions and all-cause mortality between INV and UC groups, with 90-day unplanned all-cause readmissions as the primary outcome. Effect estimates were determined via mixed logistic or Cox proportional hazards regression models adjusted for age, sex, race, stroke severity, stroke diagnosis, and documented history of stroke. The final analysis cohort included 1069 INV and 1193 UC patients (median age 74 years, 80% White, 52% women, 40% with transient ischemic attack) with median length of hospital stay of 2 days. The risk of unplanned all-cause readmission was similar between INV versus UC at 30 (9.9% versus 8.7%) and 90 days (19.9% versus 18.9%), respectively. No significant differences between randomization groups were seen in 1-year all-cause readmissions, stroke-specific readmissions, or mortality. Conclusions In this pragmatic trial of patients with complex minor stroke/transient ischemic attack, there was no difference in the risk of readmission or mortality with COMPASS-TC relative to UC. Our study could not conclusively determine the reason for the lack of effectiveness of the INV. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement.

BACKGROUND: Practice facilitation (PF) is a promising but relatively new intervention supporting data-driven practice change. There is a need to better detail research-based facilitation methods, which must balance intervention fidelity and time restrictions with the flexibility required for the intervention. As part of a multi-level 4-armed cluster randomized clinical trial (RCT), 32 rural primary care practices received PF for 1 year. We evaluated the feasibility of having facilitators guide practices to perform 4 key driver domain activities, implemented as Plan-Do-Study-Act (PDSA) cycles, to better understand facilitation "exposure." We describe the intervention and activity length such that our experiences may be useful to other PF research efforts. METHODS: Thirty-two practices serving rural patients involved in the Southeastern Collaboration to Improvement Blood Pressure Control engaged with a facilitator to develop and implement PDSAs nested within key drivers of change domains. Numbers of months practices worked on activities deemed most likely to be sustained were captured along with practice satisfaction data. RESULTS: All practices engaged in at least 4 domain-level activities, and 59% of the PDSAs were active for at least 3 months. There was variation by domain in the average length of the PDSA activities. Ninety-seven percent (31 of 32) of practices recommended similarly structured facilitation services to other primary care practices, and 84% (27 of 32) noted substantive changes in their care processes. CONCLUSION: In this trial, it was feasible for PFs to engage practices in at least 4 Key Driver quality improvement activities within 1 year, which will inform PF methods and protocol development in future trials.

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.

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.

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.

Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.

Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.

Using REDCap to track stakeholder engagement: A time-saving tool for PCORI-funded studies.

BACKGROUND: Research Electronic Data Capture (REDCap) is a secure, web-based electronic data capture application for building and managing surveys and databases. It can also be used for study management, data transfer, and data export into a variety of statistical programs. REDcap was developed and supported by the National Center for Advancing Translational Sciences Program and is used in over 3700 institutions worldwide. It can also be used to track and measure stakeholder engagement, an integral element of research funded by the Patient-Centered Outcomes Research Institute (PCORI). Continuously and accurately tracking and reporting on stakeholder engagement activities throughout the life of a PCORI-funded trial can be challenging, particularly in complex trials with multiple types of engagement. METHODS: In this paper, we show our approach for collecting and capturing stakeholder engagement activities using a shareable REDCap tool in one of the PCORI's first large pragmatic clinical trials (the Comprehensive Post-Acute Stroke Services) to inform other investigators planning cluster-randomized pragmatic trials. Benefits and challenges are highlighted for researchers seeking to consistently monitor and measure stakeholder engagement. CONCLUSIONS: We describe how REDCap can provide a time-saving approach to capturing how stakeholders engage in a PCORI-funded study and reporting how stakeholders influenced the study in progress reports back to PCORI.

Increasing collaboration on substance use disorder research with primary care practices through the National Drug Abuse Treatment Clinical Trials Network.

BACKGROUND: The National Drug Abuse Treatment Clinical Trials Network (CTN) called for its national nodes to promote the translation of evidence-based interventions from substance use disorder (SUD) research into clinical practices. This collaborative demonstration project engaged CTN-affiliated practice-based research networks (PBRNs) in research that describes aspects of opioid prescribing in primary care. METHODS: Six PBRNs queried electronic health records from a convenience sample of 134 practices (84 participants) to identify the percent of adult patients with an office visit who were prescribed an opioid medication from October 1, 2015, to September 30, 2016, and, of those, the percent also prescribed a sedative in that year. Seven PBRNs sent an e-mail survey to a convenience sample of 108 practices (58 participants) about their opioid management policies and procedures during the project year. RESULTS: Of 561,017 adult patients with a visit to one of the 84 clinics in the project year, 22.9% (PBRN range 3.1%-25.4%) were prescribed opioid medications, and 52.1% (PBRN range 8.5%-60.6%) of those were prescribed a sedative in the same year. Of the 58 practices returning a survey (45.3% response rate), 98.1% had formal written treatment agreements for chronic opioid therapy, 68.5% had written opioid prescribing policies, and 43.4% provided reports to providers with feedback on opioid management. Only 24.1% were providing buprenorphine for OUD. CONCLUSION: CTN-affiliated PBRNs demonstrated their ability to collaborate on a project related to opioid management; results highlight the important role for PBRNs in OUD treatment, research, and the need for interventions and additional policies addressing opioid prescribing in primary care practice.

COVID-19 Needs Assessment and Support for Primary Care Practices in Western North Carolina.

Background: It is critical to ensure that Primary Care Providers (PCPs) have adequate personal protective equipment (PPE), supplies, training, staffing, and contingency planning during pandemics, particularly in rural areas. In March 2020, during the onset of the COVID-19 pandemic, the Mountain Area Health Education Center (MAHEC), in collaboration with the Cecil G. Sheps Center for Health Services Research at UNC Chapel Hill, rapidly created and conducted a needs assessment of PCPs in western North Carolina (WNC). Methods: A group of twenty volunteers conducted a telephone survey of PCPs in a 16 county region of WNC. Practices were asked about their COVID-19 testing and telehealth offerings, PPE adequacy, and capacity to continue serving patients. The survey's emergency alert feature linked practices to immediate support. Descriptive data were generated to identify regional needs. Results: Out of 110 practices, 48 (43.6%) offered COVID-19 testing, with testing more common in rural counties (56.3% vs 33.9%). Telehealth services, including phone-only visits, were offered by almost all practices (91.8%). PPE needs included N-95 respirators (49.1%), face shields (45.5%), and staff gowns (38.2%). Rural practices were more likely to report the need for PPE. Assistance was requested for staff member childcare (34.5%) and providing or billing for telehealth (31.8%). The most urgent practice requests were related to finances, PPE, and telehealth. MAHEC's Practice Support team linked practices to virtual coaching, tip sheets, case-based video didactics and communication forums, and newsletters. Conclusion: During a pandemic, it is crucial to ensure that PCPs can continue to serve their patients. A rapid needs assessment of PCPs can allow for immediate and ongoing support that matches regional and practice-specific needs. Rural practices may require more assistance than their urban counterparts. Our rapid survey process jumpstarted a statewide system for enhanced communications with PCPs to better prepare for future emergencies.

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.