Comprehensive Post-Acute Stroke Services Study Research Articles

Abstract P388: Higher Social Vulnerability Was Associated With Less Community-Based Rehabilitation Utilization After Stroke

Background: Timely rehabilitation care significantly improves function and mobility after stroke, but barriers exist in access and utilization. The impact of neighborhood social determinants of health is not fully understood. Our study aims to estimate the association between Social Vulnerability Index (SVI), a measure of a community's need for support, and post-stroke rehabilitation utilization. Methods: This study is an observational, secondary analysis of the COMprehensive Post-Acute Stroke Services study, a pragmatic trial conducted in 41 North Carolina hospitals from 2016-2019. This analysis included 4765 individuals (51.2% female; 74.8% Whites; mean age 69.9) discharged directly home after stroke and linked to administrative claims. Utilization of physical or occupational therapy was obtained from outpatient, carrier file and home health claims. Geocoded participant addresses were linked to 2018 summary SVI percentile ranking and its four sub-domains at the Census tract level. Generalized estimation equations with cluster of Census tract and hospital were used to estimate the association between quintiles of SVIs and incidence proportion of rehabilitation use within 30 days. Covariates included patients’ socio-demographics, clinical characteristics, and comorbidities. Results: The overall proportion of rehabilitation use by 30 days was 38.6%, ranging from 34.6-46.5% across SVI quintiles. In multivariable analysis, quintiles of higher summary SVI were associated with lower rehabilitation use compared with the least vulnerable quintile (RD and 95% CI, Q5 vs Q1: -0.098 [-0.147 to -0.049]; Table). There was a significant decreasing trend across quintiles (P-trend < 0.001). Similar results were observed for SVI sub-domains except for minority status and language. Conclusion: Higher social vulnerability was associated with less post-stroke rehabilitation use. The finding is useful to identify communities for targeted interventions to improve access and utilization to rehabilitation.

Abstract P471: Predictors of Referral to Community-Based Rehabilitation Following Stroke

Background: While several studies have examined care transitions following stroke, few have assessed use of rehabilitation. We explored factors predictive of referral to community-based rehabilitation following stroke. Setting: 40 NC acute care hospitals that participated in the COMprehensive Post-Acute Stroke Services study from 2016-2019. Participants: Adults discharged home following stroke or TIA (N=11,195) Methods: Guided by an a priori conceptual framework, 41 predictors of referral to community-based rehabilitation were grouped into 3 patient-level domains: demographics, stroke severity, and medical history (e.g., prior stroke); 2 hospital-level domains: structural characteristics (e.g., bed size) and stroke-specific characteristics (e.g., stroke center status); and 1 community-level domain (county-level therapist supply). We estimated predictors of referral using a logistic mixed model with a hospital-specific random effect. We used a hierarchical backward selection approach, first performing domain-specific model selection, then entering retained variables into a complete model. Results: The cohort was 49% female, 72% white, with a mean age of 66.8 (SD=14.0) years and overall low stroke severity [mean [SD] NIHSS 2.4 [3.8]). Thirty-six percent of patients were referred to rehabilitation. Referral varied across hospitals, ranging from 3-78%, with a median of 35%. In the final model, older age, female sex, non-white race, higher stroke severity, longer length of stay, previous stroke, current smoking, and heart failure were associated with higher odds of referral as was hospital-employed vs. external-contracted OT services (Table). Discussion: Approximately one-third of stroke survivors discharged home were referred to community-based rehabilitation. Women and non-white patients had higher odds of referral. Hospital and community factors were largely not independent predictors of referral. Unmeasured process measures may play a role in unexplained hospital variation.

Methodological Challenges and Statistical Approaches in the COMprehensive Post-Acute Stroke Services Study.

Background:The COMprehensive Post-Acute Stroke Services study was a cluster-randomized pragmatic trial designed to evaluate a comprehensive care transitions model versus usual care. The data collected during this trial were complex and analysis methodology was required that could simultaneously account for the cluster-randomized design, missing patient-level covariates, outcome nonresponse, and substantial nonadherence to the intervention.Objective:The objective of this study was to discuss an array of complementary statistical methods to evaluate treatment effectiveness that appropriately addressed the challenges presented by the complex data arising from this pragmatic trial.Methods:We utilized multiple imputation combined with inverse probability weighting to account for missing covariate and outcome data in the estimation of intention-to-treat effects (ITT). The ITT estimand reflects the effectiveness of assignment to the COMprehensive Post-Acute Stroke Services intervention compared with usual care (ie, it does not take into account intervention adherence). Per-protocol analyses provide complementary information about the effect of treatment, and therefore are relevant for patients to inform their decision-making. We describe estimation of the complier average causal effect using an instrumental variables approach through 2-stage least squares estimation. For all preplanned analyses, we also discuss additional sensitivity analyses.Discussion:Pragmatic trials are well suited to inform clinical practice. Care should be taken to proactively identify the appropriate balance between control and pragmatism in trial design. Valid estimation of ITT and per-protocol effects in the presence of complex data requires application of appropriate statistical methods and concerted efforts to ensure high-quality data are collected.

How engagement of a diverse set of stakeholders shaped the design, implementation, and dissemination of a multicenter pragmatic trial of stroke transitional care: The COMPASS study.

Evidence is limited on how to synthesize and incorporate the views of stakeholders into a multisite pragmatic trial and how much academic teams change study design and protocol in response to stakeholder input. This qualitative study describes how stakeholders contributed to the design, conduct, and dissemination of findings of a multisite pragmatic clinical trial, the COMprehensive Post-Acute Stroke Services (COMPASS) Study. We engaged stakeholders as integral research partners by embedding them in study committees and community resource networks that supported local sites. Data stemmed from formal focus groups and continuous participation in working groups. Guided by Grounded Theory, we extracted themes from focus group and meeting notes. These were discussed as a team and with other stakeholder groups for feasibility. A consensus approach was used. Stakeholder input changed many aspects of the study including: the care model that treated stroke as a chronic condition after hospital discharge, training for hospital-based providers who often lacked awareness of the barriers to recovery that patients face, support for caregivers who were essential for stroke patients' recovery, and for community-based health and social service providers whose services can support recovery yet often go underutilized. Stakeholders brought value to both pragmatic research and health service delivery. Future studies should test the impact of elements of study implementation informed by stakeholders vs those that are not.

Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study

The purpose of this Special Communication is to discuss the rationale and design of the Movement Matters Activity Program for Stroke (MMAP) and explore implementation successes and challenges in home health and outpatient therapy practices across the stroke belt state of North Carolina. MMAP is an interventional component of the Comprehensive Postacute Stroke Services Study, a randomized multicenter pragmatic trial of stroke transitional care. MMAP was designed to maximize survivor health, recovery, and functional independence in the community and to promote evidence-based rehabilitative care. MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care. MMAP implementation strategies were aligned with the Expert Recommendations for Implementing Change project, and MMAP site champion and facilitator survey feedback were thematically organized into the Consolidated Framework for Implementation Research domains. MMAP implementation was challenging, required modification and was affected by provider- and system-level factors. Program and study participation were limited and affected by practice priorities, productivity standards, and stroke patient volume. Sites with successful implementation appeared to have empowered MMAP champions in vertically integrated systems that embraced innovation. Findings from this broad evaluation can serve as a road map for the design and implementation of other comprehensive, complex interventions that aim to bridge the currently disconnected realms of acute care, postacute care, and community resources.

Abstract NS3: A Comprehensive Post-Acute Stroke Services (COMPASS) Website for Public Use

Background: Stroke patients, caregivers, and health and human services are in need of organized, evidence-based resources to improve post-acute care and outcomes. Educational materials vetted by stakeholders are scarce and difficult to develop. The COMprehensive Post-Acute Stroke Services (COMPASS) Study developed online resources by discipline for clinical providers, patients, caregivers, and health and human services teams. Purpose: This presentation introduces the COMPASS website content available and ready for immediate use to support post-acute stroke care quality improvement. Methods: Materials were developed as a component of the PCORI-funded COMPASS Study designed to implement and evaluate comprehensive transitional care (TC) for stroke survivors. Patients discharged home from 41 NC hospitals after a stroke or TIA received COMPASS TC which incorporated Centers for Medicare and Medicaid (CMS) recommendations: a follow-up phone call within two days of discharge; a comprehensive follow-up clinic visit; and delivery of a patient care plan. An interdisciplinary team of health care providers, stakeholders, and researchers developed patient and caregiver educational materials tested for sixth grade literacy, a community resource directory, and training materials for implementation of COMPASS TC that are available on the COMPASS website at www.nccompass-study.org/. Results: Educational products, including a directory of resources, training manuals, recorded webinars, instructional handouts, animated videos, and patient/caregiver materials are on the COMPASS website. An electronic application called COMPASS-Care Plan (CP) also developed can be readily integrated into Epic and Cerner electronic health records. COMPASS-CP was developed to streamline the delivery of the TC model. Since the website was made public July 1, 2019, there have been 616 views from 15 countries with the majority reviewing patient/caregiver resources. Conclusions: The COMPASS website provides health and human services teams with organized, evidence-based resources to support delivery and management of post-acute transitional care for patients and caregivers.

Abstract WP337: Age and Race Disparities in Statin Prescribing Persist Following Discharge for Stroke or Transient Ischemic Attack

Introduction: Prescribing of high intensity statins (atorvastatin 40-80mg/d, rosuvastatin 20-40mg/d) following acute stroke and anti-coagulants in the subgroup with atrial fibrillation (AF) result in reduced risk for a second stroke. Recent data suggests that high intensity statins are less often prescribed for older patients and real-world data are limited for direct-acting oral anti-coagulants (DOAC). The present study examines discharge prescribing patterns for these medications by age and race from a prospective trial in 41 hospitals in North Carolina. Methods: Data are from the Comprehensive Post-Acute Stroke Services Study, a cluster-randomized trial of transitional care for adult stroke or TIA patients discharged directly home after hospital discharge. Analyses included 3787 patients [mean age 66 yrs., 47% female; 30% non-white] linked to the Get-with-the-Guidelines (GWTG) database. Prescribing of intensive statin therapy as well as rivaroxaban or apixaban vs. warfarin in those with a history of AF was abstracted, and was compared by age (< 65 vs. ≥ 65yr.), race (white vs. non-white) and gender. Odds ratios were obtained from logistic mixed models with a random intercept for hospital. Results: Among 3096 patients prescribed statin therapy at discharge, 61% were prescribed intensive statin therapy. Patients who were ≥ 65yr. had significantly lower odds of intensive statin therapy prescription than younger patients (OR=0.54, 95% CI 0.45-0.65); results were similar across all sex-race subgroups. Among 366 patients with a history of AF who were prescribed an anti-coagulant at discharge, 72% were prescribed rivaroxaban or apixaban. Among 254 patients ≥ 65yr., 26 of 39 non-white patients (67%) vs. 156 of 215 white patients (73%) were prescribed rivaroxaban or apixaban [p=0.29]. Conclusion: Intensive statin therapy following mild stroke or TIA is significantly less common in older patients compared with those under age 65. Among patients ≥65yr. with a history of AF and acute stroke, there was minimal difference by race in rivaroxaban or apixaban prescribing. Prescription fills/refills and adherence should be further explored in these patients.

Abstract WP197: Patient-Reported Physical Outcomes Measures in Mild-to-Moderate Stroke and TIA Patients

Introduction: Mild-to-moderate stroke and TIA patients are discharged directly home, but may have residual physical disability. The purpose of this study was to compare distributions of three patient-reported outcome measures: PROMIS GPH, Stroke Impact Scale-16 (SIS-16), and simplified modified Rankin (Rankin). Methods: PROMIS GPH includes global ratings of physical activities, physical health, pain and fatigue, SIS-16 includes ADLs, IADLs, and physical activities, and Rankin includes ADLs, IADLs, and overall comparison of function to pre-stroke function. Outcomes were measured at 90-days post-hospital discharge in 1768 stroke and TIA patients discharged directly home in the COMprehensive Post-Acute Stroke Services Study. Ceiling effects (frequency of maximum score) were evaluated for each measure. Differences in SIS-16 and PROMIS GPH scores across levels of Rankin were compared using the Kruskal-Wallis test. Spearman correlation coefficients were calculated between PROMIS GPH, SIS-16, Rankin, and individual items of the PROMIS GPH. Results: At hospital baseline, patients were 68 ± 13 years of age, 50% female, 72% stroke, 28% TIA, and with mean ± SD NIHSS of 2.3 ± 3.6. At 90 days, mean ± SD were 45.8 ± 9.8 for PROMIS GPH, 82.1 ± 19.7 for SIS-16, and 1.2 ± 1.3 for Rankin. Ceiling effects for the PROMIS GPH were (3.1%), SIS-16 (24.8%) and Rankin (38.9%). PROMIS GPH and SIS-16 scores differed significantly (p < 0.0001) across categories of the Rankin. Correlations with Rankin were moderate for SIS-16 (r=-0.64; 95% CI -0.67, -0.62) and PROMIS GPH (r=-0.54; 95% CI -0.58, -0.51). Correlations between SIS-16 and PROMIS GPH items were strong for physical activities (r=0.75; 95% CI 0.63, 0.77) and moderate for physical health (r=0.55; 95% CI 0.52, 0.59), fatigue (r=0.50; 95% CI 0.47, 0.54) and pain (r=0.44; 95% CI 0.40, 0.48). Of 438 patients at SIS-16 ceiling, the mean ± SD for global assessment of physical activities, physical health, pain, and fatigue on a scale of 0-5 were 4.8 ± 0.6, 3.7 ± 0.9, 4.4 ± 0.9, and 4.2 ± 0.7, respectively. Conclusion: PROMIS GPH may better detect physical health differences in mild-to-moderate stroke and TIA patients. Variability in global assessments of physical health, pain, and fatigue contribute to the lower PROMIS GPH ceiling effects.

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

BackgroundThe 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.MethodsWe 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.ResultsAdoption: 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.ConclusionsCOMPASS-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 registrationClinicalTrials.gov number: NCT02588664. Registered 28 October 2015.

Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study

BackgroundPragmatic randomized clinical trials are essential to determine the effectiveness of interventions in “real-world” clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers’ increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study.MethodsThe COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7–14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies.ResultsWe successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators.ConclusionsAlthough we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials.Trial registrationClinicaltrials.gov, NCT02588664. Registered on 23 October 2015.

Abstract TP169: Knowledge of Hypertension as a Stroke Risk Factor and Use of Home Blood Pressure Monitoring. A Preliminary Report From Comprehensive Post-Acute Stroke Services (COMPASS) Study

Background: Self-monitoring blood pressure (BP) among persons with hypertension is associated with lower BP. The prevalence of BP self-monitoring and factors that may predict this behavior in the early post-acute stroke setting are unknown. Our aim was to identify whether knowledge of high BP as a stroke risk factor, social support, or primary care visits would be independently associated with BP self-monitoring 30 days after discharge in stroke patients. Methods: We utilized data from consenting intervention participants in the Comprehensive Post-Acute Stroke Services (COMPASS) Study, who attended the post-discharge clinic visit, and had a 30-day follow-up call (N=528). The primary outcome was self-reported BP monitoring assessed at the 30-day call. The clinic visit included assessment of risk factor knowledge, social support and other clinical and neurological factors. Odds ratios were obtained using logistic mixed models that adjusted for confounders classified as demographic characteristics and clinical factors. Results: Among 528 patients (mean age 67 (SD=14), 50.9% female, 80.1% white), 435 (82%) reported self-monitored BP at 30 days. Fifty-seven percent of those who noted high BP as a stroke risk factor monitored BP vs 43% of those who did not acknowledge this risk factor. Knowledge of BP as risk factor was significantly associated with monitoring after adjustment for demographic, but not after adjustment for clinical factors (Table). Those with social support and recent PCP visits also had higher odds of self-monitoring than those without support or PCP visits, respectively, though estimates were highly imprecise. Conclusions: Among participants, acknowledging high BP is a stroke risk factor may lead to greater use of self-home BP monitoring at 30 days, although the magnitude of this effect is diminished when adjusted for having a history of hypertension. The COMPASS Study will determine whether BP self-monitoring leads to improved BP control at 90 days.

Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care.

The Comprehensive Post-Acute Stroke Services (COMPASS) Study is one of the first large pragmatic randomized-controlled clinical trials using comparative effectiveness research methods, funded by the Patient-Centered Outcomes Research Institute. In the COMPASS Study, we compare the effectiveness of a patient-centered, transitional care intervention versus usual care for stroke patients discharged home from acute care. Outcomes include stroke patient post-discharge functional status and caregiver strain 90 days after discharge, and hospital readmissions. A central tenet of Patient-Centered Outcomes Research Institute-funded research is stakeholder engagement throughout the research process. However, evidence on how to successfully implement a pragmatic trial that changes systems of care in combination with robust stakeholder engagement is limited. This combination is not without challenges. We present our approach for broad-based stakeholder engagement in the context of a pragmatic trial with the participation of patients, caregivers, community stakeholders, including the North Carolina Stroke Care Collaborative hospital network, and policy makers. To maximize stakeholder engagement throughout the COMPASS Study, we employed a conceptual model with the following components: (1) Patient and Other Stakeholder Identification and Selection; (2) Patient and Other Stakeholder Involvement Across the Spectrum of Research Activities; (3) Dedicated Resources for Patient and Other Stakeholder Involvement; (4) Support for Patient and Other Stakeholder Engagement Through Organizational Processes; (5) Communication with Patients and Other Stakeholders; (6) Transparent Involvement Processes; (7) Tracking of Engagement; and (8) Evaluation of Engagement. In this paper, we describe how each component of the model is being implemented and how this approach addresses existing gaps in the literature on strategies for engaging stakeholders in meaningful and useful ways when conducting pragmatic trials.

Abstract TP308: Transitional Care in Stroke Certified and Non-certified Hospitals: The Comprehensive Post-Acute Stroke Services (COMPASS) Study

Background: Greater than 50% of stroke patients are discharged home from the hospital, most with continuing care needs. In the absence of evidence-based transitional care interventions for stroke patients, procedures likely vary by hospital even among stroke-certified hospitals with requirements for transitional care protocols. We examined the standard of transitional care among NC hospitals enrolled in the COMPASS study comparing stroke-certified and non-certified hospitals. Methods: Hospitals completed an online, self-administered, web-based questionnaire to assess usual care related to hospitals’ transitional care strategy, stroke program structural components, discharge planning processes, and post-discharge patient management and follow-up. Response frequencies were compared between stroke certified versus non-certified hospitals using chi-squared statistics and Fisher’s exact test. Results: As of July 2016, the first 27 hospitals enrolled (of 40 expected) completed the survey (67% certified as a primary or comprehensive stroke center). On average, 54% of stroke patients were discharged home. Processes supporting hospital-to-home care transitions, such as timely follow-up calls and follow-up with neurology, were infrequent and overall less common for non-certified hospitals (Table). Assessment of post-discharge outcomes was particularly infrequent among non-certified sites (11%) compared with certified sites (56%). Uptake of transitional care management billing codes and quality metrics was low for both certified and non-certified hospitals. Conclusion: Significant variation exists in the infrastructure and processes supporting care transitions for stroke patients among COMPASS hospitals in NC. COMPASS as a pragmatic cluster-randomized trial will compare outcomes among hospitals that implement a CMS-directed model of transitional care with those hospitals that provide highly variable transitional care services.