Impact of a Comprehensive Transitional Care Management Model on Use of Community-Based Rehabilitation After Stroke.

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.

Background: Community-based physical therapy (PT) and occupational therapy (OT) are critical for functional recovery from stroke but are underutilized. Whether transitional care (TC) programs designed to improve hospital-to-home transitions improve the use of PT and OT is unknown. To evaluate this question, we conducted a secondary analysis of data from the COMPASS Study, a pragmatic trial comparing a TC intervention vs usual care on post-stroke functional status. Methods: The COMPASS Study randomized 40 hospitals to implement a comprehensive post-acute stroke TC model (COMPASS-TC) or maintain usual care for patients with stroke or TIA discharged home ( Figure 1 ). In Phase 2, hospitals assigned to usual care implemented COMPASS-TC. COMPASS-TC was aligned with CMS policy, comprising early phone and in-person clinic follow-up with individualized care planning supported by assessments of medical, functional, psychological, and social needs. We linked participants to administrative claims (Medicare FFS, Medicare Advantage, NC Medicaid, and Blue Cross Blue Shield of NC) to assess use of community-based PT and OT. Adjusted generalized estimating equations compared COMPASS-TC to usual care within the trial and crossover cohorts on 30 and 90-day PT or OT use, time to first visit, number of visits in 90 days, and receipt of PT and OT versus single therapy. Per protocol (PP) analysis estimated complier average causal effects using an instrumental variable approach. Results: COMPASS enrolled 8,377 patients from July 2016-March 2019; 5,261 were linked to administrative claims. Thirty-day PT or OT use ranged from 22.6% in usual care to 37.5% in Phase 2 COMPASS-TC. Receipt of intervention components was 73% for phone follow-up and 36% for the 30-day clinic visit. Figure 2 presents intention-to-treat and PP estimates of COMPASS-TC vs usual care on therapy use outcomes. Discussion: COMPASS-TC was consistently associated with shorter time to PT or OT, and with greater probability of therapy receipt in the crossover, but not the trial, analysis. Inconsistencies in results across cohorts may reflect unmeasured confounding or differences in hospitals that chose to adopt the intervention in Phase 2. PP results further support that, when received, COMPASS-TC may also increase the intensity and comprehensiveness of therapy. Implementation studies are needed to refine and test strategies to improve care transitions after stroke that facilitate access to post-acute rehabilitation.

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.

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.

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.

BackgroundPatients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes.MethodsForty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care Plan™ integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The study engages patients, caregivers, and other stakeholders (including policymakers, advocacy groups, payers, and local community coalitions) to advise and support the design, implementation, and sustainability of the COMPASS care model.DiscussionGiven the high societal and economic burden of stroke, identifying a care model to improve recovery, independence, and quality of life is critical for stroke survivors and their caregivers. The pragmatic trial design provides a real-world assessment of the COMPASS care model effectiveness and will facilitate rapid implementation into clinical practice if successful.Trial registrationClinicaltrials.gov: NCT02588664; October 23, 2015.

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.

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

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.

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.

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.

We examined transitional care management within 90 days and 1 year following discharge home among acute stroke and transient ischemic attack patients from the Comprehensive Post-Acute Stroke Services (COMPASS) Study, a cluster-randomized pragmatic trial of early supported discharge conducted in 41 hospitals (40 hospital units) in North Carolina, United States. Data for 2262 of the total 6024 (37.6%; 1069 intervention and 1193 usual care) COMPASS patients were linked with the Centers for Medicare and Medicaid Services fee-for-service Medicare claims. Time to the first ambulatory care visit was examined using Cox proportional hazard models adjusted for patient characteristics not included in the randomization protocol. Only 6% of the patients [mean (SD) age 74.9 (10.2) years, 52.1% women, 80.3% White)] did not have an ambulatory care visit within 90 days postdischarge. Mean time (SD) to first ambulatory care visit was 12.0 (26.0) and 16.3 (35.1) days in intervention and usual care arms, respectively, with the majority of visits in both study arms to primary care providers. The COMPASS intervention resulted in a 27% greater use of ambulatory care services within 1 year postdischarge, relative to usual care [HR=1.27 (95% CI: 1.14-1.41)]. The use of transitional care billing codes was significantly greater in the intervention arm as compared with usual care [OR=1.87 (95% CI: 1.54-2.27)]. The COMPASS intervention, which was aimed at improving stroke post-acute care, was associated with an increase in the use of ambulatory care services by stroke and transient ischemic attack patients discharged home and an increased use of transitional care billing codes by ambulatory providers.

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.

Each year nearly 800,000 people in the US experience a stroke.1 Those that survive are at high risk for complications after hospital discharge. Providing appropriate care during the recovery from this complex condition is a challenge for patients, caregivers, and health care providers. Understanding Emergency Department (ED) utilization after a stroke may provide insights into long-term management of stroke, inform interventions, improve patient outcomes, and reduce medical costs. A comprehensive transitional care model for post-acute stroke care may influence the need to seek ED care for downstream events after a stroke. To date, most transitional care trials exploring post-stroke healthcare utilization were conducted outside of the US health care system.2 We examined data from the Comprehensive Post-Acute Stroke Services (COMPASS) study, a cluster-randomized pragmatic trial of a post-discharge transitional care model for stroke survivors and their caregivers compared with usual care.3,4.

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. 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. 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. 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.