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.

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.

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.

Meeting Medicare requirements for transitional care: Do stroke care and policy align?

OBJECTIVE: This study (1) describes transitional care for stroke patients discharged home from hospitals, (2) compares hospitals' standards of transitional care with core transitional care management (TCM) components recognized by Medicare, and (3) examines the association of policy and hospital specialty designations with TCM implementation. METHODS: Hospitals participating in the Comprehensive Post-Acute Stroke Services (COMPASS) Study provided data on their hospital, stroke patient population, and standards of transitional care. Hospital-reported transitional care strategies were compared with the federal TCM definition (2-day follow-up, 14-day visit, non-face-to-face services). We examined the associations of TCM billing, stroke center certification, and Magnet nursing excellence designation with TCM implementation. RESULTS: Transitional care varied widely among 41 hospitals in North Carolina and no one strategy was universally applied or provided across hospitals. One third of hospitals met the TCM definition (37% provided telephone follow-up, 76% provided face-to-face provider follow-up, all provided a type of non-face-to-face support). There were no differences between groups (TCM met/not met) in hospital characteristics or transitional care resources and processes. Stroke center certification, Magnet designation, and use of TCM billing codes were not different for hospitals that did and did not meet the TCM definition. CONCLUSIONS: There was substantial variation in the provision of strategies supporting stroke patients' transition home from the hospital. Supportive stroke care transitions are essential when more than 50% of stroke patients are discharged home and more than half experience moderate to severe strokes. More research is needed to identify drivers of TCM uptake. CLINICALTRIALSGOV IDENTIFIER: NCT02588664.

A Person-Centered Approach to Poststroke Care: The COMprehensive Post-Acute Stroke Services Model.

Many individuals who have had a stroke leave the hospital without postacute care services in place. Despite high risks of complications and readmission, there is no standard in the United States for postacute stroke care after discharge home. We describe the rationale and methods for the development of the COMprehensive Post-Acute Stroke Services (COMPASS) care model and the structure and quality metrics used for implementation. COMPASS, an innovative, comprehensive extension of the TRAnsition Coaching for Stroke (TRACS) program, is a clinician-led quality improvement model providing early supported discharge and transitional care for individuals who have had a stroke and have been discharged home. The effectiveness of the COMPASS model is being assessed in a cluster-randomized pragmatic trial in 41 sites across North Carolina, with a recruitment goal of 6,000 participants. The COMPASS model is evidence based, person centered, and stakeholder driven. It involves identification and education of eligible individuals in the hospital; telephone follow-up 2, 30, and 60 days after discharge; and a clinic visit within 14 days conducted by a nurse and advanced practice provider. Patient and caregiver self-reported assessments of functional and social determinants of health are captured during the clinic visit using a web-based application. Embedded algorithms immediately construct an individualized care plan. The COMPASS model's pragmatic design and quality metrics may support measurable best practices for postacute stroke care.

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

BACKGROUND: Pragmatic 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. METHODS: The 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. RESULTS: We 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. CONCLUSIONS: Although 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 REGISTRATION: Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial.

BACKGROUND: Patients 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. METHODS: Forty-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. DISCUSSION: Given 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 REGISTRATION: Clinicaltrials.gov: NCT02588664 ; October 23, 2015.

Geographic and sociodemographic disparities in drive times to Joint Commission-certified primary stroke centers in North Carolina, South Carolina, and Georgia.

INTRODUCTION: Timely access to facilities that provide acute stroke care is necessary to reduce disabilities and death from stroke. We examined geographic and sociodemographic disparities in drive times to Joint Commission-certified primary stroke centers (JCPSCs) and other hospitals with stroke care quality improvement initiatives in North Carolina, South Carolina, and Georgia. METHODS: We defined boundaries for 30- and 60-minute drive-time areas to JCPSCs and other hospitals  by  using geographic information systems (GIS) mapping technology and calculated the proportions of the population living in these drive-time areas by sociodemographic characteristics. Age-adjusted county-level stroke death rates were overlaid onto the drive-time areas. RESULTS: Approximately 55% of the population lived within a 30-minute drive time to a JCPSC; 77% lived within a 60-minute drive time. Disparities in percentage of the population within 30-minute drive times were found by race/ethnicity, education, income, and urban/rural status; the disparity was largest between urban areas (70% lived within 30-minute drive time) and rural areas (26%). The rural coastal plains had the largest concentration of counties with high stroke death rates and the fewest JCPSCs. CONCLUSION: Many areas in this tri-state region lack timely access to JCPSCs. Alternative strategies are needed to expand provision of quality acute stroke care in this region. GIS modeling is valuable for examining and strategically planning the distribution of hospitals providing acute stroke care.

Drive-time proximity to Joint Commission Primary Stroke Centers among North Carolina residents who died of stroke.

OBJECTIVE: In developing a statewide system of stroke care, understanding the relative availability of acute stroke care at designated centers for stroke care is essential. In this article, we compare the change in availability of acute stroke care in North Carolina at Joint Commission Primary Stroke Centers (JCPSCs) between 2006 and 2008 by examining the drive-time proximity of the residential address to the nearest JCPSC among people who died of stroke. METHODS: We assigned geographic coordinates to residential addresses of North Carolinians who died of stroke and to addresses of North Carolina JCPSCs. We calculated the distance within a 40-minute drive from each JCPSC and determined whether the residential addresses of patients who died of stroke were in the areas demarcated by the drive time. In a secondary analysis, we included non-ICPSCs that participate in recognized quality-improvement programs for stroke care. RESULTS: In 2006, 37% of geocodable residences of patients who died of stroke (3,834 of 10,469) were within a 40-minute drive from a JCPSC. By the end of 2008, this percentage increased to 56% (3,482 of 6,204). Inclusion of other hospitals that participate in recognized quality-improvement programs for acute stroke care increased the 40-minute drive-time coverage to 82% (5,095 of 6,204). LIMITATIONS: As an index of the geographic distribution of the stroke burden, we used deaths due to stroke, rather incident strokes. We included several assumptions in our drive-time calculation. CONCLUSIONS: For many regions of North Carolina in which the stroke burden is high, timely care at JCPSCs for acute stroke is unavailable. To develop a statewide system for acute stroke care in North Carolina, criteria beyond JCPSC certification should be considered for designating hospitals as centers for stroke care.