Ameliorating Hemianopia with Multisensory Training.

Hemianopia (unilateral blindness), a common consequence of stroke and trauma to visual cortex, is a debilitating disorder for which there are few treatments. Research in an animal model has suggested that visual-auditory stimulation therapy, which exploits the multisensory architecture of the brain, may be effective in restoring visual sensitivity in hemianopia. It was tested in two male human patients who were hemianopic for at least 8 months following a stroke. The patients were repeatedly exposed to congruent visual-auditory stimuli within their blinded hemifield during 2 h sessions over several weeks. The results were dramatic. Both recovered the ability to detect and describe visual stimuli throughout their formerly blind field within a few weeks. They could also localize these stimuli, identify some of their features, and perceive multiple visual stimuli simultaneously in both fields. These results indicate that the multisensory therapy is a rapid and effective method for restoring visual function in hemianopia.SIGNIFICANCE STATEMENT Hemianopia (blindness on one side of space) is widely considered to be a permanent disorder. Here, we show that a simple multisensory training paradigm can ameliorate this disorder in human patients.

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.

A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

BACKGROUND: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

Physical activity and relationship to physical function, quality of life, and cognitive function in older patients with acute decompensated heart failure.

BACKGROUND: Volitional physical activity level is predictive of a variety of health outcomes, but has not been examined in patients recently hospitalized for acute decompensated HF (ADHF). METHODS: Ten to 14 days after index hospitalization for ADHF, 93 participants wore a wrist-mounted triaxial accelerometer (ActiGraph GT3X+) to objectively quantify sedentary behavior, light physical activity, and moderate-to-vigorous physical activity. Levels were compared to 2 groups of age-matched NHANES participants: healthy and chronic, stable HF. The relationship between physical activity levels and physical function [Short Physical Performance Battery (SPPB)], HF-specific quality-of-life (QOL) [Kansas City Cardiomyopathy Questionnaire (KCCQ)], and cognition [Montreal Cognitive Assessment (MOCA)] were examined. RESULTS: ADHF participants accumulated a median 1,008 (IQR 896, 1,109) minutes of sedentary time, 88 (57, 139) minutes of light physical activity, and 10 (6, 25) minutes of moderate-to-vigorous physical activity per day. Sedentary time, light physical activity, or moderate-to-vigorous activity did not differ by sex or EF subtype. ADHF participants spent only 9% of awake time nonsedentary, compared to 34% and 27% for healthy adults and adults with chronic, stable HF, respectively. Among ADHF participants, SPPB, KCCQ, and MOCA scores did not differ among quartiles of total physical activity. CONCLUSIONS: Older patients recently hospitalized for ADHF have very low levels of physical activity and high levels of sedentary time, both of which may be potential targets for interventions in this high-risk population. Physical activity level was not significantly associated with objectively measured physical function, QOL, or cognition, suggesting that this measure provides independent information regarding the patient experience of living with HF. TRIAL REGISTRATION: NCT02196038, https://clinicaltrials.gov/ct2/show/NCT02196038.

Post-acute Ambulatory Care Service Use Among Patients Discharged Home After Stroke or TIA: The Cluster-randomized COMPASS Study.

BACKGROUND AND OBJECTIVES: 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. METHODS: 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. RESULTS: 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)]. DISCUSSION: 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.

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.

Skilled Nursing and Inpatient Rehabilitation Facility Use by Medicare Fee-for-Service Beneficiaries Discharged Home After a Stroke: Findings From the COMPASS Trial.

OBJECTIVES: To examine the effect of a comprehensive transitional care model on the use of skilled nursing facility (SNF) and inpatient rehabilitation facility (IRF) care in the 12 months after acute care discharge home following stroke; and to identify predictors of experiencing a SNF or IRF admission following discharge home after stroke. DESIGN: Cluster randomized pragmatic trial SETTING: Forty-one acute care hospitals in North Carolina. PARTICIPANTS: 2262 Medicare fee-for-service beneficiaries with transient ischemic attack or stroke discharged home. The sample was 80.3% White and 52.1% female, with a mean (SD) age of 74.9 (10.2) years and a mean ± SD National Institutes of Health stroke scale score of 2.3 (3.7). INTERVENTION: Comprehensive transitional care model (COMPASS-TC), which consisted of a 2-day follow-up phone call from the postacute care coordinator and 14-day in-person visit with the postacute care coordinator and advanced practice provider. MAIN OUTCOME MEASURES: Time to first SNF or IRF and SNF or IRF admission (yes/no) in the 12 months following discharge home. All analyses utilized multivariable mixed models including a hospital-specific random effect to account for the non-independence of measures within hospital. Intent to treat analyses using Cox proportional hazards regression assessed the effect of COMPASS-TC on time to SNF/IRF admission. Logistic regression was used to identify clinical and non-clinical predictors of SNF/IRF admission. RESULTS: Only 34% of patients in the intervention arm received COMPASS-TC per protocol. COMPASS-TC was not associated with a reduced hazard of a SNF/ IRF admission in the 12 months post-discharge (hazard ratio, 1.20, with a range of 0.95-1.52) compared to usual care. This estimate was robust to additional covariate adjustment (hazard ratio, 1.23) (0.93-1.64). Both clinical and non-clinical factors (ie, insurance, geography) were predictors of SNF/IRF use. CONCLUSIONS: COMPASS-TC was not consistently incorporated into real-world clinical practice. The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period. Non-clinical factors predictive of SNF/IRF use suggest potential issues with access to this type of care.

Study Protocol: Sleep Effects on Poststroke Rehabilitation Study.

BACKGROUND: A range of sleep disturbances and disorders are problematic in people after stroke; they interfere with recovery of function during poststroke rehabilitation. However, studies to date have focused primarily on the effects of one sleep disorder-obstructive sleep apnea (OSA)-on stroke recovery. OBJECTIVES: The study protocol for the SLEep Effects on Poststroke Rehabilitation (SLEEPR) Study is presented with aims of characterizing proportion of non-OSA sleep disorders in the first 90 days after stroke, evaluating the effect of non-OSA sleep disorders on poststroke recovery, and exploring the complex relationships between stroke, sleep, and recovery in the community setting. METHODS: SLEEPR is a prospective cohort observational study across multiple study sites following individuals from inpatient rehabilitation through 90 days poststroke, with three measurement time points (inpatient rehabilitation; i.e., ~15 days poststroke, 60 days poststroke, and 90 days poststroke). Measures of sleep, function, activity, cognition, emotion, disability, and participation will be obtained for 200 people without OSA at the study's start through self-report, capacity assessments, and performance measures. Key measures of sleep include wrist actigraphy, sleep diaries, overnight oximetry, and several sleep disorders screening questionnaires (Insomnia Severity Index, Cambridge-Hopkins Restless Legs Questionnaire, Epworth Sleepiness Scale, and Sleep Disorders Screening Checklist). Key measures of function and capacity include the 10-meter walk test, Stroke Impact Scale, Barthel index, and modified Rankin scale. Key performance measures include leg accelerometry (e.g., steps/day, sedentary time, upright time, and sit-to-stand transitions) and community trips via GPS data and activity logs. DISCUSSION: The results of this study will contribute to understanding the complex interplay between non-OSA sleep disorders and poststroke rehabilitation; they provide insight regarding barriers to participation in the community and return to normal activities after stroke. Such results could lead to strategies for developing new stroke recovery interventions.

Comprehensive Stroke Care and Outcomes: Time for a Paradigm Shift.

Worldwide, stroke is prevalent, costly, and disabling in >80 million survivors. The burden of stroke is increasing despite incredible progress and advancements in evidence-based acute care therapies and despite the substantial changes being made in acute care stroke systems, processes, and quality metrics. Although there has been increased global emphasis on the importance of postacute stroke care, stroke system changes have not expanded to include postacute care and outcome follow-up. Our objectives are to describe the gaps and challenges in postacute stroke care and suboptimal stroke outcomes; to report on stroke survivors' and caregivers' perceptions of current postacute stroke care and their call for improvements in follow-up services for recovery and secondary prevention; and, ultimately, to make the case that a paradigm shift is needed in the definition of comprehensive stroke care and the designation of Comprehensive Stroke Center. Three recommendations are made for a paradigm shift in comprehensive stroke care: (1) criteria should be established for designation of rehabilitation readiness for Comprehensive Stroke Centers, (2) The American Heart Association/American Stroke Association implement an expanded Get With The Guidelines-Stroke program and criteria for comprehensive stroke centers to be inclusive of rehabilitation readiness and measure outcomes at 90 days, and (3) a public health campaign should be launched to offer hopeful and actionable messaging for secondary prevention and recovery of function and health. Now is the time to honor the patients' and caregivers' strongest ask: better access and improved secondary prevention, stroke rehabilitation, and personalized care.

Cognition, Physical Function, and Quality of Life in Older Patients With Acute Decompensated Heart Failure.

BACKGROUND: Older adults with acute decompensated heart failure have persistently poor clinical outcomes. Cognitive impairment (CI) may be a contributing factor. However, the prevalence of CI and the relationship of cognition with other patient-centered factors such a physical function and quality of life (QOL) that also may contribute to poor outcomes are incompletely understood. METHODS AND RESULTS: Older (≥60 years) hospitalized patients with acute decompensated heart failure were assessed for cognition (Montreal Cognitive Assessment [MoCA]), physical function (Short Physical Performance Battery [SPPB], 6-minute walk distance [6MWD]), and QOL (Kansas City Cardiomyopathy Questionnaire, Short Form-12). Among patients (N = 198, 72.1 ± 7.6 years), 78% screened positive for CI (MoCA of <26) despite rare medical record documentation (2%). Participants also had severely diminished physical function (SPPB 6.0 ± 2.5 units, 6MWD 186 ± 100 m) and QOL (scores of <50). MoCA positively related to SPPB (ß = 0.47, P < .001), 6MWD ß = 0.01, P = .006) and inversely related to Kansas City Cardiomyopathy Questionnaire Overall Score (ß = -0.05, P < .002) and Short Form-12 Physical Component Score (ß = -0.09, P = .006). MoCA was a small but significant predictor of the results on the SPPB, 6MWD, and Kansas City Cardiomyopathy Questionnaire. CONCLUSIONS: Among older hospitalized patients with acute decompensated heart failure, CI is highly prevalent, is underrecognized clinically, and is associated with severe physical dysfunction and poor QOL. Formal screening may reduce adverse events by identifying patients who may require more tailored care.

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

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

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

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

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.

Interventions Targeting Racial/Ethnic Disparities in Stroke Prevention and Treatment.

Systemic racism is a public health crisis. Systemic racism and racial/ethnic injustice produce racial/ethnic disparities in health care and health. Substantial racial/ethnic disparities in stroke care and health exist and result predominantly from unequal treatment. This special report aims to summarize selected interventions to reduce racial/ethnic disparities in stroke prevention and treatment. It reviews the social determinants of health and the determinants of racial/ethnic disparities in care. It provides a focused summary of selected interventions aimed at reducing stroke risk factors, increasing awareness of stroke symptoms, and improving access to care for stroke because these interventions hold the promise of reducing racial/ethnic disparities in stroke death rates. It also discusses knowledge gaps and future directions.

Safely Identifying Emergency Department Patients With Acute Chest Pain for Early Discharge.

BACKGROUND: The HEART Pathway (history, ECG, age, risk factors, and initial troponin) is an accelerated diagnostic protocol designed to identify low-risk emergency department patients with chest pain for early discharge without stress testing or angiography. The objective of this study was to determine whether implementation of the HEART Pathway is safe (30-day death and myocardial infarction rate <1% in low-risk patients) and effective (reduces 30-day hospitalizations) in emergency department patients with possible acute coronary syndrome. METHODS: A prospective pre-post study was conducted at 3 US sites among 8474 adult emergency department patients with possible acute coronary syndrome. Patients included were ≥21 years old, investigated for possible acute coronary syndrome, and had no evidence of ST-segment-elevation myocardial infarction on ECG. Accrual occurred for 12 months before and after HEART Pathway implementation from November 2013 to January 2016. The HEART Pathway accelerated diagnostic protocol was integrated into the electronic health record at each site as an interactive clinical decision support tool. After accelerated diagnostic protocol integration, ED providers prospectively used the HEART Pathway to identify patients with possible acute coronary syndrome as low risk (appropriate for early discharge without stress testing or angiography) or non-low risk (appropriate for further in-hospital evaluation). The primary safety and effectiveness outcomes, death, and myocardial infarction (MI) and hospitalization rates at 30 days were determined from health records, insurance claims, and death index data. RESULTS: Preimplementation and postimplementation cohorts included 3713 and 4761 patients, respectively. The HEART Pathway identified 30.7% as low risk; 0.4% of these patients experienced death or MI within 30 days. Hospitalization at 30 days was reduced by 6% in the postimplementation versus preimplementation cohort (55.6% versus 61.6%; adjusted odds ratio, 0.79; 95% CI, 0.71-0.87). During the index visit, more MIs were detected in the postimplementation cohort (6.6% versus 5.7%; adjusted odds ratio, 1.36; 95% CI, 1.12-1.65). Rates of death or MI during follow-up were similar (1.1% versus 1.3%; adjusted odds ratio, 0.88; 95% CI, 0.58-1.33). CONCLUSIONS: HEART Pathway implementation was associated with decreased hospitalizations, increased identification of index visit MIs, and a very low death and MI rate among low-risk patients. These findings support use of the HEART Pathway to identify low-risk patients who can be safely discharged without stress testing or angiography. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT02056964.

A Cost-Effectiveness Analysis of a Randomized Control Trial of a Tailored, Multifactorial Program to Prevent Falls Among the Community-Dwelling Elderly.

OBJECTIVE: To perform a cost-effectiveness analysis of a multifactorial, tailored intervention to reduce falls among a heterogeneous group of high-risk elderly people. DESIGN: Randomized control trial. SETTINGS: Communities. PARTICIPANTS: Adults aged at least 65 years (N=354) seen at the emergency department (ED) for a fall or fall-related injury and discharged home. INTERVENTIONS: The intervention group received a tailored program of physical therapy focused on progressive training in strength, balance, and gait for a period of 3 months. They also received screening and referrals for low vision, polypharmacy, and environmental hazards. The Short Physical Performance Battery (SPPB) test was assessed at regular intervals to allocate participants into either a home-based or group center-based program. The control group received usual care prescribed by a physician and educational materials on falls prevention. MAIN OUTCOME MEASURES: The incremental cost-effectiveness ratio (ICER) over the 9-month study period based on intervention costs and utility in terms of quality-adjusted life years (QALYs) calculated from EuroQol-5D scores. RESULTS: The ICER was 120,667 Singapore dollars (S$) per QALY gained (S$362/0.003 QALYs), above benchmark values (S$70,000). However, the intervention was more effective and cost-saving among those with SPPB scores of greater than 6 at baseline, higher cognitive function, better vision and no more than 1 fall in the preceding 6 months. The intervention was also cost-effective among those with 0-1 critical comorbidities (S$22,646/QALY). CONCLUSION: The intervention was, overall, not cost-effective, compared to usual care. However, the program was cost-effective among healthier subgroups, and even potentially cost-saving among individuals with sufficient reserve to benefit.

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.

Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. TRIAL REGISTRATION NUMBER: NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.

Unexplained Variation for Hospitals' Use of Inpatient Rehabilitation and Skilled Nursing Facilities After an Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Rehabilitation is recommended after a stroke to enhance recovery and improve outcomes, but hospital's use of inpatient rehabilitation facilities (IRFs) or skilled nursing facility (SNF) and the factors associated with referral are unknown. METHODS: We analyzed clinical registry and claims data for 31 775 Medicare beneficiaries presenting with acute ischemic stroke from 918 Get With The Guidelines-Stroke hospitals who were discharged to either IRF or SNF between 2006 and 2008. Using a multilevel logistic regression model, we evaluated patient and hospital characteristics, as well as geographic availability, in relation to discharge to either IRF or SNF. After accounting for observed factors, the median odds ratio was reported to quantify hospital-level variation in the use of IRF versus SNF. RESULTS: Of 31 775 patients, 17 662 (55.6%) were discharged to IRF and 14 113 (44.4%) were discharged to SNF. Compared with SNF patients, IRF patients were younger, more were men, had less health-service use 6 months prestroke, and had fewer comorbid conditions and in-hospital complications. Use of IRF or SNF varied significantly across hospitals (median IRF use, 55.8%; interquartile range, 34.8%-75.0%; unadjusted median odds ratio, 2.59; 95% confidence interval, 2.44-2.77). Hospital-level variation in discharge rates to IRF or SNF persisted after adjustment for patient, clinical, and geographic variables (adjusted median odds ratio, 2.87; 95% confidence interval, 2.68-3.11). CONCLUSIONS: There is marked unexplained variation among hospitals in their use of IRF versus SNF poststroke even after accounting for clinical characteristics and geographic availability. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT02284165.