Familial caregiving following stroke: findings from the comprehensive post-acute stroke services (COMPASS) pragmatic cluster-randomized transitional care study.

BACKGROUND: Stroke patients discharged home often require prolonged assistance from caregivers. Little is known about the real-world effectiveness of a comprehensive stroke transitional care intervention on relieving caregiver strain. OBJECTIVES: To describe the effect of the COMPASS transitional care (COMPASS-TC) intervention on caregiver strain and characterize the types, duration, and intensity of caregiving. METHODS: The cluster-randomized COMPASS pragmatic trial evaluated the effectiveness of COMPASS-TC versus usual care with patients with mild stroke and TIA at 40 hospitals in North Carolina, USA. Of 5882 patients enrolled, 4208 (71%) identified a familial caregiver. A follow-up Caregiver Questionnaire, including the Modified Caregiver Strain Index, was administered at approximately three months post-discharge. Demographics and frequency, duration, and intensity of caregiving were compared between groups. RESULTS: 1228 caregivers (29%) completed the questionnaire. Completion was positively associated with older patient age, white race, and spousal relationship. One-third of the caregivers provided ≥30 hours of care per week and 889 (79%) provided care ≥9 weeks. Average standardized caregiver strain was 21.9 (0-100), increasing with stroke severity and comorbidity burden. Women caregivers reported higher strain than men. Treatment allocation was not associated with caregiver strain. CONCLUSIONS: This sample of mild stroke and TIA survivors received significant assistance from familial caregivers. However, caregiver strain was relatively low. Findings support the importance of familial caregiving in stroke, the continued disproportionate burden on women within the family, and the need for future research on caregiver support.

Clarifying the concept of a learning health system for healthcare delivery organizations: Implications from a qualitative analysis of the scientific literature.

The "learning health system" (LHS) concept has been defined in broad terms, which makes it challenging for health system leaders to determine exactly what is required to transform their organization into an LHS. This study provides a conceptual map of the LHS landscape by identifying the activities, principles, tools, and conditions that LHS researchers have associated with the concept. Through a multi-step screening process, two researchers identified 79 publications from PubMed (published before January 2020) that contained information relevant to the question, "What work is required of a healthcare organization that is operating as an LHS?" Those publications were coded as to whether or not they referenced each of 94 LHS elements in the taxonomy developed by the study team. This taxonomy, named the Learning Health Systems Consolidated Framework (LHS-CF), organizes the elements into five "bodies of work" (organizational learning, translation of evidence into practice, building knowledge, analyzing clinical data, and engaging stakeholders) and four "enabling conditions" (workforce skilled for LHS work, data systems and informatics technology in place, organization invests resources in LHS work, and supportive organizational culture). We report the frequency that each of the 94 elements was referenced across the 79 publications. The four most referenced elements were: "organization builds knowledge or evidence," "quality improvement practices are standard practice," "patients and family members are actively engaged," and "organizational culture emphasizes and supports learning." By dissecting the LHS construct into its component elements, the LHS-CF taxonomy can serve as a useful tool for LHS researchers and practitioners in defining the aspects of LHS they are addressing. By assessing how often each element is referenced in the literature, the study provides guidance to health system leaders as to how their organization needs to evolve in order to become an LHS - while also recognizing that each organization should emphasize elements that are most aligned with their mission and goals.

Association of in-hospital depression and anxiety symptoms following stroke with 3 months- depression, anxiety and functional outcome.

BACKGROUND: Post-stroke depression and anxiety are common and are associated with worse post-stroke outcomes. Even though checking for depression during stroke hospitalization has become a common practice, the prognostic value of a positive in-hospital depression screen following stroke remains unclear. METHODS: This is a retrospective cohort study of patients with stroke or TIA discharged home from a tertiary care center. We examined the association between premorbid history of depression and in-hospital anxiety/depressive symptoms, with anxiety/depressive symptoms and functional outcome at 3-months post-stroke. Logistic regression models were generated using two different main predictors: 1) pre-hospital history of depression (N = 117) and 2) in-hospital depression/anxiety measured by the EQ-5D-3L (N = 66). RESULTS: In the cohort of 117 patients, the mean age was 66 years, with median NIHSS 2;44% were women and 70% White. A history of pre-stroke depression was reported by 7% (8/117). Anxiety/depression on ED-5D-3L was reported by 29/66 (43%) in the hospital and by 22/66 (33%) at three months' post-stroke. In the first adjusted model, previous history of depression was associated with 3 months EQ-5D-3L anxiety/depression (OR = 10.2;95%CI:1.12-90.9, p = 0.038). In the second adjusted model, in-hospital anxiety/depression was associated with 3-month EQ-5D-3L anxiety/depression (OR = 3.9; 95% CI:1.16-13.1, p = 0.027). In-hospital anxiety/depression was associated with a higher mRS at 3 months but not after adjusting for covariates. CONCLUSION: A previous history of depression and in-hospital anxiety/depression symptoms are associated with anxiety/depression symptoms 3-months post-stroke but not with functional outcome. Screening stroke patients for both during hospitalization is warranted because of the association with later symptoms.

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

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

Implementation of Complex Interventions: Lessons Learned From the Patient-Centered Outcomes Research Institute Transitional Care Portfolio.

BACKGROUND: Despite the well-documented risks to patient safety associated with transitions from one care setting to another, health care organizations struggle to identify which interventions to implement. Multiple strategies are often needed, and studying the effectiveness of these complex interventions is challenging. OBJECTIVE: The objective of this study was to present lessons learned in implementing and evaluating complex transitional care interventions in routine clinical care. RESEARCH DESIGN: Nine transitional care study teams share important common lessons in designing complex interventions with stakeholder engagement, implementation, and evaluation under pragmatic conditions (ie, using only existing resources), and disseminating findings in outlets that reach policy makers and the people who could ultimately benefit from the research. RESULTS: Lessons learned serve as a guide for future studies in 3 areas: (1) Delineating the function (intended purpose) versus form (prespecified modes of delivery of the intervention); (2) Evaluating both the processes supporting implementation and the impact of adaptations; and (3) Engaging stakeholders in the design and delivery of the intervention and dissemination of study results. CONCLUSION: These lessons can help guide future pragmatic studies of care transitions.

Leveraging Emergent Social Networks to Reduce Sedentary Behavior in Low-Income Parents With Preschool-Aged Children.

This study tested the hypothesis that parents participating in a pediatric obesity intervention who formed social network ties with a parent in the intervention arm would engage in more daily physical activity and less sedentary behavior (after controlling for participant covariates). Data were collected at baseline, 12 months, and 36 months from 610 low-income parent-child pairs participating in an obesity prevention intervention for 3- to 5-year-old children. A network survey was used to identify social network ties among parents and accelerometers were used to measure parental physical activity and sedentary time. Longitudinal regression analyses tested effects of social network ties on parents' physical activity and sedentary behavior. Compared with parents without a social network tie, having a tie with an intervention group participant was associated with a clinically meaningful 11.04 min/day decrease in parental sedentary behavior that approached statistical significance (95% confidence interval [Cl] = [-22.71, 0.63], p = .06). Social network ties among parents in a pediatric obesity prevention intervention were not clearly associated with reduced sedentary behavior among those parents at the traditional level of p = .05. The large effect size (over 77min per week improvement) suggests there might be potential importance of promoting new social networks in community-based health promotion interventions to elicit and support behavior change, but further examination is needed.

Identifying Social Network Conditions that Facilitate Sedentary Behavior Change: The Benefit of Being a "Bridge" in a Group-based Intervention.

Using data from one of the first trials to try to leverage social networks as a mechanism for obesity intervention, we examined which social network conditions amplified behavior change. Data were collected as part of a community-based healthy lifestyle intervention in Nashville, USA, between June 2014 and July 2017. Adults randomized to the intervention arm were assigned to a small group of 10 participants that met in person for 12 weekly sessions. Intervention small group social networks were measured three times; sedentary behavior was measured by accelerometry at baseline and 12 months. Multivariate hidden Markov models classified people into distinct social network trajectories over time, based on the structure of the emergent network and where the individual was embedded. A multilevel regression analysis assessed the relationship between network trajectory and sedentary behavior (N = 261). Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07), p = 0.04]. Certain social network conditions may make it easier to reduce adult sedentary behavior in group-based interventions. While further research will be necessary to establish causality, the implications for intervention design are discussed.

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.

Implementation of a Transitional Care Model for Stroke: Perspectives From Frontline Clinicians, Administrators, and COMPASS-TC Implementation Staff.

BACKGROUND AND OBJECTIVES: Stroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow. RESEARCH DESIGN AND METHODS: We conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework. RESULTS: Organizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not "organizationally ready" had more difficulty addressing implementation challenges. DISCUSSION AND IMPLICATIONS: Multifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention. CLINICAL TRIAL REGISTRATION: NCT02588664.

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.

Challenging a Fundamental Proposition of Patient-Centeredness.

This investigation challenged the proposition that physician patient-centeredness influences patients' experience-of-care (PEC). A theory-driven, three-factor, multigroup structural equation modeling design, using asymptotic-distribution-free and bootstrap estimation, with two national random and 5,000 bootstrap samples challenged the proposition's plausibility, measurement invariance, replicability, robustness against a competing model, and coherence with theory. The model fit [χ2(39) = 28, p =.900, RMSEA = .001, p = 1.00, CFI = 1.00], explaining 81 percent of PEC's variance; the proposition was invariant across samples, held against the competing model [χ2Δ(7) = 7.82, p = .97]; cross-validated against estimates from the 5,000 bootstrap samples; and agreed with theory. One standardized increase in patient-centeredness increased PEC, likelihood of recommending, and care ratings by .807, .765, and .771. Results converged in sustaining the plausibility of the proposition.

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.

Perceived Benefits of Peer Support Groups for Stroke Survivors and Caregivers in Rural North Carolina.

BACKGROUND Significant geographical disparities exist in stroke prevalence among southeastern states, including North Carolina. Additionally, stroke is more prevalent in rural areas. Peer support groups play an important role in stroke recovery by providing tools for effective coping, alleviating psychological stress, and creating an outlet for stroke survivors and caregivers. However, their perceived benefits have not been clearly defined for rural stroke survivors and their families.METHODS This qualitative study describes the experiences of survivors and caregivers in rural North Carolina who have participated in stroke peer support groups. Four focus groups were conducted with 32 participants (average age 67 years, 72% female) in 4 rural North Carolina counties, using a semi-structured discussion guide and an inductive coding approach.RESULTS Thematic analysis revealed that participants in rural support groups seek and receive knowledge from their support groups and feel empowered by providing and receiving this knowledge. Shared experiences cultivate a sense of community, and participants viewed support outside of the support group as necessary to their recovery process.LIMITATIONS This study reflects the views of a small group of predominantly non-Hispanic, white stroke survivors and caregivers who voluntarily participated. We did not conduct separate focus groups with survivors and caregivers.CONCLUSION Peer support groups are a sparse, but critical resource for rural stroke survivors and caregivers because they provide information and community that can assist with recovery to health and independence.

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.

Implementation of the HEART Pathway: Using the Consolidated Framework for Implementation Research.

OBJECTIVE: The HEART Pathway is an evidence-based decision tool for identifying emergency department (ED) patients with acute chest pain who are candidates for early discharge, to reduce unhelpful and potentially harmful hospitalizations. Guided by the Consolidated Framework for Implementation Research, we sought to identify important barriers and facilitators to implementation of the HEART Pathway. STUDY SETTING: Data were collected at 4 academic medical centers. STUDY DESIGN: We conducted semi-structured interviews with 25 key stakeholders (e.g., health system leaders, ED physicians). We conducted interviews before implementation of the HEART Pathway tool to identify potential barriers and facilitators to successful adoption at other regional academic medical centers. We also conducted postimplementation interviews at 1 medical center, to understand factors that contributed to successful adoption. DATA COLLECTION: Interviews were recorded and transcribed verbatim. We used a Consolidated Framework for Implementation Research framework-driven deductive approach for coding and analysis. PRINCIPAL FINDINGS: Potential barriers to implementation include time and resource burden, challenges specific to the electronic health record, sustained communication with and engagement of stakeholders, and patient concerns. Facilitators to implementation include strength of evidence for reduced length of stay and unnecessary testing and iatrogenic complications, ease of use, and supportive provider climate for evidence-based decision tools. CONCLUSIONS: Successful dissemination of the HEART Pathway will require addressing institution-specific barriers, which includes engaging clinical and financial stakeholders. New SMART-FHIR technologies, compatible with many electronic health record systems, can overcome barriers to health systems with limited information technology resources.

COMPASS-CP: An Electronic Application to Capture Patient-Reported Outcomes to Develop Actionable Stroke and Transient Ischemic Attack Care Plans.

Background Patient-reported outcomes (PROs) are clinical tools that measure patients' goals of care and assess patient-reported physical, mental, and social well-being. Despite their value in advancing patient-centered care, routine use of PROs in stroke management has lagged. As part of the pragmatic COMPASS (Comprehensive Post-Acute Stroke Services) trial, we developed COMPASS-Care Plan (CP), a clinician-facing application that captures and analyzes PROs for stroke and transient ischemic attack patients discharged home and immediately generates individualized electronic CP. In this report, we (1) present our methods for developing and implementing COMPASS-CP PROs, (2) provide examples of CP generated from COMPASS-CP, (3) describe key functional, social, and behavioral determinants of health captured by COMPASS-CP, and (4) report on clinician experience with using COMPASS-CP in routine clinical practice for care planning and engagement of stroke and transient ischemic attack patients discharged home. Methods and Results We report on the first 871 patients enrolled in 20 North Carolina hospitals randomized to the intervention arm of COMPASS between July 2016 and February 2018; these patients completed a COMPASS follow-up visit within 14 days of hospital discharge. We also report user satisfaction results from 56 clinicians who used COMPASS-CP during these visits. COMPASS-CP identified more cognitive and depression deficits than physical deficits. Within 14-day posthospitalization, less than half of patients could list the major risk factors for stroke, 36% did not recognize blood pressure as a stroke risk factor, and 19% of patients were nonadherent with prescribed medications. Three-fourths of clinicians reported that COMPASS-CP identifies important factors impacting patients' recovery that they otherwise may have missed, and two-thirds were highly satisfied with COMPASS-CP. Conclusions The COMPASS-CP application meets an immediate need to incorporate PROs into the clinical workflow to develop patient-centered CP for stroke patients and has high user satisfaction. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02588664.

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.

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.

Nursing Patient-Centeredness Improves African-American Female Medicare Patients' Experience-of-Care.

BACKGROUND: Along with clinical technical competence, nurses' interpersonal ability influences patient outcomes. Patient-centeredness, "[p]roviding care that is respectful of, and responsive to, individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions" (IOM, 2001, p. 3), is especially important in assuring that African-American Medicare patients achieve the desired outcomes. PURPOSES: This study was designed to measure the effects of nursing patient-centeredness on African-American female Medicare hospital inpatients across national random test and cross-validation samples; specifically, on their experience-of-care, likelihood of recommending the hospital, and ratings of care. The stability of effects was assessed across samples and a competing model challenge further tested the hypothesis. HYPOTHESIS: Nursing patient-centeredness improves African-American female Medicare hospital patients' experience-of-care and increases the likelihood that they will recommend and highly rate their care. RESULTS: Supporting the hypothesis, the model fit. Nursing patient-centeredness significantly influenced African-American female Medicare hospital patients' experience-of-care, likelihood of recommending the hospital, and ratings of care (χ2 = 39.35, df = 42, p = .588; RMSEA = .000, p =.982 CL90% = .000-.043; CFI = 1.000), explaining 71% of the variance of patients' experience-of-care (p < .001). A unit increase in nursing patient-centeredness increased patients' experience-of-care, likelihood of recommending the hospital, and ratings of hospital care by .842, .778, and .798 standardized units, respectively. These results were stable across both the test and cross-validation samples, and the hypothesized model was sustained when compared to the hypothesized competing model (χ2Δ = 10.974, df = 16, p = .811). DISCUSSION: Nursing performance is often chiefly associated with clinical or technical competence. Patient-centeredness concerns nurses' ability that affects the quality of their interaction with patients and concomitant outcomes. This study provided empirical evidence that nursing patient-centeredness significantly improves African-American female Medicare hospital patients' experience-of-care and increases the likelihood that they will recommend and highly rate their care.