Health Services Research: A Critical Need in Stroke Care

Evidence defining high-quality stroke care has improved dramatically in the past 20 years; however, the gap between evidence and practice persists in stroke prevention, treatment, and rehabilitation.1 Although clinical trials have been instrumental in advancing the science supporting evidence- based guidelines, research is needed to identify gaps and factors contributing to gaps in care and outcomes and to develop strategies that promote uptake of evidence-based treatment and services for stroke patients. This article discusses health services research (HSR) as a multidisciplinary field encompassing outcomes research, implementation science, and financial evaluations that can address critical evidence, practice and policy gaps in stroke care

Opening Pandora’s Box From Readmissions to Transitional Care Patient-Centered Outcome Measures

Background: Measuring the effectiveness of transitional care interventions has historically relied on health care utilization as the primary outcome. Although the Care Transitions Measure was the first outcome measure specifically developed for transitional care, its applicability beyond the hospital-to-home transition is limited. There is a need for patient-centered outcome measures (PCOMs) to be developed for transitional care settings (ie, TC-PCOMs) to ensure that outcomes are both meaningful to patients and relevant to the particular care transition. The overall objective of this paper is to describe the opportunities and challenges of integrating TC-PCOMs into research and practice. Methods and Results: This narrative review was conducted by members of the Patient-Centered Outcomes Research Institute (PCORI) Transitional Care Evidence to Action Network. We define TC-PCOMs as outcomes that matter to patients because they account for their individual experiences, concerns, preferences, needs, and values during the transition period. The cardinal features of TC-PCOMs should be that they are developed following direct input from patients and stakeholders and reflect their lived experience during the transition in question. Although few TC-PCOMs are currently available, existing patient-reported outcome measures could be adapted to become TC-PCOMs if they incorporated input from patients and stakeholders and are validated for the relevant care transition. Conclusion: Establishing validated TC-PCOMs is crucial for measuring the responsiveness of transitional care interventions and optimizing care that is meaningful to patients

Expanding access to rehabilitation using mobile health to address musculoskeletal pain and disability

Introduction: Musculoskeletal (MSK) disorders such as low back pain and osteoarthritis are a leading cause of disability and the leading contributor to the need for rehabilitation services globally. This need has surpassed the availability of trained clinicians; even in urban areas where services and providers are thought to be more abundant, access can be challenged by transportation options and financial costs associated with travel, care and lost time from work. However, continuing standard of fully in-person rehabilitation care for MSK-associated pain and disability may no longer be necessary. With increased ownership or access to even a basic mobile phone device, and evidence for remote management by trained clinicians, some individuals with MSK disorders may be able to continue their rehabilitation regimen predominantly from home after initial evaluation in primary care or an outpatient clinic. Methods: This manuscript describes application of a framework we used to culturally and contextually adapt an evidence-based approach for leveraging digital health technology using a mobile phone (mHealth) to expand access to rehabilitation services for MSK-associated pain and disability. We then conducted a multi-level analysis of policies related to the adapted approach for rehabilitation service delivery to identify opportunities to support sustainability. Results: Our study was conducted in Tanzania, a lower-middle income country with their first National Rehabilitation Strategic Plan released in 2021. Lessons learned can be applied even to countries with greater infrastructure or fewer barriers. The seven-step adaptation framework used can be applied in other regions to improve the likelihood of local mHealth adoption and implementation. Our practice and policy assessment for Tanzania can be applied in other regions and used collaboratively with government officials in support of building or implementing a national rehabilitation strategic plan. Conclusion: The work described, lessons learned and components of the plan are generalizable globally and can improve access to rehabilitation services using mHealth to address the significant and increasing burden of disability.Temple University. College of Public HealthHealth and Rehabilitation Science

Risks and Benefits Associated With Prestroke Antiplatelet Therapy Among Patients With Acute Ischemic Stroke Treated With Intravenous Tissue Plasminogen Activator

IMPORTANCE: Intravenous tissue plasminogen activator (tPA) is known to improve outcomes in ischemic stroke; however, many patients may have been receiving antiplatelet therapy before acute ischemic stroke and could face an increased risk for bleeding when treated with tPA. OBJECTIVE: To assess the risks and benefits associated with prestroke antiplatelet therapy among patients with ischemic stroke who receive intravenous tPA. DESIGN, SETTING, AND PARTICIPANTS: This observational study used data from the American Heart Association and American Stroke Association Get With the Guidelines-Stroke registry, which included 85 072 adult patients with ischemic stroke who received intravenous tPA in 1545 registry hospitals from January 1, 2009, through March 31, 2015. Data were analyzed during the same period. EXPOSURES: Prestroke antiplatelet therapy before tPA administration for acute ischemic stroke. MAIN OUTCOMES AND MEASURES: Symptomatic intracranial hemorrhage (sICH), in-hospital mortality, discharge ambulatory status, and modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]). RESULTS: Of the 85 072 registry patients, 38 844 (45.7%) were receiving antiplatelet therapy before admission; 46 228 patients (54.3%) were not. Patients receiving antiplatelet therapy were older (median [25th-75th percentile] age, 76 [65-84] vs 68 [56-80] years) and had a higher prevalence of cardiovascular risk factors. The unadjusted rate of sICH was higher in patients receiving antiplatelet therapy (5.0% vs 3.7%). After risk adjustment, prior use of antiplatelet agents remained associated with higher odds of sICH compared with no use (adjusted odds ratio [AOR], 1.18 [95% CI, 1.10-1.28]; absolute difference, +0.68% [95% CI, 0.36%-1.01%]; number needed to harm [NNH], 147). Among patients enrolled on October 1, 2012, or later, the highest odds (95% CIs) of sICH were found in 15 116 patients receiving aspirin alone (AOR, 1.19 [1.06- 1.34]; absolute difference [95% CI], +0.68% [0.21%-1.20%]; NNH, 147) and 2397 patients receiving dual antiplatelet treatment of aspirin and clopidogrel (AOR, 1.47 [1.16-1.86]; absolute difference, +1.67% [0.58%-3.00%]; NNH, 60). The risk for in-hospital mortality was similar between those who were and were not receiving antiplatelet therapy after adjustment (8.0% vs 6.6%; AOR, 1.00 [0.94-1.06]; nonsignificant absolute difference, -0.01% [-0.37% to 0.36%]). However, patients receiving antiplatelet therapy had a greater risk-adjusted likelihood of independent ambulation (42.1% vs 46.6%; AOR, 1.13 [1.08-1.17]; absolute difference, +2.23% [1.55%-2.92%]; number needed to treat, 43) and better functional outcomes (modified Rankin Scale score, 0-1) at discharge (24.1% vs 27.8%; AOR, 1.14; 1.07-1.22; absolute difference, +1.99% [0.78%-3.22%]; number needed to treat, 50). CONCLUSIONS AND RELEVANCE: Among patients with an acute ischemic stroke treated with intravenous tPA, those receiving antiplatelet therapy before the stroke had a higher risk for sICH but better functional outcomes than those who were not receiving antiplatelet therapy

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

Expanding access to rehabilitation using mobile health to address musculoskeletal pain and disability

Introduction Musculoskeletal (MSK) disorders such as low back pain and osteoarthritis are a leading cause of disability and the leading contributor to the need for rehabilitation services globally. This need has surpassed the availability of trained clinicians; even in urban areas where services and providers are thought to be more abundant, access can be challenged by transportation options and financial costs associated with travel, care and lost time from work. However, continuing standard of fully in-person rehabilitation care for MSK-associated pain and disability may no longer be necessary. With increased ownership or access to even a basic mobile phone device, and evidence for remote management by trained clinicians, some individuals with MSK disorders may be able to continue their rehabilitation regimen predominantly from home after initial evaluation in primary care or an outpatient clinic. Methods This manuscript describes application of a framework we used to culturally and contextually adapt an evidence-based approach for leveraging digital health technology using a mobile phone (mHealth) to expand access to rehabilitation services for MSK-associated pain and disability. We then conducted a multi-level analysis of policies related to the adapted approach for rehabilitation service delivery to identify opportunities to support sustainability. Results Our study was conducted in Tanzania, a lower-middle income country with their first National Rehabilitation Strategic Plan released in 2021. Lessons learned can be applied even to countries with greater infrastructure or fewer barriers. The seven-step adaptation framework used can be applied in other regions to improve the likelihood of local mHealth adoption and implementation. Our practice and policy assessment for Tanzania can be applied in other regions and used collaboratively with government officials in support of building or implementing a national rehabilitation strategic plan. Conclusion The work described, lessons learned and components of the plan are generalizable globally and can improve access to rehabilitation services using mHealth to address the significant and increasing burden of disability

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

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 PlanTM 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

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

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