Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial.

Importance: Few stroke survivors meet recommended cardiovascular goals, particularly among racial/ethnic minority populations, such as Black or Hispanic individuals, or socioeconomically disadvantaged populations. Objective: To determine if a chronic care model-based, community health worker (CHW), advanced practice clinician (APC; including nurse practitioners or physician assistants), and physician team intervention improves risk factor control after stroke in a safety-net setting (ie, health care setting where all individuals receive care, regardless of health insurance status or ability to pay). Design, Setting, and Participants: This randomized clinical trial included participants recruited from 5 hospitals serving low-income populations in Los Angeles County, California, as part of the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) clinical trial. Inclusion criteria were age 40 years or older; experience of ischemic or hemorrhagic stroke or transient ischemic attack (TIA) no more than 90 days prior; systolic blood pressure (BP) of 130 mm Hg or greater or 120 to 130 mm Hg with history of hypertension or using hypertensive medications; and English or Spanish language proficiency. The exclusion criterion was inability to consent. Among 887 individuals screened for eligibility, 542 individuals were eligible, and 487 individuals were enrolled and randomized, stratified by stroke type (ischemic or TIA vs hemorrhagic), language (English vs Spanish), and site to usual care vs intervention in a 1:1 fashion. The study was conducted from February 2014 to September 2018, and data were analyzed from October 2018 to November 2020. Interventions: Participants randomized to intervention were offered a multimodal coordinated care intervention, including hypothesized core components (ie, ≥3 APC clinic visits, ≥3 CHW home visits, and Chronic Disease Self-Management Program workshops), and additional telephone visits, protocol-driven risk factor management, culturally and linguistically tailored education materials, and self-management tools. Participants randomized to the control group received usual care, which varied by site but frequently included a free BP monitor, self-management tools, and linguistically tailored information materials. Main Outcomes and Measures: The primary outcome was change in systolic BP at 12 months. Secondary outcomes were non-high density lipoprotein cholesterol, hemoglobin A1c, and C-reactive protein (CRP) levels, body mass index, antithrombotic adherence, physical activity level, diet, and smoking status at 12 months. Potential mediators assessed included access to care, health and stroke literacy, self-efficacy, perceptions of care, and BP monitor use. Results: Among 487 participants included, the mean (SD) age was 57.1 (8.9) years; 317 (65.1%) were men, and 347 participants (71.3%) were Hispanic, 87 participants (18.3%) were Black, and 30 participants (6.3%) were Asian. A total of 246 participants were randomized to usual care, and 241 participants were randomized to the intervention. Mean (SD) systolic BP improved from 143 (17) mm Hg at baseline to 133 (20) mm Hg at 12 months in the intervention group and from 146 (19) mm Hg at baseline to 137 (22) mm Hg at 12 months in the usual care group, with no significant differences in the change between groups. Compared with the control group, participants in the intervention group had greater improvements in self-reported salt intake (difference, 15.4 [95% CI, 4.4 to 26.0]; P = .004) and serum CRP level (difference in log CRP, -0.4 [95% CI, -0.7 to -0.1] mg/dL; P = .003); there were no differences in other secondary outcomes. Although 216 participants (89.6%) in the intervention group received some of the 3 core components, only 35 participants (14.5%) received the intended full dose. Conclusions and Relevance: This randomized clinical trial of a complex multilevel, multimodal intervention did not find vascular risk factor improvements beyond that of usual care; however, further studies may consider testing the SUCCEED intervention with modifications to enhance implementation and participant engagement. Trial Registration: ClinicalTrials.gov Identifier: NCT01763203.

Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke.

OBJECTIVES: Although healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors' self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population. MATERIALS AND METHODS: One hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence. RESULTS: There were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants. CONCLUSIONS: The HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted. TRIAL REGISTRATION: NCT01550822.

A Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Design of Healthy Eating and Lifestyle after Stroke (HEALS).

BACKGROUND: Stroke survivors have high rates of subsequent cardiovascular and recurrent cerebrovascular events, and mortality. While healthy lifestyle practices - including a diet rich in fruits and vegetables, limited alcohol intake, and regular physical activity - can mitigate these outcomes, few stroke survivors adhere to them. Minorities from socioeconomically disadvantaged communities who obtain care in safety-net health systems experience the most barriers to implementing healthy lifestyle changes after stroke. PURPOSE: To report the design of Healthy Eating and Lifestyle After Stroke (HEALS), a randomized controlled trial (RCT) was designed to test the feasibility of using a manualized, lifestyle management intervention in a safety-net setting to improve lifestyle practices among ethnically diverse individuals with stroke or transient ischemic attack (TIA). METHODS: Design: Pilot RCT. PARTICIPANTS: Inclusion criteria: 1) Adults (≥40 years) with ischemic stroke or TIA (≥ 90 days prior); 2) English- or Spanish-speaking. SETTING: Outpatient clinic, safety-net setting. INTERVENTION: Weekly two-hour small group sessions led by an occupational therapist for six weeks. The sessions focused on implementing nutrition, physical activity, and self-management strategies tailored to each participant's goals. MAIN OUTCOME MEASURES: Body mass index, diet, and physical activity. CONCLUSIONS: Recruitment for this study is complete. If the HEALS intervention study is feasible and effective, it will serve as a platform for a large-scale RCT that will investigate the efficacy and cost-effectiveness of life management interventions for racially and ethnically diverse, low-income individuals with a history of stroke or TIA who seek healthcare in the safety-net system.

Tale of 2 Health-care Systems: Disparities in Demographic and Clinical Characteristics between 2 Ischemic Stroke Populations in Los Angeles County.

BACKGROUND: Individuals who present to the emergency departments of safety-net systems often have poorly controlled risk factors due to lack of primary care. Little is known about potential differences in presenting characteristics, discharge medications, and discharge destinations of patients with acute ischemic stroke (AIS) who present to safety-net settings versus university medical centers (UMCs). METHODS: Demographic characteristics, medical history, premorbid medication use, stroke severity, discharge medications, and discharge destination were assessed among consecutive admissions for AIS over a 2-year period at a UMC (n = 385) versus 2 university-affiliated safety-net hospitals (SNHs) (n = 346) in Los Angeles County. RESULTS: Compared with patients presenting to the UMC, individuals admitted to the SNHs were younger, more frequently male, nonwhite, current smokers, hypertensive, and diabetic; they were less likely to take antithrombotics and statins before admission, and had worse serum lipid and glycemic markers (all P < .05). Patients admitted to the UMC trended toward more cardioembolic strokes and had higher stroke severity scores (P < .0001). At discharge, patients admitted to the SNHs were more likely to receive antihypertensive medications than do patients admitted to the UMC (P < .001), but there were no differences in prescription of antiplatelet medications or statins. CONCLUSIONS: Individuals with AIS admitted to SNHs in Los Angeles County are younger and have poorer vascular risk factor control than their counterparts at a UMC. Discharge treatment does not vary considerably between systems. Early and more vigorous efforts at primary vascular risk reduction among patients seen at SNHs may be warranted to reduce disparities.