Pamela Woods Duncan

BACKGROUND: Electromagnetic network-targeted field (ENTF) brain stimulation therapy is a promising approach to reduce poststroke disability. Two pilot, randomized, sham-controlled trials showed safety and signals of efficacy. The aim of this study was to perform a pooled analysis with greater statistical power to characterize with precision the effect of ENTF in promoting recovery and reducing disability. METHODS: We pooled individual patient-level data from 2 double-blind, randomized, sham-controlled studies, BQ3 (BrainQ3 Trial; Unique identifier: NCT04039178) and EMAGINE 1 (Electromagnetic Field Ischemic Stroke-Novel Subacute Treatment Trial; NCT05044507). Key entry criteria in both trials were (1) 4 to 21 days post-ischemic stroke and (2) Fugl-Meyer assessment-upper extremity score of 10 to 45. For EMAGINE 1, an additional criterion was a study entry modified Rankin Scale (mRS) score of 3 to 4. The primary outcome for this pooled analysis was freedom-from-disability (mRS score, 0–1) at 8 to 12 weeks. Secondary outcomes were level of disability (ordinal mRS score distribution), disability (mRS score) change from entry to 8 to 12 weeks, and 2 focused upper extremity motor end points. RESULTS: Altogether, 124 patients were included (active n=65; sham n=59). The mean age was 58.2±13.1 years, 31% were female, the study entry Fugl-Meyer assessment-upper extremity score was 25.3 (±10.6), and the therapy started 14.5 (±4.9) days poststroke. The study entry mRS score was 3.9 (±0.36), and 123/124 (99.2%) had a study entry mRS score of 3 to 4. Study entry features were well-balanced across treatment groups. At 8 to 12 weeks, freedom-from-disability was higher with active ENTF than sham stimulation (33.8% versus 11.9%; P =0.005). Ordinal shift across 3 disability strata (mRS score, 0–1, 2, and >2) also favored ENTF ( P =0.009). Focused upper extremity motor end points nonsignificantly favored ENTF. Safety analyses showed no device- or procedure-related serious adverse events. CONCLUSIONS: In pooled data from 2 randomized, sham-controlled trials, treatment with ENTF compared with sham for patients with subacute ischemic stroke with moderate-severe study entry disability yielded increased achieved freedom-from-disability, greater disability improvement from study entry, and reduced final disability level. These findings, together with an attractive safety profile, support ENTF as a promising therapy for stroke recovery.

Background: Community‐based physical and occupational therapy (PT/OT) are critical for stroke recovery but are underused. We conducted a secondary analysis of the COMPASS (Comprehensive Post‐Acute Stroke Services) study, a pragmatic trial of comprehensive postacute transitional care (TC) to investigate whether TC programs increase PT/OT use. Methods: Forty hospitals were randomized to implement COMPASS‐TC or maintain usual care for patients with stroke/transient ischemic attack. In a crossover phase, usual care hospitals implemented COMPASS‐TC. We linked participants to administrative claims to assess PT/OT use after stroke. Adjusted generalized estimating equations compared COMPASS‐TC to usual care within the trial and crossover cohorts on 30‐/90‐day PT/OT use, time to first visit, number of visits, and receipt of PT and OT versus single therapy. Per protocol analysis estimated complier average causal effects. Results: COMPASS enrolled 8377 patients from July 2016 to March 2019; 5261 were linked to administrative claims. Thirty‐day PT/OT ranged from 22.6% in usual care to 37.5% in COMPASS‐TC. Therapy use was similar between groups in the trial cohort, and COMPASS‐TC was associated with increased use in crossover analysis (9.4% [95% CI, 5.6–13.3%] at 30 days). COMPASS‐TC was consistently associated with a shorter time to therapy (mean difference, −0.16 [95% CI, −0.03 to −0.29]). Per protocol results were larger for most outcomes. Conclusions: COMPASS‐TC was associated with shorter time to PT/OT and with greater therapy receipt in the crossover, but not the trial, analysis. Inconsistencies may reflect confounding or differences in hospitals that chose to adopt the intervention in Phase 2. Implementation studies to improve care transitions after stroke are needed to enhance use of postacute rehabilitation.

Background: Our objective was to assess the extent of sociodemographic and geographic disparities in the use of community‐based rehabilitation following stroke, an area that has been understudied. Methods: We conducted an observational, secondary analysis of data from the COMPASS (Comprehensive Post‐Acute Stroke Services) trial, linking data of 6754 survivors of stroke to insurance claims. Our primary outcome was receipt of physical or occupational therapy in the home or outpatient setting within 30 days of hospital discharge. Secondary outcomes included therapy receipt within 90 days, time to first visit, number of visits, care in the home versus outpatient setting, and therapy type (physical therapy and occupational therapy versus 1 type). Our exposures were sex, race, rurality of patient residence, and socioeconomic status (Medicaid insurance). We used generalized estimating equations to examine associations between exposures and outcomes, controlling for therapy need. Results: We found evidence of disparities in therapy receipt, setting, and type. Individuals on Medicaid (versus no Medicaid) were 8% (−0.08 [95% CI, −0.10 to −0.05]) less likely to receive therapy within 30 days, with the effect being slightly smaller for White patients (−0.05 [95% CI, −0.09 to −0.01]). Individuals living in rural versus metropolitan areas were 5% less likely (−0.05 [95% CI, −0.08 to −0.02]) to receive care within 30 days and 12% (−0.12 [95% CI, −0.22 to −0.03]) less likely to receive physical therapy and occupational therapy. Overall, we found minimal evidence of racial disparities. Conclusions: Our findings add to the limited evidence on disparities in community‐based rehabilitation after stroke.

Evidence-based rehabilitation and secondary prevention interventions improve poststroke functional recovery and reduce secondary complications. However, stroke rehabilitation expertise, processes of care, and educational resources vary among sites where postacute care (PAC) is delivered. The American Heart Association developed quality standards based on the American Heart Association 2016 Guidelines for Adult Stroke Rehabilitation and Recovery to address these gaps. An interdisciplinary PAC standards writing committee identified key areas for PAC: quality improvement, medical management, care coordination, patient/caregiver and personnel education, and program management. Subgroups developed draft standards, combining results from a national landscape survey of PAC sites with clinical practice guidelines. The committee then refined the draft standards using a consensus-based process. American Heart Association staff and PAC sites in Montana convened a learning collaborative to gather feedback and provide gap analyses of the standards relative to current practices. Qualitative input from beta testing in Montana and quantitative results from the nationwide survey and Montana sites were analyzed and used to refine the standards further. The national landscape survey demonstrated that most sites do not meet the proposed standards: stroke program oversight structure (78% fall short), stroke rehabilitation leadership (70%), stroke-specific order sets/protocols (61%), and policies requiring staff stroke education (66%). Regarding Montana findings, 41% of the PAC sites have no mechanisms to identify areas of quality improvement specific to their stroke rehabilitation programs, and 59% do not use standardized tools to ensure that performance improvement initiatives are followed. However, with adequate support and resources, most Montana sites stated that they would be able to meet the proposed standards. We conclude that the Stroke PAC Quality Standards are applicable in PAC settings and provide a pathway to improving access to high-quality care for stroke survivors. Outcome studies are needed to confirm anticipated improvements in medical and functional outcomes.

Background Obstructive sleep apnea (OSA) negatively impacts post-stroke recovery. This study’s purpose: examine the prevalence of undiagnosed OSA and describe a simple tool to identify those at-risk for OSA in the early phase of stroke recovery. Methods This was a cross-sectional descriptive study of people ∼15 days post-stroke. Adults with stroke diagnosis admitted to inpatient rehabilitation over a 3-year period were included if they were alert/arousable, able to consent/assent to participation, and excluded if they had a pre-existing OSA diagnosis, other neurologic health conditions, recent craniectomy, global aphasia, inability to ambulate 150 feet independently pre-stroke, pregnant, or inability to understand English. OSA was deemed present if oxygen desaturation index (ODI) of >=15 resulted from overnight oximetry measures. Prevalence of OSA was determined accordingly. Four participant characteristics comprised the “BASH” tool (body mass index >=35, age>=50, sex=male, hypertension=yes). A receiver operator characteristics (ROC) curve analysis was performed with BASH as test variable and OSA presence as state variable. Results Participants (n=123) were 50.4% male, averaged 64.12 years old (sd 14.08), and self-identified race as 75.6% White, 20.3% Black/African American, 2.4%>1 race, and 1.6% other; 22% had OSA. ROC analysis indicated BASH score >=3 predicts presence of OSA (sensitivity=0.778, specificity=0.656, area under the curve =0.746, pConclusions Prevalence of undiagnosed OSA in the early stroke recovery phase is high. With detection of OSA post-stroke, it may be possible to offset untreated OSA’s deleterious impact on post-stroke recovery of function. The BASH tool is an effective OSA screener for this application.

BACKGROUND: Few studies on care transitions following acute stroke have evaluated whether referral to community-based rehabilitation occurred as part of discharge planning. Our objectives were to describe the extent to which patients discharged home were referred to community-based rehabilitation and identify the patient, hospital, and community-level predictors of referral. METHODS: We examined data from 40 North Carolina hospitals that participated in the COMPASS (Comprehensive Post-Acute Stroke Services) cluster-randomized trial. Participants included adults discharged home following stroke or transient ischemic attack (N=10 702). In this observational analysis, COMPASS data were supplemented with hospital-level and county-level data from various sources. The primary outcome was referral to community-based rehabilitation (physical, occupational, or speech therapy) at discharge. Predictor variables included patient (demographic, stroke-related, medical history), hospital (structure, process), and community (therapist supply) measures. We used generalized linear mixed models with a hospital random effect and hierarchical backward model selection procedures to identify predictors of therapy referral. RESULTS: Approximately, one-third (36%) of stroke survivors (mean age, 66.8 [SD, 14.0] years; 49% female, 72% White race) were referred to community-based rehabilitation. Rates of referral to physical, occupational, and speech therapists were 31%, 18%, and 10%, respectively. Referral rates by hospital ranged from 3% to 78% with a median of 35%. Patient-level predictors included higher stroke severity, presence of medical comorbidities, and older age. Female sex (odds ratio, 1.24 [95% CI, 1.12–1.38]), non-White race (2.20 [2.01–2.44]), and having Medicare insurance (1.12 [1.02–1.23]) were also predictors of referral. Referral was higher for patients living in counties with greater physical therapist supply. Much of the variation in referral across hospitals remained unexplained. CONCLUSIONS: One-third of stroke survivors were referred to community-based rehabilitation. Patient-level factors predominated as predictors. Variation across hospitals was notable and presents an opportunity for further evaluation and possible targets for improved poststroke rehabilitative care. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02588664.

Background: The REHAB‐HF (Rehabilitation Therapy in Older Acute Heart Failure Patients) randomized trial demonstrated that a 3‐month transitional, tailored, progressive, multidomain physical rehabilitation intervention improves physical function, frailty, depression, and health‐related quality of life among older adults with acute decompensated heart failure. Whether there is differential intervention efficacy by race is unknown. Methods and Results: In this prespecified analysis, differential intervention effects by race were explored at 3 months for physical function (Short Physical Performance Battery [primary outcome], 6‐Minute Walk Distance), cognition, depression, frailty, health‐related quality of life (Kansas City Cardiomyopathy Questionnaire, EuroQoL 5‐Dimension‐5‐Level Questionnaire) and at 6 months for hospitalizations and death. Significance level for interactions was P ≤0.1. Participants (N=337, 97% of trial population) self‐identified in near equal proportions as either Black (48%) or White (52%). The Short Physical Performance Battery intervention effect size was large, with values of 1.3 (95% CI, 0.4–2.1; P =0.003]) and 1.6 (95% CI, 0.8–2.4; P P =0.56). Beneficial effects were also demonstrated in 6‐Minute Walk Distance, gait speed, and health‐related quality of life scores without significant interactions by race. There was an association between intervention and reduced all‐cause rehospitalizations in White participants (rate ratio, 0.73 [95% CI, 0.55–0.98]; P =0.034) that appears attenuated in Black participants (rate ratio, 1.06 [95% CI, 0.81–1.41]; P =0.66; interaction P =0.067). Conclusions: The intervention produced similarly large improvements in physical function and health‐related quality of life in both older Black and White patients with acute decompensated heart failure. A future study powered to determine how the intervention impacts clinical events is required. REGISTRATION: URL: https://www.clinicaltrials.gov . Identifier: NCT02196038.

Despite the clear utility of stroke rehabilitation, our understanding of the extent of disparities in rehabilitation care across specific sociodemographic characteristics (e.g., by age, sex, race, ethnicity, rurality, socioeconomic status) is limited. In this review, we aimed to synthesize the current evidence on disparities in referral to, use of, and quality of rehabilitation following stroke; identify research gaps in our understanding of disparities in rehabilitation care; and make recommendations for future research to advance the field in identifying, understanding the causes of, and minimizing disparities. We searched three electronic databases from 1997 to 2023 for cohort, case-control, cross-sectional, observational, and mixed-method studies that examined disparities in rehabilitation care following stroke. From 7,853 records screened, we identified 49 studies that met our inclusion criteria. Findings from the studies we reviewed varied, with the most consistent findings indicating that individuals with lower socioeconomic status and those living in rural areas (vs urban) are less likely to receive rehabilitation care following stroke. Findings on racial, ethnic, and sex disparities varied with some consistent findings among specific subgroups (e.g., studies examining care in the outpatient setting) and when examining results from analyses that controlled for functional status and other measures of “need” for therapy. Several gaps in our understanding of disparities in rehabilitation care following stroke were identified. Recommendations for future work were also provided.

Background: Most patients diagnosed with colorectal cancer will survive for at least 5 years; thus, engaging patients to optimize their health will likely improve outcomes. Clinical guidelines recommend patients receive a comprehensive care plan (CP) when transitioning from active treatment to survivorship, which includes support for ongoing symptoms and recommended healthy behaviors. Yet, cancer care providers find this guideline difficult to implement. Future directions for survivorship care planning include enhancing information technology support for developing personalized CPs, using CPs to facilitate self-management, and assessing CPs in clinical settings. Objective: We aimed to develop an electronic tool for colorectal cancer follow-up care (CFC) planning. Methods: Incorporating inputs from health care professionals and patient stakeholders is fundamental to the successful integration of any tool into the clinical workflow. Thus, we followed the Integrate, Design, Assess, and Share (IDEAS) framework to adapt an existing application for stroke care planning (COMPASS-CP) to meet the needs of colorectal cancer survivors (COMPASS-CP CFC). Constructs from the Consolidated Framework for Implementation Research (CFIR) guided our approach. We completed this work in 3 phases: (1) gathering qualitative feedback from stakeholders about the follow-up CP generation design and workflow; (2) adapting algorithms and resource data sources needed to generate a follow-up CP; and (3) optimizing the usability of the adapted prototype of COMPASS-CP CFC. We also quantitatively measured usability (target average score ≥70; range 0-100), acceptability, appropriateness, and feasibility. Results: In the first phase, health care professionals (n=7), and patients and caregivers (n=7) provided qualitative feedback on COMPASS-CP CFC that informed design elements such as selection, interpretation, and clinical usefulness of patient-reported measures. In phase 2, we built a minimal viable product of COMPASS-CP CFC. This tool generated CPs based on the needs identified by patient-completed measures (including validated patient-reported outcomes) and electronic health record data, which were then matched with resources by zip code and preference to support patients’ self-management. Elements of the CFIR assessed revealed that most health care professionals believed the tool would serve patients’ needs and had advantages. In phase 3, the average System Usability Scale score was above our target score for health care professionals (n=5; mean 71.0, SD 15.2) and patients (n=5; mean 95.5, SD 2.1). Participants also reported high levels of acceptability, appropriateness, and feasibility. Additional CFIR-informed feedback, such as desired format for training, will inform future studies. Conclusions: The data collected in this study support the initial usability of COMPASS-CP CFC and will inform the next steps for implementation in clinical care. COMPASS-CP CFC has the potential to streamline the implementation of personalized CFC planning to enable systematic access to resources that will support self-management. Future research is needed to test the impact of COMPASS-CP CFC on patient health outcomes.