Recruitment in Acute Stroke Trials: Challenges and Potential Solutions.

Randomized clinical trials of acute stroke have led to major advances in acute stroke therapy over the past decade. Despite these successes, recruitment in acute trials is often difficult. We outline challenges in recruitment for acute stroke trials and present potential solutions, which can increase the speed and decrease the cost of identifying new treatments for acute stroke. One of the largest opportunities to increase the speed of enrollment and make trials more generalizable is expansion of inclusion criteria whose impact on expected recruitment can be assessed by epidemiologic and registry databases. Another barrier to recruitment besides the number of eligible patients is availability of study investigators limited to business hours, which may be helped by financial support for after-hours call. The wider use of telemedicine has accelerated quicker stroke treatment at many hospitals and has the potential to accelerate research enrollment but requires training of clinical investigators who are often inexperienced with this approach. Other potential solutions to enhance recruitment include rapid prehospital notification of clinical investigators of potential patients, use of mobile stroke units, advances in the process of emergency informed consent, storage of study medication in the emergency department, simplification of study treatments and data collection, education of physicians to improve equipoise and enthusiasm for randomization of patients within a trial, and clear recruitment plans, and even potentially coenrollment, when there are competing trials at sites. Without successful recruitment, scientific advances and clinical benefit for acute stroke patients will lag.

Primary Care and Home Visiting Utilization Patterns among At-Risk Infants.

OBJECTIVE: To describe well child care (WCC) utilization in the first year of life among at-risk infants, and the relationship to home visiting enrollment. STUDY DESIGN: Retrospective cohort study using linked administrative data for infants ≥34 weeks' gestation from 2010 to 2014, within a regional, academic primary care system. Association between WCC visits and home visiting enrollment was evaluated using bivariate comparisons and multivariable Poisson regression. Latent class analysis further characterized longitudinal patterns of WCC attendance. Multivariable logistic regression tested the association between home visiting and pattern of timeliest adherence to recommended WCC. RESULTS: Of 11 936 infants, mean number of WCC visits was 4.1 in the first 12 months of life. Of 3910 infants eligible for home visiting, 28.5% were enrolled. Among enrolled infants, mean WCC visits was 4.7 vs 4.4 among eligible, nonenrolled infants, P value < .001. After multivariable adjustment, there was no significant association between enrollment and WCC visit count (adjusted incident rate ratio 1.03, 95% CI 0.99, 1.07). Using latent class analysis, 3 WCC classes were identified: infants in class 1 (77.7%) were most adherent to recommended WCC, class 2 (12.5% of cohort) had progressively declining WCC attendance over the first year of life, and class 3 (9.8%) maintained moderate attendance. In multivariable regression, home visiting was associated with class 1 membership, aOR 1.27, 95% CI 1.04, 1.57. CONCLUSIONS: A pattern of timely WCC attendance was more likely among infants in home visiting; however, most infants eligible for home visiting were not enrolled.

Age, subjective stress, and depression after ischemic stroke.

The incidence of stroke among younger adults in the United States is increasing. Few studies have investigated the prevalence of depressive symptoms after stroke among different age groups or the extent to which subjective stress at the time of stroke interacts with age to contribute to post-stroke depression. The present study examined whether there exists an age gradient in survivors' level of depressive symptoms and explored the extent to which financial, family, and health-related stress may also impact on depression. Bivariate analyses (N = 322) indicated significant differences in depression and stress by age group, as well as differences in age and stress by 3-month depression status. Linear regression analyses indicated that survivors between the ages of 25-54 and 55-64 years old had, on average, significantly higher depressive symptom scores. Those with financial, family, and health-related stress at the time of stroke, irrespective of age, also had significantly higher scores.

Characterizing the longitudinal relations between depressive and menstrual symptoms in adolescent girls.

OBJECTIVE: This study examined the association between depressive and menstrual symptoms in adolescent girls in a 3-year longitudinal study. It was hypothesized that menstrual symptoms would increase in early adolescence and decrease in later adolescence, that girls with greater depressive symptoms would report greater menstrual symptoms, and that effects would persist after adjusting for general somatic complaints. METHODS: A community sample of girls (n = 262) enrolled in an observational study by age cohort (11, 13, 15, 17 years) completed three annual visits. At each time point, girls completed the Menstrual Symptom Questionnaire, Children's Depression Inventory, and the Youth Self Report to assess general somatic complaints. RESULTS: Menstrual symptoms increased significantly across adolescence (p = .006) and began to plateau in later adolescence (p = .020). Depressive symptoms at study entry were significantly associated with menstrual symptoms (p < .001). When general somatic complaints were included in the models, the effect of depressive symptoms on menstrual symptoms remained significant for the sum score (p = .015) and the menstrual somatic symptoms subscale (p = .001). After adjusting for somatic complaints, initial report of depressive symptoms predicted change in menstrual symptoms only for girls with the lowest menstrual symptoms sum score (p = .025). Initial report of somatic complaints predicted change in menstrual symptoms (p = .020). CONCLUSIONS: Girls with higher depressive symptoms and higher somatic complaints are at greater risk for experiencing menstrual symptoms and increasing symptoms across adolescence, with a heightened vulnerability for girls with lower baseline menstrual symptoms.

Characterizing the Longitudinal Impact of Backward Locomotor Treadmill Training on Walking and Balance Outcomes in Chronic Stroke Survivors: A Randomized Single Center Clinical Trial.

Background and Purpose: Walking and balance impairments after stroke are a global health concern, causing significant morbidity and mortality. However, effective strategies for achieving meaningful recovery in the chronic stages are limited. Backward locomotor treadmill training (BLTT) is a novel walking rehabilitation protocol that is safe, feasible, and likely beneficial in stroke survivors; however, its efficacy has not been tested. This single-center, randomized, assessor-blind clinical trial aims to test the preliminary efficacy of BLTT compared to forward locomotor treadmill training (FLTT) on walking speed, symmetry, and postural stability. Methods: Forty stroke survivors [BLTT (N=19), FLTT (N=21); mean age= 56.3 ± 8.6 years; 53% Female; 30% Non-Hispanic Black] with mild-moderate walking impairment were enrolled. Participants underwent nine 30-minute BLTT or FLTT sessions over three weeks. The primary outcome was the mean change in the 10-meter walk test (10 MWT) at 24 hours post-training (24 hr POST). Secondary outcome measures were changes in spatiotemporal walking symmetry and postural stability during quiet standing at 24 hr POST. Retention was explored at Days 30- and 90 POST. Results: We report clinically meaningful (≥ 0.16 m/s) improvements in overground walking speed at 24 hr POST, with retention up to Day 90 POST with BLTT and FLTT. However, contrary to our working hypothesis, no between-group differences in walking speed were observed. Nonetheless, we found that BLTT resulted in offline improvements in spatial symmetry and retention of subcomponents of the modified clinical test of sensory interaction on balance (mCTSIB), including the testing of proprio-vestibular integration up to Day 30 POST. Conclusion: Among chronic stroke patients with mild-moderate walking impairment, BLTT and FLTT both resulted in long-lasting and clinically meaningful improvement in walking speed. However, preliminary findings suggest that BLTT may better comprehensively target walking asymmetry and sensory systems processing and integration.

Insufficiencies in sensory systems reweighting is associated with walking impairment severity in chronic stroke: an observational cohort study.

Background: Walking and balance impairment are common sequelae of stroke and significantly impact functional independence, morbidity, and mortality. Adequate postural stability is needed for walking, which requires sufficient integration of sensory information between the visual, somatosensory, and vestibular centers. "Sensory reweighting" describes the normal physiologic response needed to maintain postural stability in the absence of sufficient visual or somatosensory information and is believed to play a critical role in preserving postural stability after stroke. However, the extent to which sensory reweighting successfully maintains postural stability in the chronic stages of stroke and its potential impact on walking function remains understudied. Methods: In this cross-sectional study, fifty-eight community-dwelling ambulatory chronic stroke survivors underwent baseline postural stability testing during quiet stance using the modified Clinical test of Sensory Interaction in Balance (mCTSIB) and assessment of spatiotemporal gait parameters. Results: Seventy-six percent (45/58) of participants showed sufficient sensory reweighting with visual and somatosensory deprivation for maintaining postural stability, albeit with greater postural sway velocity indices than normative data. In contrast, survivors with insufficient reweighting demonstrated markedly slower overground walking speeds, greater spatiotemporal asymmetry, and limited acceleration potential. Conclusion: Adequate sensory system reweighting is essential for chronic stroke survivors' postural stability and walking independence. Greater emphasis should be placed on rehabilitation strategies incorporating multisensory system integration testing and strengthening as part of walking rehabilitation protocols. Given its potential impact on outcomes, walking rehabilitation trials may benefit from incorporating formal postural stability testing in design and group stratification.

Garnering effective telehealth to help optimize multidisciplinary team engagement (GET2HOME) for children with medical complexity: Protocol for a pragmatic randomized control trial.

BACKGROUND: Children and young adults with medical complexity (CMC) experience high rates of healthcare reutilization following hospital discharge. Prior studies have identified common hospital-to-home transition failures that may increase the risk for reutilization, including medication, technology and equipment issues, financial concerns, and confusion about which providers can help with posthospitalization needs. Few interventions have been developed and evaluated for CMC during this transition period. OBJECTIVE: We will compare the effectiveness of the garnering effective telehealth 2 help optimize multidisciplinary team engagement (GET2HOME) transition bundle intervention to the standard hospital-based care coordination discharge process by assessing healthcare reutilization and patient- and family-centered outcomes. DESIGNS, SETTINGS, AND PARTICIPANTS: We will conduct a pragmatic 2-arm randomized controlled trial (RCT) comparing the GET2HOME bundle intervention to the standard hospital-based care discharge process on CMC hospitalized and discharged from hospital medicine at two sites of our pediatric medical center between November 2022 and February 2025. CMC of any age will be identified as having complex chronic disease using the Pediatric Medical Complexity Algorithm tool. We will exclude CMC who live independently, live in skilled nursing facilities, are in custody of the county, or are hospitalized for suicidal ideation or end-of-life care. INTERVENTION: We will randomize participants to the bundle intervention or standard hospital-based care coordination discharge process. The bundle intervention includes (1) predischarge telehealth huddle with inpatient providers, outpatient providers, patients, and their families; (2) care management discharge task tracker; and (3) postdischarge telehealth huddle with similar participants within 7 days of discharge. As part of the pragmatic design, families will choose if they want to complete the postdischarge huddle. The standard hospital-based discharge process includes a pharmacist, social worker, and care management support when consulted by the inpatient team but does not include huddles between providers and families. MAIN OUTCOME AND MEASURES: Primary outcome will be 30-day urgent healthcare reutilization (unplanned readmission, emergency department, and urgent care visits). Secondary outcomes include 7-day urgent healthcare reutilization, patient- and family-reported transition quality, quality of life, and time to return to baseline using electronic health record and surveys at 7, 30, 60, and 90 days following discharge. We will also evaluate heterogeneity of treatment effect for the intervention across levels of financial strain and for CMC with high-intensity neurologic impairment. The primary analysis will follow the intention-to-treat principle with logistic regression used to study reutilization outcomes and generalized linear mixed modeling to study repeated measures of patient- and family-reported outcomes over time. RESULTS: This pragmatic RCT is designed to evaluate the effectiveness of enhanced discharge transition support, including telehealth huddles and a care management discharge tool, for CMC and their families. Enrollment began in November 2022 and is projected to complete in February 2025. Primary analysis completion is anticipated in July 2025 with reporting of results following.

Serial Backward Locomotor Treadmill Training Improves Bidirectional Walking Performance in Chronic Stroke.

Background and Research Question: Walking impairment remains a major limitation to functional independence after stroke. Yet, comprehensive and effective strategies to improve walking function after stroke are presently limited. Backward Locomotor Treadmill Training (BLTT) is a promising training approach for improving walking function; however, little is known about its mechanism of effect or the relationship between backward walking training and resulting overground forward walking performance. This study aims to determine the effects of serial BLTT on spatial aspects of backward and forward walking in chronic post-stroke individuals with residual walking impairment. Methods: Thirty-nine adults (>6 months post-stroke) underwent 6 days of BLTT (3 × /week) over 2 weeks. Outcome measures included PRE-POST changes in backward and forward walking speeds, paretic and non-paretic step lengths, and single-support center of pressure distances. To determine the association between BLTT and overground walking, correlation analyses comparing training-related changes in these variables were performed. Results: We report an overall improvement in BLTT and overground walking speeds, bilateral step lengths, and single-support center of pressure distances over six training sessions. Further, there were weak positive associations between PRE-POST changes in BLTT speed, BLTT paretic step length, and overground forward walking speed. Conclusion and Significance: Our findings suggest that individuals with chronic post-stroke walking impairment experience improvements in spatial walking measures during BLTT and overground. Therefore, BLTT may be a potential adjunctive training approach for post-stroke walking rehabilitation.

Backward Locomotor Treadmill Training Differentially Improves Walking Performance across Stroke Walking Impairment Levels.

BACKGROUND: Post-stroke walking impairment is a significant cause of chronic disability worldwide and often leads to loss of life roles for survivors and their caregivers. Walking impairment is traditionally classified into mild (>0.8 m/s), moderate (0.41-0.8 m/s), and severe (≤0.4 m/s), and those categorized as "severe" are more likely to be homebound and at greater risk of falls, fractures, and rehospitalization. In addition, there are minimal effective walking rehabilitation strategies currently available for this subgroup. Backward locomotor treadmill training (BLTT) is a novel and promising training approach that has been demonstrated to be safe and feasible across all levels of impairment; however, its benefits across baseline walking impairment levels (severe (≤0.4 m/s) vs. mild-moderate (>0.4 m/s)) have not been examined. METHODS: Thirty-nine adults (>6 months post-stroke) underwent 6 days of BLTT (3×/week) over 2 weeks. Baseline and PRE to POST changes were measured during treadmill training and overground walking. RESULTS: Individuals with baseline severe walking impairment were at a more significant functional disadvantage across all spatiotemporal walking measures at baseline and demonstrated fewer overall gains post-training. However, contrary to our working hypothesis, both groups experienced comparable increases in cadence, bilateral percent single support times, and step lengths. CONCLUSION: BLTT is well tolerated and beneficial across all walking impairment levels, and baseline walking speed (≤0.4 m/s) should serve as a covariate in the design of future walking rehabilitation trials.

Differential Impact of Home Nurse Contact After Discharge by Financial Strain, Primary Care Access, and Medical Complexity.

BACKGROUND: The Hospital to Home Outcomes (H2O) trials examined the effectiveness of postdischarge nurse support on reuse after pediatric discharge. Unexpectedly, children randomly assigned to a nurse visit had higher rates of reuse than those in the control group. Participants in randomized control trials are heterogeneous. Thus, it is possible that the effect of the intervention differed across subgroups (ie, heterogeneity of treatment effect [HTE]). We sought to determine if different subgroups responded differently to the interventions. METHODS: The H2O trial is a randomized controlled trial comparing standard hospital discharge processes with a nurse home visit within 96 hours of discharge. The second trial, H2O II, was similar, except the tested intervention was a postdischarge nurse phone call. For the purposes of the HTE analyses, we examined our primary trial outcome measure: a composite of unplanned 30-day acute health care reuse (unplanned readmission or emergency department or urgent care visit). We identified subgroups of interest before the trials related to (1) financial strain, (2) primary care access, (3) insurance, and (4) medical complexity. We used logistic regression modeling with an interaction term between subgroup and treatment group (intervention or control). RESULTS: For the phone call trial (H2O II), financial strain significantly modified the effect of the intervention such that the subgroup of children with high financial strain who received the intervention experienced more reuse than their control counterparts. CONCLUSIONS: In HTE analyses of 2 randomized controlled trials, only financial strain significantly modified the nurse phone call. A family's financial resources may affect the utility of postdischarge support.

Backward locomotor treadmill training combined with transcutaneous spinal direct current stimulation in stroke: a randomized pilot feasibility and safety study.

Walking impairment impacts nearly 66% of stroke survivors and is a rising cause of morbidity worldwide. Despite conventional post-stroke rehabilitative care, the majority of stroke survivors experience continued limitations in their walking speed, temporospatial dynamics and walking capacity. Hence, novel and comprehensive approaches are needed to improve the trajectory of walking recovery in stroke survivors. Herein, we test the safety, feasibility and preliminary efficacy of two approaches for post-stroke walking recovery: backward locomotor treadmill training and transcutaneous spinal direct current stimulation. In this double-blinded study, 30 chronic stroke survivors (>6 months post-stroke) with mild-severe residual walking impairment underwent six 30-min sessions (three sessions/week) of backward locomotor treadmill training, with concurrent anodal (N = 19) or sham transcutaneous spinal direct current stimulation (N = 11) over the thoracolumbar spine, in a 2:1 stratified randomized fashion. The primary outcomes were: per cent participant completion, safety and tolerability of these two approaches. In addition, we collected data on training-related changes in overground walking speed, cadence, stride length (baseline, daily, 24-h post-intervention, 2 weeks post-intervention) and walking capacity (baseline, 24-h post-intervention, 2 weeks post-intervention), as secondary exploratory aims testing the preliminary efficacy of these interventions. Eighty-seven per cent (N = 26) of randomized participants completed the study protocol. The majority of the study attrition involved participants with severe baseline walking impairment. There were no serious adverse events in either the backward locomotor treadmill training or transcutaneous spinal direct current stimulation approaches. Also, both groups experienced a clinically meaningful improvement in walking speed immediately post-intervention that persisted at the 2-week follow-up. However, in contrast to our working hypothesis, anodal-transcutaneous spinal direct current stimulation did not enhance the degree of improvement in walking speed and capacity, relative to backward locomotor treadmill training + sham, in our sample. Backward locomotor treadmill training and transcutaneous spinal direct current stimulation are safe and feasible approaches for walking recovery in chronic stroke survivors. Definitive efficacy studies are needed to validate our findings on backward locomotor treadmill training-related changes in walking performance. The results raise interesting questions about mechanisms of locomotor learning in stroke, and well-powered transcutaneous spinal direct current stimulation dosing studies are needed to understand better its potential role as a neuromodulatory adjunct for walking rehabilitation.

Effect of Parental Adverse Childhood Experiences and Resilience on a Child's Healthcare Reutilization.

BACKGROUND: Adverse childhood experiences (ACEs) are associated with poor health outcomes in adults. Resilience may mitigate this effect. There is limited evidence regarding how parents' ACEs and resilience may be associated with their children's health outcomes. OBJECTIVE: To determine the association of parental ACEs and resilience with their child's risk of unanticipated healthcare reutilization. DESIGN, SETTING, AND PARTICIPANTS: We conducted a prospective cohort study (August 2015 to October 2016) at a tertiary, freestanding pediatric medical center in Cincinnati, Ohio. Eligible participants were English-speaking parents of children hospitalized on a Hospital Medicine or Complex Services team. A total of 1,320 parents of hospitalized children completed both the ACE questionnaire and the Brief Resilience Scale Survey. EXPOSURE: Number of ACEs and Brief Resilience Scale Score among parents. MAIN OUTCOMES: Unanticipated reutilization by children, defined as returning to the emergency room, urgent care, or being readmitted to the hospital within 30 days of hospital discharge. RESULTS: In adjusted analyses, children of parents with 4 or more ACEs had 1.69-times higher odds (95% CI, 1.11-2.60) of unanticipated reutilization after an index hospitalization, compared with children of parents with no ACEs. Resilience was not significantly associated with reutilization. CONCLUSION: Parental history of ACEs is strongly associated with higher odds of their child having unanticipated healthcare reutilization after a hospital discharge, highlighting an intergenerational effect. Screening may be an important tool for outcome prediction and intervention guidance following pediatric hospitalization.

Racial Differences in Atrial Cardiopathy Phenotypes in Ischemic Stroke Patients.

OBJECTIVE: To test the hypothesis that thrombogenic atrial cardiopathy may be relevant to stroke-related racial disparities, we compared atrial cardiopathy phenotypes between Black versus White ischemic stroke patients. METHODS: We assessed markers of atrial cardiopathy in the Greater Cincinnati/Northern Kentucky Stroke Study, a study of stroke incidence in a population of 1.3 million. We obtained ECGs and reports of echocardiograms performed during evaluation of stroke during the 2010/2015 study periods. Patients with atrial fibrillation (AF) or flutter (AFL) were excluded. Investigators blinded to patients' characteristics measured P-wave terminal force in ECG lead V1 (PTFV1), a marker of left atrial fibrosis and impaired inter-atrial conduction, and abstracted left atrial diameter from echocardiogram reports. Linear regression was used to examine the association between race and atrial cardiopathy markers after adjustment for demographics, body mass index, and vascular comorbidities. RESULTS: Among 3,426 ischemic stroke cases in Black or White patients without AF/AFL, 2,391 had a left atrial diameter measurement (mean, 3.65 ±0.70 cm). Black race was associated with smaller left atrial diameter in unadjusted (ß coefficient, -0.11; 95% CI, -0.17 to -0.05) and adjusted (ß, -0.15; 95% CI, -0.21 to -0.09) models. PTFV1 measurements were available in 3,209 patients (mean, 3,434 ±2,525 µV*ms). Black race was associated with greater PTFV1 in unadjusted (ß, 1.59; 95% CI, 1.21 to 1.97) and adjusted (ß, 1.45; 95% CI, 1.00 to 1.80) models. CONCLUSIONS: We found systematic Black-White racial differences in left atrial structure and pathophysiology in a population-based sample of ischemic stroke patients. CLASSIFICATION OF EVIDENCE: This study provides class II evidence that the rate of atrial cardiopathy is greater among Black people with acute stroke compared to White people.

Comparison of Parent Report with Administrative Data to Identify Pediatric Reutilization Following Hospital Discharge.

Healthcare providers rely on historical data reported by parents to make medical decisions. The Hospital to Home Outcomes (H2O) trial assessed the effects of a onetime home nurse visit following pediatric hospitalization for common conditions. The H2O primary outcome, reutilization (hospital readmission, emergency department visit, or urgent care visit), relied on administrative data to identify reutilization events after discharge. We sought to compare parent recall of reutilization events two weeks after discharge with administrative records. Agreement was relatively high for any reutilization (kappa 0.74); however, this high agreement was driven by agreement between sources when no reutilization occurred (sources agreed 98%-99%). Agreement between sources was lower when reutilization occurred (48%-76%). Some discrepancies were related to parents misclassifying the site of care. The possibility of inaccurate parent report of reutilization has clinical implications that may be mitigated by confirmation of parent-reported data through verification with additional sources, such as electronic health record review.

Effect of Recombinant Activated Coagulation Factor VII on Hemorrhage Expansion Among Patients With Spot Sign-Positive Acute Intracerebral Hemorrhage: The SPOTLIGHT and STOP-IT Randomized Clinical Trials.

Importance: Intracerebral hemorrhage (ICH) is a devastating stroke type that lacks effective treatments. An imaging biomarker of ICH expansion-the computed tomography (CT) angiography spot sign-may identify a subgroup that could benefit from hemostatic therapy. Objective: To investigate whether recombinant activated coagulation factor VII (rFVIIa) reduces hemorrhage expansion among patients with spot sign-positive ICH. Design, Setting, and Participants: In parallel investigator-initiated, multicenter, double-blind, placebo-controlled randomized clinical trials in Canada ("Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy [SPOTLIGHT]) and the United States (The Spot Sign for Predicting and Treating ICH Growth Study [STOP-IT]) with harmonized protocols and a preplanned individual patient-level pooled analysis, patients presenting to the emergency department with an acute primary spontaneous ICH and a spot sign on CT angiography were recruited. Data were collected from November 2010 to May 2016. Data were analyzed from November 2016 to May 2017. Interventions: Eligible patients were randomly assigned 80 µg/kg of intravenous rFVIIa or placebo as soon as possible within 6.5 hours of stroke onset. Main Outcomes and Measures: Head CT at 24 hours assessed parenchymal ICH volume expansion from baseline (primary outcome) and total (ie, parenchymal plus intraventricular) hemorrhage volume expansion (secondary outcome). The pooled analysis compared hemorrhage expansion between groups by analyzing 24-hour volumes in a linear regression model adjusted for baseline volumes, time from stroke onset to treatment, and trial. Results: Of the 69 included patients, 35 (51%) were male, and the median (interquartile range [IQR]) age was 70 (59-80) years. Baseline median (IQR) ICH volumes were 16.3 (9.6-39.2) mL in the rFVIIa group and 20.4 (8.6-32.6) mL in the placebo group. Median (IQR) time from CT to treatment was 71 (57-96) minutes, and the median (IQR) time from stroke onset to treatment was 178 (138-197) minutes. The median (IQR) increase in ICH volume from baseline to 24 hours was small in both the rFVIIa group (2.5 [0-10.2] mL) and placebo group (2.6 [0-6.6] mL). After adjustment, there was no difference between groups on measures of ICH or total hemorrhage expansion. At 90 days, 9 of 30 patients in the rFVIIa group and 13 of 34 in the placebo group had died or were severely disabled (P = .60). Conclusions and Relevance: Among patients with spot sign-positive ICH treated a median of about 3 hours from stroke onset, rFVIIa did not significantly improve radiographic or clinical outcomes. Trial Registration: ClinicalTrials.gov identifier: NCT01359202 and NCT00810888.

Parental Adverse Childhood Experiences and Resilience on Coping After Discharge.

BACKGROUND AND OBJECTIVES: Adults with a history of adverse childhood experiences (ACEs) (eg, abuse) have suboptimal health outcomes. Resilience may blunt this effect. The effect of parental ACEs (and resilience) on coping with challenges involving their children (eg, hospitalization) is unclear. We sought to quantify ACE and resilience scores for parents of hospitalized children and evaluate their associations to parental coping after discharge. METHODS: We conducted a prospective cohort study at a children's hospital (August 2015-May 2016). Eligible participants were English-speaking parents of children hospitalized on the Hospital Medicine or Complex Services team. The ACE questionnaire measured the responding parent's past adversity (ACE range: 0-10; ≥4 ACEs = high adversity). The Brief Resilience Scale (BRS) was used to measure their resilience (range: 1-5; higher is better). The primary outcome was measured by using the Post-Discharge Coping Difficulty Scale via a phone call 14 days post-discharge (range: 0-100; higher is worse). Associations were assessed by using multivariable linear regression, adjusting for parent- and patient-level covariates. RESULTS: A total of 671 (81% of eligible parents) responded. Respondents were primarily women (90%), employed (66%), and had at least a high school degree (65%); 60% of children were white, 54% were publicly insured. Sixty-four percent of parents reported ≥1 ACE; 19% had ≥4 ACEs. The mean Brief Resilience Scale score for parents was 3.95. In adjusted analyses, higher ACEs and lower resilience were significantly associated with more difficulty coping after discharge. CONCLUSIONS: More parental adversity and less resilience are associated with parental coping difficulties after discharge, representing potentially important levers for transition-focused interventions.

Effects of a 1-Time Nurse-Led Telephone Call After Pediatric Discharge: The H2O II Randomized Clinical Trial.

Importance: Families often struggle after discharge of a child from the hospital. Postdischarge challenges can lead to increased use of urgent health care services. Objective: To determine whether a single nurse-led telephone call after pediatric discharge decreased the 30-day reutilization rate for urgent care services and enhanced overall transition success. Design, Setting, and Participants: This Hospital-to-Home Outcomes (H2O) randomized clinical trial included 966 children and adolescents younger than 18 years (hereinafter referred to as children) admitted to general medicine services at a free-standing tertiary care children's hospital from May 11 through October 31, 2016. Data were analyzed as intention to treat and per protocol. Interventions: A postdischarge telephone call within 4 days of discharge compared with standard discharge. Main Outcomes and Measures: The primary outcome was the 30-day reutilization rate for urgent health care services (ie, unplanned readmission, emergency department visit, or urgent care visit). Secondary outcomes included additional utilization measures, as well as parent coping, return to normalcy, and understanding of clinical warning signs measured at 14 days. Results: A total of 966 children were enrolled and randomized (52.3% boys; median age [interquartile range], 2.4 years [0.5-7.8 years]). Of 483 children randomized to the intervention, the nurse telephone call was completed for 442 (91.5%). Children in the intervention and control arms had similar reutilization rates for 30-day urgent health care services (intervention group, 77 [15.9%]; control group, 63 [13.1%]; P = .21). Parents of children in the intervention group recalled more clinical warning signs at 14 days (mean, 1.8 [95% CI, 1.7-2.0] in the intervention group; 1.5 [95% CI, 1.4-1.6] in the control group; ratio of intervention to control, 1.2 [95% CI, 1.1-1.3]). Conclusions and Relevance: Although postdischarge nurse contact did not decrease the reutilization rate of postdischarge urgent health care services, this method shows promise to bolster postdischarge education. Trial Registration: ClinicalTrials.gov Identifier: NCT02081846.

Postdischarge Nurse Home Visits and Reuse: The Hospital to Home Outcomes (H2O) Trial.

BACKGROUND: Hospital discharge is stressful for children and families. Poor transitional care is linked to unplanned health care reuse. We evaluated the effects of a pediatric transition intervention, specifically a single nurse home visit, on postdischarge outcomes in a randomized controlled trial. METHODS: We randomly assigned 1500 children hospitalized on hospital medicine, neurology services, or neurosurgery services to receive either a single postdischarge nurse-led home visit or no visit. We excluded children discharged with skilled home nursing services. Primary outcomes included 30-day unplanned, urgent health care reuse (composite measure of unplanned readmission, emergency department, or urgent care visit). Secondary outcomes, measured at 14 days, included postdischarge parental coping, number of days until parent-reported return to normal routine, and number of "red flags" or clinical warning signs a parent or caregiver could recall. RESULTS: The 30-day reuse rate was 17.8% in the intervention group and 14.0% in the control group. In the intention-to-treat analysis, children randomly assigned to the intervention group had higher odds of 30-day health care use (odds ratio: 1.33; 95% confidence interval: 1.003-1.76). In the per protocol analysis, there were no differences in 30-day health care use (odds ratio: 1.14; confidence interval: 0.84-1.55). Postdischarge coping scores and number of days until returning to a normal routine were similar between groups. Parents in the intervention group recalled more red flags at 14 days (mean: 1.9 vs 1.6; P < .01). CONCLUSIONS: Children randomly assigned to the intervention had higher rates of 30-day postdischarge unplanned health care reuse. Parents in the intervention group recalled more clinical warning signs 2 weeks after discharge.

Optimizing a Nurse-led Transitional Home Visit Program in Preparation for a Randomized Control Trial.

INTRODUCTION: The Hospital to Home Outcomes study began with the end goal of evaluating the effectiveness of a single, nurse-led transitional home visit (home visit) program, for acutely ill, pediatric patients, which had been piloted at our institution. As part of the overall study design, building on prior randomized control trials that utilized a run-in period prior to the trial, our study team designed an optimization period to test the home visit and study procedures under real-world conditions. METHODS: For this optimization project, there were 3 process improvement goals: to improve the referral process to the home visit, to optimize the home visit content, and to define and operationalize measures of patient- and family-centered outcomes to be used in the subsequent randomized control trial. During the optimization period, a multidisciplinary study team met weekly to review family and stakeholder feedback about the iterative modifications made to the home visit process, content, and outcome measures. RESULTS: Optimization home visits were completed with 301 families across a variety of discharge diagnoses. The outcomes planned for the clinical trial were tested and refined. Feedback from families and stakeholders indicated that the content changes made to the home visits resulted in increased family knowledge of warning signs to monitor postdischarge. Thirty-one percent of families reported that they altered the care of their child after the home visit. CONCLUSION: Through iterative testing, informed by multistakeholder feedback, we leveraged patient and family engagement to maximize the effectiveness and generalizability of the home visit intervention.

Area-Level Socioeconomic Factors Are Associated With Noncompletion of Pediatric Preventive Services.

We examined 4872 infants born consecutively, 2011-2012, and seen at 3 primary care centers to determine whether area-based socioeconomic measures were associated with noncompletion of common preventive services within the first 15 months. Addresses were geocoded and linked to census tract poverty, adult educational attainment, and household vehicle ownership rates. The quartile of patients in the highest poverty (adjusted odds ratio [aOR] 1.25; 95% confidence interval [CI] 1.01-1.54) and lowest vehicle ownership tracts (aOR 1.32; 95% CI 1.07-1.63) had significantly increased odds of service noncompletion. There were significant spatial clusters of low completion in Cincinnati's urban core. These findings have implications for preventive service delivery.