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Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation. For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18–75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565. Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36–73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6–30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3–67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7–59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed. Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment. National Heart, Lung, and Blood Institute.

ABSTRACT BACKGROUND Patient activation is linked to better health outcomes and lower rates of health service utilization. The role of patient activation in the rate of hospital readmission within 30 days of hospital discharge has not been examined. METHODS A secondary analysis using data from the Project RED-LIT randomized controlled trial conducted at an urban safety net hospital. Data from 695 English-speaking general medical inpatient subjects were analyzed. We used an adapted, eight-item version of the validated Patient Activation Measure (PAM). Total scores were categorized, according to standardized methods, as one of four PAM levels of activation: Level 1 (lowest activation) through Level 4 (highest activation). The primary outcome measure was total 30-day post-discharge hospital utilization, defined as total emergency department (ED) visits plus hospital readmissions including observation stays. Poisson regression was used to control for confounding. RESULTS Of the 695 subjects, 67 (9.6 %) were PAM Level 1, 123 (17.7 %) were Level 2, 193 (27.8 %) were Level 3, and 312 (44.9 %) were Level 4. Compared with highly activated patients (PAM Level 4), a higher rate of 30-day post-discharge hospital utilization was observed for patients at lower levels of activation (PAM Level 1, incident rate ratio [IRR] 1.75, 95 % CI,1.18 to 2.60) and (PAM Level 2, IRR 1.50, 95 % CI 1.06 to 2.13). The rate of returning to the hospital among patients at PAM Level 3 was not statistically different than patients with PAM Level 4 (IRR 1.30, 95 % CI, 0.94 to 1.80). The rate ratio for PAM Level 1 was also higher compared with Level 4 for ED use alone (1.68(1.07 to 2.63)) and for hospital readmissions alone (1.93 [1.22 to 3.06]). CONCLUSION Hospitalized adult medical patients in an urban academic safety net hospital with lower levels of Patient Activation had a higher rate of post-discharge 30-day hospital utilization.

Background The purpose of this study was two-fold: (1) describe the relationship between patient or caregiver reported preparedness for care transitions, and acute care use in 30 days after discharge from a skilled nursing facility (SNF); and (2) explore how this relationship is influenced by patient, Charlson index, race and social determinants. Method The design was a secondary analysis of data collected as part of a cluster randomized trial of the Connect-Home transitional care intervention. The setting was 6 skilled nursing facilities located in the US state of North Carolina. The sample was 249 patient and caregiver dyads with acute care use data (i.e., emergency department or hospital readmission) in 30 days after transfers from SNFs to home. Preparedness for care transitions was measured with the Care Transitions Measure-15 (CTM-15), a 15 item Likert scaled measure with scores potentially ranging from 0 to 100, with higher scores indicating better preparedness. The association of preparedness and acute care use, in the overall study sample and within subgroups defined by five selected dyad background characteristics, was quantified as an incident rate ratio corresponding to the multiplicative change in the mean number of acute care use days for a 10 unit increase in CTM-15 score, using marginalized zero-inflated negative binomial regression. Results Patients had a mean age of 76.4 years, 63.8% were female, and 73.6% were White. Caregivers were female (73.6%) and adult children (42.3%). The mean CTM-15 score was 72.9 and the mean days of acute care use in 30 days after SNF discharge was 0.62. For a 10 unit increase in preparedness score, among male patients the mean number of acute care use days decreased by 33% (IRR = 0.67; 95%CI: 0.44, 0.99); White patients had a 25% reduction (IRR = 0.75; 95%CI: 0.55, 1.02), patients with low area deprivation score (lower quartile, ADI = 54) had a 31% reduction in acute care use (IRR = 0.69; 95%CI: 0.47, 1.01), and patients with a high Charlson total score (upper quartile of 9) have a 22% reduction in acute care use (IRR = 0.78; 95%CI: 0.61, 1.02). Conclusion Preparedness of care transitions is an important outcome of high-quality SNF care and is associated with reduced use of further acute care. More research is necessary to evaluate the CTM-15 as an outcome measure among sociodemographic subgroups.

BackgroundTime-sensitive alerts are among the many types of clinical notifications delivered to physicians’ secure InBaskets within commercial electronic health records (EHRs). A delayed alert review can impact patient safety and compromise care.ObjectiveTo characterize factors associated with opening of non-interruptive time-sensitive alerts delivered into primary care provider (PCP) InBaskets.Design and ParticipantsWe analyzed data for 799 automated alerts. Alerts highlighted actionable medication concerns for older patients post-hospital discharge (2010–2011). These were study-generated alerts sent 3 days post-discharge to InBaskets for 75 PCPs across a multisite healthcare system, and represent a subset of all urgent InBasket notifications.Main MeasuresUsing EHR access and audit logs to track alert opening, we performed bivariate and multivariate analyses calculating associations between patient characteristics, provider characteristics, contextual factors at the time of alert delivery (number of InBasket notifications, weekday), and alert opening within 24 h.Key ResultsAt the time of alert delivery, the PCPs had a median of 69 InBasket notifications and had received a median of 379.8 notifications (IQR 295.0, 492.0) over the prior 7 days. Of the 799 alerts, 47.1% were opened within 24 h. Patients with longer hospital stays (>4 days) were marginally more likely to have alerts opened (OR 1.48 [95% CI 1.00–2.19]). Alerts delivered to PCPs whose InBaskets had a higher number of notifications at the time of alert delivery were significantly less likely to be opened within 24 h (top quartile >157 notifications: OR 0.34 [95% CI 0.18–0.61]; reference bottom quartile ≤42). Alerts delivered on Saturdays were also less likely to be opened within 24 h (OR 0.18 [CI 0.08–0.39]).ConclusionsThe number of total InBasket notifications and weekend delivery may impact the opening of time-sensitive EHR alerts. Further study is needed to support safe and effective approaches to care team management of InBasket notifications.

BackgroundFollow-up of tests pending at discharge (TPADs) is poor. We previously demonstrated a twofold increase in awareness of any TPAD by attendings and primary care physicians (PCPs) using an automated email interventionObjectiveTo determine whether automated notification improves documented follow-up for actionable TPADsDesignCluster-randomized controlled trialSubjectsAttendings and PCPs caring for adult patients discharged from general medicine and cardiology services with at least one actionable TPAD between June 2011 and May 2012InterventionAn automated system that notifies discharging attendings and network PCPs of finalized TPADs by emailMain MeasuresThe primary outcome was the proportion of actionable TPADs with documented action determined by independent physician review of the electronic health record (EHR). Secondary outcomes included documented acknowledgment, 30-day readmissions, and adjusted median days to documented follow-up.Key ResultsOf the 3378 TPADs sampled, 253 (7.5%) were determined to be actionable by physician review. Of these, 150 (123 patients discharged by 53 attendings) and 103 (90 patients discharged by 44 attendings) were assigned to intervention and usual care groups, respectively, and underwent chart review. The proportion of actionable TPADs with documented action was 60.7 vs. 56.3% (p = 0.82) in the intervention vs. usual care groups, similar for documented acknowledgment. The proportion of patients with actionable TPADs readmitted within 30 days was 22.8 vs. 31.1% in the intervention vs. usual care groups (p = 0.24). The adjusted median days [95% CI] to documented action was 9 [6.2, 11.8] vs. 14 [10.2, 17.8] (p = 0.04) in the intervention vs. usual care groups, similar for documented acknowledgment. In sub-group analysis, the intervention had greater impact on documented action for patients with network PCPs compared with usual care (70 vs. 50%, p = 0.03).ConclusionsAutomated notification of actionable TPADs shortened time to action but did not significantly improve documented follow-up, except for network-affiliated patients. The high proportion of actionable TPADs without any documented follow-up (~ 40%) represents an ongoing safety concern.Clinical Trials IdentifierNCT01153451

Smokers with coronary heart disease (CHD) benefit from in-hospital cessation treatment, but relapse is common without ongoing support postdischarge. The purpose of this study was to determine if smoking abstinence would be higher after hospital discharge in smokers who received automated telephone follow-up (ATF) and nurse-counseling, compared with a standard care (SC) control group. A total of 440 smokers hospitalized with CHD were randomly assigned to the ATF group (n = 216) or to the SC group (n = 224). Participants in the ATF group received automated phone calls 3, 14, 30, 60, 90, 120, 150, and 180 days after hospital discharge. The ATF system posed questions concerning smoking status, confidence in staying smoke-free, and need for assistance. If flagged by the ATF system, a nurse-counselor provided additional counseling by phone. Self-reported continuous smoking abstinence was assessed 26 and 52 weeks postdischarge using intention-to-treat analysis. The main outcome measure was continuous abstinence for weeks 1-26 postdischarge. Participants in the ATF group achieved higher abstinence rates for weeks 1-26 than those in the SC group (odds ratio [OR] = 1.53, 95% confidence interval [CI] = 1.01 to 2.33). There was no significant difference between groups in abstinence rates for weeks 27-52 (OR = 1.37; 95% CI = 0.89 to 2.09). ATF-mediated follow-up helped smokers with CHD achieve abstinence during the intervention period. There was a trend toward clinically important improvements for weeks 27-52; but between-group differences for this time point did not achieve statistical significance. NCT00449852. Automated telephone follow-up exerts its effect by reinforcing participants' efforts to be smoke-free and by proactively linking people requiring assistance to individualized support (eg, telephone counseling). This study shows that automated telephone follow-up can assist smokers with CHD in remaining smoke-free; however, the success of automated telephone follow-up is limited to the treatment period and abstinence rates after the treatment period were not statistically different from among those receiving standard care. Extended treatment via automated telephone follow-up may provide a solution to extend cessation assistance beyond hospital discharge.

BackgroundCessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation.ObjectiveTo compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation.DesignUnblinded, randomized clinical trialParticipantsHospitalized smokers referred from primarily rural hospitalsInterventionsCounseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker’s health care team and help for the smoker in obtaining pharmacotherapy. At 6 months post-hospitalization, persistent smokers were re-engaged with either CCC or C.Main MeasuresUtilization of pharmacotherapy and smoking cessation at 3, 6, and 12 months post-discharge.Key ResultsAmong 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6 months (55.2%) and between 6 and 12 months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6–12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12 months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)).ConclusionSupplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6 months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications.Trial RegistrationNCT01063972

Background Clinical pharmacists can play an important role in chronic diseases management, but limited attention has been given to the pharmaceutical care of nephrotic syndrome patients. Objective To evaluate the impact of inpatient pharmaceutical care on medication adherence and clinical outcomes in nephrotic syndrome patients. Setting A tertiary first-class hospital in Shanxi, China. Method We conducted a randomized controlled trial on 61 patients with nephrotic syndrome. The intervention consisted of medication reconciliation, pharmacist visits every day, discharge counseling and education by 2 certificated pharmacist, while the control group received usual care. Assessments were performed at baseline, month-1, month-3 and month-6 after hospital discharge. Main outcome measure medication adherence and patients’ clinical outcomes. Results 61 patient completed the trial. Baseline variables were comparable between the two groups. The decline in medication adherence of patients in the intervention group after hospital discharge was restrained effectively at month-6 (p < 0.05). However, the groups did not differ in clinical outcomes, medication discrepancies, adverse drug events and readmission rate. The rate of return visits of the pharmaceutical care group was higher at month-1 and month-6 after discharge (p < 0.05). Conclusion Pharmaceutical inpatient care improved adherence in patients with nephrotic syndrome after hospital discharge, the effect of the intervention on clinical outcomes, medication discrepancies, adverse drug events or readmission was insignificant. These results are promising but should be tested in other settings prior to broader dissemination.

Persons with a mental disorder smoke at higher rates and suffer disproportionate tobacco-related burden compared with the general population. The aim of this study was to determine if a smoking cessation intervention initiated during a psychiatric hospitalization and continued postdischarge was effective in reducing smoking behaviors among persons with a mental disorder. A randomized controlled trial was conducted at an Australian inpatient psychiatric facility. Participants were 205 patient smokers allocated to a treatment as usual control (n = 101) or a smoking cessation intervention (n = 104) incorporating psychosocial and pharmacological support for 4 months postdischarge. Follow-up assessments were conducted at 1 week, 2, 4, and 6 months postdischarge and included abstinence from cigarettes, quit attempts, daily cigarette consumption, and nicotine dependence. Rates of continuous and 7-day point prevalence abstinence did not differ between treatment conditions at the 6-month follow-up; however, point prevalence abstinence was significantly higher for intervention (11.5%) compared with control (2%) participants at 4 months (OR = 6.46, p = .01). Participants in the intervention condition reported significantly more quit attempts (F[1, 202.5] = 15.23, p = .0001), lower daily cigarette consumption (F[4, 586] = 6.5, p < .001), and lower levels of nicotine dependence (F[3, 406] = 8.5, p < .0001) compared with controls at all follow-up assessments. Postdischarge cessation support was effective in encouraging quit attempts and reducing cigarette consumption up to 6 months postdischarge. Additional support strategies are required to facilitate longer-term cessation benefits for smokers with a mental disorder.

Abstract Aims In addition to giving optimal medical and device therapy, promoting self-care of chronic heart failure (CHF) patients also plays an important role in comprehensive disease management for better outcomes. The study was aimed to investigate whether short message service (SMS) would help to improve death or readmission-free survival and self-care behaviour in CHF patients. Methods and results This was a randomized controlled trial. Between December 2011 and September 2015, patients admitted with decompensated CHF in a tertiary referral hospital who fulfilled the inclusion criteria were enrolled and randomized to receive SMS, structured telephone support (STS), or usual care after discharge. All patients were followed up to 180 days after discharge by phone call or clinic visit. Primary endpoint was the 180 day composite event, defined as all-cause mortality or readmission. Secondary endpoints included self-care behaviour and quality of life. Seven hundred sixty-seven patients (61 ± 15 years, 56.5% male) were finally randomized to receive SMS (n = 252), STS (n = 255), or usual care (n = 260). Baseline characteristics were similar among the three groups. Five hundred twenty-five (68.4%) patients were in New York Heart Association Class III or IV, and 472 (61.5%) patients had an ejection fraction of <50%. During a 180 day follow-up, 76 (9.9%) patients died and 274 (35.7%) patients experienced at least one readmission. In a short-term follow-up of 30 days, there was no difference in mortality and the composite endpoint among the three groups (SMS vs. STS vs. usual care: 2.8% vs. 3.1% vs. 3.8% for mortality, P = 0.786; 12.3% vs. 14.5% vs. 15.4% for the composite endpoint, P = 0.588). The 180 day composite event rate was significantly lower in the SMS and STS groups (50.4% vs. 41.3% and 36.5%, both P < 0.05) than in the usual care group, but no difference was observed between the two phone-based intervention groups (P = 0.268). Although there was no difference between the two groups, better self-care behaviour was reported in the SMS and STS groups than in the control group (medication compliance, 78.9% vs. 81.4% vs. 69.5%, P = 0.011; water restriction, 70.8% vs. 74.5% vs. 61.5%, P = 0.013). Quality-of-life score was similar among the three groups at 180 days (P = 0.526). Conclusions In CHF patients, post-discharge SMS, which appeared as efficient as STS, reduced the 180 day composite event and improved self-care behaviour. SMS intervention could be integrated into CHF management.