Feasibility of the TARGET-EFT trial in frail and pre-frail cardiovascular inpatients

Hospitalization for cardiovascular disease (CVD) may be complicated by hospital-acquired disability (HAD) and subsequently poor health-related quality of life (HRQOL). While frailty has been shown to be a risk factor, it has yet to be studied as a therapeutic target to improve outcomes. This trial sought to determine the effects of an in-hospital multicomponent intervention targeting physical weakness, cognitive impairment, malnutrition, and anemia on patient-centered outcomes compared to usual care. A single-center parallel-group randomized clinical trial was conducted in older patients with acute CVD and evidence of frailty or pre-frailty as measured by the Essential Frailty Toolset (EFT). Patients were randomized to usual care or a multicomponent intervention. Outcomes were HRQOL (EQ-5D-5L score) and disability (Older Americans Resources and Services score) at 30 days post-discharge and mood disturbances (Hospital Anxiety and Depression Scale) at discharge. The trial cohort consisted of 142 patients with a mean age of 79.5 years and 55% females. The primary diagnosis was heart failure in 29%, valvular heart disease in 28%, ischemic heart disease in 14%, arrhythmia in 11%, and other CVDs in 18%. The intervention improved HRQOL scores (coefficient 0.08; 95% CI 0.01, 0.15; p=0.03) and mood scores (coefficient -1.95; 95% CI -3.82, -0.09; p=0.04) but not disability scores (coefficient 0.18; 95% CI -1.44, 1.81; p=0.82). There were no intervention-related adverse events. In frail older patients hospitalized for acute CVDs, an in-hospital multicomponent intervention targeted to frailty was safe and led to modest yet clinically meaningful improvements in HRQOL and mental well-being. The downstream impact of these effects on event-free survival and functional status remains to be evaluated in future research, as does the generalizability to other healthcare systems. NCT04291690.

Frailty is disproportionately prevalent in cardiovascular disease patients and exacerbated during hospital admissions, heightening the risk for adverse events and functional decline. Using the Essential Frailty Toolset (EFT) to target physical weakness, cognitive impairment, malnourishment, and anaemia, we tested a multicomponent targeted intervention to de-frail older adults with acute cardiovascular conditions during their hospital admission. The TARGET-EFT trial was a single-center randomized clinical trial at the Jewish General Hospital, Montreal, Canada. We compared a multicomponent de-frailing intervention with usual clinical care. Intervention group patients received exercise, cognitive stimulation, protein supplementation, and iron replacement, as required. In this study, the primary outcome was frailty, as assessed by the SPPB score (Short Physical Performance Battery) at discharge, and the secondary outcome was the SARC-F score (Strength, Assistance walking, Rising from chair, Climbing, Falls) assessed 30 days later. The analysis consisted of 135 patients (mean age of 79.3 years; 54% female) who survived and completed the frailty assessments.Compared with control patients, intervention group patients had a 1.52-point superior SPPB score and a 0.74-point superior SARC-F score. Subgroup analysis suggested that patients with low left ventricular ejection fraction may have attenuated benefits, and that patients who underwent invasive cardiac procedures had the greatest benefits from the intervention. We achieved our objective of de-frailing older cardiac inpatients on a short-term basis by improving their physical performance and functioning using a pragmatic multicomponent intervention. This could have positive impacts on their clinical outcomes and ability to maintain independent living in the future. The multicomponent intervention targeted to the deficits of vulnerable older adults hospitalized with acute cardiovascular diseases successfully de-frailed them on a short-term basis, which can have positive implications on their post-discharge health outcomes.

Postoperative pneumonia and delayed physical recovery are significant problems after emergency laparotomy. No randomized controlled trial has assessed the feasibility, safety, or effectiveness of intensive postoperative physical therapy in this high-risk acute population. The internal pilot phase of the Incidence of Complications after Emergency Abdominal Surgery: Get Exercising (ICEAGE) trial was a prospective, randomized controlled trial that evaluated the feasibility, safety, and clinical trial processes of providing intensive physical therapy immediately following emergency laparotomy. Fifty consecutive patients were recruited at the principal participating hospital and randomly assigned to standard-care or intensive physical therapy of twice daily coached breathing exercises for 2 days and 30 minutes of daily supervised rehabilitation over the first 5 postoperative days. Interventions were provided exactly as per protocol in 35% (78 of 221 patients) of planned treatment sessions. Main barriers to protocol delivery were physical therapist unavailability on weekends (59 of 221 patients [27%]), awaiting patient consent (18 of 99 patients [18%]), and patient fatigue (26 of 221 patients [12%]). Despite inhibitors to treatment delivery, the intervention group still received twice as many breathing exercise sessions and four times the amount of physical therapy over the first 5 postoperative days (23 minutes [interquartile range, 12-29 minutes] vs. 86 minutes [interquartile range, 53-121 minutes]; p < 0.001). One adverse event was reported from 78 rehabilitation sessions (1.3%), which resolved fully on cessation of activity without escalation of medical care. Intensive postoperative physical therapy can be delivered safely and successfully to patients in the first week after emergency laparotomy. The ICEAGE trial protocol resulted in intervention group participants receiving more coached breathing exercises and spending significantly more time physically active over the first 5 days after surgery compared with standard care. It was therefore recommended to progress into the multicenter phase of ICEAGE to definitively test the effect of intensive physical therapy to prevent pneumonia and improve physical recovery after emergency laparotomy. Therapeutic/Care Management; Level II.

Erratum

Readmission to the hospital within 30 days of discharge is used as a surrogate marker for quality and value of care in the United States (US) healthcare system. Concern exists regarding the value of 30-day readmission as a quality of care metric in neurosurgical patients. Few studies have assessed 30-day readmission rates in neurosurgical patients outside the US. The authors performed a retrospective review of all adult neurosurgical patients admitted to a single Canadian neurosurgical academic center and who were discharged to home to assess for the all-cause 30-day readmission rate, unplanned 30-day readmission rate, and avoidable 30-day readmission rate. A retrospective review was performed assessing 30-day readmission rates after discharge to home in all neurosurgical patients admitted to a single academic neurosurgical center from January 1, 2011, to December 31, 2011. The primary outcomes included rates of all-cause, unplanned, and avoidable readmissions within 30 days of discharge. Secondary outcomes included factors associated with unplanned and avoidable 30-day readmissions. A total of 184 of 950 patients (19.4%) were readmitted to the hospital within 30 days of discharge. One-hundred three patients (10.8%) were readmitted for an unplanned reason and 81 (8.5%) were readmitted for a planned or rescheduled operation. Only 19 readmissions (10%) were for a potentially avoidable reason. Univariate analysis identified factors associated with readmission for a complication or persistent/worsening symptom, including age (p = 0.009), length of stay (p = 0.007), general neurosurgery diagnosis (p < 0.001), cranial pathology (p < 0.001), intensive care unit (ICU) admission (p < 0.001), number of initial admission operations (p = 0.01), and shunt procedures (p < 0.001). Multivariate analysis identified predictive factors of readmission, including diagnosis (p = 0.002, OR 2.4, 95% CI 1.4-5.3), cranial pathology (p = 0.002, OR 2.7, 95% CI 1.4-5.3), ICU admission (p = 0.004, OR 2.4, 95% CI 1.3-4.2), and number of first admission operations (p = 0.01, OR 0.51, 95% CI 0.3-0.87). Univariate analysis performed to identify factors associated with potentially avoidable readmissions included length of stay (p = 0.03), diagnosis (p < 0.001), cranial pathology (p = 0.02), and shunt procedures (p < 0.001). Multivariate analysis identified only shunt procedures as a predictive factor for avoidable readmission (p = 0.02, OR 5.6, 95% CI 1.4-22.8). Almost one-fifth of neurosurgical patients were readmitted within 30 days of discharge. However, only about half of these patients were admitted for an unplanned reason, and only 10% of all readmissions were potentially avoidable. This study demonstrates unique challenges encountered in a publicly funded healthcare setting and supports the growing literature suggesting 30-day readmission rates may serve as an inappropriate quality of care metric in neurosurgical patients. Potentially avoidable readmissions can be predicted, and further research assessing predictors of avoidable readmissions is warranted.

BackgroundCollaboration is vital within health care institutions, and it allows for the effective use of collective health care worker (HCW) expertise. Human-computer interactions involving electronic health records (EHRs) have become pervasive and act as an avenue for quantifying these collaborations using statistical and network analysis methods.ObjectiveWe aimed to measure HCW collaboration and its characteristics by analyzing concurrent EHR usage.MethodsBy extracting concurrent EHR usage events from audit log data, we defined concurrent sessions. For each HCW, we established a metric called concurrent intensity, which was the proportion of EHR activities in concurrent sessions over all EHR activities. Statistical models were used to test the differences in the concurrent intensity between HCWs. For each patient visit, starting from admission to discharge, we measured concurrent EHR usage across all HCWs, which we called temporal patterns. Again, we applied statistical models to test the differences in temporal patterns of the admission, discharge, and intermediate days of hospital stay between weekdays and weekends. Network analysis was leveraged to measure collaborative relationships among HCWs. We surveyed experts to determine if they could distinguish collaborative relationships between high and low likelihood categories derived from concurrent EHR usage. Clustering was used to aggregate concurrent activities to describe concurrent sessions. We gathered 4 months of EHR audit log data from a large academic medical center’s neonatal intensive care unit (NICU) to validate the effectiveness of our framework.ResultsThere was a significant difference (P<.001) in the concurrent intensity (proportion of concurrent activities: ranging from mean 0.07, 95% CI 0.06-0.08, to mean 0.36, 95% CI 0.18-0.54; proportion of time spent on concurrent activities: ranging from mean 0.32, 95% CI 0.20-0.44, to mean 0.76, 95% CI 0.51-1.00) between the top 13 HCW specialties who had the largest amount of time spent in EHRs. Temporal patterns between weekday and weekend periods were significantly different on admission (number of concurrent intervals per hour: 11.60 vs 0.54; P<.001) and discharge days (4.72 vs 1.54; P<.001), but not during intermediate days of hospital stay. Neonatal nurses, fellows, frontline providers, neonatologists, consultants, respiratory therapists, and ancillary and support staff had collaborative relationships. NICU professionals could distinguish high likelihood collaborative relationships from low ones at significant rates (3.54, 95% CI 3.31-4.37 vs 2.64, 95% CI 2.46-3.29; P<.001). We identified 50 clusters of concurrent activities. Over 87% of concurrent sessions could be described by a single cluster, with the remaining 13% of sessions comprising multiple clusters.ConclusionsLeveraging concurrent EHR usage workflow through audit logs to analyze HCW collaboration may improve our understanding of collaborative patient care. HCW collaboration using EHRs could potentially influence the quality of patient care, discharge timeliness, and clinician workload, stress, or burnout.

Identifying older emergency department (ED) patients with clinical features associated with adverse postdischarge outcomes may lead to improved clinical reasoning and better targeting for preventative interventions. Previous studies have used single-country samples to identify limited sets of determinants for a limited number of proxy outcomes. The objective of this study was to identify and compare geriatric syndromes that influence the probability of postdischarge outcomes among older ED patients from a multinational context. A multinational prospective cohort study of ED patients aged 75 years or older was conducted. A total of 13 ED sites from Australia, Belgium, Canada, Germany, Iceland, India, and Sweden participated. Patients who were expected to die within 24 hours or did not speak the native language were excluded. Of the 2,475 patients approached for inclusion, 2,282 (92.2%) were enrolled. Patients were assessed at ED admission with the interRAI ED Contact Assessment, a geriatric ED assessment. Outcomes were examined for patients admitted to a hospital ward (62.9%, n=1,436) or discharged to a community setting (34.0%, n=775) after an ED visit. Overall, 3% of patients were lost to follow-up. Hospital length of stay (LOS) and discharge to higher level of care was recorded for patients admitted to a hospital ward. Any ED or hospital use within 28 days of discharge was recorded for patients discharged to a community setting. Unadjusted and adjusted odds ratios (ORs) were used to describe determinants using standard and multilevel logistic regression. A multi-country model including living alone (OR=1.78, p≤0.01), informal caregiver distress (OR=1.69, p=0.02), deficits in ambulation (OR=1.94, p≤0.01), poor self-report (OR = 1.84, p≤0.01), and traumatic injury (OR=2.18, p≤0.01) best described older patients at risk of longer hospital lengths of stay. A model including recent ED visits (OR=2.10, p≤0.01), baseline functional impairment (OR=1.68, p≤0.01), and anhedonia (OR=1.73, p≤0.01) best described older patients at risk of proximate repeat hospital use. A sufficiently accurate and generalizable model to describe the risk of discharge to higher levels of care among admitted patients was not achieved. Despite markedly different health care systems, the probability of long hospital lengths of stay and repeat hospital use among older ED patients is detectable at the multinational level with moderate accuracy. This study demonstrates the potential utility of incorporating common geriatric clinical features in routine clinical examination and disposition planning for older patients in EDs.

Early Initiation of Physical Therapy While on Extracorporeal Life Support Improves Patients’ Functional Activity on Discharge

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Meta-analyses have suggested that initiating pulmonary rehabilitation after an exacerbation of chronic obstructive pulmonary disease (COPD) was associated with improved survival, although the number of patients studied was small and heterogeneity was high. Current guidelines recommend that patients enroll in pulmonary rehabilitation after hospital discharge. To determine the association between the initiation of pulmonary rehabilitation within 90 days of hospital discharge and 1-year survival. This retrospective, inception cohort study used claims data from fee-for-service Medicare beneficiaries hospitalized for COPD in 2014, at 4446 acute care hospitals in the US. The final date of follow-up was December 31, 2015. Initiation of pulmonary rehabilitation within 90 days of hospital discharge. The primary outcome was all-cause mortality at 1 year. Time from discharge to death was modeled using Cox regression with time-varying exposure to pulmonary rehabilitation, adjusting for mortality and for unbalanced characteristics and propensity to initiate pulmonary rehabilitation. Additional analyses evaluated the association between timing of pulmonary rehabilitation and mortality and between number of sessions completed and mortality. Of 197 376 patients (mean age, 76.9 years; 115 690 [58.6%] women), 2721 (1.5%) initiated pulmonary rehabilitation within 90 days of discharge. A total of 38 302 (19.4%) died within 1 year of discharge, including 7.3% of patients who initiated pulmonary rehabilitation within 90 days and 19.6% of patients who initiated pulmonary rehabilitation after 90 days or not at all. Initiation within 90 days was significantly associated with lower risk of death over 1 year (absolute risk difference [ARD], -6.7% [95% CI, -7.9% to -5.6%]; hazard ratio [HR], 0.63 [95% CI, 0.57 to 0.69]; P < .001). Initiation of pulmonary rehabilitation was significantly associated with lower mortality across start dates ranging from 30 days or less (ARD, -4.6% [95% CI, -5.9% to -3.2%]; HR, 0.74 [95% CI, 0.67 to 0.82]; P < .001) to 61 to 90 days after discharge (ARD, -11.1% [95% CI, -13.2% to -8.4%]; HR, 0.40 [95% CI, 0.30 to 0.54]; P < .001). Every 3 additional sessions was significantly associated with lower risk of death (HR, 0.91 [95% CI, 0.85 to 0.98]; P = .01). Among fee-for-service Medicare beneficiaries hospitalized for COPD, initiation of pulmonary rehabilitation within 3 months of discharge was significantly associated with lower risk of mortality at 1 year. These findings support current guideline recommendations for pulmonary rehabilitation after hospitalization for COPD, although the potential for residual confounding exists and further research is needed.

BackgroundNatural health products (NHP) use may have implications with respect to adverse effects, drug interactions and adherence yet the prevalence of NHP use by patients with acute cardiovascular disease and the best method to ascertain this information is unknown.ObjectiveTo identify the best method to ascertain information on NHP, and the prevalence of use in a population with acute cardiovascular disease.MethodsStructured interviews were conducted with a convenience sample of consecutive patients admitted with acute cardiovascular disease to the University of Alberta Hospital during January 2009. NHP use was explored using structured and open-ended questions based on Health Canada's definition of NHP. The medical record was reviewed, and documentation of NHP use by physicians, nurses, and pharmacists, compared against the gold-standard structured interview.Results88 patients were interviewed (mean age 62 years, standard deviation [SD 14]; 80% male; 41% admitted for acute coronary syndromes). Common co-morbidities included hypertension (59%), diabetes (26%) and renal impairment (19%). NHP use was common (78% of patients) and 75% of NHP users reported daily use. The category of NHP most commonly used was vitamins and minerals (73%) followed by herbal products (20%), traditional medicines including Chinese medicines (9%), homeopathic preparations (1%) and other products including amino acids, essential fatty acids and probiotics (35%). In a multivariable model, only older age was associated with increased NHP use (OR 1.5 per age decile [95%CI 1.03 to 2.2]). When compared to the interview, the highest rate of NHP documentation was the pharmacist history (41%). NHP were documented in 22% of patients by the physician and 19% by the nurse.ConclusionsNHP use is common in patients admitted with acute cardiovascular disease. However, health professionals do not commonly identify NHP as part of the medication profile despite its potential importance. Structured interview appears to be the best method to accurately identify patient use of NHP.

MOON-AAA GCP clinical trial: early lessons from an early interventional trial in patients within 1 week after ACL tear

BackgroundDisfigurement (visible difference) from wide-ranging congenital or acquired conditions, injuries, or treatments can negatively impact adolescents’ psychological well-being, education and health behaviours. Alongside medical interventions, appearance-specific cognitive behavioural and social skills training to manage stigma and appearance anxiety may improve psychosocial outcomes. YP Face IT (YPF), is a Web-based seven session self-help program plus booster quiz, utilising cognitive behavioural and social skills training for young people (YP) struggling with a visible difference. Co-designed by adolescents and psychologists, it includes interactive multimedia and automated reminders to complete sessions/homework. Adolescents access YPF via a health professional who determines its suitability and remotely monitors clients’ usage.ObjectiveTo establish the feasibility of evaluating YPF for 12-17 year olds self-reporting appearance-related distress and/or bullying associated with a visible difference.MethodsRandomized controlled trial with nested qualitative and economic study evaluating YPF compared with usual care (UC). Feasibility outcomes included: viability of recruiting via general practitioner (GP) practices (face to face and via patient databases) and charity advertisements; intervention acceptability and adherence; feasibility of study and data collection methods; and health professionals’ ability to monitor users’ online data for safeguarding issues. Primary psychosocial self-reported outcomes collected online at baseline, 13, 26, and 52 weeks were as follows: appearance satisfaction (Appearance Subscale from Mendleson et al’s (2001) Body Esteem Scale); social anxiety (La Greca’s (1999) Social Anxiety Scale for Adolescents). Secondary outcomes were; self-esteem; romantic concerns; perceived stigmatization; social skills and healthcare usage. Participants were randomised using remote Web-based allocation.ResultsThirteen charities advertised the study yielding 11 recruits, 13 primary care practices sent 687 invitations to patients on their databases with a known visible difference yielding 17 recruits (2.5% response rate), 4 recruits came from GP consultations. Recruitment was challenging, therefore four additional practices mass-mailed 3,306 generic invitations to all 12-17 year old patients yielding a further 15 participants (0.5% response rate). Forty-seven YP with a range of socioeconomic backgrounds and conditions were randomised (26% male, 91% white, mean age 14 years (SD 1.7)); 23 to YPF, 24 to UC). At 52 weeks, 16 (70%) in the intervention and 20 (83%) in UC groups completed assessments. There were no intervention-related adverse events; most found YPF acceptable with three withdrawing because they judged it was for higher-level concerns; 12 (52%) completed seven sessions. The study design was acceptable and feasible, with multiple recruitment strategies. Preliminary findings indicate no changes from baseline in outcome measures among the UC group and positive changes in appearance satisfaction and fear of negative evaluation among the YPF group when factoring in baseline scores and intervention adherence.ConclusionsYPF is novel, safe and potentially helpful. Its full psychosocial benefits should be evaluated in a large-scale RCT, which would be feasible with wide-ranging recruitment strategies.Trial RegistrationISRCTN registry ISRCTN40650639; http://www.isrctn.com/ISRCTN40650639

This lecture focuses on the regulatory framework and legal practices regarding provision of medical care without the consent of the patient or their legal representative. It discusses the grounds for delivering medical care in the absence of consent and provides a procedural algorithm for healthcare professionals to follow in such situations, as well as in cases where a patient refuses medical intervention. The lecture also highlights the documentation requirements for instances of medical care provided without consent and cases of patient (or legal representative) refusal of medical intervention.

Background: The short-term safety and long-term cardiovascular benefits of initiating new antihyperglycemic medications at hospital discharge are unclear, especially for elderly patients with acute cardiovascular disease. This study aimed to determine if initiation of a new diabetes medication is associated with differences in outcomes in this patient population. Methods: This was a population-based cohort study of individuals ≥65 years with diabetes on antihyperglycemic medication who were discharged from a hospitalization for heart failure, acute myocardial infarction, or stroke in Ontario, Canada from April 2011 to March 2019. We categorized individuals based on initiation of a new diabetes medication (initiators) within 30 days of discharge. Primary outcome was a composite of death or cardiovascular hospitalization. Secondary outcome was rate of hypoglycemia. We performed a Cox-regression on a propensity matched cohort. Results: A total of 54,117 individuals were included, with 5,129 (9.5%) initiators and 48,988 (90.5%) non-initiators. Median age was 78 years (IQR 71-84) and 56.7% were male. Matched pair analysis included 4,844 pairs of initiators and non-initiators with standardized differences of ≤0.05 for all baseline variables. Median follow-up was near 2.2 years in both groups. There were no significant differences in the hazard of the composite of death/cardiovascular hospitalization (HR 0.97, 95% CI 0.92-1.02, p=0.18) or the hazard of death (HR 0.98, 95% CI 0.93-1.04, p=0.56). There was a higher risk of hypoglycemia among initiators (113 [2.3%] vs 76 [1.6%]) within one year of follow-up (HR: 1.49, 95% CI 1.12-1.98, p=0.007). Conclusion: Starting a new antihyperglycemic medication in patients with diabetes who are discharged after hospitalization for a cardiovascular event is associated with an increased risk of hypoglycemia but does not reduce mortality or cardiovascular events. Disclosure A.Farahvash: None. A.Sivaswamy: None. H.Abdel-qadir: Other Relationship; AstraZeneca, JAZZ Pharmaceuticals. I.C.Lega: None.