Self-Management Support Using Advertising Principles for Older Adults With Low Income at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: Self-management education and support (SMES) interventions have modest effects on intermediate outcomes for those at risk of cardiovascular disease, but few studies have measured or demonstrated an effect on clinical end points. Advertising for commercial products is known to influence behavior, but advertising principles are not typically incorporated into SMES design. METHODS: This randomized trial studied the effect of a novel tailored SMES program designed by an advertising firm among a population of older adults with low income at high cardiovascular risk in Alberta, Canada. The intervention included health promotion messaging from a fictitious "peer" and facilitated relay of clinical information to patients' primary care provider and pharmacist. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and hospitalizations for cardiovascular-related ambulatory care-sensitive conditions. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (EQ-5D [EuroQoL 5-dimension] index score), medication adherence, and overall health care costs. RESULTS: We randomized 4761 individuals, with a mean age of 74.4 years, of whom 46.8% were female. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. Over a median follow-up time of 36 months, the rate of the primary outcome was lower in the group that received SMES compared with the control group (incidence rate ratio, 0.78 [95% CI, 0.61 to 1.00]; P=0.047). No significant between-group changes in quality of life over time were observed (mean difference, 0.0001 [95% CI, -0.018 to 0.018]; P=0.99). The proportion of participants who were adherent to medications was not different between the 2 groups (P=0.199 for statins and P=0.754 for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Overall adjusted health care costs did not differ between those receiving SMES and the control group ($2015 [95% CI, -$1953 to $5985]; P=0.320). CONCLUSIONS: For older adults with low income, a tailored SMES program using advertising principles reduced the rate of clinical outcomes compared with usual care. The mechanisms of improvement are unclear and further studies are required. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled Trial.

BACKGROUND: One in eight people with heart disease has poor medication adherence that, in part, is related to copayment costs. This study tested whether eliminating copayments for high-value medications among low-income older adults at high cardiovascular risk would improve clinical outcomes. METHODS: This randomized 2×2 factorial trial studied 2 distinct interventions in Alberta, Canada: eliminating copayments for high-value preventive medications and a self-management education and support program (reported separately). The findings for the first intervention, which waived the usual 30% copayment on 15 medication classes commonly used to reduce cardiovascular events, compared with usual copayment, is reported here. The primary outcome was the composite of death, myocardial infarction, stroke, coronary revascularization, and cardiovascular-related hospitalizations over a 3-year follow-up. Rates of the primary outcome and its components were compared using negative binomial regression. Secondary outcomes included quality of life (Euroqol 5-dimension index score), medication adherence, and overall health care costs. RESULTS: A total of 4761 individuals were randomized and followed for a median of 36 months. There was no evidence of statistical interaction (P=0.99) or of a synergistic effect between the 2 interventions in the factorial trial with respect to the primary outcome, which allowed us to evaluate the effect of each intervention separately. The rate of the primary outcome was not reduced by copayment elimination, (521 versus 533 events, incidence rate ratio 0.84 [95% CI, 0.66-1.07], P=0.162). The incidence rate ratio for nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death (0.97 [95% CI, 0.67-1.39]), death (0.94 [95% CI, 0.80 to 1.11]), and cardiovascular-related hospitalizations (0.78 [95% CI, 0.57 to 1.06]) did not differ between groups. No significant between-group changes in quality of life over time were observed (mean difference, 0.012 [95% CI, -0.006 to 0.030], P=0.19). The proportion of participants who were adherent to statins was 0.72 versus 0.69 for the copayment elimination versus usual copayment groups, respectively (mean difference, 0.03 [95% CI, 0.006-0.06], P=0.016). Overall adjusted health care costs did not differ ($3575 [95% CI, -605 to 7168], P=0.098). CONCLUSIONS: In low-income adults at high cardiovascular risk, eliminating copayments (average, $35/mo) did not improve clinical outcomes or reduce health care costs, despite a modest improvement in adherence to medications. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02579655.

The impact of the COVID-19 pandemic on transfers between long-term care and emergency departments across Alberta.

BACKGROUND: Long-term care (LTC) was overwhelmingly impacted by COVID-19 and unnecessary transfer to emergency departments (ED) can have negative health outcomes. This study aimed to explore how the COVID-19 pandemic impacted LTC to ED transfers and hospitalizations, utilization of community paramedics and facilitated conversations between LTC and ED physicians during the first four waves of the pandemic in Alberta, Canada. METHODS: In this retrospective population-based study, administrative databases were linked to identify episodes of care for LTC residents who resided in facilities in Alberta, Canada. This study included data from January 1, 2018 to December 31, 2021 to capture outcomes prior to the onset of the pandemic and across the first four waves. Individuals were included if they visited an emergency department, received care from a community paramedic or whose care involved a facilitated conversation between LTC and ED physicians during this time period. RESULTS: Transfers to ED and hospitalizations from LTC have been gradually declining since 2018 with a sharp decline seen during wave 1 of the pandemic that was greatest in the lowest-priority triage classification (CTAS 5). Community paramedic visits were highest during the first two waves of the pandemic before declining in subsequent waves; facilitated calls between LTC and ED physicians increased during the waves. CONCLUSIONS: There was a reduction in number of transfers from LTC to EDs and in hospitalizations during the first four waves of the pandemic. This was supported by increased conversations between LTC and ED physicians, but was not associated with increased community paramedic visits. Additional work is needed to explore how programs such as community paramedics and facilitated conversations between LTC and ED providers can help to reduce unnecessary transfers to hospital.

Impact of lifetime lactation on the risk and duration of frequent vasomotor symptoms: A longitudinal dose-response analysis.

OBJECTIVE: To examine the association between lifetime lactation and risk and duration of frequent vasomotor symptoms (VMS). DESIGN: Prospective cohort. SETTING: USA, 1995-2008. SAMPLE: 2356 parous midlife women in the Study of Women's Health Across the Nation. METHODS: Lifetime lactation was defined as the duration of breastfeeding across all births in months. We used generalised estimating equations to analyse risk of frequent VMS and Cox regression to analyse duration of frequent VMS in years. MAIN OUTCOME MEASURES: Frequent VMS (hot flashes and night sweats) were measured annually for 10 years, defined as occurring ≥6 days in the past 2 weeks. RESULTS: Overall, 57.1% of women reported hot flashes and 43.0% reported night sweats during follow-up. Lifetime lactation was inversely associated with hot flashes plateauing at 12 months of breastfeeding (6 months: adjusted odds ratio [AOR] 0.85, 95% confidence interval (CI) 0.75-0.96; 12 months: AOR 0.78, 95% CI 0.65-0.93) and was inversely associated with night sweats in a downward linear fashion (6 months: AOR 0.93, 95% CI 0.81-1.08; 18 months: AOR 0.82, 95% CI 0.67-1.02; 30 months: AOR 0.73, 95% CI 0.56-0.97). Lifetime lactation was associated with shorter duration of hot flashes and night sweats in a quadratic (bell-shaped) fashion. The association was strongest at 12-18 months of breastfeeding and significant for hot flashes (6 months: adjusted hazard ratio [AHR] 1.35, 95% CI 1.11-1.65; 18 months: AHR 1.54, 95% CI 1.16-2.03; 30 months: AHR 1.18, 95% CI 0.83-1.68). CONCLUSIONS: Longer lifetime lactation is associated with decreased risk and duration of frequent VMS.

Barriers to Care for Poststroke Visual Deficits in Alberta, Canada.

Poststroke visual impairment (VI) negatively affects rehabilitation potential and quality of life for stroke survivors. In this cross-sectional observational study, stroke survivors and providers were surveyed to quantify perspectives regarding care for poststroke VI in Alberta, Canada (n = 46 survivors; n = 87 providers). Few patients (35%) felt prepared to cope with VI at the time of discharge from acute stroke and inpatient rehabilitation settings. Less than 25% of stroke survivors, and <16% of providers, felt referral processes were adequate. 95.2% of providers and 82% of stroke survivors advocated for a provincial clinical pathway to improve care quality for poststroke VI.

Implementation strategies for hospital-based probiotic administration in a stepped-wedge cluster randomized trial design for preventing hospital-acquired Clostridioides difficile infection.

BACKGROUND: Clostridioides difficile infection (CDI) is associated with considerable morbidity and mortality in hospitalized patients, especially among older adults. Probiotics have been evaluated to prevent hospital-acquired (HA) CDI in patients who are receiving systemic antibiotics, but the implementation of timely probiotic administration remains a challenge. We evaluated methods for effective probiotic implementation across a large health region as part of a study to assess the real-world effectiveness of a probiotic to prevent HA-CDI (Prevent CDI-55 +). METHODS: We used a stepped-wedge cluster-randomized controlled trial across four acute-care adult hospitals (n = 2,490 beds) to implement the use of the probiotic Bio-K + ® (Lactobacillus acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®; Laval, Quebec, Canada) in patients 55 years and older receiving systemic antimicrobials. The multifaceted probiotic implementation strategy included electronic clinical decision support, local site champions, and both health care provider and patient educational interventions. Focus groups were conducted during study implementation to identify ongoing barriers and facilitators to probiotic implementation, guiding needed adaptations of the implementation strategy. Focus groups were thematically analyzed using the Theoretical Domains Framework and the Consolidated Framework of Implementation Research. RESULTS: A total of 340 education sessions with over 1,800 key partners and participants occurred before and during implementation in each of the four hospitals. Site champions were identified for each included hospital, and both electronic clinical decision support and printed educational resources were available to health care providers and patients. A total of 15 individuals participated in 2 focus group and 7 interviews. Key barriers identified from the focus groups resulted in adaptation of the electronic clinical decision support and the addition of nursing education related to probiotic administration. As a result of modifying implementation strategies for identified behaviour change barriers, probiotic adherence rates were from 66.7 to 75.8% at 72 h of starting antibiotic therapy across the four participating acute care hospitals. CONCLUSIONS: Use of a barrier-targeted multifaceted approach, including electronic clinical decision support, education, focus groups to guide the adaptation of the implementation plan, and local site champions, resulted in a high probiotic adherence rate in the Prevent CDI-55 + study.

Association of co-morbidity with acute stroke mortality by age and time since stroke: A population-based study.

OBJECTIVE: To examine whether the association of co-morbidity with mortality after acute stroke is influenced by stroke type, age, sex, or time since stroke. MATERIALS AND METHODS: We conducted a province-wide population-based study using linked administrative databases to identify all admissions for acute stroke between 2007-2018 in Alberta, Canada. We used Cox proportional hazard models to determine the association of severe co-morbidity based on the Charlson Co-morbidity Index with 1-year mortality after stroke, assessing for effect modification by stroke type, age, and sex, and with adjustment for estimated stroke severity, comprehensive stroke centre care, hypertension, atrial fibrillation, and year of study. We used a piecewise model to analyze the impact of co-morbidity across four time periods. RESULTS: We had 28,672 patients in our final cohort (87.8% ischemic stroke). The hazard of mortality with severe co-morbidity was higher for individuals with ischemic stroke (adjusted hazard ratio [aHR] 2.20, 95% CI 2.07-2.32) compared to those with intracerebral hemorrhage (aHR 1.70, 95% CI 1.51-1.92; pint<0.001), and higher in individuals under age 75 (aHR 3.20, 95% CI 2.90-3.53) compared to age ≥75 (aHR 1.93, 95% CI 1.82-2.05, pint<0.001). There was no interaction by sex. The hazard ratio increased in a graded fashion at younger ages and was higher after the first 30 days of acute stroke. CONCLUSION: There was a stronger association between co-morbidity and mortality at younger age and in the subacute phase of stroke. Further research is needed to determine the reason for these findings and identify ways to improve outcomes among those with stroke and co-morbid conditions at young age.

Impact of an emergency endovascular aneurysm repair protocol on 30-day ruptured abdominal aortic aneurysm mortality.

OBJECTIVE: To characterize the longstanding impact of an emergency endovascular aneurysm repair (EVAR) protocol for ruptured abdominal aortic aneurysm (rAAA) on 30-day mortality. METHODS: All adult patients with an rAAA who underwent a surgical or endovascular intervention at a tertiary care center between March 2001 and December 2018 were evaluated. An emergency EVAR protocol was introduced in January 2004. The primary outcome was 30-day mortality, which was calculated using risk-adjusted logistic regression for the preprotocol and postprotocol periods. A risk-adjusted cumulative sum analysis examined changes in 30-day mortality after protocol implementation. RESULTS: We identified 376 patients with rAAA between 2001 and 2018 (75 preprotocol and 301 postprotocol), with a decreasing incidence of rAAA during the study period. The introduction of the protocol in 2004 was associated with increased EVAR use (63.6% vs 6.7%; P < .001). Patients managed according to the protocol were more frequently unstable (systolic blood pressure [SBP] of ≤80 mm Hg, 46.5% postprotocol vs 22.7% preprotocol; P < 0.001), with a lower average SBP (87.4 mm Hg postprotocol vs 106 mm Hg preprotocol; P < .001) and worse renal function (estimated glomerular filtration rate 61.5 mL/min postprotocol vs 83.2 mL/min preprotocol; P < .001). The risk-adjusted 30-day mortality was 23.2% with the emergency EVAR protocol, versus 35.8% preprotocol (P = .0727). A subgroup analysis demonstrated improved the 30-day mortality for unstable patients (SBP of ≤80 mm Hg) at 38.0% (vs 62.4% preprotocol introduction; P = .0190). A cumulative sum analysis demonstrated worse than expected mortality outcomes in the preprotocol period, and stability of surgical performance over 15 years after protocol introduction. CONCLUSIONS: On reflection of a 17-year experience with EVAR for rAAA, the implementation of an emergency EVAR protocol demonstrated stable surgical performance for all patients with an rAAA and evidence of improved 30-day mortality for unstable patients with an rAAA. Since the protocol introduction, EVAR has become a mainstay intervention and, despite an increase in comorbid patients, the overall incidence of rAAA is declining. EVAR should be considered the first-line intervention for the appropriate patient unstable with an rAAA.

Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial.

BACKGROUND: Recurrent vasovagal syncope is common, responds poorly to treatment, and causes physical trauma and poor quality of life. Midodrine prevents hypotension and syncope during tilt tests in patients with vasovagal syncope. OBJECTIVE: To determine whether midodrine can prevent vasovagal syncope in usual clinical conditions. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT01456481). SETTING: 25 university hospitals in Canada, the United States, Mexico, and the United Kingdom. PATIENTS: Patients with recurrent vasovagal syncope and no serious comorbid conditions. INTERVENTION: Patients were randomly assigned 1:1 to placebo or midodrine and followed for 12 months. MEASUREMENTS: The primary outcome measure was the proportion of patients with at least 1 syncope episode during follow-up. RESULTS: The study included 133 patients who had had a median of 6 syncope episodes in the prior year (median age, 32 years; 73% female). Compared with patients receiving placebo, fewer patients receiving midodrine had at least 1 syncope episode (28 of 66 [42%] vs. 41 of 67 [61%]). The relative risk was 0.69 (95% CI, 0.49 to 0.97; P = 0.035). The absolute risk reduction was 19 percentage points (CI, 2 to 36 percentage points), and the number needed to treat to prevent 1 patient from having syncope was 5.3 (CI, 2.8 to 47.6). The time to first syncope was longer with midodrine (hazard ratio, 0.59 [CI, 0.37 to 0.96]; P = 0.035; log-rank P = 0.031). Adverse effects were similar in both groups. LIMITATION: Small study size, young and healthy patients, relatively short observation period, and high proportion of patients from 1 center. CONCLUSION: Midodrine can reduce the recurrence of syncope in healthy, younger patients with a high syncope burden. PRIMARY FUNDING SOURCE: The Canadian Institutes of Health Research.

Effect of Clinical Decision Support With Audit and Feedback on Prevention of Acute Kidney Injury in Patients Undergoing Coronary Angiography: A Randomized Clinical Trial.

Importance: Contrast-associated acute kidney injury (AKI) is a common complication of coronary angiography and percutaneous coronary intervention (PCI) that has been associated with high costs and adverse long-term outcomes. Objective: To determine whether a multifaceted intervention is effective for the prevention of AKI after coronary angiography or PCI. Design, Setting, and Participants: A stepped-wedge, cluster randomized clinical trial was conducted in Alberta, Canada, that included all invasive cardiologists at 3 cardiac catheterization laboratories who were randomized to various start dates for the intervention between January 2018 and September 2019. Eligible patients were aged 18 years or older who underwent nonemergency coronary angiography, PCI, or both; who were not undergoing dialysis; and who had a predicted AKI risk of greater than 5%. Thirty-four physicians performed 7820 procedures among 7106 patients who met the inclusion criteria. Participant follow-up ended in November 2020. Interventions: During the intervention period, cardiologists received educational outreach, computerized clinical decision support on contrast volume and hemodynamic-guided intravenous fluid targets, and audit and feedback. During the control (preintervention) period, cardiologists provided usual care and did not receive the intervention. Main Outcomes and Measures: The primary outcome was AKI. There were 12 secondary outcomes, including contrast volume, intravenous fluid administration, and major adverse cardiovascular and kidney events. The analyses were conducted using time-adjusted models. Results: Of the 34 participating cardiologists who were divided into 8 clusters by practice group and center, the intervention group included 31 who performed 4327 procedures among 4032 patients (mean age, 70.3 [SD, 10.7] years; 1384 were women [32.0%]) and the control group included 34 who performed 3493 procedures among 3251 patients (mean age, 70.2 [SD, 10.8] years; 1151 were women [33.0%]). The incidence of AKI was 7.2% (310 events after 4327 procedures) during the intervention period and 8.6% (299 events after 3493 procedures) during the control period (between-group difference, -2.3% [95% CI, -0.6% to -4.1%]; odds ratio [OR], 0.72 [95% CI, 0.56 to 0.93]; P = .01). Of 12 prespecified secondary outcomes, 8 showed no significant difference. The proportion of procedures in which excessive contrast volumes were used was reduced to 38.1% during the intervention period from 51.7% during the control period (between-group difference, -12.0% [95% CI, -14.4% to -9.4%]; OR, 0.77 [95% CI, 0.65 to 0.90]; P = .002). The proportion of procedures in eligible patients in whom insufficient intravenous fluid was given was reduced to 60.8% during the intervention period from 75.1% during the control period (between-group difference, -15.8% [95% CI, -19.7% to -12.0%]; OR, 0.68 [95% CI, 0.53 to 0.87]; P = .002). There were no significant between-group differences in major adverse cardiovascular events or major adverse kidney events. Conclusions and Relevance: Among cardiologists randomized to an intervention including clinical decision support with audit and feedback, patients undergoing coronary procedures during the intervention period were less likely to develop AKI compared with those treated during the control period, with a time-adjusted absolute risk reduction of 2.3%. Whether this intervention would show efficacy outside this study setting requires further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT03453996.

Association between delirium in the intensive care unit and subsequent neuropsychiatric disorders.

BACKGROUND: Patients in the intensive care unit (ICU) are known to be at increased risk of developing delirium, but the risk of subsequent neuropsychiatric disorders is unclear. We therefore sought to examine the association between the presence of delirium in the ICU and incident neuropsychiatric disorders (including depressive, anxiety, trauma-and-stressor-related, and neurocognitive disorders) post-ICU stay among adult medical-surgical ICU patients. METHODS: Retrospective cohort study utilizing clinical and administrative data from both inpatient and outpatient healthcare visits to identify the ICU cohort and diagnostic information 5 years prior to and 1 year post-ICU stay. Patients ≥ 18 years of age admitted to one of 14 medical-surgical ICUs across Alberta, Canada, January 1, 2014-June 30, 2016, and survived to hospital discharge were included. The main outcome of interest was a new diagnosis of any neuropsychiatric disorder 1 year post-ICU stay. The exposure variable was delirium during the ICU stay identified through any positive delirium screen by the Intensive Care Unit Delirium Screening Checklist (ICDSC) during the ICU stay. RESULTS: Of 16,005 unique patients with at least one ICU admission, 4033 patients were included in the study of which 1792 (44%) experienced delirium during their ICU stay. The overall cumulative incidence of any neuropsychiatric disorder during the subsequent year was 19.7% for ICU patients. After adjusting for hospital characteristics using log-binomial regression, patients with delirium during the ICU stay had a risk ratio (RR) of 1.14 (95% confidence interval [CI] 0.98-1.33) of developing any neuropsychiatric disorder within 1 year post-ICU compared to those who did not experience delirium. Delirium was significantly associated with neurocognitive disorders (RR 1.59, 95% CI 1.08-2.35), but not depressive disorders (RR 1.16, 95% CI 0.92-1.45), anxiety (RR 1.16, 95% CI 0.92-1.47), and trauma-and-stressor-related (RR 0.82, 95% CI 0.53-1.28) disorders. CONCLUSIONS: The diagnosis of new onset of neurocognitive disorders is associated with ICU-acquired delirium. In this study, significant associations were not observed for depressive, anxiety, and trauma-and-stressor-related disorders.

Pregnancy complications and risk of preterm birth according to maternal age: A population-based study of delivery hospitalizations in Alberta.

INTRODUCTION: Pregnancy-related medical complications are associated with a 2- to 5-fold increased risk of preterm birth (PTB), but the nature of this etiologic relation in context with maternal factors remains poorly understood. Previous studies have generally treated maternal age as a confounder but overlooked its potential as an effect modifier, whereby the magnitude of the effect of complications on PTB could differ significantly across age groups. We investigated whether advanced maternal age (≥35 years) modified the association between pregnancy complications and PTB, and compared population-attributable fractions of PTB from complications in women older vs younger than 35 years. MATERIAL AND METHODS: We analyzed population-based, cross-sectional data from the Alberta Discharge Abstract Database for women aged 18-50 years with singleton live births in hospital between 2014 and 2017 (n = 152 246). Complications were preeclampsia, gestational diabetes, and placental disorders identified using diagnostic codes. Outcomes were spontaneous (sPTB) or iatrogenic (iPTB) PTB before 37 weeks of gestation. We estimated risk ratios and risk differences using modified Poisson and log binomial regression, respectively, adjusting for confounders (pregnancy history, comorbidities). Population-attributable fractions estimates were calculated from risk ratios. Age modification was tested using interaction terms and Z-tests. RESULTS: Prevalence of advanced maternal age was 19.2%. Pregnancy complications and s/iPTB were more common among women aged ≥35 years. Age modified the risk of PTB from preeclampsia only, with risk differences of 9.9% (95% CI 7.2%-12.6%) in older women vs 6.1% (95% CI 4.8%-7.4%) in younger women (P-interaction = 0.012) for sPTB, and 29.5% (95% CI 26.0%-33.1%) vs 20.8% (95% CI 18.9%-22.6%, P-interaction <0.001) for iPTB. Population-attributable fractions of s/iPTB types for all complications were consistently 2%-5% larger in women aged ≥35 years, and significantly larger for preeclampsia (sPTB: 5.1% vs 2.7%, P = 0.002; iPTB: 18.8% vs 14.0%, P < 0.001) and placental disorders (sPTB: 12.5% vs 8.7%, P < 0.001; iPTB: 13.2% vs 8.9%, P < 0.001). CONCLUSIONS: Of the pregnancy complications studied, advanced maternal age only modified the association between PTB and preeclampsia, such that older women with preeclampsia have a higher risk for s/iPTB than younger counterparts. Pregnancy complications contribute to a sizable proportion of PTBs in Alberta, especially among women aged ≥35 years. Findings may inform clinical risk assessment and population-level policy targeting PTB.

Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial.

BACKGROUND: Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits. METHODS: In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge. RESULTS: We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups. CONCLUSIONS: Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.

Improving care for residents in long term care facilities experiencing an acute change in health status.

BACKGROUND: Long term care (LTC) facilities provide health services and assist residents with daily care. At times residents may require transfer to emergency departments (ED), depending on the severity of their change in health status, their goals of care, and the ability of the facility to care for medically unstable residents. However, many transfers from LTC to ED are unnecessary, and expose residents to discontinuity in care and iatrogenic harms. This knowledge translation project aims to implement a standardized LTC-ED care and referral pathway for LTC facilities seeking transfer to ED, which optimizes the use of resources both within the LTC facility and surrounding community. METHODS/DESIGN: We will use a quasi-experimental randomized stepped-wedge design in the implementation and evaluation of the pathway within the Calgary zone of Alberta Health Services (AHS), Canada. Specifically, the intervention will be implemented in 38 LTC facilities. The intervention will involve a standardized LTC-ED care and referral pathway, along with targeted INTERACT® tools. The implementation strategies will be adapted to the local context of each facility and to address potential implementation barriers identified through a staff completed barriers assessment tool. The evaluation will use a mixed-methods approach. The primary outcome will be any change in the rate of transfers to ED from LTC facilities adjusted by resident-days. Secondary outcomes will include a post-implementation qualitative assessment of the pathway. Comparative cost-analysis will be undertaken from the perspective of publicly funded health care. DISCUSSION: This study will integrate current resources in the LTC-ED pathway in a manner that will better coordinate and optimize the care for LTC residents experiencing an acute change in health status.

The cirrhosis care Alberta (CCAB) protocol: implementing an evidence-based best practice order set for the management of liver cirrhosis - a hybrid type I effectiveness-implementation trial.

BACKGROUND: Liver cirrhosis is a leading cause of morbidity, premature mortality and acute care utilization in patients with digestive disease. In the province of Alberta, hospital readmission rates for patients with cirrhosis are estimated at 44% at 90 days. For hospitalized patients, multiple care gaps exist, the most notable stemming from i) the lack of a structured approach to best practice care for cirrhosis complications, ii) the lack of a structured approach to broader health needs and iii) suboptimal preparation for transition of care into the community. Cirrhosis Care Alberta (CCAB) is a 4-year multi-component pragmatic trial which aims to address these gaps. The proposed intervention is initiated at the time of hospitalization through implementation of a clinical information system embedded electronic order set for delivering evidence-based best practices under real-world conditions. The overarching objective of the CCAB trial is to demonstrate effectiveness and implementation feasibility for use of the order set in routine patient care within eight hospital sites in Alberta. METHODS: A mixed methods hybrid type I effectiveness-implementation design will be used to evaluate the effectiveness of the order set intervention. The primary outcome is a reduction in 90-day cumulative length of stay. Implementation outcomes such as reach, adoption, fidelity and maintenance will also be evaluated alongside other patient and service outcomes such as readmission rates, quality of care and cost-effectiveness. This theory-based trial will be guided by Normalization Process Theory, Consolidated Framework on Implementation Research (CFIR) and the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Framework. DISCUSSION: The CCAB project is unique in its breadth, both in the comprehensiveness of the multi-component order set and also for the breadth of its roll-out. Lessons learned will ultimately inform the feasibility and effectiveness of this approach in "real-world" conditions as well as adoption and adaptation of these best practices within the rest of Alberta, other provinces in Canada, and beyond. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04149223, November 4, 2019.

Return on investment of the Enhanced Recovery After Surgery (ERAS) multiguideline, multisite implementation in Alberta, Canada.

Background: Enhanced Recovery After Surgery (ERAS) is a global surgical qualityimprovement initiative. Little is known about the economic effects of implementing multiple ERAS guidelines in both the short and long term. Methods: We performed a return on investment (ROI) analysis of the implementation of multiple ERAS guidelines (for colorectal, pancreas, cystectomy, liver and gynecologic oncology procedures) across multiple sites (9 hospitals) in Alberta using 30-, 180- and 365-day time horizons. The effects of ERAS on health services utilization (length of stay of the primary admission, number of readmissions, length of stay of the readmissions, number of emergency department visits, number of outpatient clinic visits, number of specialist visits and number of general practitioner visits) were assessed by mixed-effect multilevel multivariate negative binomial regressions. Net benefits and ROI were estimated by a decision analytic modelling analysis. All costs were reported in 2019 Canadian dollars. Results: The net health system savings per patient ranged from $26.35 to $3606.44 and ROI ranged from 1.05 to 7.31, meaning that every dollar invested in ERAS brought $1.05 to $7.31 in return. Probabilities for ERAS to be cost-saving were from 86.5% to 99.9%. The effects of ERAS were found to be larger in the longer time horizons, indicating that if only the 30-day time horizon had been used, the benefits of ERAS would have been underestimated. Conclusion: These results demonstrated that ERAS multiguideline implementation was cost-saving in Alberta. To produce a better ROI, it is important to consider a broad range of health service utilizations, long-term impact, economies of scale, productive efficiency and allocative efficiency for sustainability, scale and spread of ERAS implementations.

Contexte: L'initiative de récupération améliorée après la chirurgie (RAAC) est un projet international d'amélioration de la qualité en chirurgie. On en sait peu sur les retombées économiques, tant à court qu'à long terme, de la mise en œuvre de multiples lignes directrices de RAAC. Méthodes: Nous avons réalisé une analyse du rendement sur l'investissement (RSI) visant la mise en œuvre de multiples lignes directrices de RAAC (pour les opérations colorectales, pancréatiques, hépatiques ou d'oncologie gynécologique et la cystectomie) dans 9 hôpitaux albertains sur un horizon temporel de 30, 180 et 365 jours. L'incidence de la RAAC sur l'utilisation des services de santé (durée du séjour à l'hospitalisation initiale, nombre de réadmissions, durée du séjour à la réhospitalisation et nombre de visites à l'urgence, en consultation externe, chez un spécialiste et chez un omnipraticien) a été évaluée à l'aide d'un modèle multiniveau de régressions binomiales négatives à effets mixtes multivariés. Les bénéfices nets et le RSI ont été estimés à l'aide d'un processus de modélisation analytique décisionnelle. Tous les coûts ont été rapportés en dollars canadiens de 2019. Résultats: Les économies nettes du système de santé allaient de 26,35 $ à 3606,44 $ par patient, et le RSI variait de 1,05 à 7,31; chaque dollar investi dans l'initiative de RAAC a donc généré un retour sur l'investissement de 1,05 $ à 7,31 $. Les probabilités d'économie grâce au RAAC allaient de 86,5% à 99,9%. Les retombées générées augmentaient avec un horizon temporel à plus long terme, ce qui suggère que l'utilisation unique d'un horizon temporel de 30 jours aurait mené à une sousestimation des bénéfices. Conclusion: Les résultats montrent que la mise en œuvre de multiples lignes directrices de RAAC a permis des économies en Alberta. En vue d'obtenir un RSI optimal, il est important de tenir compte d'une grande variété d'utilisations des services de santé, des retombées à long terme, des économies d'échelle, de l'efficacité productive et de l'efficience des allocations pour la pérennité, la mise à l'échelle et la diffusion des projets de mise en œuvre de RAAC.

The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy.

Cancer patients often experience poor quality of life (QoL) during chemotherapy (CT) treatments due to side effects including fatigue, insomnia, pain and nausea/vomiting. Mindfulness-based cancer recovery (MBCR) is an evidence-based intervention for treating such symptoms, but has not been investigated as an adjunctive treatment during CT. This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real-time interactive weekly sessions for managing fatigue (primary outcome). Secondary outcomes include sleep disturbance, pain, nausea/vomiting, mood, stress and QoL. Exploratory outcomes include cognitive function, white blood cell counts and return to work. The study is a two-armed randomised controlled waitlist trial with 2:1 allocation to treatment (online group MBCR during CT) or control (waitlist usual care; online MBCR following CT completion) with a target sample size of N = 178. Participants are breast or colorectal cancer patients undergoing common CT regimens in Calgary, Canada. Online assessments using validated self-reported instruments will take place at baseline, post-MBCR, post-CT and 12 months' post-baseline. If online MBCR delivered during CT significantly reduces fatigue in cancer patients' post-CT and also impacts secondary symptoms, this would provide evidence for including mindfulness training as an adjunctive symptom management therapy during CT.

Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations.

BACKGROUND: As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems. MAIN BODY: In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture. CONCLUSION: We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.

Effectiveness of a standardized electronic admission order set for acute exacerbation of chronic obstructive pulmonary disease.

BACKGROUND: Variation in hospital management of patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) may prolong length of stay, increasing the risk of hospital-acquired complications and worsening quality of life. We sought to determine whether an evidence-based computerized AECOPD admission order set could improve quality and reduce length of stay. METHODS: The order set was designed by a provincial COPD working group and implemented voluntarily among three physician groups in a Canadian tertiary-care teaching hospital. The primary outcome was length of stay for patients admitted during order set implementation period, compared to the previous 12 months. Secondary outcomes included length of stay of patients admitted with and without order set after implementation, all-cause readmissions, and emergency department visits. RESULTS: There were 556 admissions prior to and 857 admissions after order set implementation, for which the order set was used in 47%. There was no difference in overall length of stay after implementation (median 6.37 days (95% confidence interval 5.94, 6.81) pre-implementation vs. 6.02 days (95% confidence interval 5.59, 6.46) post-implementation, p = 0.26). In the post-implementation period, order set use was associated with a 1.15-day reduction in length of stay (95% confidence interval - 0.5, - 1.81, p = 0.001) compared to patients admitted without the order set. There was no difference in readmissions. CONCLUSIONS: Use of a computerized guidelines-based admission order set for COPD exacerbations reduced hospital length of stay without increasing readmissions. Interventions to increase order set use could lead to greater improvements in length of stay and quality of care.

Ethnic disparities in children's oral health: findings from a population-based survey of grade 1 and 2 schoolchildren in Alberta, Canada.

BACKGROUND: Although oral health has improved remarkably in recent decades, not all populations have benefited equally. Ethnic identity, and in particular visible minority status, has been identified as an important risk factor for poor oral health. Canadian research on ethnic disparities in oral health is extremely limited. The aim of this study was to examine ethnic disparities in oral health outcomes and to assess the extent to which ethnic disparities could be accounted for by demographic, socioeconomic and caries-related behavioral factors, among a population-based sample of grade 1 and 2 schoolchildren (age range: 5-8 years) in Alberta, Canada. METHODS: A dental survey (administered during 2013-14) included a mouth examination and parent questionnaire. Oral health outcomes included: 1) percentage of children with dental caries; 2) number of decayed, extracted/missing (due to caries) and filled teeth; 3) percentage of children with two or more teeth with untreated caries; and 4) percentage of children with parental-ratings of fair or poor oral health. We used multivariable regression analysis to examine ethnic disparities in oral health, adjusting for demographic, socioeconomic and caries-related behavioral variables. RESULTS: We observed significant ethnic disparities in children's oral health. Most visible minority groups, particularly Filipino and Arab, as well as Indigenous children, were more likely to have worse oral health than White populations. In particular, Filipino children had an almost 5-fold higher odds of having severe untreated dental problems (2 or more teeth with untreated caries) than White children. Adjustment for demographic, socioeconomic, and caries-related behavior variables attenuated but did not eliminate ethnic disparities in oral health, with the exception of Latin American children whose outcomes did not differ significantly from White populations after adjustment. CONCLUSIONS: Significant ethnic disparities in oral health exist in Alberta, Canada, even when adjusting for demographic, socioeconomic and caries-related behavioral factors, with Filipino, Arab, and Indigenous children being the most affected.