Usual Care Group Research Articles

Patient-initiated follow-up supported by asynchronous telemedicine versus usual care in spondyloarthritis (TeleSpA-study): a randomised controlled trial of clinical and cost-effectiveness

With rising health-care expenditures and workforce shortages, sustainable alternatives to traditional outpatient follow-up strategies are required to optimise care efficiency. We aimed to investigate the cost-effectiveness and clinical effectiveness of patient-initiated follow-up (PIFU) supported by asynchronous telemedicine for patients with spondyloarthritis compared with usual care in daily practice. TeleSpA was a multicentre, pragmatic, open-label, randomised controlled trial. Patients with spondyloarthritis and stable disease were randomly assigned (1:1) to either the PIFU and asynchronous telemedicine group or usual care group. All patients received a scheduled outpatient visit at baseline and after 1 year. Patients were monitored remotely at 6 months (PIFU and asynchronous telemedicine) or at the discretion of the treating rheumatologist (usual care). The primary outcome was the number of rheumatology visits within a 1-year period. A trial-based 1-year health-economic evaluation from a Dutch health-care perspective (only including health-care costs) and societal perspective (also including travel costs and work productivity losses), per the Dutch guidelines was used to estimate cost-effectiveness. The safety analysis was done in the intention-to-treat population and was based on spontaneous reports of adverse events and serious adverse events or as observed by the research team. The primary analysis was in the intention-to-treat population. Individuals with relevant lived experience were involved in the study design. This trial was registered with the Dutch National Trial Register (NL71041.068.19) and ClinicalTrials.gov (NCT04673825) and is completed. Between Dec 2, 2020, and June 20, 2022, 200 patients were randomly assigned to PIFU and asynchronous telemedicine (n=100) or usual care (n=100). 79 (40%) of 200 participants were women, 121 (60%) were men, and the mean age was 55·0 years (SD 11·9). After 1 year, the mean number of rheumatology visits was 1·9 (SD 1·5) for the PIFU and asynchronous telemedicine group and 2·6 (1·3) in the usual care group (mean difference -0·7 [95% CI -1·0 to -0·3]; 25·4% reduction; p<0·0001). PIFU and asynchronous telemedicine was cost-effective from a health-care perspective, saving health-care costs (-€180 [95% CI -921 to 560]) without a loss in quality-adjusted life-years (0·004 [95 % CI -0·022 to 0·030]). Seven non-trial-related adverse events occurred in the PIFU and asynchronous telemedicine group and eight in usual care group (including one death). PIFU and asynchronous telemedicine resulted in significant and clinically meaningful reductions in rheumatology visits. This was not at the expense of health outcomes and saved health-care costs. Dutch Arthritis Society.

Effect of a home-based exercise program on subsequent falls among community-dwelling older adults with cognitive frailty: A sub-group analysis of a randomized controlled trial

ObjectivesCognitive frailty is characterized by concurrent physical frailty and mild cognitive impairment and is associated with increased risk of falls. Exercise is an evidence-based strategy to prevent falls, but whether exercise reduces falls in people with cognitive frailty is unknown. We examined the effects of home-based exercise on subsequent falls among community-dwelling older adults with cognitive frailty who have previously fallen. Study designA sub-group analysis of a 12-month, single-blind, randomized controlled trial among 344 adults aged 70 years or more who had fallen within the past 12 months. Participants were randomized to either 12 months of home-based exercise (n = 172) or usual care (n = 172). In this sub-analysis, we included 192 participants with cognitive frailty (home-based exercise = 93; usual care = 99) with Short Physical Performance Battery scores ≤9/12 and Montreal Cognitive Assessment scores <26/30. Main outcome measuresOur primary analysis examined the effect of exercise on self-reported falls rate over 12 months. Secondary analyses investigated the intervention's effects on scores on the Short Physical Performance Battery and the Montreal Cognitive Assessment. We also explored whether greater than or equal to mean average monthly adherence (i.e., ≥45.5 %) moderated treatment effects. ResultsAt 12 months, falls rates were 35 % lower in the home-based exercise group compared with the usual care group (IRR = 0.65; p = 0.042). Score on the Short Physical Performance Battery significantly improved among home-based exercise participants with greater than or equal to mean adherence vs. those with less than mean adherence (estimated mean difference: 0.94; p = 0.022). ConclusionsExercise is a promising strategy for reducing subsequent falls in people with cognitive frailty. Greater exercise adherence improved physical function in this population.ClinicalTrials.gov identifier: NCT01029171

Strategies to Limit Benzodiazepine Use in Anesthesia for Older Adults

Despite guidelines recommending avoidance of benzodiazepine administration to older patients, many of them now receive benzodiazepines as a part of anesthesia care. The effectiveness of clinician- and patient-facing interventions to discourage such use remains insufficiently characterized. To evaluate the effect of clinician peer comparison, patient informational mail, or a combination of these interventions compared with usual care on the rate of perioperative benzodiazepine administration to older patients. This 2 × 2 factorial, stepped-wedge, cluster randomized clinical trial of a corporate quality improvement initiative was conducted between August 8, 2022, and May 28, 2023, across 415 hospitals, surgery centers, and physician offices in 8 US states served by anesthesia clinicians from a national anesthesia practice. Participants were adults aged 65 years or older who underwent an elective surgical or endoscopic procedure with general anesthesia. Data analyses followed the intention-to-treat principle. Patients were randomly assigned to 1 of 4 groups-clinician peer comparison (wherein clinicians received feedback regarding their performance compared with other clinicians in the practice), patient informational mail (wherein patients received an informational letter encouraging them to have a discussion regarding medication selection with their clinician on the day of surgery), both interventions, or usual care (no intervention). Rate of benzodiazepine administration during anesthesia care and patient satisfaction with anesthesia care (measured by the Anesthesia Patient Satisfaction Questionnaire, version 2). Among the 509 269 enrolled participants (255 871 females [50.2%]; mean [SD] age, 74 [7] years), 81 363 (16.0%) were assigned to clinician peer comparison, 98 520 (19.3%) to patient informational mail, 169 712 (33.3%) to both interventions, and 159 674 (31.4%) to usual care. Among patients who received benzodiazepine during anesthesia care, 24.5% were in the usual care group compared with 19.7% in the clinician peer comparison group, 20.0% in the patient informational mail group, and 19.7% in the combination group. After adjustment for time, none of the study interventions were associated with lower odds of benzodiazepine administration compared with usual care (odds ratio [OR], 1.02 [95% CI, 0.98-1.07]; P = .35 for clinician peer comparison; OR, 1.01 [95% CI, 0.96-1.05]; P = .81 for patient informational mail; and OR, 1.11 [95% CI, 1.05-1.16]; P < .001 for combined interventions). Satisfaction scores were high in all groups and did not vary by treatment assignment. This randomized clinical trial found that clinician peer comparison, patient informational mail, or a combination of both interventions did not reduce benzodiazepine administration to older patients compared with usual care; patient satisfaction remained high throughout the study. Overall, the findings suggest a need to explore other patient-targeted interventions to improve anesthesia care. Clinicaltrials.gov Identifier: NCT05436392.

Functional echocardiography for management of shock in neonates - study protocol for a randomized controlled trial

Background: Shock is common in sick neonates and is associated with a high mortality. Detection and management of shock by monitoring clinical parameters may be inadequate due to inconsistent association with tissue perfusion. We hypothesize that objective assessments of cardiac functions may help to match the pathophysiology of shock with the pharmacological action of a vasoactive drug. This may lead to earlier resolution of shock and reduced incidence of mortality or brain injury. To test this hypothesis, this study aims to evaluate the efficacy of adding functional echocardiography to standard clinical assessment in improving short-term outcome of neonates with clinical features of shock. Methods: This study will be an open-labeled randomized controlled trial, conducted in all inborn neonates born at &gt;27 weeks of gestation who develop clinical signs of shock. Enrolled neonates will be randomized into two groups: the echo group and the control group. Neonates in the echo group will be assessed for management of shock by both standard clinical evaluation and functional echocardiography. Neonates in the control group will be assessed for the management of shock by standard clinical evaluation. Primary outcome will be survival without requirement of inotropic support at 72 hours of randomization. Secondary outcomes include time to hemodynamic stability, duration of inotropic support and incidence of abnormal cranial ultrasound. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p&lt;0.001). Conclusions: The trial intends to deduce the advantages, if any, of addition of functional echocardiography to standard clinical assessment to guide management of shock among preterm and term neonates. Trial registration: CTRI number: CTRI/2023/08/056672.

A Tailored Postpartum eHealth Physical Activity Intervention for Individuals at High Risk of Postpartum Depression-the POstpartum Wellness Study (POW): Protocol and Data Overview for a Randomized Controlled Trial.

Postpartum depression (PPD) is associated with significant health consequences for the parent and child. Current recommendations for PPD prevention require intense health care system resources. Evidence-based interventions for PPD prevention that do not further burden the health care system are needed. Evidence suggests that physical activity (PA) can generally reduce depressive symptoms. Technology-based interventions may help decrease common barriers to PA. This study aims to report the protocol and provide a data overview of the POstpartum Wellness study (POW)-an effectiveness trial evaluating whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among individuals at high PPD risk. This remote parallel-group randomized controlled trial included postpartum individuals with a history of depression or at least moderate current depressive symptoms not meeting the PPD diagnostic threshold and with low PA levels from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The intervention group received access to a library of web-based workout videos designed for postpartum individuals, which included interaction with their infants. At baseline and follow-up (3 and 6 months), PA was measured using questionnaires and a wrist-worn accelerometer. Depressive symptoms were measured using the Patient Health Questionnaire-8 (PHQ-8). Data were collected to assess exploratory outcomes of sleep, perceived stress, anxiety, parent-infant bonding, and infant development. The study was funded in January 2020. Participants were enrolled via REDCap (Research Electronic Data Capture) or telephonically between November 2020 and September 2022; data collection ended in April 2023. Randomized participants (N=99) were 4 months post partum at baseline with moderately severe depressive symptoms (mean PHQ-8 score 12.6, SD 2.2). Intervention (n=50) and usual care (n=49) groups had similar sociodemographic characteristics, months post partum, baseline depressive symptoms, number of children at home, and prepregnancy PA levels. Retention in assessments was ≥66% for questionnaires and ≥48% for accelerometry, with modest differences by group. At 3-month follow-up, 73 of 99 (74%) participants (intervention: 35/50, 70%; usual care: 38/49, 78%) completed questionnaires; 53 of 99 (54%) wore the accelerometer for 7 days (27 of 50 (54%) intervention, 26 of 49 (53%) usual care). At 6-month follow-up, 66 of 99 (67%) participants (30 of 50 (60%) intervention, 36 of 49 (73%) usual care) completed questionnaires and 43 of 99 (43%) wore the accelerometer for 7 days (21 of 50 (42%) intervention, 22 of 49 (45%) usual care). Data analysis is completed, and a manuscript with these findings is currently under review for publication. The POW trial evaluates the effectiveness of an eHealth PA intervention for improving depressive symptoms and increasing PA among postpartum individuals at high PPD risk. Results have implications for the design and delivery of behavioral interventions among vulnerable patients. ClinicalTrials.gov NCT04414696; https://clinicaltrials.gov/ct2/show/NCT04414696. DERR1-10.2196/56882.

Factors influencing low-density-lipoprotein cholesterol after acute coronary syndrome and effectiveness of intensive teleconsultation monitoring, the teleobjectif cohort study

Abstract Context: Low-density lipoprotein cholesterol (LDL-c) plays a key role in the development and progression of atherosclerotic cardiovascular disease (ASCVD). Despite the availability of effective lipid-lowering treatments, patients who have experienced an acute coronary syndrome (ACS) continue to face a high risk of recurrent cardiovascular events and mortality. Achieving the recommended LDL-c target of &amp;lt;0.55 g/L in secondary cardiovascular prevention remains a significant challenge, with fewer than 30% of patients reaching this goal. Aim To investigate the factors influencing LDL-c control after ACS and the effectiveness of intensive teleconsultation monitoring to control LDL-c, even in sub-groups where control is poorest. Methods This bi-centric prospective cohort study conducted between december 2019 and december 2021 compared a group that received standard follow-up after an ACS with an interventional group that received regular follow-up by teleconsultation in addition of usual care to optimize lipid-lowering treatment. A subgroup analysis was carried out to examine the effect of teleconsultation in subpopulations known to be significantly associated with better or worse LDL-c control in the usual care group or described in the literature. Results 1602 patients met the inclusion criteria for our study (814 in the usual care group and 788 in the teleconsultation group). Baseline characteristics were similar between groups. In the usual care group, factors influencing lipid control included gender, diabetes, cardiology consultation, distance to the nearest cardiologist, social deprivation and initial LDL-C levels. Teleconsultation significantly improved LDL-C target attainment compared to usual care (74.7% vs. 26.6%, p&amp;lt;0.001 with multivariate analysis OR 5.06 [4.21 ; 6.07]), particularly benefiting geographically and socially disadvantaged patients. Conclusion Teleconsultation significantly improves lipid control in acute coronary syndrome patients compared to usual care. This universal intervention, particularly beneficial for geographically and socially disadvantaged patients, highlights the potential of telemedicine in enhancing cardiovascular management.analysis in usual care groupTeleconsultation effect in sub-groups

Impact of teleconsultation follow-up to control low-density-lipoprotein cholesterol at one year after acute coronary syndrome: the teleobjectif prospective cohort study

Abstract Context High level of low-density lipoprotein cholesterol (LDL-c) is one of the most important causal and independent risk factor for recurrent atheromatous cardiovascular events. Despite the availability of several treatments that can reduce LDL-c by up to 85%, less than 30% of patients achieve the LDL-c target &amp;lt; 0.55 g/dl, recommended by the European Society of Cardiology for secondary cardiovascular prevention. Aim We hypothesized that teleconsultation monitoring would allow better control of LDL-c blood levels at one year in a population after acute coronary syndrom (ACS). Methods This bi-centric prospective cohort study, conducted between december 2019 and december 2021, compared a group that received standard follow-up after an ACS with an interventional group that received regular follow-up by teleconsultation, in addition of usual care, to optimise lipid-lowering treatments. Results 1602 patients met the inclusion criteria for our study (814 in the usual care group and 788 in the teleconsultation group). The proportion of patients with LDL-c &amp;lt; 0.55 g/L at one year was statistically significant in the teleconsultation group (74.7%) compared with the usual care group (26.6%) (p&amp;lt;0.001). The average (standard deviation) absolute value of LDL-c at 1 year was 0.48 g/L (0.2) in the teleconsultation group and 0.75 g/L (0.32) in the usual care group (p&amp;lt;0.001). In the multivariate analysis, receiving teleconsultation follow-up made it more likely to achieve the LDL-c target (4.88 [4,09 ; 5,85], p&amp;lt;0.001). The use of lipid-lowering treatments, including statins, ezetimibe and anti-PCSK9 inhibitors was much higher in the teleconsultation group (p&amp;lt;0.001). There was a significant difference in overall survival (p=0.016) and cardiovascular survival (p=0.013) in favor of the teleconsultation group. Conclusion teleconsultation follow-up after ACS significantly improved lipid control and survival at one year.% patients achieving 1-year LDL-c targetOverall survival

Early rhythm control of atrial fibrillation in cancer survivors: a nationwide population-based cohort study

Abstract Background Though early rhythm control (ERC) in patients with atrial fibrillation (AF) is effective in reducing stroke, the benefit of ERC has not been well-elucidated in cancer survivors. This study aimed to compare the risk of ischemic stroke between ERC and usual care in cancer survivors with AF and cancer. Methods This nationwide observational study was conducted using the Korean National Health Insurance Service database. Patients aged 20 years or older with newly diagnosed AF between 2009 and 2018 were included. Patients who received rhythm control therapy within 1-year of AF diagnosis were defined as the ERC group, while the remaining patients were defined as the usual care group. The risk of ischemic stroke in the ERC group compared to the usual care group was evaluated in long-term cancer survivors (cancer diagnosis ≥5 years) and the non-cancer group. Results A total of 591,692 patients were included in the study (18,747 patients [3.2 %] with cancer, mean age 65.7±14.6 years, 53.7% men, mean CHA2DS2-VASc score 3.3±2.0). The proportion of patients receiving ERC was slightly higher in cancer survivors compared to the non-cancer group (28.0% vs 25.3%, p&amp;lt;0.001). During a mean 4-year follow-up, incident stroke occurred in 52,500 patients (1,338 in cancer survivors, 51,182 in non-cancer). The ERC group showed a lower risk of stroke than the usual care group, regardless of the presence of cancer history(Figure); adjusted hazard ratio [95% confidence interval] 0.67 [0.58-0.76] in cancer survivors, 0.76 [0.74-0.78] in the non-cancer group (p-for-interaction=0.125). The effect of ERC on the risk of ischemic stroke in cancer group was consistent across all subgroups, including different cancer types or use of chemotherapy. Conclusion ERC was associated with a lower risk of ischemic stroke among long-term cancer survivors. An integrated approach incorporating appropriate rhythm control strategies should be considered for cancer survivors with newly diagnosed AF.

Impact of an Active Nutrition Program on Weight Loss and Metabolic Health in Overweight and Obese Adults: A Randomized Controlled Trial.

The purpose of this study was to evaluate the impact of a 60-day low-calorie nutrition-rich diet plan compared to usual care on weight loss, physiological factors, markers of metabolic health, and perceived wellness. Overweight or obese adults (N = 60) were randomly assigned to either the active nutrition group (n = 30) or the usual care group (n = 30). The active nutrition plan consisted of two meal replacement shakes, an electrolyte replacement drink, a metabolic support supplement, one whole food meal, and three to five servings of whole food snacks (e.g., vegetables and fruits), which totaled approximately 1200-1600 calories daily. Participants were evaluated at baseline and 30- and 60-day follow-ups for mean changes in anthropometric characteristics, biochemical variables, self-reported feelings of health and well-being, and dietary intake. Of the 60 participants, 49 were women and 11 were men, with a mean age of 38 ± 12 years. Adhering to the active nutrition program for 60 days resulted in a mean weight loss of approximately 6.5 pounds, with a 2-pound weight gain noted for subjects in the usual care group. Related to this, reductions were noted in BMI (p< 0.001), percent fat (p = 0.017), and waist (4 cm, p< 0.001) and hip (3 cm, p< 0.001) circumferences for the active nutrition group but not usual care. Clinically relevant changes were noted for reductions in blood pressure (5 mm Hg) and triglycerides (12 mg/dL) for the active nutrition group. From a subjective perspective, participants in the active nutrition group reported improvements in their self-esteem, motivation, endurance, physical appearance, and strength (p< 0.001). The above was achieved without participants reporting any significant increase in hunger during the intervention, despite the expected reduction in calories. Adhering to a semi-structured diet plan that allows for one "regular" whole-food meal daily is well-tolerated and enhances weight loss, physiological factors, and perceived wellness. Follow-up studies with a balanced representation of biological men and women are warranted to determine the longer-term impact of this nutrition program on weight loss and markers of metabolic health.

Effectiveness of hybrid comprehensive telerehabilitation in women with heart failure - subanalysis of the TELEREH-HF RCT

Abstract Background Despite the known benefits of cardiac rehabilitation, it remains underutilized among women. In particular, little is known about the effectiveness of hybrid comprehensive telerehabilitation (HCTR) in women with heart failure (HF). Purpose: The purpose of this study was to assess effectiveness and safety of HCTR in women with HF. Methods: The present analysis formed part of TELEREH-HF multicenter, randomized trial that enrolled 850 HF patients (NYHA I-III, LVEF ≤ 40%). Patients were randomized 1:1 to HCTR plus usual care (UC) or UC alone. Patients underwent either an HCTR (1 week in hospital and 8 weeks at home, five times weekly) or UC with observation. The effectiveness of HCTR was assessed by changes in peak oxygen consumption (VO2 peak), workload duration (t) in cardiopulmonary exercise test and quality of life (QoL) based on Medical Outcome Survey Short Form 36 Questionnaire (SF-36). Measurements were made before and after intervention/observation. Results: Women constituted 11.5 % of population in the TELEREH-HF study. Forty women in HCTR group and 44 women in UC group completed HCTR and observation respectively. HCTR resulted in significant improvement in VO2peak, workload duration and QoL. We did not observe these favorable results in the UC group except for an increase workload duration. In the HCTR group, there was a significantly greater improvement in physical component of QoL than in the UC group. All results are presented in Table 1. In neither group were there deaths nor major adverse events related to exercise training. Conclusion In women with HF, hybrid comprehensive telerehabilitation is safe and resulted in a significant improvement in physical capacity and QoL.

Liver function tests in patients receiving high-intensity care after hospital admission for acute heart failure: the STRONG-HF trial

Abstract Background/Introduction Episodes of acute heart failure (AHF) unfavorably affect extra-cardiac organs such as the liver due to altered hemodynamics and neurohormonal activation. In AHF, elevated levels of levels of alanine aminotransferase (ALT) and total bilirubin (tBil) may reflect congestion and impaired liver function, while lower levels of ALT (which is also produced in muscle cells) correlate with malnutrition and sarcopenia. Thus, the clinical importance of these markers in AHF and the post-discharge period is unclear. Purpose To assess circulating concentrations of ALT and tBil in patients with AHF before discharge and during high-intensity care (HIC) vs usual care follow-up in association with clinical outcomes. Methods ALT and tBil concentrations were measured 1-2 days before discharge in patients hospitalized for AHF (baseline), and again after 90 days of either HIC or usual care according to the STRONG-HF protocol. Baseline values and changes in ALT and tBil were analyzed in association with the primary outcome of all-cause death or HF readmission by day 180. Results At baseline, the median (Q1-Q3) concentrations of ALT and tBil were 21 (15-32) U/L and 14 (10-21) umol/L, respectively. Lower levels of both ALT and tBil were associated with female sex, Black race, lower BMI, higher LVEF, lower hemoglobin, lower creatinine and less frequent atrial fibrillation/flutter, while there were no significant associations with age. Patients with lower ALT, but not tBil, were more likely to have edema, elevated JVP and orthopnea, and used higher loop diuretic doses and less beta-blockers, pre-randomization (Figure, panel A). ALT was inversely associated with risk for the primary outcome (HR 0.81 [95%CI 0.65,1.00) per log increment, p=0.05), while there was no association with risk for tBil (HR 1.04 [95%Ci 0.84-1.28], p=0.73) (Figure, panel B). After 90 days, ALT and tBil concentrations were lower than at baseline, with a greater reduction in tBil in the HIC group vs usual care group (mean -1.7 [95%CI -3.0,-0.4] umol/L, p=0.01), while there was no significant between-group differences in ALT changes (mean -0.6 [95%CI -4.7,3.4] U/L, p=0.75) (Figure, panel C). The treatment effect of HIC over usual care on the primary outcome was consistent across the range of baseline ALT (P-interaction=0.30) and tBil (P-interaction=0.80) (Figure, panel D). Conclusion Contrary to our hypothesis of higher liver function tests with hepatic congestion in AHF, lower ALT was associated with more congestion and worse outcomes among patients hospitalized for AHF in STRONG-HF. There was no prognostic value from tBil levels. This suggests that ALT may be a marker of sarcopenia in these patients. Importantly, the beneficial effect of HIC on clinical outcomes is consistent irrespective of ALT and tBil levels at discharge.Figure

REDUCE-HF: a stronger heart go a long way

Abstract Introduction/Purpose Heart failure (HF) is a serious cardiovascular condition with a significant global health concern. The risk of heart failure rehospitalisation is high globally and locally, the 30-day HF readmission was about 32% from a local study (1). The study aims to adopt an intensive treatment strategy similar to Strong-HF trial (2) and evaluate rapid up-titration of guideline directed medical therapy (GDMT) and close follow-up will improve patients' outcomes after acute heart failure (AHF). Objectives The Reduction of Decompensation and Unnecessary Cardiac failure Emergency admissions: ambulatory Heart Failure service model (REDUCE-HF) is a non-randomised prospective study evaluating clinical outcome of patients discharged from AHF. Exclusion criteria included primary valvular disorders, end-stage renal failure and metastatic cancer. After HF discharge, eligible patients were recruited into our REDUCE-HF program irrespective of LVEF. They were subsequently managed in our ambulatory HF centre within two weeks, where intensive up-titration of GDMT and close follow-up would be proceeded. The data of our service model will be compared with our 5-year historical cohort. Primary outcome comprised of all-cause mortality and heart failure hospitalisation. Secondary outcome will be comparison of clinical and functional status at baseline and 3-month on follow up. Results Between October 2022, and December 2023, 245 patients were successfully recruited into our REDUCE-HF service model. Historical cohort of 6867 patients with primary diagnosis of acute heart failure were served as control (usual care pathway), data extracted from 2018 to 2022. Their mean age was 67.8+/-12.2 and 72.2%were male. 60% of them were HFrEF (EF&amp;lt;=40%) and 28% were ischaemic cardiomyopathy. The mean follow up period was 3 months. At 90 days, REDUCE-HF cohort group has shown much lower all-cause mortality than usual care group (2.5% vs 9.3%, HR 0.26, 95% CI 0.18-0.41, p&amp;lt;0.001). There was a much lower incidence of heart failure hospitalisation in REDUCE-HF group as compared to control (8.6% vs 13.1%, HR 0.65; 95% CI 0.55 to 0.74, p&amp;lt;0.01). In secondary outcome, there was significant reduction of NT-ProBNP of 45.2% (from 4229 to 2319pg/m, p&amp;lt;0.001), tremendous increment of 6-minute walk test (from 211 to 250m, p&amp;lt;0.001) and remarkable improvement of KCCQ score from 55.1 to 86.7, p&amp;lt;0.001. The overall LVEF was significantly increased from 39% to 44%, p&amp;lt;0.05. The positive outcome were attributed to good adherence to GDMT: ACEi/ARB/ARNI 91%, Betablocker 90.3%, MRA 72.4% and SGLT2i 95.5%. Conclusion The REDUCE-HF ambulatory service model has been proven effective in reducing mortality, decompensation and preventing unnecessary heart failure hospitalisation in this prospective study. By intervening proactively, this model not only enhances the quality of life but also hold promise in alleviating the burden of in-patient services on heart failure.

Impact on healthcare costs of adding telemedicine to a multidisciplinary disease management program for heart failure: a sub-analysis of the iCOR trial

Abstract Background Impact of telemedicine on heart failure outcomes has shown conflicting results. Little is known about the effect of these programs on mid-term healthcare costs. Purpose To evaluate the cost-efficacy of a comprehensive telemonitoring program within the vulnerable post-discharge period after an acute heart failure admission. Methods The insuficiència cardiaca Optimizació Remota (iCOR) trial was a single-centre, randomized, open-label study designed to evaluate the efficacy of the addition of telemonitoring and teleintervention to a specialized multidisciplinary nurse-led heart failure (HF) program. Adult patients with a recent hospital admission for acute HF and an acceptable social support and cognitive ability were recruited. This sub-analysis evaluates the effect of telemedicine on mid-term healthcare costs, including clinical events, drugs and devices, technology purchase and maintenance, outpatient care, days of hospitalization, procedures and complementary tests. t-test via bootstrap estimation is used to compare differences between the telemedicine (TM) and the usual care (UC) groups. Results 81 patients were assigned to the TM group and 97 patients to the UC group. Mean age was 74 years, more than 50% had HF with preserved ejection fraction and 25% were frail. Baseline characteristics were well-balanced between groups. Among the TM subgroup, adherence was very high (&amp;lt; 1% of missed biometric daily transmissions). During 6 months of follow-up, mean total healthcare cost per patient was 7949 euros (€) in the UC cohort and 4383 € in the TM cohort (relative risk reduction [RRR] of 45%; between-group differences 3546 €, 95% confidence interval 627-6464 €, bootstrap achieved significance level 0.022). This result was consistent across several subgroups (age, sex, frailty, left ventricular ejection fraction, educational level) and mainly driven by a 63% RRR in costs of hospitalization (which accounted for two-thirds of the total costs) in the TM cohort. 20 patients required HF admissions in the TM group, compared to 51 patients in the TM group (p &amp;lt; 0.001). This was associated with a 59% RRR in the need for diagnostic procedures. Total number of days of hospitalization per patient decreased from 12.2 in the UC group to 4.2 days in the TM group (p = 0.003), impelled by a reduction in HF and cardiovascular days of hospital stay. On the contrary, ambulatory care costs increase two-fold in the TM group compared to UC group. Nevertheless, these costs only accounted for a 19% of the total costs. Cost of devices needed to implement TM supposed 698 € per patient. Use of TM was associated with a 355 € increase in the cost of ambulatory neurohormonal treatment for HF. Conclusions TM implementation during the vulnerable phase after an acute HF admission was associated to a 45% RR reduction in mean total healthcare cost per patient. This result was driven by an almost two-thirds decrease in costs of hospitalization.UC and TM total healthcare costs

The cost-effectiveness of a digitally enabled telerehabilitation program delivered nationally to patients in Australia

Abstract Introduction Traditionally delivered cardiac rehabilitation (CR) programs have considerable benefits, yet access and participation remains low. Emerging digital health models offer promise in healthcare delivery, but their benefits and impact on healthcare utilization and cost-effectiveness are uncertain. We conducted a cost-effectiveness analysis of a telehealth program with a CR mobile app for post-hospitalization coronary heart disease (CHD) patients. Purpose To assess whether a digitally enabled CR program is cost-effective compared with a propensity matched usual care control group in the Australian health system. Methods Patients were recruited nationally, through a health insurer, following hospitalization for CHD. Participants received weekly telehealth consultations for up to 8 weeks, supplemented by use of an mHealth app. Using administrative private health insurance claims data, we assessed differences in hospital costs, mortality rates and bed days at 12-months post discharge. Incremental cost effectiveness ratios (ICERS) were calculated to determine the cost per deaths prevented and cost per bed days saved for the digital-CR group (n=133) compared with usual care (n=266). Results Among the cohort, 36% lived in regional/rural areas, 70% were male and the mean age was 68 years. The mean total hospital all cause readmission costs at 12-months were $1,488 AUD less in the digital-CR group ($16,411) compared to the usual care group ($17,899). Digital-CR had fewer total hospital days relative to the usual care group (median of 2 vs 3 days) and patients in the digital-CR group had a significantly lower mortality rate at 12-months post discharge. The ICERs were -$337 per 100 patient deaths prevented and -$3,033 per median bed days saved. Conclusion The implementation of a digital-CR program demonstrates cost-effectiveness for patients with CHD when compared to usual care. Thus, advocating for the widespread availability of digital-CR programs as an option for CHD patients following hospital discharge is warranted.

Early, Individualized Recommendations for Hospitalized Patients With Acute Kidney Injury

Acute kidney injury (AKI) is a common complication during hospitalization and is associated with adverse outcomes. To evaluate whether diagnostic and therapeutic recommendations sent by a kidney action team through the electronic health record improve outcomes among patients hospitalized with AKI compared with usual care. Randomized clinical trial conducted at 7 hospitals in 2 health systems: in New Haven, Bridgeport, New London, and Waterbury, Connecticut, and Westerly, Rhode Island; and in Baltimore, Maryland. Hospitalized patients with AKI were randomized between October 29, 2021, and February 8, 2024. Final follow-up occurred February 22, 2024. An alert about AKI was sent to the kidney action team, consisting of a study physician and study pharmacist, which sent personalized recommendations through the electronic health record in 5 major categories (diagnostic testing, volume, potassium, acid base, and medications) within 1 hour of AKI detection. The note was immediately visible to anyone with access to the electronic health record. Randomization to the intervention or usual care occurred after the recommendations were generated, but the note was only delivered to clinicians of patients randomized to the intervention group. The primary outcome was a composite outcome consisting of AKI progression to a higher stage of AKI, dialysis, or mortality occurring while the patient remained hospitalized and within 14 days from randomization. Of the 4003 patients randomized (median age, 72 years [IQR, 61-81 years), 1874 (47%) were female and 931 (23%) were Black patients. The kidney action team made 14 539 recommendations, with a median of 3 (IQR, 2-5) per patient. The primary outcome occurred in 19.8% of the intervention group and in 18.4% in the usual care group (difference, 1.4%, 95% CI, -1.1% to 3.8,% P = .28). Of 6 secondary outcomes, only 1 secondary outcome, rates of recommendation implementation, significantly differed between the 2 groups: 2459 of 7270 recommendations (33.8%) were implemented in the intervention group and 1766 of 7269 undelivered recommendations (24.3%) were implemented in the usual care group within 24 hours (difference, 9.5%; 95% CI, 8.1% to 11.0%). Among patients hospitalized with AKI, recommendations from a kidney action team did not significantly reduce the composite outcome of worsening AKI stage, dialysis, or mortality, despite a higher rate of recommendation implementation in the intervention group than in the usual care group. ClinicalTrials.gov Identifier: NCT04040296.

Effectiveness of a package of community-based mental healthcare services to address perinatal mental disorders in Bangladesh: A cluster-randomized controlled trial

BackgroundPerinatal mental disorders of women have an impact on their pregnancy and their child’s brain development across low and middle-income countries. However, to address this issue, there are no specific guidelines for community-level service providers in Bangladesh. Therefore, we aimed to develop a community-based mental healthcare (CBMHC) service package and test its effectiveness in reducing depression, anxiety, and stress among mothers during the perinatal period. MethodsA cluster-randomized controlled trial (cRCT) was applied to test the CBMHC package in 2017 and 2018. It was provided to one group of mothers along with routine maternal care while another group received only routine maternal care. Paired sample t-test was applied to assess mean changes at baseline and endline in the Depression, Anxiety, and Stress Scales-21 (DASS-21) and EuroQol-5 Dimension and 3 Level (EQ5D3L) scales. A linear mixed-effects model was used to assess the relationship between the DASS-21 score and EQ5D3L. Results1215 participants were enrolled, including 605 in the intervention group and 610 in the control group. Measures of depression, anxiety, and stress were significantly decreased in both groups. Reduction in the levels of stress, as measured by changes in the stress score, were significantly greater in the intervention than in the control group (diff: 1.2, 95 % CI: 0.1, 2.2). The EQ5D3L index improved significantly, 0.02 units more at endline in the intervention group than in the control group (diff: 0.02, 95 % CI: 0.007, 0.03). The levels of mobility, usual activities, pain or discomfort, depression, and anxiety improved by 1.4 %, 7.6 %, 4.4 %, 2.6 %, and 0.4 % more, respectively, in the intervention group compared to the control groups. These improvements were statistically significant. The DASS-21 score was negatively and significantly correlated with both the EQ-5D3L index and the Visual Analogue Scale (VAS) score for the intervention group as well as for the usual care group, indicating that EQ5D3L improved when common mental disorders decreased. ConclusionAlthough the improvements were modest, a CBMHC service package was effective in reducing perinatal levels of stress among Bangladeshi rural women. Trial RegistrationClinicalTrials.gov ID: NCT03678415

A Mail-Based HPV Self-Collection Program to Increase Cervical Cancer Screening in Appalachia: Results of a Group Randomized Trial.

Despite the promise of mail-based human papillomavirus (HPV) self-collection programs for increasing cervical cancer screening, few have been evaluated in the United States. We report the results of a mail-based HPV self-collection program for underscreened women living in Appalachia. We conducted a group randomized trial during 2021-2022 in the Appalachian regions of Kentucky, Ohio, Virginia, and West Virgnia. Participants were women ages 30-64 who were underscreened for cervical cancer and from a participating health system. Participants in the intervention group (n=464) were mailed an HPV self-collection kit followed by telephone-based patient navigation (if needed), and participants in the usual care group (n=338) were mailed a reminder letter to get a clinic-based cervical cancer screening test. Generalized linear mixed models compared cervical cancer screening between study groups. Overall, 14.9% of participants in the intervention group and 5.0% of participants in the usual care group were screened for cervical cancer. The mail-based HPV self-collection intervention increased cervical cancer screening compared to the usual care group (OR=3.30, 95% CI: 1.90-5.72, p=0.005). One or more high-risk HPV types were detected in 10.5% of the returned HPV self-collection kits. Among participants in the intervention group who patient navigators attempted to contact, 44.2% were successfully reached. HPV self-collection increased cervical cancer screening, and future efforts are needed to determine how to optimize such programs, including the delivery of patient navigation services. Mail-based HPV self-collection programs are a viable strategy for increasing cervical cancer screening among underscreened women living in Appalachia.

Advancing Community Care and Access to Follow-Up after Acute Kidney Injury Hospitalization: A Randomized Clinical Trial.

Key Points A risk-guided intervention improved adherence to processes of care for AKI survivors.Further supports are necessary to improve uptake of processes of care for AKI survivors in primary care. Background AKI is associated with development and progression of CKD. Gaps in recommended care for CKD are common after AKI. Methods In this randomized controlled trial conducted in Alberta, Canada, we allocated adults hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or greater AKI to a risk-guided, transition of care intervention versus usual practices at the time of hospital discharge. For people in the intervention group, we used a validated risk index to predict risk of severe CKD after AKI. People at low risk (&lt;1%) received patient education alone. People at medium risk received additional clinical guidance, provided to their primary care physician. People at high risk (&gt;10%) were referred to nephrology. The primary outcome was the proportion of patients who received treatment with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin II receptor blocker (ARB), statin, and nephrology specialist follow-up within 90 days of discharge. Results One hundred fifty-five patients were recruited; the mean (SD) age was 60 (15) years, 91 (60%) were male, and 96 (62%) had eGFR &lt;60 ml/min per 1.73 m2 or urine albumin-creatinine ratio &gt;30 mg/g at discharge. The proportion of participants who received ACE-I/ARB, statin treatment, and nephrologist follow-up was 28% in the intervention group versus 3% in the usual care group (absolute risk difference [RD], 25%; 95% confidence interval [CI], 15% to 36%). The use of ACE-I or ARB in participants with urine albumin-creatinine ratio &gt;300 mg/g or diabetes was greater in the high-risk group with the intervention versus usual care (RD, 37%; 95% CI, 6% to 67%), as was statin use among those with CKD (RD, 30%; 95% CI, 5% to 56%) and nephrologist follow-up for those with sustained eGFR &lt;30 ml/min per 1.73 m2 at discharge (RD, 78%; 95% CI, 56% to 100%). Hyperkalemia was more frequent in the intervention group (RD, 10%; 95% CI, 9% to 19%). Conclusions A risk-guided intervention for patients hospitalized with AKI increased recommended processes of care for CKD for high-risk patients after hospital discharge. Clinical Trial registry name and registration number: Improving Post Discharge Care after Acute Kidney Injury (AFTER AKI), NCT02915575.

High-Risk Medications in Persons Living With Dementia

Individuals with Alzheimer disease (AD) and Alzheimer disease-related dementias (ADRD) may be at increased risk for adverse outcomes relating to inappropriate prescribing of certain high-risk medications, including antipsychotics, sedative-hypnotics, and strong anticholinergic agents. To evaluate the effect of a patient/caregiver and prescriber-mailed educational intervention on potentially inappropriate prescribing to patients with AD or ADRD. This prospective, open-label, pragmatic randomized clinical trial, embedded in 2 large national health plans, was conducted from April 2022 to June 2023. The trial included patients with AD or ADRD and use of any of 3 drug classes targeted for deprescribing (antipsychotics, sedative-hypnotics, or strong anticholinergics). Patients were randomized to 1 of 3 arms: (1) a mailing of educational materials specific to the medication targeted for deprescribing to both the patient and their prescribing clinician; (2) a mailing to the prescribing clinician only; or (3) a usual care arm. Analysis was performed using a modified intention-to-treat approach. The primary study outcome was the dispensing of the medication targeted for deprescribing during a 6-month study observation period. Secondary outcomes included changes in medication-specific mean daily dose and health service utilization. Among 12 787 patients included in the modified intention-to-treat analysis, 8742 (68.4%) were female, and the mean (SD) age was 77.3 (9.4) years. The cumulative incidence of being dispensed a medication targeted for deprescribing was 76.7% (95% CI, 75.4-78.0) in the patient and prescriber mailing group, 77.9% (95% CI, 76.5-79.1) in the prescriber mailing only group, and 77.5% (95% CI, 76.2-78.8) in the usual care group. Hazard ratios were 0.99 (95% CI, 0.94-1.04) for the patient and prescriber group and 1.00 (95% CI, 0.96-1.06) for the prescriber only group compared with the usual care group. There were no differences between the groups for secondary outcomes. These findings suggest medication-specific educational mailings targeting patients with AD or ADRD and their clinicians are not effective in reducing the use of high-risk medications. ClinicalTrials.gov Identifier: NCT05147428.

Organized cervical cancer screening: A randomized controlled trial assessing the effect of sending invitation letters

ObjectiveTo evaluate the effect of implementing two modalities of organized Cervical Cancer Screening (CCS) program on screening uptake after a six-month delay. MethodsA three-armed cluster randomized control trial was conducted in France between January 8 and July 2, 2021, involving148 510 women aged 40 to 65 and 1070 general practitioners.In the Optimized screening group, an invitation letter was posted to non-adherent women, and general practitioners were sent a list of their non-adherent patients.In the Organized screening group, an invitation letter was posted to non-adherent women.In the Usual care group, no invitation was sent.The endpoint was cervical cancer screening uptake after a six months period a) among all eligible women (primary endpoint); and b) among initially non-adherent women (post-hoc analysis).Statistical analysis was based on a logistic mixed model that compared between-group percentages of adherent women. A hierarchical comparison successively tested differences between the three arms (alpha 5 % risk). ResultsAmong all 148,510 eligible women, screening uptake was 63.6 % (31,731/49910) in the Optimized screening group vs 61.8 % (30,210/48847) in the Usual care group (OR [IC95 %] = 1.05[0.93; 1.18]).Among the 64,370 initially non-adherent women, screening uptake was 17.9 % (3955/22134) in the Optimized screening group vs 11.6 % (5321/20995) in the Usual care group (OR [IC95 %] = 1.70[1.56;1.86]). There was no significant difference between Optimized and Organized screening groups (17.2 % vs 17.9 %; OR [IC95 %] = 1.02[0.94; 1.11]). ConclusionsThe implementation of an organized screening based on an invitation letter resulted in a modest increase in participation among non-adherent women six months later.