Usual Care Patients Research Articles

Abstract 4127909: Smartphone-enabled, home-based exercise in patients with symptomatic peripheral arterial disease: the Smart Step Grady randomized trial

Introduction: About 10% of peripheral artery disease (PAD) patients develop claudication, with African Americans at higher risk and more severe symptoms. While supervised exercise therapy (SET) is a primary treatment, its uptake is low. We assessed the feasibility and effectiveness of smartphone-delivered home-based exercise therapy (HBET) in improving functional capacity and PAD symptoms in low-resource settings lacking SET. Methods: We conducted an interim analysis of Smart Step, a pilot randomized trial (1:1 ratio) comparing smartphone-enabled HBET to usual care (UC) in symptomatic PAD patients at Grady Memorial Hospital, a public safety net hospital in Atlanta, GA, from August 2018 to March 2024. The HBET group received virtual exercise coaching, app-based education, messaging, and reminders for 12 weeks. The primary outcome was the change in 6-minute walking distance (6MWD) at 12 weeks. Secondary outcomes included changes in the Walking Impairment Questionnaire (WIQ) and Short Form 36 (SF-36) scores. Data were analyzed using intention-to-treat, with mixed model repeated measures regression assessing the association between 6MWD and treatment. Results: We screened 102 patients and enrolled 46. To date, 26 (56%) participants have completed the study, 6 (13%) dropped out, and 14 (30%) are pending completion. The mean [SD] age was 63 [12] years, with 50% female and 90% African American. After 12 weeks, the mean 6MWD increased by 15.7 m from a baseline of 336.0 m in the HBET arm (n=13) and decreased by 6.6 from a baseline of 310.2 m in the UC arm (n=13). The between-group difference was 22.4 [95% CI -11.8 – 56.6] m; p=0.19). The WIQ stair climbing score changed by -10.9 in the UC arm vs. 7.1 in the HBET arm (between group difference 17.9 [95% CI 1.1-34.8]; p=0.04), while the other WIQ sub-scores were more similar between groups. The 12-week changes in SF-36 scores were not different by group. Conclusion: In this preliminary analysis, the HBET arm showed within-group improvements in 6MWD and symptoms after 12 weeks, but most changes were not significantly different when comparing them with the UC arm. Future analyses are pending and will provide the necessary statistical power for a more precise measure of the treatment effects.

Does Implementation of Office Based Addiction Treatment by a Nurse Care Manager Increase the Duration of OUD Treatment in Primary Care? A Secondary Analysis of the PROUD Randomized Control Trial

BackgroundImplementation of office-based addiction treatment (OBAT) by nurse care managers increases overall use of OUD medication, but it is unknown whether it increases treatment duration among treated patients. MethodsThe Primary Care Opioid Use Disorders Treatment (PROUD) trial was a pragmatic, cluster-randomized trial testing whether implementation of OBAT increased OUD treatment in 12 primary care clinics in 6 systems. One of 2 clinics per system was randomized to implement OBAT (intervention), the other, usual care (UC). We evaluated treatment duration for the 3 years after nurses began seeing patients at clinics randomized to intervention vs. UC. The primary sample included patients newly initiating OUD medication; the secondary sample included patients with ongoing OUD medication. The primary outcome was percentage of days with OUD medications after treatment initiation, modeled using linear generalized estimating equations (GEE). Modified Poisson GEE models assessed secondary outcomes (≥80% of days covered, ≥6 months on treatment). ResultsIn adjusted analyses, the mean difference between intervention and UC in percent days treated was 6.3% (95% CI -9.6%, 22.1%) in the primary sample and 2.3% (95% CI -36.4%, 31.8%) in the secondary sample. There was no significant difference in treatment duration between intervention and UC patients in either primary or secondary outcomes. ConclusionsImplementation of OBAT in this trial did not measurably increase duration of medication treatment among those treated for OUD compared to UC, suggesting that benefits of OBAT, at least in this trial, largely reflect increases in treatment access.

Prehabilitation in Patients at Risk of Poorer Outcomes Following Total Knee Arthroplasty: A Systematic Review

IntroductionWhile total knee arthroplasty (TKA) is a generally successful procedure, 10 to 30% of patients still report suboptimal outcomes after surgery. Prehabilitation may offer potential benefits to improve poorer outcomes, although its effectiveness remains uncertain. Our study aimed to assess the efficacy of prehabilitation interventions on patients at risk of poor outcomes following TKA. MethodThere were six electronic databases searched up until December 2023. All randomized controlled trials (RCTs) comparing prehabilitation versus usual care in adult patients with osteoarthritis undergoing primary TKA and at risk of poorer outcomes were included. There were four reviewers who independently extracted data and assessed the risk of bias for each study. ResultsThe 13 included studies assessed prehabilitation among patients at risk of poor outcomes, identified with various factors including range of motion deficit, functional limitations, high body mass index, psychological factors, frailty, older age, central sensitization, and high risk of discharge to inpatient rehabilitation. The interventions were initiated across a wide range, from four to 277 days before surgery. The efficacy of exercise therapy and multidisciplinary rehabilitation remains inconclusive due to limited, low-quality evidence. The results failed to indicate that various forms of non-exercise therapy, including education, psychological intervention, and weight loss therapy, were effective in improving outcomes after TKA. The included studies have major limitations such as small sample size, inappropriate comparators, substantial clinical heterogeneity in intervention characteristics, inadequate blinding for providers and participants, a lack of justification for identifying patients at risk of poor recovery, and a lack of appropriate interventions for managing modifiable factors. ConclusionWhile our finding fails to show that non-exercise therapy is effective, results of exercise therapy and multidisciplinary rehabilitation remain inconclusive. Further high-quality research is warranted to establish evidence on modifiable factors predictive of poorer postoperative outcomes and investigate how they can be effectively managed.

Ferric derisomaltose versus usual care in patients with heart failure, reduced ejection fraction, and iron deficiency: a short-term UK cost-utility analysis based on the IRONMAN RCT

Abstract Background In the IRONMAN trial, patients with heart failure (HF), a reduced ejection fraction and iron deficiency who were randomly assigned to ferric derisomaltose (FDI), rather than usual care, had a lower rate of the composite of hospitalization for heart failure (HHF) and cardiovascular (CV) death (rate ratio, RR, 0.82; 95% CI 0.66 to 1.02; p=0.07). A COVID-19 sensitivity analysis, censoring data at 1 year of follow-up showed a greater magnitude of treatment effect (RR 0.66; 95% CI 0.48 to 0.91; p=0.011). Purpose Patient-level data from IRONMAN were used to evaluate the effectiveness and cost-utility of FDI compared to usual care for patients with a current or recent HHF, or raised plasma natriuretic peptide concentrations, from a UK National Health Service (NHS) perspective. Methods A cost-utility analysis (CUA) was conducted covering the first year after randomization. Numbers-needed-to-treat (NNTs) were calculated for the primary endpoint censored at 1 year. In the CUA model, patient survival and rates of (re)hospitalization due to HF, other CV events, infections, respiratory conditions, and other non-CV events were modeled based directly on data from the IRONMAN RCT. UK-specific costs were obtained from the national schedule of NHS costs. Quality of life was estimated based on EQ-5D-5L data collected from patients included in the IRONMAN RCT. Results were undiscounted and reported as absolute and incremental costs in 2023 pounds sterling, and quality-adjusted life expectancy in quality-adjusted life years (QALYs). A willingness-to-pay threshold of £20,000 per QALY was adopted to allow calculation of a net monetary benefit (NMB), a summary measure of the overall value of FDI in monetary terms, capturing changes in both cost and QALY outcomes. Results The NNT analysis showed that 9 patients would need to be treated with FDI to avoid one composite primary endpoint event (CV death and HHF) over 1 year. Relative to usual care, FDI was associated with an improvement of 0.01 QALYs per patient over 1 year (0.58 versus 0.57 QALYs). Total average costs per-patient were £1,672 for FDI, versus £1,975 for usual care, leading to a saving of £302 per patient with FDI. The cost of iron procurement was more than offset by reductions in costs of (re)hospitalizations (Figure). FDI was therefore dominant over usual care, yielding an NMB of £483 over 1 year. Conclusions This short-term, within-trial CUA suggests that FDI both improves QALYs and reduces healthcare expenditure versus usual care when administered to patients with HF and iron deficiency in the UK. Iron repletion with FDI may be a prudent allocation of healthcare resources in this patient population.Breakdown of costs

Low-density lipoprotein cholesterol goal attainment with "inclisiran first" versus usual care in patients with atherosclerotic cardiovascular disease

Abstract Background Rapid and sustained attainment of guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals is critical for patients with atherosclerotic cardiovascular disease (ASCVD). In VICTORION-INITIATE, inclisiran administered twice-yearly by a healthcare professional earlier in the treatment pathway allowed more patients with ASCVD to achieve and sustain LDL-C goals vs current usual care (UC). Purpose To evaluate cumulative LDL-C exposure in the overall population and LDL-C goal attainment and safety in subgroups of participants (type of ASCVD, timing of ASCVD event, and history of statin intolerance) who received an "inclisiran first" implementation strategy (IF; adding inclisiran immediately on failure to achieve LDL-C <70 mg/dL [1.8 mmol/L] with maximally tolerated statins) compared with UC. Methods VICTORION-INITIATE was a 330-day, prospective, pragmatically designed trial that randomised participants 1:1 (stratified by insurance status) to IF (open-label inclisiran 284 mg at Days 0, 90 and 270 plus UC) or UC alone (lipid management directed by treating physician’s discretion). The study took place at 45 sites across 20 states in the USA. Treating physicians had access to LDL-C measurements and were encouraged to intensify treatment per clinical practice guidelines. This prespecified subgroup analysis evaluated LDL-C goal attainment by timing of the most recent ASCVD event (<1 year/≥1 year prior to consent), ASCVD subtype (coronary heart disease [CHD], peripheral arterial disease [PAD], and cerebrovascular disease [CVD]) and statin intolerance status. Cumulative LDL-C exposure over time in the overall population and safety by subgroup were also evaluated. Results Of 450 patients randomised to IF or UC, 11.1% and 84.2% had an ASCVD event <1 year or ≥1 year prior to consent, respectively; 91.8%, 18.2% and 14.7% had a history of CHD, CVD or PAD, and 25.8% were statin intolerant. Cumulative exposure to LDL-C to Day 330 was lower in patients treated with IF vs UC (mean time-adjusted LDL-C: 42.4 mg/dL vs 90.7 mg/dL, Figure). Significantly more patients who received IF achieved LDL-C goals of <70 mg/dL and <55 mg/dL at Day 330 vs UC, irrespective of subgroup (Table). Across subgroups, the incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs were similar between IF and UC (IF: 52.6−71.2%, UC: 46.2−66.0% and IF: 10.7−28.3%, UC: 11.4−22.2%, respectively). Conclusions Participants with ASCVD and LDL-C >70 mg/dL who received IF had lower cumulative LDL-C exposure over the study period than those treated with UC. IF resulted in rapid and sustained achievement of LDL-C goals regardless of ASCVD subtype, event timing and statin intolerance. The safety profile of IF was consistent across the subgroups analysed.

VA-ECMO-related complications seem not causally related to mortality in patients with acute myocardial infarction complicated by cardiogenic shock

Abstract Background Recently published randomized controlled trials and an individual patient data meta-analysis showed that the routine use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) did not reduce mortality compared to medical therapy alone in patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). Purpose The aim of this study was to investigate as to whether possible VA-ECMO-related medical complications might be associated with an increased mortality risk, which might explain the observed equipoise among mortality outcomes between VA-ECMO and usual care in patients with AMI-CS. Methods Using data from the randomized ECLS-SHOCK trial (Extracorporeal Life Support in Infarct-Related Cardiogenic Shock), which compared routine VA-ECMO use versus medical therapy alone. Causal mediation analyses (primary analysis; VA-ECMO-related complications used as a mediator), logistic regression and causes of death analyses (secondary analyses) were utilised to test potential effects of possible VA-ECMO-related complications on 30-day mortality. Analyses were adjusted for risk factors of bleeding and vascular complications. Results In total, 417 patients were included in this analysis. Moderate and severe bleeding as well as peripheral vascular complications requiring intervention were identified as possible VA-ECMO-related complications. A total of 88 patients (21.1%) developed possible VA-ECMO-related complications, which mostly occurred within five days after randomisation and more frequently in the VA-ECMO group than in the control group: 49 (23.4%) vs. 20 (9.6%) patients, p<0.001 for bleeding and 23 (11.0%) vs. 8 (3.8%) patients, p=0.01 for peripheral vascular complications, respectively. Causal mediation analyses revealed no significant mediation effect of possible VA-ECMO-related complications on 30-day mortality (p=n.s.; Figure). Logistic regression and causes of death analyses of possible VA-ECMO-related complications confirmed no significant associations between the incidence of VA-ECMO-related complications and mortality (p=n.s.). Conclusion VA-ECMO use in patients with AMI-CS was associated with increased incidences of moderate to severe bleeding as well as vascular complications warranting intervention. In this causal mediation analysis, VA-ECMO-related complications do not appear to mediate an increased mortality risk.

Value-based versus usual care for heart failure patients leads to reduction in cost, hospital admissions and improved survival

Abstract Background OptumCare (OC) in our city, Nevada established a heart failure (HF) program comprised of a team of outpatient cardiologists including two who are board certified in advanced heart failure. Referred patients are enrolled in the HF program once HF is diagnosed by a cardiologist. Patients are managed by an interdisciplinary team of cardiologists, advanced practice clinicians (APC), registered nurse case managers (RNCM), and a social worker. Patients at higher risk for HF admissions are enrolled in remote patient telemonitoring. In contrast, OC in Arizona utilizes a "usual" care approach of fee-for-service contracted cardiology groups to manage HF patients in outpatient and in-patient settings. Purpose A head-to-head comparison was performed between the cohort of patients enrolled in HF program in OC Nevada (treatment group) and patients with HF diagnosis in OC Arizona (control group). The groups were compared on the following measures: medical cost, hospital admissions, and survival rates. Methods In this retrospective study, a 1:1 iterative propensity score (PS) matching was performed to closely approximate patient demographics and comorbidities, which resulted in 818 matched pairs (total n=1,636) of the patients with program enrollment or 1st HF diagnosis between March 1, 2019 and June 30, 2022. For Difference-in-Difference Analysis (Diff-in-Diff), generalized linear models were used on PS matched data to test the difference in difference in medical cost and utilizations changes between control and treatment group over a six month period. Log-Binomial regression was used to estimate the relative risk of post period 30-day readmission and hospice enrollment. Kaplan Meier Estimator was used to test the difference in survival rates over time. Results Average age of patients was 77.6 years old, and 49% were female. The treatment group resulted in significantly lower overall medical costs per member per month (PMPM), significantly less emergency room (ER) visits, less acute hospital and skilled nursing facility (SNF) admissions, and shorter overall hospital length of stays. The control group was twice as likely to be readmitted to the hospital. Lastly, the treatment group had a significantly better survival rate than the control group. 19% of the patients in the control group expired within 12 months of enrollment vs. 10% of the patients in the treatment group expired during the same time period. Average survival was 142 days in the control group vs. 200 days in the treatment group. Conclusions A value-based care approach involving a multidisciplinary team in an outpatient-based cardiology HF program resulted in statistically significant improvement in medical costs, acute care visits/admissions, and survival rates compared to "usual" care approach for HF patients.

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.

Effect of correcting iron deficiency on the risk of serious infection in heart failure: Insights from the IRONMAN trial.

Concerns exist that intravenous (IV) iron might increase the risk of infections. The IRONMAN trial provided an opportunity to investigate whether giving IV ferric derisomaltose (FDI) to patients with heart failure and iron deficiency alters the rate of hospitalization or death due to infections. IRONMAN was a randomized trial of IV FDI versus usual care in patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤45%, and transferrin saturation (TSAT) <20% or ferritin <100 μg/L. Infection was a pre-specified, blindly-adjudicated, safety endpoint. The primary analysis of interest was infection as the main reason for hospitalization or death, using first and recurrent events analyses. The composite primary event of interest tended to be lower in those randomized to FDI when analysed as first (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.62-1.01, p = 0.055) or recurrent event (rate ratio 0.85, 95% CI 0.64-1.13, p = 0.089). The composite results were driven by fewer hospitalizations for infection (HR 0.76, 95% CI 0.49-0.98, p = 0.032), with 5% fewer patients (absolute reduction) experiencing such an event if assigned to FDI. Similar trends were observed for recurrent events (HR 0.82, 95% CI 0.62-1.10). Further analyses suggested that the reduction in hospitalizations due to infection with FDI was restricted to patients with TSAT <20%. In patients with heart failure and a reduced LVEF, correction of iron deficiency is not associated with an increased risk of hospitalization or death from infection, and may reduce such events, especially when TSAT is <20%. ClinicalTrials.gov, NCT02642562.

The effectiveness of early mobilisation on physical function in patients after heart valve surgery: a systematic review

Background/Aims Literature suggests that early mobilisation, defined as the initiation of physical activity within 48 hours following surgery, improves outcomes after cardiac surgery. This systematic review assessed the effectiveness of early mobilisation on physical function and other outcomes, including length of hospital stay and cost following heart valve surgery. Methods The Physiotherapy Evidence Database, MEDLINE, EMBASE, CINAHL and Cochrane Library were systematically searched from inception until May 2022 using relevant key words. Randomised controlled trials comparing early mobilisation and usual care for patients who had received heart valve surgery were included in the review. Methodological quality was assessed using the Physiotherapy Evidence Database scale and risk of bias using the Cochrane Risk of Bias 2 tool. The data were narratively synthesised. Results The search identified 210 articles, with 98 remaining after duplicates were removed. Upon screening for eligibility, nine articles were assessed in full and three randomised controlled trials involving 161 patients were included in the review. Early mobilisation protocols varied across trials. Two trials (n=124) reported significantly greater improvement in physical function with early mobilisation compared to usual care, including handgrip strength (P=0.001). One study (n=41) found early mobilisation significantly reduced the length of hospital stay (P=0.000), in-hospital care costs (P=0.000) and intensive care unit stay (P=0.000) compared to usual care. Methodological quality scores ranged from six to nine on the Physiotherapy Evidence Database scale. The risk of biased judgement was ‘low’ in one study and ‘some concerns’ in two studies. Conclusions Early mobilisation may improve physical function and reduce hospital and intensive care unit stays after heart valve surgery. However, differences in protocols and limited studies indicate further high-quality research is needed, particularly regarding cost-effectiveness. Establishing clear early mobilisation protocols could enhance recovery in this population. Implications for practice Early mobilisation may require the coordinated effort of a multidisciplinary team of physiotherapists, nurses and possibly other medical professionals. For its seamless and effective implementation, it is essential to understand whether this intervention falls under the domain of physiotherapists or requires broader team collaboration. Given these complexities, strategies targeting early mobilisation that balance both safety and resource considerations are advised to improve physical function after heart valve surgery, especially among patients who are frail.

Health Literacy Directed Weight Loss Intervention in Primary Care Clinics.

Low income and low health literacy are associated with poorer health knowledge, health behaviors and poor health outcomes. The effectiveness of health literacy-directed weight loss treatment interventions in primary care clinics is lacking. The aim of this study was to conduct a pragmatic cluster-randomized trial (PROmoting Successful Weight Loss in Primary CarE in Louisiana ([PROPEL]) to test the effectiveness of a 24-month, patient-centered, literacy-directed obesity treatment program delivered within primary care in an underserved population. This study reports the association between health literacy and program effectiveness, examining potential correlates of weight loss related to patient adherence to the program. We randomly assigned 18 clinics to usual care (UC) or a health literacy-directed lifestyle intervention (HLI). The primary outcome was percent weight loss at 24 months. Of 803 adult participants (84% women; 67% Black), 31% had limited health literacy. Patients in UC lost an average of 0.44%of their enrollment weight after 24 months. Those with adequate literacy lost 0.57% and those with limited literacy lost 0.30%, which was not significantly different. The HLI patient group lost an average of 4.9% of their enrollment weight. Those with adequate literacy lost 5.2% and those with limited literacy, 4.7%, which was not significantly different. The advantage of adequate health literacy was consistent across the 24-month study period, though not significant. Patients in the HLI group with adequate health literacy had greater percent weight loss by a margin of 0.50 ± 0.75 (p = .50), while the UC margin was 0.27 ± 0.84 (p = .74). The percent weight loss difference between HLI and UC groups was 4.6 ± 0.8 (p < .001) among patients with adequate health literacy and 4.4 ± 1.0 (p < .001) among patients with limited health literacy. The difference in percent weight loss between the HLI and UC groups was 0.2 ± 1.1 (p = .84) higher for adequate literacy patients. A health literacy directed health coaching intervention in community clinics led to significant weight loss over 24 months but did not vary by level of patient health literacy. [HLRP: Health Literacy Research and Practice. 2024;8(4):e204-e211.].

Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of a Presurgical Toolkit (OPTI-Surg)-Final Results of a Phase III Cluster Randomized Trial (Alliance A231601CD).

To assess the effect of a practice-level preoperative frailty screening and optimization toolkit (OPTI-Surg) on postoperative functional recovery and complications in elderly cancer patients undergoing major surgery. Frailty is common in older adults. It increases the risk of poor postoperative functional recovery and complications. The potential for a practice-level screening/optimization intervention to improve outcomes is unknown. Thoracic, gastrointestinal, and urologic oncological surgery practices within the National Cancer Institute Community Oncology Research Program (NCORP) were randomized 1:1:1 to usual care (UC), OPTI-Surg, or OPTI-Surg with an implementation coach. OPTI-Surg consisted of the Edmonton Frail Scale and guided recommendations for referral interventions. Patients 70 years old or above undergoing curative intent surgery were eligible. The primary outcome was 8 weeks postoperative function (kcal/wk). The key secondary outcome was complications within 90 days. Mixed models were used to compare UC to the 2 OPTI-Surg arms combined. From July 2019 to September 2022, 325 patients were enrolled in 29 practices. One hundred ninety-nine (64 UC, 135 OPTI-Surg) and 279 (78 UC, 201 OPTI-Surg) were evaluable for primary and secondary analysis, respectively. UC and OPTI-Surg patients did not significantly differ in total caloric expenditure (2.2 UC, 2.0 OPTI-Surg) after adjusting for baseline function ( P =0.53). UC and OPTI-Surg patients did not significantly differ in postoperative complications (25.6% UC, 35.3% OPTI-Surg, P =0.5). Frailty assessment was successfully performed, but the OPTI-Surg intervention did not improve postoperative function nor reduce postoperative complications compared with UC. Future analysis will explore practice-level factors associated with toolkit implementation and the differences between the coaching and noncoaching arms.

Cost-Effectiveness of an Extended-Role General Practitioner Clinic for Persistent Physical Symptoms: Results From the Multiple Symptoms Study 3 Pragmatic Randomized Controlled Trial

ObjectivesThis study aimed to evaluate the cost-effectiveness of an extended-role general practitioner symptoms clinic (SC), added to usual care (UC) for patients with multiple persistent physical symptoms (sometimes known as medically unexplained symptoms). MethodsThis was a 52-week within-trial cost-utility analysis of a pragmatic multicenter randomized controlled trial comparing SC + UC (n = 178) with UC alone (n = 176), conducted from the primary perspective of the UK National Health Service and personal and social services (PSS). Base-case quality-adjusted life-years (QALYs) were measured using EQ-5D-5L. Missing data were imputed using multiple imputation. Cost-effectiveness results were presented as incremental cost-effectiveness ratios and incremental net monetary benefits. Uncertainty was explored using cost-effectiveness acceptability curves (using 1000 nonparametric bootstrapped samples) and sensitivity analysis (including societal costs, using SF-6D and capability measure for adults outcomes to estimate QALYs and years of full capability, respectively, varying intervention costs, missing data mechanism assumptions). ResultsMultiple imputation analysis showed that compared with UC alone, SC + UC was more expensive (adjusted mean cost difference: 704; 95% CI £605-£807) and more effective (adjusted mean QALY difference: 0.0447; 95% CI 0.0067-0.0826), yielding an incremental cost-effectiveness ratio of £15 765/QALY, incremental net monetary benefit of £189.22 (95% CI −£573.62 to £948.28) and a 69% probability of the SC + UC intervention arm being cost-effective at a threshold of £20 000 per QALY. Results were robust to most sensitivity analyses but sensitive to missing data assumptions (2 of the 8 scenarios investigated), SF-6D, and capability measure for adults quality-of-life outcomes. ConclusionsA symptoms clinic is likely to be a potentially cost-effective treatment for patients with persistent physical symptoms.

Four-year follow-up of weight loss maintenance using electronic medical record data: The PROPEL trial.

Short-term weight loss is possible in a variety of settings. However, long-term, free-living weight loss maintenance following structured weight loss interventions remains elusive. The purpose was to study body weight trajectories over 2years of intensive lifestyle intervention (ILI) and up to 4years of follow-up versus usual care (UC). Data were obtained from electronic medical records (EMRs) from participating clinics. Baseline (Day 0) was established as the EMR data point closest but prior to the baseline date of the trial. The sample included 111 ILI and 196 UC patients. The primary statistical analysis focused on differentiating weight loss trajectories between ILI and UC. The ILI group experienced significantly greater weight loss compared with the UC group from Day 100 to Day 700, beyond which there were no significant differences. Intensive lifestyle intervention patients who maintained ≥5% and ≥10% weight loss at 24months demonstrated significantly greater weight loss (p<0.001) across the active intervention and follow-up. Following 24months of active intervention, patients with ILI regained weight toward their baseline to the point where ILI versus UC differences were no longer statistically or clinically significant. However, patients in the ILI who experienced ≥5% or ≥10% weight loss at the cessation of the active intervention maintained greater weight loss at the end of the follow-up phase. ClinicalTrials.gov: NCT02561221.

Mindfulness to enhance quality of life and support advance care planning: a pilot randomized controlled trial for adults with advanced cancer and their family caregivers

BackgroundPatients with advanced cancer and family caregivers often use avoidant coping strategies, such as delaying advance care planning discussions, which contribute to deterioration in their quality of life. Mindfulness-based interventions have shown promise in improving quality of life in this population but have rarely been applied to advance care planning. This pilot trial examined the preliminary efficacy of a group-based Mindfulness to Enhance Quality of Life and Support Advance Care Planning (MEANING) intervention for patient-caregiver dyads coping with advanced cancer. Primary outcomes were patient and caregiver quality of life or well-being, and secondary outcomes included patient advanced care planning engagement (self-efficacy and readiness) and other psychological and symptom outcomes.MethodsIn this pilot trial, dyads coping with advanced cancer were recruited from five oncology clinics in the midwestern U.S. and randomized to six weekly group sessions of a mindfulness intervention (n = 33 dyads) or usual care (n = 22 dyads). Outcomes were assessed via surveys at baseline, post-intervention, and 1 month post-intervention. All available data were included in the multilevel models assessing intervention efficacy.ResultsPatients in the MEANING condition experienced significant increases in existential well-being and self-efficacy for advance care planning across follow-ups, whereas usual care patients did not. Other group differences in outcomes were not statistically significant. These outcomes included other facets of patient well-being, caregiver quality of life, patient readiness for advance care planning, caregiver burden, and patient and caregiver depressive symptoms, anxiety, sleep disturbance, cognitive avoidance, and peaceful acceptance of cancer. However, only MEANING patients showed moderate increases in psychological well-being across follow-ups, and MEANING caregivers showed moderate increases in quality of life at 1-month follow-up. Certain psychological outcomes, such as caregiver burden at 1-month follow-up, also showed moderate improvement in the MEANING condition. Patients in both conditions reported small to moderate increases in readiness to engage in advance care planning.ConclusionsA mindfulness-based intervention showed promise in improving quality-of-life and advance care planning outcomes in patients and caregivers coping with advanced cancer and warrants further testing.Trial RegistrationClinicalTrials.gov NCT03257007. Registered 22 August 2017, https://clinicaltrials.gov/ct2/show/NCT03257007.

Effect of electronic alerts on the care and outcomes in patients with acute kidney injury: a meta-analysis and trial sequential analysis

BackgroundAlthough electronic alerts are being increasingly implemented in patients with acute kidney injury (AKI), their effect remains unclear. Therefore, we conducted this meta-analysis aiming at investigating their impact on the care and outcomes of AKI patients.MethodsPubMed, Embase, Cochrane Library, and Clinical Trial Registries databases were systematically searched for relevant studies from inception to March 2024. Randomized controlled trials comparing electronic alerts with usual care in patients with AKI were selected.ResultsSix studies including 40,146 patients met the inclusion criteria. The pooled results showed that electronic alerts did not improve mortality rates (relative risk (RR) = 1.02, 95% confidence interval (CI) = 0.97–1.08, P = 0.44) or reduce creatinine levels (mean difference (MD) = − 0.21, 95% CI = − 1.60–1.18, P = 0.77) and AKI progression (RR = 0.97, 95% CI = 0.90–1.04, P = 0.40). Instead, electronic alerts increased the odds of dialysis and AKI documentation (RR = 1.14, 95% CI = 1.05–1.25, P = 0.002; RR = 1.21, 95% CI = 1.01–1.44, P = 0.04, respectively), but the trial sequential analysis (TSA) could not confirm these results. No differences were observed in other care-centered outcomes including renal consults and investigations between the alert and usual care groups.ConclusionsElectronic alerts increased the incidence of AKI and dialysis in AKI patients, which likely reflected improved recognition and early intervention. However, these changes did not improve the survival or kidney function of AKI patients. The findings warrant further research to comprehensively evaluate the impact of electronic alerts.

COVID-19 and Cancer Care: A Review and Practical Guide to Caring for Cancer Patients in the Era of COVID-19.

COVID-19, a novel infectious disease caused by the emergence of the SARS-CoV-2 virus in 2020, has had a profound impact on healthcare, both at the individual and population level. The impact at the population level was felt most acutely during the emergency phase of the pandemic, with hospital capacity issues leading to widespread disruptions and delays in the delivery of healthcare services such as screening programs and elective surgeries. While hospitals are no longer being acutely overwhelmed by COVID-19 patients, the impact of the virus on vulnerable patient populations such as cancer patients continues to be of ongoing consequence. Cancer patients remain at high risk of hospitalization, ICU admission, and death due to COVID-19, even in the era of vaccination. Infection prevention and risk mitigation strategies such air quality control, masking, testing, vaccination, and treatment should therefore be integrated into the usual care and counseling of cancer patients moving forward to avoid preventable morbidity and mortality from this infection and ensure the safety of this vulnerable cohort as they navigate their cancer diagnosis and treatment in the era of COVID-19.

Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones

The 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year. To gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up. This randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023. Patients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy. The primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction. Among 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, -7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction. In the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes. CCMO Identifier: NTR4022.

A palliative care approach for adult non-cancer patients with life-limiting illnesses is cost-saving or cost-neutral: a systematic review of RCTs

BackgroundPatients living with life-limiting illnesses other than cancer constitute the majority of patients in need of palliative care globally, yet most previous systematic reviews of the cost impact of palliative care have not exclusively focused on this population. Reviews that tangentially looked at non-cancer patients found inconclusive evidence. Randomised controlled trials (RCTs) are the gold standard for treatment efficacy, while total health care costs offer a comprehensive measure of resource use. In the sole review of RCTs for non-cancer patients, palliative care reduced hospitalisations and emergency department visits but its effect on total health care costs was not assessed. The aim of this study is to review RCTs to determine the difference in costs between a palliative care approach and usual care in adult non-cancer patients with a life-limiting illness.MethodsA systematic review using a narrative synthesis approach. The protocol was registered with PROSPERO prospectively (no. CRD42020191082). Eight databases were searched: Medline, CINAHL, EconLit, EMBASE, TRIP database, NHS Evidence, Cochrane Library, and Web of Science from inception to January 2023. Inclusion criteria were: English or German; randomised controlled trials (RCTs); adult non-cancer patients (> 18 years); palliative care provision; a comparator group of standard or usual care. Quality of studies was assessed using Drummond’s checklist for assessing economic evaluations.ResultsSeven RCTs were included and examined the following diseases: neurological (3), heart failure (2), AIDS (1) and mixed (1). The majority (6/7) were home-based interventions. All studies were either cost-saving (3/7) or cost-neutral (4/7); and four had improved outcomes for patients or carers and three no change in outcomes.ConclusionsIn a non-cancer population, this is the first systematic review of RCTs that has demonstrated a palliative care approach is cost-saving or at least cost-neutral. Cost savings are achieved without worsening outcomes for patients and carers. These findings lend support to calls to increase palliative care provision globally.

Shared Medical Appointments in Heart Failure for Post Acute Care Follow-Up: A Randomized Controlled Trial.

Shared medical appointments (SMAs) in heart failure (HF) are medical visits where several patients with HF meet with multidisciplinary providers at the same time for efficient and comprehensive care. It is unknown whether HF-SMAs can improve overall and cardiac health status for high-risk patients with HF discharged from acute care. A 3-site, open-label, randomized-controlled-trial was conducted. Participants within 12 weeks of HF acute care (emergency-room/hospitalization) requiring intravenous diuretic therapy were randomized to receive either HF-SMA or usual HF clinical care (usual-care) on a 1:1 ratio. The HF-SMA team, which consisted of a nurse, nutritionist, psychologist, nurse practitioner and/or a clinical pharmacist, provided four 2-hour session HF-SMAs that met every other week for 8 weeks. Primary outcomes were the overall health status measured by European Quality of Life Visual Analog Scale and cardiac health status by Kansas City Cardiomyopathy Questionnaire, 180 days postrandomization. Of the 242 patients enrolled (HF-SMA n=117, usual-care n=125, mean age 69.3±9.4 years, 71.5% White patients, 94.6% male), 84% of participants completed the study (n=8 HF-SMA and n=9 usual-care patients died). After 180 days, both HF-SMA and usual-care participants had significant improvements from baseline in Kansas City Cardiomyopathy Questionnaire that were not statistically different. Only HF-SMA participants had significant improvements in European Quality of Life Visual Analog Scale (mean change = 7.2±15.8 in HF-SMA versus -0.4±19.0 points in usual-care, P < 0.001). Both HF-SMA and usual-care in participants with HF achieved significant improvements in cardiac health status, but only a team approach through HF-SMA achieved significant improvements in overall health status. Future larger studies are needed to evaluate hospitalization and death outcomes. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02481921.