Use of Imaging-guided Decongestion for Reducing Heart Failure Readmission and Death in High-risk Patients: A Multi-site Randomized Trial of a Nurse-led Strategy at the Point of Care.

BACKGROUND: Nurse-led disease management programs (DMPs) decrease readmission after acute decompensated heart failure (HF). We sought whether readmissions could be further reduced by lung ultrasound (LUS)-guided decongestion before discharge and during DMP. METHODS AND RESULTS: Of 290 patients hospitalized with acute decompensated HF, 122 at high risk for readmission or mortality were randomized to receive usual care (UC) (n = 64) or UC plus intervention (DMP-Plus) (n = 58), comprising LUS-guided management before discharge and during at-home follow-up. Residual congestion was identified by ≥10 B-lines detected in 8 lung zones. The outcomes included a composite of readmission and/or mortality at 30 and 90 days, and 90-day HF readmission. Residual congestion was detected equally among the patient groups. The 30-day composite outcome occurred in 28% DMP-plus patients and 22% UC patients (odd ratio [OR], 1.36; 95% confidence interval [CI], 0.59-3.1; P = .5) and the 90-day HF readmission outcome occurred in 22% and 31%, respectively (odds ratio, 0.63; 95% CI, 0.28-1.43; P = .3). Residual congestion, identified at predischarge LUS examination in high-risk patients, was associated with early (<14-day) HF readmission (relative risk, 1.19; 95% CI, 1.06-1.32; P = .002) and multiple (≥2) readmissions over 90 days of follow-up (relative risk, 1.09; 95% CI, 1.01-1.16; P = .012), independent of demographics and comorbidities. CONCLUSIONS: Readmission in patients with incomplete decongestion before discharge occurs within the first 2 weeks. However, our DMP-plus strategy did not improve the primary outcome.

Optimising the implementation of digital-supported interventions for the secondary prevention of heart disease: a systematic review using the RE-AIM planning and evaluation framework.

BACKGROUND: mHealth technologies are now widely utilised to support the delivery of secondary prevention programs in heart disease. Interventions with mHealth included have shown a similar efficacy and safety to conventional programs with improvements in access and adherence. However, questions remain regarding the successful wider implementation of digital-supported programs. By applying the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework to a systematic review and meta-analysis, this review aims to evaluate the extent to which these programs report on RE-AIM dimensions and associated indicators. METHODS: This review extends our previous systematic review and meta-analysis that investigated the effectiveness of digital-supported programs for patients with coronary artery disease. Citation searches were performed on the 27 studies of the systematic review to identify linked publications that reported data for RE-AIM dimensions. All included studies and, where relevant, any additional publications, were coded using an adapted RE-AIM extraction tool. Discrepant codes were discussed amongst reviewers to gain consensus. Data were analysed to assess reporting on indicators related to each of the RE-AIM dimensions, and average overall reporting rates for each dimension were calculated. RESULTS: Searches found an additional nine publications. Across 36 publications that were linked to the 27 studies, 24 (89%) of the studies were interventions solely delivered at home. The average reporting rates for RE-AIM dimensions were highest for effectiveness (75%) and reach (67%), followed by adoption (54%), implementation (36%) and maintenance (11%). Eleven (46%) studies did not describe relevant characteristics of their participants or of staff involved in the intervention; most studies did not describe unanticipated consequences of the intervention; the ongoing cost of intervention implementation and maintenance; information on intervention fidelity; long-term follow-up outcomes, or program adaptation in other settings. CONCLUSIONS: Through the application of the RE-AIM framework to a systematic review we found most studies failed to report on key indicators. Failing to report these indicators inhibits the ability to address the enablers and barriers required to achieve optimal intervention implementation in wider settings and populations. Future studies should consider alternative hybrid trial designs to enable reporting of implementation indicators to improve the translation of research evidence into routine practice, with special consideration given to the long-term sustainability of program effects as well as corresponding ongoing costs. REGISTRATION: PROSPERO-CRD42022343030.

Digital Health Programs to Reduce Readmissions in Coronary Artery Disease: A Systematic Review and Meta-Analysis.

Background: The use of mobile health (mHealth, wireless communication devices, and/or software technologies) in health care delivery has increased rapidly in recent years. Their integration into disease management programs (DMPs) has tremendous potential to improve outcomes for patients with coronary artery disease (CAD), yet a more robust evaluation of the evidence is required. Objectives: The purpose of this study was to undertake a systematic review and meta-analysis of mHealth-enabled DMPs to determine their effectiveness in reducing readmissions and mortality in patients with CAD. Methods: We systematically searched English language studies from January 1, 2007, to August 3, 2021, in multiple databases. Studies comparing mHealth-enabled DMPs with standard DMPs without mHealth were included if they had a minimum 30-day follow-up for at least one of all-cause or cardiovascular-related mortality, readmissions, or major adverse cardiovascular events. Results: Of the 3,411 references from our search, 155 full-text studies were assessed for eligibility, and data were extracted from 18 publications. Pooled findings for all-cause readmissions (10 studies, n = 1,514) and cardiac-related readmissions (9 studies, n = 1,009) indicated that mHealth-enabled DMPs reduced all-cause (RR: 0.68; 95% CI: 0.50-0.91) and cardiac-related hospitalizations (RR: 0.55; 95% CI: 0.44-0.68) and emergency department visits (RR: 0.37; 95% CI: 0.26-0.54) compared to DMPs without mHealth. There was no significant reduction for mortality outcomes (RR: 1.72; 95% CI: 0.64-4.64) or major adverse cardiovascular events (RR: 0.68; 95% CI: 0.40-1.15). Conclusions: DMPs integrated with mHealth should be considered an effective intervention for better outcomes in patients with CAD.

Economic evaluation of a nurse-led home and clinic-based secondary prevention programme to prevent progressive cardiac dysfunction in high-risk individuals: The Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) randomized controlled study.

OBJECTIVE: The objective of this study was to assess the cost-effectiveness of a long-term, nurse-led, multidisciplinary programme of home/clinic visits in preventing progressive cardiac dysfunction in patients at risk of developing de novo chronic heart failure (CHF). METHODS: A trial-based analysis was conducted alongside a pragmatic, single-centre, open-label, randomized controlled trial of 611 patients (mean age: 66 years) with subclinical cardiovascular diseases (without CHF) discharged to home from an Australian tertiary referral hospital. A nurse-led home and clinic-based programme (NIL-CHF intervention, n = 301) was compared with standard care ( n=310) in terms of life-years, quality-adjusted life-years (QALYs) and healthcare costs. The uncertainty around the incremental cost and QALYs was quantified by bootstrap simulations and displayed on a cost-effectiveness plane. RESULTS: During a median follow-up of 4.2 years, there were no significant between-group differences in life-years (-0.056, p=0.488) and QALYs (-0.072, p=0.399), which were lower in the NIL-CHF group. The NIL-CHF group had slightly lower all-cause hospitalization costs (AUD$2943 per person; p=0.219), cardiovascular-related hospitalization costs (AUD$1142; p=0.592) and a more pronounced reduction in emergency/unplanned hospitalization costs (AUD$4194 per person; p=0.024). When the cost of intervention was added to all-cause, cardiovascular and emergency-related readmissions, the reductions in the NIL-CHF group were AUD$2742 ( p=0.313), AUD$941 ( p=0.719) and AUD$3993 ( p=0.046), respectively. At a willingness-to-pay threshold of AUD$50,000/QALY, the probability of the NIL-CHF intervention being better-valued was 19%. CONCLUSIONS: Compared with standard care, the NIL-CHF intervention was not a cost-effective strategy as life-years and QALYs were slightly lower in the NIL-CHF group. However, it was associated with modest reductions in emergency/unplanned readmission costs.

Systematic review of trial-based analyses reporting the economic impact of heart failure management programs compared with usual care.

BACKGROUND: The cost-effectiveness of heart failure management programs (HF-MPs) is highly variable. We explored intervention and clinical characteristics likely to influence cost outcomes. METHODS: A systematic review of economic analyses alongside randomized clinical trials comparing HF-MPs and usual care. Electronic databases were searched for English peer-reviewed articles published between 1990 and 2013. RESULTS: Of 511 articles identified, 34 comprising 35 analyses met the inclusion criteria. Eighteen analyses (51%) reported a HF-MP as more effective and less costly; four analyses (11%), and five analyses (14%) also reported they were more effective but with no significant or an increased cost difference, respectively. Alternatively, five analyses (14%) reported no statistically significant difference in effects or costs, and one analysis (3%) reported no statistically significant effect difference but was less costly. Finally, two analyses (6%) reported no statistically significant effect difference but were more costly. Interventions that reduced hospital admissions tended to result in favorable cost outcomes, moderated by increased resource use, intervention cost and/or the durability of the intervention effect. The reporting quality of economic evaluation assessed by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist varied substantially between 5% and 91% (median 45%; 34 articles) of the checklist criteria adequately addressed. Overall, none of the study, patient or intervention characteristics appeared to independently influence the cost-effectiveness of a HF-MP. CONCLUSION: The extent that HF-MPs reduce hospital readmissions appears to be associated with favorable cost outcomes. The current evidence does not provide a sufficient evidence base to explain what intervention or clinical attributes may influence the cost implications.

Impact of nurse-mediated management on achieving blood pressure goal levels in primary care: Insights from the Valsartan Intensified Primary carE Reduction of Blood Pressure Study.

BACKGROUND: Blood pressure targets in individuals treated for hypertension in primary care remain difficult to attain. AIMS: To assess the role of practice nurses in facilitating intensive and structured management to achieve ideal BP levels. METHODS: We analysed outcome data from the Valsartan Intensified Primary carE Reduction of Blood Pressure Study. Patients were randomly allocated (2:1) to the study intervention or usual care. Within both groups, a practice nurse mediated the management of blood pressure for 439 patients with endpoint blood pressure data (n=1492). Patient management was categorised as: standard usual care (n=348, 23.3%); practice nurse-mediated usual care (n=156, 10.5%); standard intervention (n=705, 47.3%) and practice nurse-mediated intervention (n=283, 19.0%). Blood pressure goal attainment at 26-week follow-up was then compared. RESULTS: Mean age was 59.3±12.0 years and 62% were men. Baseline blood pressure was similar in practice nurse-mediated (usual care or intervention) and standard care management patients (150 ± 16/88 ± 11 vs. 150 ± 17/89 ± 11 mmHg, respectively). Practice nurse-mediated patients had a stricter blood pressure goal of ⩽125/75 mmHg (33.7% vs. 27.3%, p=0.026). Practice nurse-mediated intervention patients achieved the greatest blood pressure falls and the highest level of blood pressure goal attainment (39.2%) compared with standard intervention (35.0%), practice nurse-mediated usual care (32.1%) and standard usual care (25.3%; p<0.001). Practice nurse-mediated intervention patients were almost two-fold more likely to achieve their blood pressure goal compared with standard usual care patients (adjusted odds ratio 1.92, 95% confidence interval 1.32 to 2.78; p=0.001). CONCLUSION: There is greater potential to achieve blood pressure targets in primary care with practice nurse-mediated hypertension management.

Establishing a pragmatic framework to optimise health outcomes in heart failure and multimorbidity (ARISE-HF): A multidisciplinary position statement.

BACKGROUND: Multimorbidity in heart failure (HF), defined as HF of any aetiology and multiple concurrent conditions that require active management, represents an emerging problem within the ageing HF patient population worldwide. METHODS: To inform this position paper, we performed: 1) an initial review of the literature identifying the ten most common conditions, other than hypertension and ischaemic heart disease, complicating the management of HF (anaemia, arrhythmias, cognitive dysfunction, depression, diabetes, musculoskeletal disorders, renal dysfunction, respiratory disease, sleep disorders and thyroid disease) and then 2) a review of the published literature describing the association between HF with each of the ten conditions. From these data we describe a clinical framework, comprising five key steps, to potentially improve historically poor health outcomes in this patient population. RESULTS: We identified five key steps (ARISE-HF) that could potentially improve clinical outcomes if applied in a systematic manner: 1) Acknowledge multimorbidity as a clinical syndrome that is associated with poor health outcomes, 2) Routinely profile (using a standardised protocol - adapted to the local health care system) all patients hospitalised with HF to determine the extent of concurrent multimorbidity, 3) Identify individualised priorities and person-centred goals based on the extent and nature of multimorbidity, 4) Support individualised, home-based, multidisciplinary, case management to supplement standard HF management, and 5) Evaluate health outcomes well beyond acute hospitalisation and encompass all-cause events and a person-centred perspective in affected individuals. CONCLUSIONS: We propose ARISE-HF as a framework for improving typically poor health outcomes in those affected by multimorbidity in HF.

Economic implications of cardiovascular disease management programs: moving beyond one-off experiments.

Substantial variation in economic analyses of cardiovascular disease management programs hinders not only the proper assessment of cost-effectiveness but also the identification of heterogeneity of interest such as patient characteristics. The authors discuss the impact of reporting and methodological variation on the cost-effectiveness of cardiovascular disease management programs by introducing issues that could lead to different policy or clinical decisions, followed by the challenges associated with net intervention effects and generalizability. The authors conclude with practical suggestions to mitigate the identified issues. Improved transparency through standardized reporting practice is the first step to advance beyond one-off experiments (limited applicability outside the study itself). Transparent reporting is a prerequisite for rigorous cost-effectiveness analyses that provide unambiguous implications for practice: what type of program works for whom and how.

Patient preferences and willingness-to-pay for a home or clinic based program of chronic heart failure management: findings from the Which? trial.

BACKGROUND: Beyond examining their overall cost-effectiveness and mechanisms of effect, it is important to understand patient preferences for the delivery of different modes of chronic heart failure management programs (CHF-MPs). We elicited patient preferences around the characteristics and willingness-to-pay (WTP) for a clinic or home-based CHF-MP. METHODOLOGY/PRINCIPAL FINDINGS: A Discrete Choice Experiment was completed by a sub-set of patients (n = 91) enrolled in the WHICH? trial comparing home versus clinic-based CHF-MP. Participants provided 5 choices between hypothetical clinic and home-based programs varying by frequency of nurse consultations, nurse continuity, patient costs, and availability of telephone or education support. Participants (aged 71±13 yrs, 72.5% male, 25.3% NYHA class III/IV) displayed two distinct preference classes. A latent class model of the choice data indicated 56% of participants preferred clinic delivery, access to group CHF education classes, and lower cost programs (p<0.05). The remainder preferred home-based CHF-MPs, monthly rather than weekly visits, and access to a phone advice service (p<0.05). Continuity of nurse contact was consistently important. No significant association was observed between program preference and participant allocation in the parent trial. WTP was estimated from the model and a dichotomous bidding technique. For those preferring clinic, estimated WTP was ≈AU$9-20 per visit; however for those preferring home-based programs, WTP varied widely (AU$15-105). CONCLUSIONS/SIGNIFICANCE: Patient preferences for CHF-MPs were dichotomised between a home-based model which is more likely to suit older patients, those who live alone, and those with a lower household income; and a clinic-based model which is more likely to suit those who are more socially active and wealthier. To optimise the delivery of CHF-MPs, health care services should consider their patients' preferences when designing CHF-MPs.