Patient engagement in a trial testing a new strategy of care for acute heart failure.
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ABSTRACT:
SUBMITTER: Lee DS
PROVIDER: S-EPMC6472457 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
Publications
Patient engagement in a trial testing a new strategy of care for acute heart failure.
Lee Douglas S DS Armstrong Robert R Mohamed Shanas S
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20181101 Suppl
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Project description:BackgroundDue to the complexity and chronicity of heart failure, engaging yet simple patient self-management tools are needed.ObjectiveThis study aimed to assess the feasibility and patient engagement with a smartphone app designed for heart failure.MethodsPatients with heart failure were randomized to intervention (smartphone with the Habits Heart App installed and Bluetooth-linked scale) or control (paper education material) groups. All intervention group patients were interviewed and monitored closely for app feasibility while receiving standard of care heart failure management by cardiologists. The Atlanta Heart Failure Knowledge Test, a quality of life survey (Kansas City Cardiomyopathy Questionnaire), and weight were assessed at baseline and final visits.ResultsPatients (N=28 patients; intervention: n=15; control: n=13) with heart failure (with reduced ejection fraction: 15/28, 54%; male: 20/28, 71%, female: 8/28, 29%; median age 63 years) were enrolled, and 82% of patients (N=23; intervention: 12/15, 80%; control: 11/13, 85%) completed both baseline and final visits (median follow up 60 days). In the intervention group, 2 out of the 12 patients who completed the study did not use the app after study onboarding due to illnesses and hospitalizations. Of the remaining 10 patients who used the app, 5 patients logged ≥1 interaction with the app per day on average, and 2 patients logged an interaction with the app every other day on average. The intervention group averaged 403 screen views (per patient) in 56 distinct sessions, 5-minute session durations, and 22 weight entries per patient. There was a direct correlation between duration of app use and improvement in heart failure knowledge (Atlanta Heart Failure Knowledge Test score; ρ=0.59, P=.04) and quality of life (Kansas City Cardiomyopathy Questionnaire score; ρ=0.63, P=.03). The correlation between app use and weight change was ρ=-0.40 (P=.19). Only 1 out of 11 patients in the control group retained education material by the follow-up visit.ConclusionsThe Habits Heart App with a Bluetooth-linked scale is a feasible way to engage patients in heart failure management, and barriers to app engagement were identified. A larger multicenter study may be warranted to evaluate the effectiveness of the app.Trial registrationClinicalTrials.gov NCT03238729; http://clinicaltrials.gov/ct2/show/NCT03238729.
| S-EPMC7857947 | biostudies-literature
Project description:BackgroundAdult chronic heart failure mainly affects an elderly population with multiple comorbidities that often require frequent medical visits to prevent poor health outcomes. However, the heart failure disease process reduces their independence by reducing mobility, exercise tolerance, and cognitive decline. Remote care technologies can bridge the gap in care for these patients by allowing them to be followed up within the comfort of their home and encourage their self-care. However, patients, carers, and health care professionals need to engage with the technology for it to be useful.ObjectiveThis systematic review explores qualitative primary studies of remote care technologies used in heart failure, to determine the factors that affect user engagement with the technology. This is explored from the perspective of patients, carers, and health care professionals.MethodsRelevant studies published between January 1, 1990, and September 19, 2020, were identified from EMBASE, Ovid MEDLINE, PubMed, Cochrane Library, and Scopus. These studies were then synthesized using thematic analysis. Relevant user experiences with remote care were extracted using line-by-line coding. These codes were summarized into secondary codes and core concepts, which were further merged into overarching themes that encapsulate user experience with remote care.ResultsThe review included 47 studies, which led to the generation of 5 overarching themes that affect engagement: (1) "Convenience" relates to time saved by the intervention; (2) "Clinical Care" relates to perceived quality of care and health outcomes; (3) "Communication" involves feedback and interaction between patients, staff, and carers; (4) "Education" concerns the tailored information provided; and (5) "Ease of Use" relates to accessibility and technical barriers to engagement. Each theme was applied to each user base of patient, carer, and health care professional in a different manner.ConclusionsThe 5 themes identified highlight aspects of remote care that facilitate engagement, and should be considered in both future design and trials evaluating these technologies.
| S-EPMC9021943 | biostudies-literature
Project description:ImportanceShort-term infusions of single vasodilators, usually given in a fixed dose, have not improved outcomes in patients with acute heart failure (AHF).ObjectiveTo evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation using individualized up-titrated doses of established vasodilators in patients with AHF.Design, setting, and participantsRandomized, open-label blinded-end-point trial enrolling 788 patients hospitalized for AHF with dyspnea, increased plasma concentrations of natriuretic peptides, systolic blood pressure of at least 100 mm Hg, and plan for treatment in a general ward in 10 tertiary and secondary hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Enrollment began in December 2007 and follow-up was completed in February 2019.InterventionsPatients were randomized 1:1 to a strategy of early intensive and sustained vasodilation throughout the hospitalization (n = 386) or usual care (n = 402). Early intensive and sustained vasodilation was a comprehensive pragmatic approach of maximal and sustained vasodilation combining individualized doses of sublingual and transdermal nitrates, low-dose oral hydralazine for 48 hours, and rapid up-titration of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or sacubitril-valsartan.Main outcomes and measuresThe primary end point was a composite of all-cause mortality or rehospitalization for AHF at 180 days.ResultsAmong 788 patients randomized, 781 (99.1%; median age, 78 years; 36.9% women) completed the trial and were eligible for primary end point analysis. Follow-up at 180 days was completed for 779 patients (99.7%). The primary end point, a composite of all-cause mortality or rehospitalization for AHF at 180 days, occurred in 117 patients (30.6%) in the intervention group (including 55 deaths [14.4%]) and in 111 patients (27.8%) in the usual care group (including 61 deaths [15.3%]) (absolute difference for the primary end point, 2.8% [95% CI, -3.7% to 9.3%]; adjusted hazard ratio, 1.07 [95% CI, 0.83-1.39]; P = .59). The most common clinically significant adverse events with early intensive and sustained vasodilation vs usual care were hypokalemia (23% vs 25%), worsening renal function (21% vs 20%), headache (26% vs 10%), dizziness (15% vs 10%), and hypotension (8% vs 2%).Conclusions and relevanceAmong patients with AHF, a strategy of early intensive and sustained vasodilation, compared with usual care, did not significantly improve a composite outcome of all-cause mortality and AHF rehospitalization at 180 days.Trial registrationClinicalTrials.gov Identifier: NCT00512759.
| S-EPMC6990838 | biostudies-literature
Project description:Purpose of reviewPalliative care is increasingly acknowledged as beneficial in supporting patients and families affected by heart failure, but policy documents have generally focused on the chronic form of this disease. We examined palliative care provision for those with acute heart failure, based on the recently updated National Consensus Project Clinical Practice Guidelines for Quality Palliative Care.Recent findingsThe commonest reason for hospitalization in those > 65 years, acute heart failure admissions delineate crisis points on the unpredictable disease trajectory. Palliative care is underutilized, often perceived as limited to end-of-life care rather than determined by regular systematic needs assessment. No dominant paradigm of palliative care provision has emerged from the nascent evidence base related to this clinical cohort, underscoring the need for further research. Embedding palliative support as mainstream to heart failure care from the point of diagnosis may better ensure treatment strategies for those admitted with acute heart failure remain consistent with patients' preferences and values.
| S-EPMC7683469 | biostudies-literature
Project description:BACKGROUND:Although implantable cardioverter-defibrillators (ICDs) reduce sudden death, these patients die of heart failure (HF) or other diseases. To prevent shocks at the end of life, clinicians should discuss deactivating the defibrillation function. OBJECTIVES:The purpose of this study was to determine if a clinician-centered teaching intervention and automatic reminders increased ICD deactivation discussions and increased device deactivation. METHODS:In this 6-center, single-blinded, cluster-randomized, controlled trial, primary outcomes were proportion of patients: 1) having ICD deactivation discussions; and 2) having the shocking function deactivated. Secondary outcomes included goals of care conversations and advance directive completion. RESULTS:A total of 525 subjects were included with advanced HF who had an ICD: 301 intervention and 224 control. At baseline, 52% (n = 272) were not candidates for advanced therapies (i.e., cardiac transplant or mechanical circulatory support). There were no differences in discussions (41 [14%] vs. 26 [12%]) or deactivation (33 [11%] vs. 26 [12%]). In pre-specified subgroup analyses of patients who were not candidates for advanced therapies, the intervention increased deactivation discussions (32 [25%] vs. 16 [11%]; odds ratio: 2.90; p = 0.003). Overall, 99 patients died; there were no differences in conversations or deactivations among decedents. SECONDARY OUTCOMES:Among all participants, there was an increase in goals of care conversations (47% intervention vs. 38% control; odds ratio: 1.53; p = 0.04). There were no differences in completion of advance directives. CONCLUSIONS:The intervention increased conversations about ICD deactivation and goals of care. HF clinicians were able to apply new communication techniques based on patients' severity of illness. (An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations [WISDOM]; NCT01459744).
| S-EPMC7000126 | biostudies-literature
Project description: Not available
| S-EPMC3878083 | biostudies-literature
Project description:AimsMany European healthcare providers struggle to adopt multidisciplinary, integrated care pathways for people with heart failure (HF) as recommended by the European Society of Cardiology. PRO-HF (Program to Optimize Heart Failure Patient Pathways) was developed to help clinicians identify strengths, gaps, and shortcomings in their HF pathways and support tailored interventions to optimize pathways and enhance patient care. We report initial findings from baseline assessments of HF pathway characteristics and challenges from 10 hospitals in six European countries (France, Ireland, Portugal, Spain, The Netherlands, and United Kingdom).Methods and resultsBaseline assessments were holistic appraisals of full HF services to calibrate current status and development needs and assist management teams in prioritizing improvement projects. Assessments were performed using a comprehensive checklist of measures covering the HF patient journey from diagnosis to ongoing follow-up. These included a digital survey sent to full HF care teams and one-to-one interviews. The digital survey focused on four key areas (HF outpatient clinic; remote patient management; efficient device implantation and inpatient pathways; and network maximization) and 16 dimensions of excellence. Priority areas and themes for action identified in baseline assessments were (i) provision of HF specialist care; (ii) data capture and analysis; (iii) institutional care protocols; (iv) hospital-wide strategies; and (v) multidisciplinary teams (MDTs). Suboptimal specialist care of emergency inpatients was an issue at all hospitals and prioritized at 8/10. Availability and accessibility of data on patients, activities, and outcomes was an issue at all hospitals and prioritized by 4/10. A lack of clear protocols, templates, and tools for some HF activities created variability in patient care (e.g., HF specialist consultations, diagnostic testing, follow-up appointments, medications, and device eligibility) and inefficient use of clinician time. This made it difficult to initiate new technologies (e.g., remote patient monitoring) due to the risk of overburdening staff. MDTs were frequently understaffed. Multiple interventions were identified to address gaps and shortcomings that could be tailored to specific needs of individual hospitals (e.g., inpatient pathway optimization, creation/optimization of HF outpatient clinics, development of an HF performance dashboard, enhancement of protocol adherence, streamlining cardiac resynchronisation therapy pathways, and MDT coordination).ConclusionsPRO-HF provides a valuable opportunity to identify gaps and significant shortcomings in HF pathways in European hospitals. Preliminary findings from hospitals that have initiated suggested changes to address these challenges are encouraging, though longer-term follow-up from more hospitals is needed to confirm the impact of PRO-HF on HF pathway optimization and patient care.
| S-EPMC11424341 | biostudies-literature
Project description:AimsIn this study, we aimed to investigate whether body composition analysis (BCA) derived from bioelectrical impedance vector analysis (BIVA) could be used to monitor the hydration status of patients with acute heart failure (AHF) during intensified diuretic therapy.Methods and resultsThis observational, single-centre study involved a novel, validated eight-electrode segmental body composition analyser to perform BCA derived from BIVA with an alternating current of 100 μA at frequencies of 5, 7.5, 50, and 75 kHz. The BCA-derived and BIVA-derived parameters were estimated and compared with daily body weight measurements in hospitalized patients with AHF. A total of 867 BCA and BIVA assessments were conducted in 142 patients (56.3% men; age 76.8 ± 10.7 years). Daily changes in total body water (TBW) and extracellular water (ECW) were significantly associated with changes in body weight in 62.2% and 89.1% of all measurements, respectively (range, ±1 kg). Repeated measures correlation coefficients between weight loss and TBW loss resulted with rho 0.43, P < 0.01, confidence interval (CI) [0.36, 0.50] and rho 0.71, P > 0.01, CI [0.67, 0.75] for ECW loss. Between the first and last assessments, the mean weight loss was -2.5 kg, compared with the -2.6 L mean TBW loss and -1.7 L mean ECW loss. BIVA revealed an increase in mean Resistance R and mean Reactance Xc across all frequencies, with the subsequent reduction in body fluid (including corresponding body weight) between the first and last assessments.ConclusionsBody composition analysis derived from BIVA with a focus on ECW is a promising approach to detect changes in hydration status in patients undergoing intensified diuretic therapy. Defining personalized BIVA reference values using bioelectrical impedance devices is a promising approach to monitor hydration status.
| S-EPMC8712800 | biostudies-literature
Project description:BackgroundSeniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department.ObjectiveThe aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context.MethodsThis 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration sooner.ResultsIt is hypothesized that TEC4Home will be a cost-effective strategy to decrease 90-day emergency department revisits and hospital admission rates and improve comfort and quality of life for seniors with heart failure. The results from this project will also help establish an innovation pathway for rapid and rigorous introduction of innovation into the health system.ConclusionsWhile there is some evidence about the effectiveness of home telemonitoring for some patients and conditions, the TEC4Home project will be one of the first protocols that implements and evaluates the technology for patients with heart failure as they transition from the emergency department to home care. The results from this research are expected to inform the full scale and spread of the home monitoring approach throughout British Columbia and Canada and to other chronic diseases.ClinicaltrialClinicalTrials.gov NCT02821065; https://clinicaltrials.gov/ct2/show/NCT02821065 (Archived by WebCite at http://www.webcitation.org/6ml2iwKax).
| S-EPMC5295826 | biostudies-literature
Project description:BackgroundThe Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial aimed to determine whether a pragmatic education intervention in general practice could improve the quality of life of patients with chronic heart failure (CHF) compared with routine care.ResultsThis cluster randomised controlled clinical trial included 241 patients with CHF attending 54 general practitioners (GPs) in France and involved 19 months of follow-up. The GPs in the Intervention Group were trained during a 2-day interactive workshop to provide a patient education programme. The mean age of the patients was 74 years (±10.5), 62 % were men and their mean left-ventricular ejection fraction was 49.3 % (± 14.3). At the end of the follow-up period, the mean Minnesota Living with Heart Failure Questionnaire scores in the Intervention and Control Groups were 33.4 (± 22.1) versus 27.2 (± 23.3; P = 0.74, intra-cluster coefficient [ICC] = 0.11). At the end of the follow-up period, the 36-Item Short Form Health Survey (mental health and physical health) scores in the Intervention and Control Groups were 58 (± 22.1) versus 58.7 (± 23.9; P = 0.58, ICC = 0.01) and 52.8 (± 23.8) versus 51.6 (± 25.5; P = 0.57, ICC = 0.01), respectively.ConclusionsPatient education delivered by GPs to elderly patients with stable heart failure in the ETIC programme did not achieve an improvement in their quality of life compared with routine care. Further research on improving the quality of life and clinical outcomes of elderly patients with CHF in primary care is necessary.Trial registrationThe Education Thérapeutique des patients Insuffisants Cardiaques (ETIC; Therapeutic Education for Patients with Cardiac Failure) trial is a cluster randomised controlled trial registered with ClinicalTrials.gov (Registration numberNCT01065142 ) and the French Drug Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé;Registration number2009-A01142-55).
| S-EPMC4949928 | biostudies-literature