scholarly journals Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Beatriz Sánchez ◽  
Carlos Guijarro ◽  
María Velasco ◽  
María Jesús Vicente ◽  
Miguel Galán ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Decision Making ◽  
Advanced Heart Failure ◽  
Care Planning ◽  
Advanced Care Planning ◽  
Health Decisions ◽  
The Impact

Abstract Background An Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients’ autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients’ caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death. Methods Randomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients’ allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF. Discussion The characteristics of patients with advanced HF make them a model for designing ACP programs, given the high prevalence of this disease, the progressive increase in its incidence and it’s clinical characteristics. Until now, the efficacy of this type of program has not been measured, so this Clinical Trial can provide relevant data for future ACP projects. Trial registration ClinicalTrials.gov Identifier: NCT04424680. Registered 9 June 2020. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04424680?term=NCT04424680&draw=2&rank=1.

scholarly journals Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0244453
Author(s):  
Waguih William IsHak ◽  
Samuel Korouri ◽  
Tarneem Darwish ◽  
Brigitte Vanle ◽  
Jonathan Dang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Depressive Symptoms ◽  
Caregiver Burden ◽  
Medical Center ◽  
Advanced Heart Failure ◽  
Morbidity And Mortality ◽  
The Impact

Objectives Heart Failure is a chronic syndrome affecting over 5.7 million in the US and 26 million adults worldwide with nearly 50% experiencing depressive symptoms. The objective of the study is to compare the effects of two evidence-based treatment options for adult patients with depression and advanced heart failure, on depressive symptom severity, physical and mental health related quality of life (HRQoL), heart-failure specific quality of life, caregiver burden, morbidity, and mortality at 3, 6 and 12-months. Methods Trial design. Pragmatic, randomized, comparative effectiveness trial. Interventions. The treatment interventions are: (1) Behavioral Activation (BA), a patient-centered psychotherapy which emphasizes engagement in enjoyable and valued personalized activities as selected by the patient; or (2) Antidepressant Medication Management administered using the collaborative care model (MEDS). Participants. Adults aged 18 and over with advanced heart failure (defined as New York Heart Association (NYHA) Class II, III, and IV) and depression (defined as a score of 10 or above on the PHQ-9 and confirmed by the MINI International Neuropsychiatric Interview for the DSM-5) selected from all patients at Cedars-Sinai Medical Center who are admitted with heart failure and all patients presenting to the outpatient programs of the Smidt Heart Institute at Cedars-Sinai Medical Center. We plan to randomize 416 patients to BA or MEDS, with an estimated 28% loss to follow-up/inability to collect follow-up data. Thus, we plan to include 150 in each group for a total of 300 participants from which data after randomization will be collected and analyzed. Conclusions The current trial is the first to compare the impact of BA and MEDS on depressive symptoms, quality of life, caregiver burden, morbidity, and mortality in patients with depression and advanced heart failure. The trial will provide novel results that will be disseminated and implemented into a wide range of current practice settings. Registration ClinicalTrials.Gov Identifier: NCT03688100.

scholarly journals The Effect of Advance Care Planning on Heart Failure: a Systematic Review and Meta-analysis

2019 ◽  
Vol 35 (3) ◽  
pp. 874-884 ◽  
Author(s):  
Markus Schichtel ◽  
Bee Wee ◽  
Rafael Perera ◽  
Igho Onakpoya
Keyword(s):  
Heart Failure ◽  
End Of Life ◽  
Advance Care Planning ◽  
End Of Life Care ◽  
Meta Analysis ◽  
Care Planning ◽  
Life Care ◽  
Advance Care

Abstract Background Advance care planning is widely advocated to improve outcomes in end-of-life care for patients suffering from heart failure. But until now, there has been no systematic evaluation of the impact of advance care planning (ACP) on clinical outcomes. Our aim was to determine the effect of ACP in heart failure through a meta-analysis of randomized controlled trials (RCTs). Methods We searched CINAHL, Cochrane Central Register of Controlled Trials, Database of Systematic Reviews, Embase, ERIC, Ovid MEDLINE, Science Citation Index and PsycINFO (inception to July 2018). We selected RCTs including adult patients with heart failure treated in a hospital, hospice or community setting. Three reviewers independently screened studies, extracted data, assessed the risk of bias (Cochrane risk of bias tool) and evaluated the quality of evidence (GRADE tool) and analysed interventions according to the Template for Intervention Description and Replication (TIDieR). We calculated standardized mean differences (SMD) in random effects models for pooled effects using the generic inverse variance method. Results Fourteen RCTs including 2924 participants met all of the inclusion criteria. There was a moderate effect in favour of ACP for quality of life (SMD, 0.38; 95% CI [0.09 to 0.68]), patients’ satisfaction with end-of-life care (SMD, 0.39; 95% CI [0.14 to 0.64]) and the quality of end-of-life communication (SMD, 0.29; 95% CI [0.17 to 0.42]) for patients suffering from heart failure. ACP seemed most effective if it was introduced at significant milestones in a patient’s disease trajectory, included family members, involved follow-up appointments and considered ethnic preferences. Several sensitivity analyses confirmed the statistically significant direction of effect. Heterogeneity was mainly due to different study settings, length of follow-up periods and compositions of ACP. Conclusions ACP improved quality of life, patient satisfaction with end-of-life care and the quality of end-of-life communication for patients suffering from heart failure and could be most effective when the right timing, follow-up and involvement of important others was considered.

Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16524-e16524
Author(s):  
Rahber Thariani ◽  
David K Blough ◽  
William Barlow ◽  
Norah Lynn Henry ◽  
Julie Gralow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Tumor Marker ◽  
Tumor Markers ◽  
Societal Value ◽  
Cancer Tumor ◽  
The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

scholarly journals Implications for Future Research

2021 ◽  
pp. 161-189
Author(s):  
Xiu-bao Yu
Keyword(s):  
Decision Making ◽  
Decision Makers ◽  
Strategic Decision ◽  
Strategic Decision Making ◽  
Future Research ◽  
Decision Factors ◽  
Research Questions ◽  
The Impact

AbstractOn the basis of the three elements of strategy, this chapter puts forward some follow-up research questions and prospects mainly from the following aspects. The first is the study of factors that have influences on the quality of strategic decision. Factors include individual aspects of decision-maker, strategic decision-making information factors, approaches of strategic decision-making, etc. The second is about normative studies. They are about how the world ought to be or how strategy decisions ought to be in given situations. Outcomes of the studies can provide guidance to industry decision makers when facing development issues. Future research includePerhaps the impact of strategic decision-makers on the quality of strategies is far beyond our imagination.

scholarly journals Determining the Impact of COVID-19 on End-of-Life Experiences of Family Caregivers for People Living With Dementia

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 321-321
Author(s):  
Sameer Mithani ◽  
Gwen McGhan ◽  
Deirdre McCaughey ◽  
Kristin Flemons
Keyword(s):  
Public Health ◽  
Focus Group ◽  
End Of Life ◽  
Family Caregivers ◽  
End Of Life Care ◽  
Care Planning ◽  
Advanced Care Planning ◽  
Life Care ◽  
The Impact

Abstract COVID-19 has impacted all of our lives, but the population most at risk are older adults. Family caregivers (FCGs) for people living with dementia (PLWD) face challenges in providing care, which are compounded with the introduction of COVID-19 public health policies. The purpose of this study was to examine the experiences of FCGs where the PLWD died during the COVID-19 pandemic. FCGs were invited to participate in an online survey to examine their caregiving experiences during the COVID-19 pandemic, with the option of participating in a follow-up focus group. Sixteen FCGs whose family members with dementia died during the pandemic participated in the survey. A follow-up focus group was conducted to further examine how COVID-19 policies impacted their role as a caregiver in long-term care (LTC) and affected their ability to grieve. The results of the survey and focus group suggest that a lack of role clarity and inadequate communication channels between the FCG and LTC due to COVID-19 increased the strain FCGs faced during end-of-life care. At the end of life, public policies, such as reduced or no visitation, led to feelings of inadequacy and regret. Several participants also expressed appreciation for completing Advanced Care Planning documentation prior to COVID-19. Based on these results, policymakers can help ease the increased turmoil faced by FCGs during end-of-life care in future public health emergencies by involving FCGs of PLWD in the decision-making process. The completion of Advanced Care Planning documentation can also ease the burden FCGs may experience during end-of-life care.

scholarly journals 2203It is more than simple interventions needed to improve heart failure patients health related quality of life

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Lambrinou ◽  
A Protopapas ◽  
V Barberis ◽  
L Paikousis ◽  
M Kyriakou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Social Dimension ◽  
Control Group ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
The Impact

Abstract Background In order to improve health-related quality of life (HR-QoL) of heart failure (HF) patients, different disease management programs have been developed at the discharged and follow-up phase. Aim To determine the effectiveness of a three-month telephone follow-up, a telephone follow-up with education before discharge, or education only before discharge (all performed by nurse specialists) on HR-QoL in HF patients. The results of the randomized clinical trial (RCT) MEETinCY are presented. Method This is a multicenter RCT with 3 different intervention groups (IGs) and one control group (CG) The first IG included only patients' education before discharge (E). The second IG included patients' education and telephone follow-up after discharge for three months (ET). The third IG included only telephone follow-up for three months (T). The Greek version of the MLHFQ was used. The statistical analysis of the impact of the intervention was done using ANCOVA. The magnitude of the effect of the intervention was studied with the Cohen's d coefficient for repeated measurements. The exploration of clinical and demographic factors in the relationship of HR-QoL was done by using linear coefficients of regression. The investigation of the robustness of the results and the intention to treat was carried out by sensitivity analysis. The management of missing value of the MLHFQ was done by using multiple imputation. Results The study included 334 patients. The analysis demonstrated that the study groups differentiates the level of HR-QoL post-intervention measurement in terms of the Overall QoL (F=2.8, 47, p=0.04). The mean level of Overall HR-QoL adjusted for the pre-intervention measurement, in the T: 40.3 (SE=2.2) and ET: 42 (2.2) groups was higher than that of the E group: 39 (2.2) and the CG: 47 (2). Study group differences were also detected statistically in the Social dimension (F=3.4, p=0.02) but not in in the Physical dimension (F=1.9, p=0.11) or the Emotional dimension (F=0.99, p=0.40). However, in the ET and T groups, higher adjusted average levels of the Physical and Social dimension are observed compared to the E and Control group. Overall, IGs exhibited low to moderate effect size improvements (drm = 0.4) while the CG had negligible improvement (drm = 0.02). Women exhibit lower overall HR-QoL scores compared to men by 13.9 points in the MLHFQ scale (b=13.9, p<0.015). NYHA IV (38.5, p<0.001), NYHA III (29.5, p<0.001) and NYHA II (9.15, p<0.001) patients exhibit worse overall HR-QoL compared to NYHA I patients. Conclusion Patients' education before discharge was not found to have an important role over the three- months telephone follow-up after discharge. On the other hand, improvement was found in patients who had the telephone intervention and the possibility to call researchers (nurses) whenever they needed. Patients seem to need continuing communication and support and to feel the availability of contacting and seeking help when needed. Acknowledgement/Funding Cyprus University of Technology's state funded budget [Startup Fund EX2007 (04)]

scholarly journals Reducing Death Anxiety: The Impact of Advanced Care Planning

2020 ◽  
Vol 3 ◽  
Author(s):  
Kendra Hollenbeck ◽  
Tom Gutwein
Keyword(s):  
Informed Consent ◽  
Death Anxiety ◽  
Medical Center ◽  
Future Research ◽  
Care Planning ◽  
Advanced Care Planning ◽  
Improve Quality ◽  
Advanced Directives ◽  
The Impact

Background/Objective: Death anxiety affects multiple areas of patient’s physical and mental health. Reducing this phenomenon has the potential to improve quality of end of life (EOL). The effects of spirituality, age, self-esteem, biological sex, presence of symptoms and level of isolation have been previously studied. Advanced care planning (ACP), a simple intervention, which has known positive impacts on quality of EOL by decreasing healthcare costs and undesired hospitalizations, however, only 33% of the population has completed it. This study will examine the correlation between death anxiety and ACP. We hypothesize that there will be a statistically significant lower level of death anxiety in participants with ACP.  Methods: The study population will include patients presenting to the Parkview Regional Medical Center ED who are ≥65, with a sample size of 1,000. We will use a translated and adapted version of the 17 question Likert-type Scale of Death Anxiety; developed and validated by Cai et al. in 2017. It will be presented via REDCap and will include electronic signature of informed consent. Finally, we will include questions about ACP and advanced directives. Participants will also complete a basic demographic survey to account for confounding factors. Analysis will include a Mann Whitney test, univariate and multivariate regressions.   Results: This project resulted in a IRB submission drafts of a study protocol, informed consent, SDA survey and REDCap data collection tool. The researchers are seeking Parkview Health-IRB approval in Fall 2020, with an anticipated study start date of Spring 2021.   Impact: This project has the potential to improve quality of life by decreasing death anxiety and resulting negative stress reactions. Interventions for decreasing death anxiety have not been extensively studied so directions for future research are broad and could include impacts of ACP in varying ages and contexts outside of the ED.  

scholarly journals Gender and Age at Enrolment: the Predictor of Advanced Heart failure in Gene-negative Patients with Hypertrophic Cardiomyopathy

2021 ◽  
Author(s):  
Lin Qi ◽  
Zhengyi Shan ◽  
Ying Wei ◽  
Qing Yao Wang ◽  
Peng Zhao
Keyword(s):  
Heart Failure ◽  
Hypertrophic Cardiomyopathy ◽  
Multivariable Analysis ◽  
Clinical Findings ◽  
Advanced Heart Failure ◽  
Whole Exome ◽  
Increase Risk ◽  
Echocardiographic Parameters ◽  
The Impact

Abstract BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) may develop concomitant advanced heart failure (HF). However, there is a paucity of data on the clinical outcomes of HCM patients without mutations who have advanced HF. Methods: A total of 1529 unrelated patients with HCM were enrolled and followed up. All patients were genotyped by whole exome or panel sequencing. Patients without mutations were studied to assess the impact of family history, clinical findings and echocardiographic parameters on advanced HF. Results: A total of 735unrelated patients with HCM were included in the study. The mean follow up duration was 3.2±2.3years. During follow-up,97 patients had advanced HF. Multivariable analysis revealed that risk factors significantly associated with advanced HF were gender [adjusted hazard ratio (HR)2.499, 95% confidence interval (CI) 1.531-4.081, P<0.001]and age at enrolment (adjusted HR 1.298,95% CI 1.00-1.682, P= 0.049) during the follow-up period. Conclusion: Female and older at enrolment can increase risk of advanced HF in gene-negative patients with HCM . Early detection and treatment have an important role to play in management and prevention of disease-related complications for gene-negative patients.

Hospitalization Rate for Remote Monitored Advanced Heart Failure Device Patients Compared to Conventional Care during COVID-19 lockdown (Preprint)

2020 ◽  
Author(s):  
Peter Ezer ◽  
Marin Gergics ◽  
Istvan Szokodi ◽  
Attila Konyi
Keyword(s):  
Heart Failure ◽  
Observational Study ◽  
Advanced Heart Failure ◽  
Functional Class ◽  
Hospitalization Rate ◽  
Cardiac Resynchronization ◽  
Heart Failure Patients ◽  
End Point ◽  
The Impact

BACKGROUND The impact of remote monitoring (RM) in advanced heart failure cardiac implantable electronic device (CIED) patients during COVID-19 lockdown has not been established. OBJECTIVE RM can play crucial role in the follow-up of CIED implanted heart failure patients during COVID-19 pandemia. METHODS This single centre observational study was aimed to assess follow-up data of 61 remote monitored (RMG) vs. 71 conventional followed (CFG), symptomatic heart failure patients with implantable cardiac defibrillators (ICD) or cardiac resynchronization-therapy (CRT) pacemakers/defibrillators during 6 months of lockdown. The investigation analyzed worsening heart failure, arrhythmia, device related adverse evet rates (primary end point) and hospitalization rates for worsening heart failure (secondary end point). RESULTS Although, patients in the RMG had significantly more cardiovascular comorbidities and significantly worse functional class at baseline than CFG patients (NYHA class mean ± SD: [2,74 ± 0,44] vs. [2,34 ± 0,48]; P < .001), there was no difference in the composite end point of worsening heart failure, arrhythmia or device related adverse events. However, RMG patients had relative modest deterioration in heart failure functional class at in-office patient evaluations for worsening heart failure events (∆NYHA mean: 0,8 ; ∆NYHA mean: 1,5 ; P = .026). In addition, patients in RMG were significantly less hospitalized for worsening heart failure (0,0164 event/patient vs. 0,169 event/patient; P = .012). CONCLUSIONS : In this observational study remote monitored CIED implanted heart failure patients had significant benefit of lower hospitalization rate for worsening heart failure even on short term follow-up during lockdown.

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