Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study.

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. THERAPEUTIC AREA: Healthcare interventions for the management of older patients with multiple morbidities. AIMS: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. HYPOTHESIS: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. METHODS: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan-customized to the patients' individual needs and preferences-into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. CONCLUSIONS: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Symptom Severity and Health-Related Quality of Life in Patients with Atrial Fibrillation: Findings from the Observational ARENA Study.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with impaired health-related quality of life (HRQoL), high symptom severity, and poor cardiovascular outcomes. Both clinical and psychological factors may contribute to symptom severity and HRQoL in AF. METHODS: Using data from the observational Atrial Fibrillation Rhine-Neckar Region (ARENA) trial, we identified medical and psychosocial factors associated with AF-related symptom severity using European Heart Rhythm Association symptom classification and HRQoL using 5-level EuroQoL- 5D. RESULTS: In 1218 AF patients (mean age 71.1 ± 10.5 years, 34.5% female), female sex (OR 3.7, p < 0.001), preexisting coronary artery disease (CAD) (OR 1.7, p = 0.020), a history of cardioversion (OR 1.4, p = 0.041), cardiac anxiety (OR 1.2; p < 0.001), stress from noise (OR 1.4, p = 0.005), work-related stress (OR 1.3, p = 0.026), and sleep disturbance (OR 1.2, p = 0.016) were associated with higher AF-related symptom severity. CAD (ß = -0.23, p = 0.001), diabetes mellitus (ß = -0.25, p < 0.001), generalized anxiety (ß = -0.30, p < 0.001), cardiac anxiety (ß = -0.16, p < 0.001), financial stress (ß = -0.11, p < 0.001), and sleep disturbance (ß = 0.11, p < 0.001) were associated with impaired HRQoL. CONCLUSIONS: Psychological characteristics, preexisting CAD, and diabetes may play an important role in the identification of individuals at highest risk for impaired HRQoL and high symptom severity in patients with AF.

Feasibility and preliminary efficacy of perioperative interventions in patients undergoing coronary artery bypass grafting: the randomized controlled I-COPE trial.

OBJECTIVES: Patients undergoing coronary artery bypass graft (CABG) surgery are exposed to multiple treatment-related stressors, which can impact coping and health-related quality of life (HRQoL). The objective of this trial was to analyse the feasibility and preliminary efficacy of a multi-component intervention that combines psychological support and reduction of hospital-specific stressors on HRQoL, length of hospital and intensive care unit stay, self-efficacy, and plasma interleukin (IL)-6 and -8 levels in CABG patients. METHODS: This three-arm, randomized controlled, single-centre pilot trial assessed the Intervention for CABG to Optimize Patient Experience in 88 patients undergoing elective CABG. Standard medical care (SMC, n = 29) was compared with 2 intervention groups: (i) psychological interventions to optimize treatment expectations (IA group, n = 30) and (ii) multi-component intervention (IB group, n = 29) with psychological interventions plus an additional treatment package (light therapy, noise reduction, music, and if desired, 360° images delivered via virtual reality). RESULTS: The implementation of psychological interventions in routine medical treatment was feasible (91.5% of participants completed all intervention sessions). Both interventions were associated with significantly shorter hospital stay compared to SMC (IA/IB 9.8/9.3 days vs SMC 12.5 days). Self-efficacy expectations at post-surgery were significantly higher compared to SMC both in the IA group (P = 0.011) and marginally in the IB group (P = 0.051). However, there were no treatment effects of the interventions on HRQoL and plasma levels of IL-6 or IL-8 after CABG. CONCLUSIONS: A perioperative multi-component intervention may lead to shorter hospital stay and higher self-efficacy after CABG. Further studies are needed to determine its impact on HRQoL and inflammation. CLINICAL TRIAL REGISTRATION NUMBER: Ethical approval (# 21/2/18) for the study was obtained from the Research Ethics Committee of the University of Göttingen Medical Center, and the trial was registered in the German Clinical Trials Register (DRKS00015309, https://www.drks.de/drks_web/setLocale_EN.do).

How family history of premature myocardial infarction affects patients at cardiovascular risk.

OBJECTIVE: Family history of premature myocardial infarction (FH-MI) increases the risk for coronary heart disease (CHD). Research has shown that this effect cannot be accounted for by increased genetic vulnerability alone. We tested the hypothesis that FH-MI is associated with psychological distress, which is known to increase CHD risk, and that this effect is sustained over years and mediated by personality traits and coping strategies. METHOD: Levels of distress (i.e., exhaustion, depression, and anxiety) were compared between patients with versus without FH-MI and those with versus without own history of myocardial infarction (MI) from the large observational Diagnostic trial on Prevalence and Clinical Course of Diastolic Dysfunction and Heart Failure (DIAST-CHF) study of patients with cardiovascular risk factors or manifest heart disease (N = 1,470). RESULTS: FH-MI was associated with a range of personality traits and coping strategies and independently predicted psychological distress, whereas own MI did not. In mediation analysis, we found that sociotropy and avoidant coping serially mediated significant portions of the effect of FH-MI on distress. Proportions of explained variance ranged from R2 = .11 for depressive symptoms to R2 = .25 for anxiety. Effects remained stable at 1-year follow-up. Several alternative hypotheses were tested and found to be less well supported by the data. CONCLUSIONS: Participants with cardiovascular risk factors and FH-MI report increased distress, even years after the event, which might be one component leading to their increased CHD risk. They should be offered support for dealing with distress and life events recurring on sociotropy and avoidant coping as important diathesis factors. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Telephone-based peer support intervention to reduce depressive symptoms in women with coronary heart disease, a randomized controlled trial in Germany.

Depressive symptoms in patients with coronary heart disease (CHD) predict adverse outcomes regarding e.g. cardiovascular complications. We trained women with CHD to support female peers through telephone-based counseling and tested whether depressive symptoms can be reduced, and perceived social support can be improved by the intervention over six months. 108 women with CHD and self-reported depressive or anxiety symptoms were included in a randomized controlled trial. The intervention group was offered immediate telephone-based peer support for six months, while the waiting list control group received the intervention with a 6-months delay. Primary outcomes were depressive symptoms and perceived social support immediately after the intervention period and at 6-months-follow-up. 40% of the women made use of the peer support. During the first six months, both groups showed a reduction in depressive symptoms (IIG: t(169) = -1.79, p = .08; WCG: t(169) = -2.76, p = .007) and a significant improvement in social support (IIG: t(175) = 3.54, p < .001; WCG: t(175) = 3.36, p < .001). We found no significant group × time interactions. There was no influence of telephone-based peer support on depressive symptoms and social support. We discuss potential causes for both lack of specific treatment effects and the general improvement over time in both groups.

Health-related quality of life, anxiety and depression up to 12 months post-stroke: Influence of sex, age, stroke severity and atrial fibrillation - A longitudinal subanalysis of the Find-AFRANDOMISED trial.

BACKGROUND: Stroke can negatively impact the health-related quality of life (HRQoL). Anxiety or depression after stroke have been associated with poorer HRQoL, higher mortality and greater dependence in activities of daily living. We aimed to analyze HRQoL, anxiety and depressive symptoms in patients with and without atrial fibrillation (AF) up to 12 months post-stroke. METHODS: Find-AFRANDOMISED was a prospective, randomized multicenter study, which included 398 patients ≥60 years with acute cerebral ischemia. HRQoL data were collected using the 3-level EuroQol-5D (EQ-5D-3L) and Stroke Impact Scale (SIS-16). Anxiety and depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS). The severity of stroke was measured using the modified Rankin Scale (mRS). RESULTS: In this study (mean age 72.7 ± 7.5 years, 40.2% females), there was a significant improvement in HRQoL using EQ-5D-3L after 3 months (ß = 0.37, p < .01), 6 months (ß = 0.43, p < .01) and 12 months (ß = 0.44, p < .01) post-stroke compared to baseline. HADS anxiety scores after 3 months (ß = -0.22, p < .01) and 12 months (ß = -0.28, p < .01) were significantly reduced. Older patients reported reduced HRQoL and more depressive symptoms. Females indicated lower HRQoL and more anxiety. mRS score at baseline was an independent predictor for HRQoL. There was a significant but small effect of AF on EQ-5D-3L and on HADS anxiety. CONCLUSIONS: Patients showed significant improvement in HRQoL and reduced anxiety after 3 and 12 months after stroke. We could demonstrate that the severity of stroke as well as sex and age impact long-term post-stroke HRQoL. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01855035.

Blended collaborative care in the secondary prevention of coronary heart disease improves risk factor control: Results of a randomised feasibility study.

BACKGROUND: Risk factor control is essential in limiting the progression of coronary heart disease, but the necessary active patient involvement is often difficult to realise, especially in patients suffering psychosocial risk factors (e.g. distress). Blended collaborative care has been shown as an effective treatment addition, in which a (non-physician) care manager supports patients in implementing and sustaining lifestyle changes, follows-up on patients, and integrates care across providers, targeting both, somatic and psychosocial risk factors. AIMS: The aim of this study was to test the feasibility, acceptance and effect of a six-month blended collaborative care intervention in Germany. METHODS: For our randomised controlled pilot study with a crossover design we recruited coronary heart disease patients with ⩾1 insufficiently controlled cardiac risk factors and randomised them to either immediate blended collaborative care intervention (immediate intervention group, n=20) or waiting control (waiting control group, n=20). RESULTS: Participation rate in the intervention phase was 67% (n=40), and participants reported high satisfaction (M=1.63, standard deviation=0.69; scale 1 (very high) to 5 (very low)). The number of risk factors decreased significantly from baseline to six months in the immediate intervention group (t(60)=3.07, p=0.003), but not in the waiting control group t(60)=-0.29, p=0.77). Similarly, at the end of their intervention following the six-month waiting period, the waiting control group also showed a significant reduction of risk factors (t(60)=3.88, p<0.001). CONCLUSION: This study shows that blended collaborative care can be a feasible, accepted and effective addition to standard medical care in the secondary prevention of coronary heart disease in the German healthcare system.

Genomic information and a person's right not to know: A closer look at variations in hypothetical informational preferences in a German sample.

In clinical practice and in research, there is an ongoing debate on how to return incidental and secondary findings of genetic tests to patients and research participants. Previous investigations have found that most of the people most of the time are in favor of full disclosure of results. Yet, the option to reject disclosure, based on the so-called right not to know, can be valuable especially for some vulnerable subgroups of recipients. In the present study we investigated variations in informational preferences in the context of genetic testing in a large and diverse German sample. This survey examined health care professionals, patients, participants of genetic counseling sessions and members of the general population (N = 518). Survey participants were assessed regarding their openness to learning about findings under various hypothetical scenarios, as well as their attitudes about the doctor-patient-relationship in a disclosure situation and about informational transfer to third parties. While the majority of participants wanted to learn about their findings, the extent of support of disclosure varied with features of the hypothetical diagnostic scenarios (e.g., controllability of disease; abstract vs. concrete scenario description) and demographic characteristics of the subjects. For example, subjects with higher levels of education were more selective with regards to the kind of information they want to receive than those with lower levels of education. We discuss implications of these findings for the debate about the right not to know and for the clinical practice of informed consent procedures.

Lucky or clever? From expectations to responsibility judgments.

How do people hold others responsible for the consequences of their actions? We propose a computational model that attributes responsibility as a function of what the observed action reveals about the person, and the causal role that the person's action played in bringing about the outcome. The model first infers what type of person someone is from having observed their action. It then compares a prior expectation of how a person would behave with a posterior expectation after having observed the person's action. The model predicts that a person is blamed for negative outcomes to the extent that the posterior expectation is lower than the prior, and credited for positive outcomes if the posterior is greater than the prior. We model the causal role of a person's action by using a counterfactual model that considers how close the action was to having been pivotal for the outcome. The model captures participants' responsibility judgments to a high degree of quantitative accuracy across three experiments that cover a range of different situations. It also solves an existing puzzle in the literature on the relationship between action expectations and responsibility judgments. Whether an unexpected action yields more or less credit depends on whether the action was diagnostic for good or bad future performance.

Scale Effects in Moral Relevance Assessment.

Research on moral judgment often employs bipolar rating scales to assess whether the difference between two contrasted options is judged to be morally relevant. We give an account of how different numbers of response options provided on such scales (odd vs. even) change the meaning of the test question by communicating different implicit presuppositions. We demonstrate experimentally that these changes can qualitatively affect the moral relevance judgments that subjects express in response to a given judgment problem. Several alternative explanations in terms of trivial measurement distortion are tested and refuted, and we present suggestive evidence as to what kind of factors might be prone to scale effects. The findings underscore that expressed moral judgments are constructed ad hoc and do not necessarily reflect the content of underlying stable moral commitments. We discuss implications for theories and methodology in moral psychology and in judgment and decision-making research more generally.

Deconfounding distance effects in judgments of moral obligation.

A heavily disputed question of moral philosophy is whether spatial distance between agent and victim is normatively relevant for the degree of obligation to help strangers in need. In this research, we focus on the associated descriptive question whether increased distance does in fact reduce individuals' sense of helping obligation. One problem with empirically answering this question is that physical proximity is typically confounded with other factors, such as informational directness, shared group membership, or increased efficaciousness. In a series of 5 experiments, we show that distance per se does not influence people's moral intuitions when it is isolated from such confounds. We support our claims with both frequentist and Bayesian statistics. We relate these findings to philosophical arguments concerning the normative relevance of distance and to psychological theories linking distance cues to higher level social cognition. The effects of joint versus separate evaluation paradigms on moral judgments are also discussed.