The Cardiac Care Bridge randomized trial in high‐risk older cardiac patients: A mixed‐methods process evaluation

Aim: To evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse-coordinated transitional care intervention in older cardiac patients to understand and interpret the study results. Design: A mixed-methods process evaluation based on the Medical Research Council Process Evaluation framework. Methods: Quantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi-structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data-analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence. Results: The overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in-hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention. Conclusion: Although involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non-significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population. Impact: In addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients

The nurse-coordinated cardiac care bridge transitional care programme: a randomised clinical trial

Background: after hospitalisation for cardiac disease, older patients are at high risk of readmission and death. Objective: the cardiac care bridge (CCB) transitional care programme evaluated the impact of combining case management, disease management and home-based cardiac rehabilitation (CR) on hospital readmission and mortality. Design: single-blind, randomised clinical trial. Setting: the trial was conducted in six hospitals in the Netherlands between June 2017 and March 2020. Community-based nurses and physical therapists continued care post-discharge. Subjects: cardiac patients ≥ 70 years were eligible if they were at high risk of functional loss or if they had had an unplanned hospital admission in the previous 6 months. Methods: the intervention group received a comprehensive geriatric assessment-based integrated care plan, a face-to-face handover with the community nurse before discharge and follow-up home visits. The community nurse collaborated with a pharmacist and participants received home-based CR from a physical therapist. The primary composite outcome was first all-cause unplanned readmission or mortality at 6 months. Results: in total, 306 participants were included. Mean age was 82.4 (standard deviation 6.3), 58% had heart failure and 92% were acutely hospitalised. 67% of the intervention key-elements were delivered. The composite outcome incidence was 54.2% (83/153) in the intervention group and 47.7% (73/153) in the control group (risk differences 6.5% [95% confidence intervals, CI -4.7 to 18%], risk ratios 1.14 [95% CI 0.91-1.42], P = 0.253). The study was discontinued prematurely due to implementation activities in usual care. Conclusion: in high-risk older cardiac patients, the CCB programme did not reduce hospital readmission or mortality within 6 months. Trial registration: Netherlands Trial Register 6,316, https://www.trialregister.nl/trial/6169. Keywords: cardiac rehabilitation; cardiology; case management; disease management; transitional care

Multiple Data Analyses and Statistical Approaches for Analyzing Data from Metagenomic Studies and Clinical Trials

Metagenomics, also known as environmental genomics, is the study of the genomic content of a sample of organisms (microbes) obtained from a common habitat. Metagenomics and other “omics” disciplines have captured the attention of researchers for several decades. The effect of microbes in our body is a relevant concern for health studies. There are plenty of studies using metagenomics which examine microorganisms that inhabit niches in the human body, sometimes causing disease, and are often correlated with multiple treatment conditions. No matter from which environment it comes, the analyses are often aimed at determining either the presence or absence of specific species of interest in a given metagenome or comparing the biological diversity and the functional activity of a wider range of microorganisms within their communities. The importance increases for comparison within different environments such as multiple patients with different conditions, multiple drugs, and multiple time points of same treatment or same patient. Thus, no matter how many hypotheses we have, we need a good understanding of genomics, bioinformatics, and statistics to work together to analyze and interpret these datasets in a meaningful way. This chapter provides an overview of different data analyses and statistical approaches (with example scenarios) to analyze metagenomics samples from different medical projects or clinical trials

The Cardiac Care Bridge randomized trial in high-risk older cardiac patients: A mixed-methods process evaluation

Aim: To evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse-coordinated transitional care intervention in older cardiac patients to understand and interpret the study results. Design: A mixed-methods process evaluation based on the Medical Research Council Process Evaluation framework. Methods: Quantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi-structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data-analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence. Results: The overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in-hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention. Conclusion: Although involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non-significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population. Impact: In addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients

The prognostic value of heart rate recovery in patients with coronary artery disease: A systematic review and meta-analysis

Background: Routine outpatient care of patients with coronary artery disease (CAD) lacks a simple measure of physical fitness and risk of mortality. Heart rate recovery (HRR) is noninvasive and easily obtainable in outpatient settings. Prior studies have suggested that delayed postexercise HRR in the first minutes is associated with mortality in several types of populations. However, a comprehensive overview of the prognostic value of delayed HRR for time to mortality specifically in CAD patients is not available. The purpose of the current meta-analysis is to evaluate the prognostic value of delayed HRR in CAD patients. Methods: We conducted a systematic search in OVID MEDLINE and OVID EMBASE to identify studies reporting on HRR and risk of incident cardiovascular events or mortality in CAD patients. Hazard ratios for delayed versus nondelayed HRR were pooled using random-effects meta-analysis. Results: Four studies were included, comprising 2,428 CAD patients. The study quality of the included studies was rated moderate (n = 2) to high (n = 2). Delayed HRR was defined by ≤12 to ≤21 beat/min in the recovery period. During follow-up (range 2.0-9.8 years), 151 patients died (6.2% [range 2.5%-19.5%]). Only data on mortality could be pooled. Heterogeneity was limited (I2 = 32%; P =.23); pooled unadjusted hazard ratio for mortality, based on 3 studies, was 5.8 (95% CI 3.2-10.4). Conclusions: In CAD patients, delayed HRR is significantly associated with all-cause mortality. As exercise testing is performed routinely in CAD patients, HRR can be considered in monitoring exercise; still, further research must investigate the addition of HRR in current risk scores

Knee osteoarthritis and comorbidity: a feasibility study on an interactive exercise therapy course for physiotherapists

Purpose : A structured, tailored exercise therapy strategy was found to significantly improve physical functioning, reduce pain and was safe for patients with knee osteoarthritis (OA) and severe comorbidity. The intervention was performed in a specialized, secondary care center. Before the intervention can be implemented in primary care, appropriate education as well as insight into barriers and facilitators is needed. This study aimed to 1) evaluate the feasibility and effect of an interactive course on the exercise therapy strategy for patients with OA and comorbidity for physiotherapists (PTs) working in primary care; and 2) map barriers for a larger scale implementation of the protocol in primary care. Methods : A pre-posttest study was performed among PTs who were member of a network for rheumatic diseases and PTs from regional subdivisions of the Royal Dutch Society for Physical Therapy (KNGF) in the Netherlands (North-Holland and Mid-Holland) all working in primary care. PTs were offered a postgraduate blended educational course consisting of an e-learning lecture (7 hours study load) and two interactive workshops (each 3 hours study load). Measures of its feasibility and effectiveness included a questionnaire on knowledge (50 multiple choice questions, score ranging from 1 to 50) before (T0) and two weeks after the course (T1)) and a patient vignette to measure clinical reasoning (nine open questions, score ranging from 0 to 5) before the course (T0) and six months after the course (T2). Course satisfaction was administered on a 0-10 point scale (higher score means more satisfaction), directly after the course. Barriers for using the protocol were measured at T2 by means of a 27 item questionnaire, comprising five different dimensions: (i) Design, Content and Feasibility; (ii) Change in working method; (iii) Knowledge and Skills; (iv) Applicability; and (v) Social environment (each item was scored on a 5-point Likert scale, ranging from 0 totally agree to 4 totally disagree). Results : In total, 34 physiotherapists were included. Statistically significant (P < 0.05) improvement was found in knowledge about knee OA and comorbidity between baseline and two- weeks post education, with an average increase of 4.4 points above the baseline score. Also, a statistically significant improvement (P < 0.05) was found for clinical reasoning on adapting knee OA exercise therapy to the comorbid disease between baseline and six- months post education. Overall, the PTs were satisfied with the educational course (7.9 points (SD 0.9) (n ¼ 33)). The majority of PTs found the protocol to be supportive regarding clinical reasoning and clinical decision making. In a period of six months, 15 out of 34 PTs had treated at least one patient with knee OA and comorbidity according to the protocol. Perceived barriers for implementation included the small number of patients with OA and severe comorbidity being referred or referring themselves, treatment time needed to provide care according the protocol, and the limited number of treatments reimbursement by the insurance companies. Conclusions : An interactive educational course on exercise therapy for knee OA patients with comorbidity proved to be effective in improving knowledge and clinical reasoning skills of primary care PTs. Main barriers for larger scale implementation include limited referrals of patients with knee OA and severe comorbidity to PTs and limited number of treatments reimbursement by the insurance companies. Specialists and patients should be encouraged to consider exercise therapy as a treatment option for patients with knee OA and comorbidity

The Cardiac Care Bridge randomized trial in high-risk older cardiac patients: A mixed-methods process evaluation

Aim To evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse‐coordinated transitional care intervention in older cardiac patients to understand and interpret the study results. Design A mixed‐methods process evaluation based on the Medical Research Council Process Evaluation framework. Methods Quantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi‐structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data‐analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence. Results The overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in‐hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention. Conclusion Although involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non‐significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population. Impact In addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients

The Cardiac Care Bridge randomized trial in high-risk older cardiac patients: A mixed-methods process evaluation

Aim: To evaluate healthcare professionals' performance and treatment fidelity in the Cardiac Care Bridge (CCB) nurse-coordinated transitional care intervention in older cardiac patients to understand and interpret the study results. Design: A mixed-methods process evaluation based on the Medical Research Council Process Evaluation framework. Methods: Quantitative data on intervention key elements were collected from 153 logbooks of all intervention patients. Qualitative data were collected using semi-structured interviews with 19 CCB professionals (cardiac nurses, community nurses and primary care physical therapists), from June 2017 until October 2018. Qualitative data-analysis is based on thematic analysis and integrated with quantitative key element outcomes. The analysis was blinded to trial outcomes. Fidelity was defined as the level of intervention adherence. Results: The overall intervention fidelity was 67%, ranging from severely low fidelity in the consultation of in-hospital geriatric teams (17%) to maximum fidelity in the comprehensive geriatric assessment (100%). Main themes of influence in the intervention performance that emerged from the interviews are interdisciplinary collaboration, organizational preconditions, confidence in the programme, time management and patient characteristics. In addition to practical issues, the patient's frailty status and limited motivation were barriers to the intervention. Conclusion: Although involved healthcare professionals expressed their confidence in the intervention, the fidelity rate was suboptimal. This could have influenced the non-significant effect of the CCB intervention on the primary composite outcome of readmission and mortality 6 months after randomization. Feasibility of intervention key elements should be reconsidered in relation to experienced barriers and the population. Impact: In addition to insight in effectiveness, insight in intervention fidelity and performance is necessary to understand the mechanism of impact. This study demonstrates that the suboptimal fidelity was subject to a complex interplay of organizational, professionals' and patients' issues. The results support intervention redesign and inform future development of transitional care interventions in older cardiac patients