Design and methodology of the COACH-2 (Comparative study on guideline adherence and patient compliance in heart failure patients) study: HF clinics versus primary care in stable patients on optimal therapy

Abstract

Background Since the number of heart failure (HF) patients is still growing and long-term treatment of HF patients is necessary, it is important to initiate effective ways for structural involvement of primary care services in HF management programs. However, evidence on whether and when patients can be referred back to be managed in primary care is lacking. Aim To determine whether long-term patient management in primary care, after initial optimisation of pharmacological and non-pharmacological treatment in a specialised HF clinic, is equally effective as long-term management in a specialised HF clinic in terms of guideline adherence and patient compliance. Method The study is designed as a randomised, controlled, non-inferiority trial. Two-hundred patients will be randomly assigned to be managed and followed in primary care or in a HFclinic. Patients are eligible to participate if they are (1) clinically stable, (2) optimally up-titrated on medication (according to ESC guidelines) and, (3) have received optimal education and counselling on pre-specified issues regarding HF and its treatment. Furthermore, close cooperation between secondary and primary care in terms of back referral to or consultation of the HF clinic will be provided.The primary outcome will be prescriber adherence and patient compliance with medication after 12 months. Secondary outcomes measures will be readmission rate, mortality, quality of life and patient compliance with other lifestyle changes. Expected results The results of the study will add to the understanding of the role of primary care and HF clinics in the long-term follow-up of HF patients.

Serial soluble ST2 for the monitoring of pharmacologically optimised chronic stable heart failure

“…Risk stratification and identification of these patients who are likely to decompensate remain an inexact science with fears of discharging optimised patients to general practice deterring those in secondary and tertiary care from this option. Recent results from the NorthStar [26] and COACH-2 [27] trials have, however, indicated that stable patients who are pharmacologically optimised may indeed be safe to 'graduate' to primary care follow-up. With previous disappointing results using the natriuretic peptides, questions remain as to how best to monitor such individuals.…”

Improving kNowledge Transfer to Efficaciously RAise the level of Contemporary Treatment in Heart Failure (INTERACT-in-HF): Study protocol of a mixed methods study

“…This may, however, cause organisational and/or communicational uncertainties in daily practice. 17 , 18 , 20 , 23 , 24 , 40 – 42 …”

“… 17 , 18 In addition to healthcare providers, patient involvement is an important part of DMPs. 12 , 19 , 20 However, DMPs are not uniformly implemented in Europe. In part, this may be related to the fact that DMPs do not refer to one single, clearly defined programme, but to an overall concept of delivering care.…”

Exercise training in chronic heart failure: mechanisms and therapies

“…Indeed, our understanding of the exact mechanisms of progressive intolerance to exercise is far from complete. Failure of inotropic and vasodilatory agents to improve exercise capacity implies that cardiac dysfunction is not the only factor contributing to progressive exercise intolerance [4]; impaired pulmonary and skeletal muscle function are also thought to have a role [5,6].…”