Advance Care Planning in Patients With Heart Failure in Denmark (DanHFacp): a Study Protocol

Background Advance care planning (ACP) represents a way to fulfil patients' end-of-life preferences and wishes and the opportunity to improve the quality of life (QoL) for patients with life-limiting diagnoses and their relatives. ACP is advocated to improve end-of-life care for patients with heart failure (HF). The American Heart Association (AHA) has emphasized the importance of discussing with patients via ACP to better co-ordinate future healthcare based on the patient's values, preferences, and wishes, as well as their current clinical status such as their symptoms and QoL, prognosis and potential treatment options. It is important to discuss ACP not only when the HF is exacerbated, but also early in the disease process because a person's preferences may change over time. This is supported by the European Society of Cardiology (ESC) in their recently published guidelines for the diagnosis and treatment of acute and chronic HF. Here they state that proactive decisions and ACP with regard to palliative and end-of-life care should be regularly reviewed and documented. A recent systematic review and meta-analysis showed that ACP discussions improved QoL, patient satisfaction with end-of-life care and the quality of end-of-life communication for patients suffering from HF and could be most effective when the right timing, follow-up and involvement of important others was considered. Previous reviews had investigated the effectiveness of interventions to implement ACP. However, they did not investigate the impact of ACP on HF.

A Danish position statement on palliative care (PC) and advanced heart disease was recently published. The intention was to inform and influence policy and practice and focused on HF, increases the awareness of the need for PC care among patients with non-malignant diseases and inspires the process of implementing and organizing PC in advanced heart disease in Denmark and Internationally. In line with AHA this Danish position statement includes the importance of communication and ensuring ACP support. However, despite the growing emphasis on communication with HF patients and their relatives in Denmark, there is no tradition for systematical communication about wishes for end-of-life care in the Hf patients and their relatives.

This study has been designed through a systematic intervention development based on best current knowledge and our hypothesis is that ACP could be adapted and feasible in a danish healthcare population of HF patients, New York Heart Association (NYHA) Functional Classification III and IV. However, there are some uncertainties that need to be tested before we progress to a fully powered randomized controlled trial (RCT). Therefore, the aim of the study is to adapt the ACP intervention to a new contest and target group and determine the feasibility and acceptable recruitment rate and completeness of potential outcome measures for a future RCT.

Study design Implementing evidence-informed population health interventions in new contexts often requires adaptations. Therefore, an adaptation study of a complex intervention will be conducted to address all elements of the planned intervention to ensure that the intervention is feasible in HF patients and their relatives in the current context. The study will be conducted in a manner that increase external validity.

The methods regarding ACP discussions are adapted from a previous danish study. The inclusion criteria are based on the ESC guidelines according to patients with HF in whom PC and end-of-life care should be considered. To ensure a viable design, the existing model will be adapted and modified to our current context. The study will include 20 patients and their relatives with the purpose to test the feasibility and evaluate the intervention in our setting. Four new patients will be invited every month and the inclusion period is approximately expected to last 5 months. Criteria's will be agreed to provide a transparent decision process on readiness to progress to a fully powered RCT. Likewise, to identify where and to what extent the study design and/or intervention may need to be amended. There are three areas that need special attention; 1) how many HF patients will meet the inclusion criteria; 2) will the HF patients and their relatives accept and be engaged in the intervention; and 3) are the HF patients and their relatives able to complete the online survey. The study will be reported according to the CONSORT extension for pilot and feasibility trials.