Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05269875 |
| Other study ID # |
ACP-P-2020-790 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Nordsjaellands Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Advance care planning (ACP) represents a process whereby a patient, in consultation with
healthcare professionals, family members and important others, makes decisions about his or
her future healthcare and wishes for end-of-life care and is widely advocated to improve
end-of-life care for patients with heart failure (HF). Despite the growing emphasis on
communication with HF patients and their relatives, there is no tradition in Denmark for
systematical communication about wishes for end-of-life care. The aim of the study is to
adapt the ACP 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.
A study of a complex intervention will be conducted to address all elements of an adapted ACP
intervention in HF patients (NYHA class III, IV) and their relatives. Patients will be
identified and recruited by HF specialist nurses or a cardiologist from the Department of
Cardiology at North Zealand Hospital. The HF specialist nurses or the cardiologist will
inform the patients about the study and obtain consent for the research staff to contact the
patients by telephone. The patients will be further informed by the research staff and asked
to fill out the baseline questionnaires. The patients will be asked to select the closest
relatives who also will be offered participation. Included patients will receive an
invitation with the date and time of their ACP meeting in their electronic patient record.
They will be offered an ACP discussion which covers components e.g. symptom control,
discussions on prognosis and illness limitations, and wishes for future and end-of-life care.
Baseline and follow-up (4 and 12 weeks after the ACP meeting) will be made with
disease-specific and generic questionnaires. Qualitative interview data will be obtained, and
thematic analysis will uncover the patients, relatives and the clinician's perspectives and
satisfaction with the intervention.
Description:
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.
Participants Patients ≥18 years with HF NYHA class III-IV in acute exacerbation who are
admitted to the Department of Cardiology, North Zealand Hospital and fulfil the inclusion
criteria will be asked to participate. The patients will be asked to select the closest
relatives, who also will be offered participation.
Intervention The patient will be offered a intervention by the Department of Cardiology. The
intervention covers a ACP discussion including symptom control. The intervention consists of
a dialogue between the patient, the closest relative, a cardiologist, a PC physician and a HF
nurse. Based on the ACP approach the North Zealand hospital have built a smartphrase for
documentation in the electronic patients' records. The smartphase includes eight questions;
1. Introduction to the purpose of the ACP discussion; 2. Clarification of the closest
relative(s); 3. Clarification of what the patient and the relatives know about the disease
and its trajectory; 4. Clarification of what the most important things are to the patient to
be able to do; 5. Clarification of the patient's and relatives' experiences of incurable
disease and their preferences regarding end-of-life care; 6. Clarification of the patients'
wishes and possibilities to level of treatment; 7. Clarification of the patient's wishes in
preferred place of care and death; 8. Clarification of whether there is something the health
professionals need to know in order to fulfill the patient's wishes at the preferred place of
care and death. The intervention will be implemented on the basis of Detering et al. five
factors for improving patient satisfaction with end-of-life care discussions: (1) using
trained facilitators,(2) conducting a patient-centred discussion,(3) the involvement of the
family,(4) correctly filing and communicating the ACP documentation with all parties, and (5)
education of doctors in communicating ACP. A future plan will be made in collaboration by the
patient, the relative, the cardiologist, the PC physician, and the HF nurse at the end of the
ACP discussion. After the end of discussion, the patient's wishes and future preferences will
be documented in their individual patient record. With the patient's acceptance their GP will
receive a copy of the ACP document.
Evaluation To identify potential primary outcomes for a future effect study and provide
limited efficacy testing, data will be collected in a structured way to investigate changes
in the patient-reported outcome measurements (PROMs), including assessments of symptoms,
health-related quality of life (HRQoL) and caregiver burden.
All questionnaires will be sent electronically to the patients and the relatives through
REDCap. This is a secure web application for building and managing online surveys and
databases. The research staff will support all patients and relatives not used to filling out
questionnaires in electronically systems.
Patient, relatives and clinician satisfaction Qualitative interview is a well-suited method
when knowledge is wanted on how informants describe their experiences. After the ACP meeting
an evaluative semi-structured telephone interview will be conducted with all participants to
obtain a deeper understanding of their experiences. The interviews will take place maximum
two weeks after the ACP meeting. All interviews will be performed by research staff. The
interviews will be guided by questions based on an interview guide. Each interview will be
initiated with an open question on the patient's disease trajectory followed by their
recollection of positive or negative experiences with the ACP meeting.
A qualitative focus group-interview will be conducted with the clinicians involved after
study completion where the clinician's satisfaction with the intervention will be
investigated. All interviews will be recorded, transcribed. All interviews with patients will
be rendered anonymous.
Analyses Statistical analysis will be performed, considering the selection of appropriate
analysis methods. For self-reported outcome scores, continuous data will be checked for
normality and presented as mean ± standard deviation (SD). Frequencies will be expressed as
percentages. Mean difference will be determined to investigate change in outcomes from
baseline to follow-up time points. Due to the small numbers planned to be included in the
present study only simple statistics will be applied. Effect size will be estimated with
Cohen's d; values of 0.3, 0.5 and 0.8 will be interpreted as small, medium and large effect
sizes respectively. All analyzes will be performed in SAS 9.4.
Thematic analysis will be used to analyze all the interviews and was chosen to extract data,
and to identify and report patterns. NVivo will be used to code and retrieve data.
Strengths The ACP intervention has proved to be feasible and successful in different patient
populations and has specific strengths. It includes both patients and their relatives and has
been adapted to be HF specific and the intervention includes individually tailored provision
of and discussion of prognostic information and end-of-life care preferences and wishes. This
study, also, has methodological strengths. It is a study of a complex intervention where the
process is dynamic, iterative, creative, open to change and forward looking to future
evaluation and implementation if proven to be successful. Finally, the study will be the key
to inform of the feasibility and design of a full-scale RCT.
Limitations The proportion of patients who participate in the trial will be documented.
However, it is likely that there will be systematic differences between those who participate
in the ACP trial and those who do not want to participate. Also, it is unavoidable that in
conducting a study involving patients with incurable HF, a number of participants may die
before follow-up data can be collected or wish to withdraw from the study before completion.
Disclosures and dissemination The study will be performed in accordance with the Declaration
of Helsinki and will be registered on clinicaltrials.gov. It has been approved by the Danish
Data Protection Agency (P-2020-790) and assessed by the Danish Ethics Committee (H-20041951).
Results from the study will be reported through oral presentations at national and
International meetings and publication in international journals. The results will be
published according to the 'CONSORT Statement' (www.consort-statement.org).
Funding The study is supported by Aase og Ejnar Danielsens foundation and the Department of
Cardiology and the Department of Oncology and Palliative Care at the North Zealand Hospital.
