Evaluating the efficacy of an ACP Program for Heart Failure
Research type
Research Study
Full title
Evaluating the efficacy of an Advance Care Planning Programme for Health Decisions in patients with Advanced Heart Failure
IRAS ID
302603
Contact name
Ian Jones
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Introduction: The Advance Care Planning (ACP) Programme for Health Decisions establishes a deliberative process of reflection between healthcare professionals, the patient and their relatives, so that the patient can make decisions about their health and that these are respected. Planning is based on respect for the patient’s autonomy, and seeks for the patient’s active participation in decisions about their illness, including the medical team and their relatives in this process. The efficacy of ACP has not been assessed previously despite having the potential to positively impact the patient and family experience of end of life care
Objectives: The main goal of the study is to evaluate the efficacy of an Advance Care Planning (ACP) program in patients with advanced heart failure (HF). In addition, the study's secondary objectives are to analyse the impacts of the program on the quality of life and death of the patients, on the patient’s degree of satisfaction with the program and on the patient's caregiver.
Material and method: Randomised multicentre clinical trial with patients recruited from the Out-Patient Department Aintree University Hospital (Liverpool University Hospitals NHS Foundation Trust).Once included in the study, the procedure for assigning patients to groups (control vs intervention) will be carried out by alternative sampling. The ACP program will be applied to the intervention group, while usual follow-ups will be carried out to the control group in their HF clinics. After a 12 month follow-up of all patients, the questionnaires and tests related to the study objectives will be carried out again, to calibrate the effect (efficacy) of an ACP program in patients with advanced HF.
HYPOTHESIS
An “Advance Care Planning Program for Health Decisions” improves the participation of patients with advanced HF in clinical decision-making. This improvement could have a positive impact on their quality of life and death.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
22/NW/0063
Date of REC Opinion
9 Mar 2022
REC opinion
Unfavourable Opinion