RT Journal Article
T1 Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial
A1 Sánchez, Beatriz
A1 Guijarro, Carlos
A1 Velasco, María
A1 Vicente Galán, María Jesús
A1 Galán, Miguel
A1 Herreros Ruiz-Valdepeñas, Benjamín
AB BackgroundAn Advanced Care Planning (ACP) program of health decisions is the result of a process of reflection and relationship-building between the patient, their relatives and health professionals. It is based on respect for patients’ autonomy, involving them in making decisions about their disease in a way that is shared between the medical team, the patient and their relatives. Up until now, the efficacy of an ACP has not been measured in the existing literature, and therefore it is unknown if these programs reach their goal. The main objective of our study is to evaluate the efficacy of an ACP program for decision-making in patients with advanced heart failure (HF) in comparison to usual follow up and care. This objective will be evaluated by the Patient Activation Measure test, which measures the participation and self-management of the patient in decision-making. Secondary objectives: to evaluate the effect of the program on quality of life, to know if the patients wishes expressed through the ACP program are fulfilled, to measure the impact of the program on patients’ caregivers, to determine the satisfaction of patients included in the program and to evaluate the effect on quality of death.MethodsRandomized multicentre clinical trial at four hospitals in Madrid. Once they are included in the study, patients’ allocation to groups (control vs intervention) will be made by alternative sampling. ACP will be applied to the intervention group, whereas in the Control Group usual follow-up will be carried out in HF units. All patients will fulfil questionnaires and tests related to the objectives of the study again after a 12-month follow-up period in order to gauge the effect of ACP in patients with advanced HF.DiscussionThe characteristics of patients with advanced HF make them a model for designing ACP programs, given the high prevalence of this disease, the progressive increase in its incidence and it’s clinical characteristics. Until now, the efficacy of this type of program has not been measured, so this Clinical Trial can provide relevant data for future ACP projects.Trial registration ClinicalTrials.gov Identifier: NCT04424680. Registered 9 June 2020. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04424680?term=NCT04424680&draw=2&rank=1.
PB BioMed Central Ltd
YR 2020
FD 2020-10-21
LK https://hdl.handle.net/20.500.14352/138673
UL https://hdl.handle.net/20.500.14352/138673
LA eng
NO Sánchez B, Guijarro C, Velasco M, Vicente MJ, Galán M, Herreros B. Evaluating the efficacy of an Advanced Care Planning Program for Health Decisions in patients with advanced heart failure: protocol for a Randomized Clinical Trial. BMC Cardiovascular Disorders. 2020;20(1).
NO El estudio cuenta con el apoyo del Hospital Universitario Fundación Alcorcón mediante una ayuda pública del Fondo de Investigaciones Sanitarias (Instituto de Salud Carlos III; Ministerio de Ciencia, Innovación y Universidades). Número de ayuda FIS: PI19/01647. Los autores declaran que el Fondo de Investigaciones Sanitarias (Instituto de Salud Carlos III) realizó una revisión independiente durante el proceso de financiación.
DS Docta Complutense
RD 20 ago 2026