Clinical trial NCT04424680: Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure
Official title: Evaluating the Efficacy of an Advanced Care Planning Program for Health Decisions in Patients With Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once patients have been included in the study, the assignment process will be carried out by random sampling to the study groups. In the First Group (control group), patients will be followed in HF outpatients units according to the usual established protocol. In the Second Group (intervention group), patients will participate in the ACP program. Treatment for HF will be the same in both groups. The research team has developed the ACP program based on the published bibliography on ACP and advanced HF. The four hospitals mentioned will start recruiting at the beginning of the study. The principal investigator will be responsible for interrupting recruitment once the sample size has been reached.
Primary purpose: OTHER

Brief summary: An "Advanced Planning Program of Health Decisions" (APPHD) is a process of reflection and relationship between the patient, their relatives and health professionals. It is based on respect for patient's autonomy, to engage patients in making decisions about their disease so that the process is shared between the medical team, the patient and their relatives. Until now, it has not been measured whether the APPHD is effective and, therefore, really fulfills its purpose

Detailed description: BACKGROUND: An 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. OBJETIVES: 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. METHODS: randomized 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.

Eligibility criteria: Inclusion Criteria:

* Patients with HF defined by Framingham diagnostic criteria.
* Stage C or D of the ACCF / AHA classification.
* Full capacity to decide.
* Signing of informed consent.

Exclusion Criteria:

* Cognitive impairment, measured by Mini-Mental Status Examination (\< 27).
* Presence of another disease other than HF that may severely affect the quality of life: stroke with significant residual deficit, end-stage renal failure, Child C cirrhosis, extreme obesity, haemoglobin \<8 g / dl, advanced peripheral artery disease (stage III-IV), severe thyroid or adrenal disease, neoplastic with estimated survival of less than 2 years.
* Patients who do not sign the informed consent.

Primary outcomes:
measure: To evaluate the efficacy of an Advanced Care Planning program for decision-making in patients with advanced Heart Failure in comparison to usual follow up and care: questionnaire
timeFrame: 24 months
Secondary outcomes:
measure: To evaluate the effect of the ACP program on quality of life: questionnaire
timeFrame: 24 months
measure: To know if the patients wishes expressed through the ACP program are fulfilled
timeFrame: 24 months
measure: To determine the level of satisfaction with the ACP program of patients included in the program.
timeFrame: 24 months
measure: To evaluate the effect on quality of death: questionnaire
timeFrame: 24 months
measure: To measure the impact of the ACP program on patients' caregivers
timeFrame: 24 months
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
Study officials:
References:
citation: Perez M, Herreros B, Martin MD, Molina J, Kanouzi J, Velasco M. Do Spanish Hospital Professionals Educate Their Patients About Advance Directives? : A Descriptive Study in a University Hospital in Madrid, Spain. J Bioeth Inq. 2016 Jun;13(2):295-303. doi: 10.1007/s11673-016-9703-7. Epub 2016 Jan 21.
citation: Perez M, Herreros B, Martin MD, Molina J, Guijarro C, Velasco M. [Changes in knowledge and carrying out the advance directives of patients admitted to internal medicine]. Rev Calid Asist. 2013 Sep-Oct;28(5):307-12. doi: 10.1016/j.cali.2013.03.008. Epub 2013 Sep 7. Spanish.
citation: Molina J, Perez M, Herreros B, Martin MD, Velasco M. [Knowledge and attitude regarding previous instructions for the patients of a public hospital of Madrid]. Rev Clin Esp. 2011 Oct;211(9):450-4. doi: 10.1016/j.rce.2011.06.007. Epub 2011 Aug 2. Spanish.
citation: Miles SH, Koepp R, Weber EP. Advance end-of-life treatment planning. A research review. Arch Intern Med. 1996 May 27;156(10):1062-8.
citation: Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, Espaulella J, Villanueva A, Oller R, Martori JC, Constante C. Utility of the NECPAL CCOMS-ICO(c) tool and the Surprise Question as screening tools for early palliative care and to predict mortality in patients with advanced chronic conditions: A cohort study. Palliat Med. 2017 Sep;31(8):754-763. doi: 10.1177/0269216316676647. Epub 2016 Nov 4.
citation: Sanchez B, Guijarro C, Velasco M, Vicente MJ, Galan 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 Cardiovasc Disord. 2020 Oct 21;20(1):456. doi: 10.1186/s12872-020-01738-0.