Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure

  • STATUS
    Recruiting
  • participants needed
    140
  • sponsor
    Hospital Universitario Fundación Alcorcón
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Updated on 5 August 2020
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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

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.

Details
Condition Heart failure, Heart failure, Heart disease, Heart disease
Age 18years - 100years
Treatment Advanced Care Planning program of health decisions
Clinical Study IdentifierNCT04424680
SponsorHospital Universitario Fundación Alcorcón
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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