Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-01-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Patients will be followed in heart failure outpatients units according to the usual established protocol. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed.

Treatment for heart failure will be the same in both groups.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Patients will participate in the Advanced Care Planning Program. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed.

Treatment for heart failure will be the same in both groups.

Group Type EXPERIMENTAL

Advanced Care Planning program of health decisions

Intervention Type BEHAVIORAL

Application of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care.

Interventions

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Advanced Care Planning program of health decisions

Application of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No