Efficacy of an Advanced Care Planning Program in Advanced Heart FAilure

NCT04424680 | Unknown

• 1 other identifier: HUFAlcoron
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

  This objective will be evaluated by the PAM (Patient Activation Measure) test, which measures the participation and self-management of the patient in decision making. PAM measures the activation (participation and self-management) of the patient in decision-making. It evaluates the knowledge, skills and confidence of patients' self-management classifying patients in levels of self-management activation. Level 1: They do not feel responsible for their own health and care. (Score 47.0 or lower); Level 2: They may lack basic understanding about their condition, treatment options, and / or self-care. (47.1 to 55.1); Level 3: They know the basic facts of their illness and treatments. (55.2 to 67); Level 4: They have made most of the decisions, but they may have difficulties in maintaining behaviours over time or in stressful situations (67.1 or higher).

  24 months

Secondary Outcomes (5)

• To evaluate the effect of the ACP program on quality of life: questionnaire

  24 months

• To know if the patients wishes expressed through the ACP program are fulfilled

  24 months

• To determine the level of satisfaction with the ACP program of patients included in the program.

  24 months

• To evaluate the effect on quality of death: questionnaire

  24 months

• To measure the impact of the ACP program on patients' caregivers

  24 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Behavioral: Advanced Care Planning program of health decisions

Interventions

Advanced Care Planning program of health decisions 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Fundación Alcorcón: lead

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 26797513 RESULT

• 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.

  PMID: 24021533 RESULT

• 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.

  PMID: 21813119 RESULT

• 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.

  PMID: 8638992 RESULT

• 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.

  PMID: 27815556 RESULT

• 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.

  PMID: 33087061 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Internal Medicine Unit

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: January 1, 2023
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months
• Access Criteria: Study investigators

Locations

ES (1)