Advance Care Planning in Patients With Heart Failure in Denmark

NCT05269875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-04

No results posted yet for this study

Summary

Advance care planning (ACP) represents a process whereby a patient, in consultation with healthcare professionals, family members and important others, makes decisions about his or her future healthcare and wishes for end-of-life care and is widely advocated to improve end-of-life care for patients with heart failure (HF). Despite the growing emphasis on communication with HF patients and their relatives, there is no tradition in Denmark for systematical communication about wishes for end-of-life care. The aim of the study is to adapt the ACP to a new contest and target group and determine the feasibility and acceptable recruitment rate and completeness of potential outcome measures for a future RCT.

A study of a complex intervention will be conducted to address all elements of an adapted ACP intervention in HF patients (NYHA class III, IV) and their relatives. Patients will be identified and recruited by HF specialist nurses or a cardiologist from the Department of Cardiology at North Zealand Hospital. The HF specialist nurses or the cardiologist will inform the patients about the study and obtain consent for the research staff to contact the patients by telephone. The patients will be further informed by the research staff and asked to fill out the baseline questionnaires. The patients will be asked to select the closest relatives who also will be offered participation. Included patients will receive an invitation with the date and time of their ACP meeting in their electronic patient record. They will be offered an ACP discussion which covers components e.g. symptom control, discussions on prognosis and illness limitations, and wishes for future and end-of-life care. Baseline and follow-up (4 and 12 weeks after the ACP meeting) will be made with disease-specific and generic questionnaires. Qualitative interview data will be obtained, and thematic analysis will uncover the patients, relatives and the clinician's perspectives and satisfaction with the intervention.

Conditions

  • Heart Failure
  • Advance Care Planning
  • Communication
  • Feasibility Studies

Interventions

OTHER

ACP

The intervention covers a formal ACP discussion, including provision of a holistic approach (physical, psychological, spiritual, social) and includes symptom control and discussion on illness limitations and prognosis, goal assessment and goal adjustment, financial issue, (un)desirable treatments for current and future care, hopes and wishes, and possibility of involvement of a palliative care team.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER
  • University of Southern Denmark

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Zealand University Hospital

    collaborator OTHER
  • REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care

    collaborator OTHER
  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Camilla Lykke, Postdoc · Department of Oncology and palliative Care and the Department of Cardiology, North Zeeland Hospital

  • Camilla Lykke, Postdoc · Department of Oncology and palliative Care and the Department of Cardiology, North Zeeland Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269875 on ClinicalTrials.gov