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Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure

NCT02299180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2019-02-08

No results posted yet for this study

Summary

Aims: Advance care planning (ACP) is considered to be one of the most promising interventions to enable patients with life limiting illnesses to receive treatment at the end of life (EOL) according to their own preferences and to promote EOL conversations between patients and their health care providers. Through a 2-arm randomized controlled trial (RCT) of patients with Class III and IV heart failure (New York Heart Association Functional Classification), we propose to assess:

1. Whether patients in the ACP arm have a greater likelihood of receiving EOL care consistent with their preferences as stated in the latter of the last ACP document or the last patient interview, compared to patients in the control arm.
2. Heath care costs during study duration between patients in ACP and control arms.
3. Patient's understanding of own illness and their participation in decision making between the ACP and control arms.
4. Patient's quality of life, anxiety and depression between ACP and control arms.

Methodology: A total of 254 patients with advance heart failure will be randomized to receive intervention (ACP arm; N=127) or usual care (control arm; N=127).

The RCT will be conducted at the National Heart Centre and Singapore General Hospital. Patients in both arms will be followed for one year or till death, whichever is earlier, and interviewed every 4 months during this duration.

Clinical Significance: If benefits of ACP are shown to add value through this trial, then this study will help to promote acceptance of ACP among patients and health care providers across Singapore and elsewhere.

Conditions

Interventions

BEHAVIORAL

ACP

Sponsors & Collaborators

  • National Heart Centre Singapore

    collaborator OTHER

  • Singapore General Hospital

    collaborator OTHER

  • Duke-NUS Graduate Medical School

    lead OTHER

Principal Investigators

  • Chetna Malhotra, MD, MPH · Duke-NUS Graduate Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

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 NCT02299180 on ClinicalTrials.gov