NCT Number: NCT02299180
Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure
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.
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Notify MeKey information
Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
National Heart Centre Singapore, Singapore
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient participant:
- Patients must be 21 years old or older and must be diagnosed with advanced heart failure (New York Heart Association Class III and IV). Patients must be aware of their diagnosis
- Caregiver/Decision-maker participant: Subject must be 21 years old or older Participant must be either
- appointed substitute decision maker or
- most likely to be substitute decision maker for patient (if patient were to lose decision-making capacity)
Exclusion criteria
- Patient participant: Patients must not have any psychiatric or cognitive disorders
- Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker
Treatment and study plan
Primary outcomes
-
Proportion of patients receiving end of life care consistent with their stated preferences
Time frame: one year
Patient's stated preferences for cardiopulmonary resuscitation (CPR) and life prolonging treatments (e.g. mechanical ventilation, dialysis, feeding tube, intravenous antibiotics, blood transfusion) will be assessed from their last survey or their ACP document. The actual treatment received by the patient will be assessed from medical records after the patient's death. Proportion of patients who died and received treatment consistent with their stated preferences will be calculated and compared between ACP and control arms
Secondary outcomes
-
Total health care expenditure of patients during study duration
Time frame: one year
Total healthcare expenditures during the study duration will be assessed from institutional databases and compared between ACP and control arms.
-
Patient scores for Quality of life
Time frame: every four months for one year
Quality of life will be assessed through McGill Quality of Life scale and compared between ACP and control arms.
-
Patient's understanding of own illness
Time frame: every four months for one year
Patient's understanding of own prognosis will be assessed and compared between ACP and control arms.
-
Patient scores for anxiety and depression
Time frame: every four months for one year
Patient's anxiety and depression will be assessed through Hospital Anxiety and Depression scale and scores will be compared between ACP and control arms.
-
Patient's participation in decision-making
Time frame: every four months for one year
Patient scores on decision conflict scale will be assessed and compared between ACP and control arms.
Sponsors and collaborators
Lead sponsor
Duke-NUS Graduate Medical School
Other
Collaborators
- National Heart Centre Singapore
- Singapore General Hospital
Registry information
Official study title
Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Nov 24, 2014
- Registry last updated
- Feb 8, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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