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

Heart Failure Clinical Trial

Official title:

Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299180
• Other study ID #: LCPC IN14-0001
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 2018

Study information

• Verified date: February 2019
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• ACP

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	National Heart Centre Singapore, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving end of life care consistent with their stated preferences	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	one year
Secondary	Total health care expenditure of patients during study duration	Total healthcare expenditures during the study duration will be assessed from institutional databases and compared between ACP and control arms.	one year
Secondary	Patient scores for Quality of life	Quality of life will be assessed through McGill Quality of Life scale and compared between ACP and control arms.	every four months for one year
Secondary	Patient's understanding of own illness	Patient's understanding of own prognosis will be assessed and compared between ACP and control arms.	every four months for one year
Secondary	Patient scores for anxiety and depression	Patient's anxiety and depression will be assessed through Hospital Anxiety and Depression scale and scores will be compared between ACP and control arms.	every four months for one year
Secondary	Patient's participation in decision-making	Patient scores on decision conflict scale will be assessed and compared between ACP and control arms.	every four months for one year