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

Duke University

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: ACP

Study type: Interventional

Funder types: Other

Identifiers

NCT02299180

LCPC IN14-0001

Details and patient eligibility

About

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.

Enrollment: 282 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Control arm

No Intervention group

Description:

The control arm patients will not take part in ACP discussions and documentation, but will continue to receive usual care.

Intervention (ACP) arm

Experimental group

Description:

The patient and his/her family members will be referred to an ACP facilitator and will undergo ACP as an ongoing process, integrated with patient's care, from the facilitator, in coordination with a coordinator/nurse, and treating physician. The ACP facilitator will be certified in providing ACP and will possess sufficient knowledge of the risks, benefits, and harms of treatments and procedures available to the patient. The ACP facilitator will be supported by the physician with the specialized knowledge of treatment options, especially with regards to prognosis. Family members will be encouraged to be present during the ACP discussion so that the whole family unit will be able to explore goals, values and beliefs towards the patient's medical care.

Treatment:

Behavioral: ACP