Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial
Brief 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.


Options:
A: Patients with a confirmed diagnosis in accordance with the criteria proposed by the European Society of Cardiology and with NYHA III-IV symptoms. And at least one of following criteria;

1. At least one episode of worsening heart failure that resolved with injection / infusion of diuretics or the addition of other heart failure treatment in the last 6 months and regarded optimally treated according to the responsible physician.
2. Need for infusions-treatment.
3. Chronic poor quality of life (VAS \< 50)
4. Signs of cardiac cachexia (involuntary non-oedematous weight loss ≥ 6% of total body weight within the last 6-12 months)
5. less than one year life expectancy.

Exclusion Criteria:

Ineligible are patients:

1. who do not want to participate in the study;
2. with severe communication problems;
3. with severe dementia;
4. with other serious disease in which heart failure is of secondary importance;
5. with other life-threatening illness as the primary diagnosis with expected short survival;
6. when the Primary Care Center which is responsible for patient care is geographically located from more than 30 km radius outside the hospital; and
7. participating in another clinical trial. -
B: 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
C: Inclusion Criteria

* Symptomatic Heart Failure (NYHA II-IV)
* Hospitalized or recently for acute decompensation with at least one of the following high-risk features

  * Prior hospitalization for Heart Failure (HF) within 1 year
  * Age \> 80 years
  * Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/m2)
  * Systolic Blood Pressure \< 100 mm Hg
  * Serum sodium \< 130 meq/L
  * Cardiogenic Shock (Cardiac Index \< 2.0)
  * Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
* Ability to Provide Informed Consent
* Permission of attending physician

Exclusion Criteria

* Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
* Already enrolled in hospice or receiving outpatient palliative care
D: Inclusion Criteria:

* Eligible patients from the departments of oncology, cardiology and respiratory medicine at Aarhus University Hospital
* the patient is over 18
* acceptable Danish language skills

Exclusion Criteria:

* cognitive impairment
* expected to dy within the next month
* has no relatives

Answer: B