Clinical trial NCT02299180: Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure
Official title: Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Advanced care planning
End of life care
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: National Heart Centre Singapore
name: Singapore General Hospital
First posted: 2014-11-24
Enrollment: 282
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients receiving end of life care consistent with their stated preferences
timeFrame: one year
Secondary outcomes:
measure: Total health care expenditure of patients during study duration
timeFrame: one year
measure: Patient scores for Quality of life
timeFrame: every four months for one year
measure: Patient's understanding of own illness
timeFrame: every four months for one year
measure: Patient scores for anxiety and depression
timeFrame: every four months for one year
measure: Patient's participation in decision-making
timeFrame: every four months for one year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Chetna Malhotra, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malhotra C, Hu M, Malhotra R, Sim D, Jaufeerally FR, Bundoc FG, Finkelstein EA. Instability in End-of-Life Care Preference Among Heart Failure Patients: Secondary Analysis of a Randomized Controlled Trial in Singapore. J Gen Intern Med. 2020 Jul;35(7):2010-2016. doi: 10.1007/s11606-020-05740-2. Epub 2020 Feb 26.
citation: Malhotra C, Sim D, Jaufeerally F, Finkelstein EA. Associations between understanding of current treatment intent, communication with healthcare providers, preferences for invasive life-sustaining interventions and decisional conflict: results from a survey of patients with advanced heart failure in Singapore. BMJ Open. 2018 Sep 19;8(9):e021688. doi: 10.1136/bmjopen-2018-021688.
citation: Malhotra C, Sim DK, Jaufeerally F, Vikas NN, Sim GW, Tan BC, Ng CS, Tho PL, Lim J, Chuang CY, Fong FH, Liu J, Finkelstein EA. Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial. Trials. 2016 Jun 10;17(1):285. doi: 10.1186/s13063-016-1414-1.