NCT02299180

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. 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. 2.Heath care costs during study duration between patients in ACP and control arms.
  3. 3.Patient's understanding of own illness and their participation in decision making between the ACP and control arms.
  4. 4.Patient's quality of life, anxiety and depression between ACP and control arms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

3.3 years

First QC Date

November 18, 2014

Last Update Submit

February 6, 2019

Conditions

Heart Failure

Keywords

Advanced care planningEnd of life care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Total health care expenditure of patients during study duration

    one year

  • Patient scores for Quality of life

    every four months for one year

  • Patient's understanding of own illness

    every four months for one year

  • Patient scores for anxiety and depression

    every four months for one year

  • Patient's participation in decision-making

    every four months for one year

Study Arms (2)

Control arm

NO INTERVENTION

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

Intervention (ACP) arm

EXPERIMENTAL

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.

Behavioral: ACP

Interventions

ACPBEHAVIORAL
Intervention (ACP) arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patient participant: Patients must not have any psychiatric or cognitive disorders
  • Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Related Publications (3)

  • 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.

    PMID: 32103441DERIVED

  • 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.

    PMID: 30232107DERIVED

  • 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.

    PMID: 27287330DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Chetna Malhotra, MD, MPH

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 24, 2014

Study Start

February 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

SG(2)