Heart FailureNCT02299180
Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure
A study testing ACP in people with Heart Failure, run by Duke-NUS Graduate Medical School at 2 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- ACP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 2 sitesSingapore
- Study dates
- Feb 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patient participant: Patients must not have any psychiatric or cognitive disorders
- Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
National Heart Centre Singapore
Singapore, 169609
About this study
Official title: Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial
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:
- 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.
- Heath care costs during study duration between patients in ACP and control arms.
- Patient's understanding of own illness and their participation in decision making between the ACP and control arms.
- Patient's quality of life, anxiety and depression between ACP and control arms.
Read more
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.
- Conditions
- Heart Failure
- Being tested
- ACP
- Keywords
- Advanced care planning, End of life care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACPBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (5)
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.
Measured: one year
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.
Measured: every four months for one year
Patient's understanding of own illness
Patient's understanding of own prognosis will be assessed and compared between ACP and control arms.
Measured: every four months for one year
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.
Measured: every four months for one year
Patient's participation in decision-making
Patient scores on decision conflict scale will be assessed and compared between ACP and control arms.
Measured: every four months for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Centre Singapore, Singapore General Hospital
- Responsible party
- Principal investigator, Chetna Malhotra, Duke-NUS Graduate Medical School
- Investigators
- Chetna Malhotra, MD, MPH, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299180
- Sponsor's protocol ID
- LCPC IN14-0001
- Status last verified
- Feb 2019
- First submitted
- 18 Nov 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32103441Malhotra 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.
PubMed 30232107Malhotra 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.
PubMed 27287330
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02299180
- Acronym / sponsor ID
- LCPC IN14-0001
- Conditions
- Heart Failure
- Keywords
- Advanced care planning, End of life care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- National Heart Centre Singapore, Singapore General Hospital
- Study start
- Feb 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Heath care costs during study duration between patients in ACP and control arms.
- Patient's understanding of own illness and their participation in decision making between the ACP and control arms.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: ACPThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient participant: Patients must not have any psychiatric or cognitive disorders
- Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP | Behavioural | Intervention (ACP) arm |
Primary outcome
Proportion of patients receiving end of life care consistent with their stated preferences
Time frame: one year
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
5 secondary outcomes
Total health care expenditure of patients during study duration
Time frame: one year
Patient scores for Quality of life
Time frame: every four months for one year
Patient's understanding of own illness
Time frame: every four months for one year
Patient scores for anxiety and depression
Time frame: every four months for one year
Patient's participation in decision-making
Time frame: every four months for one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 32103441Malhotra 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.
- Derived from this study: PubMed 30232107Malhotra 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.
- Derived from this study: PubMed 27287330Malhotra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chetna Malhotra, MD, MPH principal investigator
Duke-NUS Graduate Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP in people with Heart Failure, run by Duke-NUS Graduate Medical School at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients receiving end of life care consistent with their stated preferences (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299180, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.