Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare PreferencesNCT03499847
Increasing the Uptake of Advanced Directives in SingHealth Polyclinics
A study testing standardised face-to-face counselling session and advanced medical directive pamphlet in people with Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences, run by SingHealth Polyclinics at 4 sites in Singapore.
Trial summary
An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. Read more about this study
- Who is it for?
- Ages 41 to 100 years
- Conditions the study is for
- Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences
- What is being tested?
- standardised face-to-face counselling session and advanced medical directive pamphlet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 4 sitesSingapore
- Study dates
- 29 Mar 2018to 19 Dec 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 41 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40
- Patient who seeks medical consultation at Singhealth Polyclinics (Bedok, Marine Parade, Outram, Tampines)
Who cannot join
- History of dementia
- History of depression
- Known diagnosis of terminal illness
- Signed Advanced Medical Directive/Advanced Care Plan previously
Trial locations and contacts
4 sites in 1 country.
Singapore4 sites
Outram Polyclinic
Singapore, 168937
Marine Parade Polyclinic
Singapore, 440080
Bedok Polyclinic
Singapore, 469662
Tampines Polyclinic
Singapore, 529203
About this study
Official title: Assessing the Effectiveness of Different Interventions in Increasing the Completion Rates of the Advanced Medical Directive in the Polyclinic Setting in Singapore - A Randomized Controlled Trial
An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. Despite the AMD act being passed in Singapore Parliament in 1996, uptake remains low among the population. Several intervention studies have shown that education and communication can be effective in promoting end-of-life discussion and planning. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.
Read the detailed description
An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. It may be completed by any person, of sound mind, aged 21 years and above.The AMD Act was passed in the Singapore Parliament in May 1996.
A cross-sectional, community-based study surveyed 1200 selected households in Singapore. Only 37.9% of the sample population had heard of the AMD prior to the study, though when approached, 60.6% were willing to sign an AMD. As of 2017, less than 25,000 people (0.45%) in Singapore have opted to sign an AMD.
Past studies have shown that end of life discussions reduce stress, anxiety, and depression in surviving relatives. A local study in 2010 revealed a 33% patient-surrogate discrepancy in end-of-life decision making.
There are a lack of intervention studies regarding AMD in Singapore. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.
- Conditions
- Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences
- Being tested
- standardised face-to-face counselling session, advanced medical directive pamphlet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardised face-to-face counselling sessionBehavioural
the healthcare provider will conduct a standardised face-to-face counselling session guided with subjects guided by a check-list of topics to cover regarding the Advanced Medical Directive.
advanced medical directive pamphletBehavioural
A standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Active comparator | subjects will be given a pamphlet about the advanced medical directive, and a standardized face-to-face counselling session will be conducted with their healthcare provider Receives: Behavioral: standardised face-to-face counselling session; Behavioral: advanced medical directive pamphlet |
| Passive Intervention | Active comparator | subjects will be given a pamphlet about the advanced medical directive Receives: Behavioral: advanced medical directive pamphlet |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who completed the Advanced Medical Directive
Measured: 4 months
Number of patient who expressed interest to complete the Advanced Medical Directive
Measured: 4 months
Secondary outcomes (1)
Barriers to completion of the Advanced Medical Directive
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start29 Mar 2018
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare PreferencesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm, randomised control trial 1. Active Intervention group (n=65) Counselling provided Pamphlet given 2. Passive Intervention group (n=65) Pamphlet given 3. Control group (n=65) Neither counselling nor pamphlet given
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Cunzhi, SingHealth Polyclinics
- Investigators
- Lian Leng Low, MBBS, Principal investigator, low.lian.leng@singhealth.com.sg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499847
- Sponsor's protocol ID
- Polyclinics AMD Intervention
- Status last verified
- Sep 2019
- First submitted
- 8 Apr 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tay M, Chia SE, Sng J. Knowledge, attitudes and practices of the Advance Medical Directive in a residential estate in Singapore. Ann Acad Med Singap. 2010 Jun;39(6):424-8.
PubMed 20625616Ramsaroop SD, Reid MC, Adelman RD. Completing an advance directive in the primary care setting: what do we need for success? J Am Geriatr Soc. 2007 Feb;55(2):277-83. doi: 10.1111/j.1532-5415.2007.01065.x.
PubMed 17302667Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
PubMed 15665319Foo AS, Lee TW, Soh CR. Discrepancies in end-of-life decisions between elderly patients and their named surrogates. Ann Acad Med Singap. 2012 Apr;41(4):141-53.
PubMed 22635278Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014 Jul;15(7):477-489. doi: 10.1016/j.jamda.2014.01.008. Epub 2014 Mar 2.
PubMed 24598477Tamayo-Velazquez MI, Simon-Lorda P, Villegas-Portero R, Higueras-Callejon C, Garcia-Gutierrez JF, Martinez-Pecino F, Barrio-Cantalejo IM. Interventions to promote the use of advance directives: an overview of systematic reviews. Patient Educ Couns. 2010 Jul;80(1):10-20. doi: 10.1016/j.pec.2009.09.027. Epub 2009 Oct 29.
PubMed 19879090Xu C, Yan S, Chee J, Lee EP, Lim HW, Lim SWC, Low LL. Increasing the completion rate of the advance directives in primary care setting - a randomized controlled trial. BMC Fam Pract. 2021 Jun 18;22(1):115. doi: 10.1186/s12875-021-01473-1.
PubMed 34144695
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Different Interventions in Increasing the Completion Rates of the Advanced Medical Directive in the Polyclinic Setting in Singapore - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03499847
- Acronym / sponsor ID
- Polyclinics AMD Intervention
- Conditions
- Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 17 Apr 2018 (actual)
- 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.
An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. Despite the AMD act being passed in Singapore Parliament in 1996, uptake remains low among the population. Several intervention studies have shown that education and communication can be effective in promoting end-of-life discussion and planning. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.
Detailed description
An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. It may be completed by any person, of sound mind, aged 21 years and above.The AMD Act was passed in the Singapore Parliament in May 1996.
A cross-sectional, community-based study surveyed 1200 selected households in Singapore. Only 37.9% of the sample population had heard of the AMD prior to the study, though when approached, 60.6% were willing to sign an AMD. As of 2017, less than 25,000 people (0.45%) in Singapore have opted to sign an AMD.
Past studies have shown that end of life discussions reduce stress, anxiety, and depression in surviving relatives. A local study in 2010 revealed a 33% patient-surrogate discrepancy in end-of-life decision making.
There are a lack of intervention studies regarding AMD in Singapore. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm, randomised control trial 1. Active Intervention group (n=65) Counselling provided Pamphlet given 2. Passive Intervention group (n=65) Pamphlet given 3. Control group (n=65) Neither counselling nor pamphlet given
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Active comparator | Behavioral: standardised face-to-face counselling session, Behavioral: advanced medical directive pamphletsubjects will be given a pamphlet about the advanced medical directive, and a standardized face-to-face counselling session will be conducted with their healthcare provider |
| Passive Intervention | Active comparator | Behavioral: advanced medical directive pamphletsubjects will be given a pamphlet about the advanced medical directive |
| Control | No intervention | – |
Who may qualify
- Ages
- 41 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 40
- Patient who seeks medical consultation at Singhealth Polyclinics (Bedok, Marine Parade, Outram, Tampines)
Key exclusion criteria (4 listed)
- History of dementia
- History of depression
- Known diagnosis of terminal illness
- Signed Advanced Medical Directive/Advanced Care Plan previously
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 |
|---|---|---|
| standardised face-to-face counselling sessionthe healthcare provider will conduct a standardised face-to-face counselling session guided with subjects guided by a check-list of topics to cover regarding the Advanced Medical Directive. | Behavioural | Active Intervention |
| advanced medical directive pamphletA standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore. | Behavioural | Active Intervention, Passive Intervention |
Primary outcome
Number of patients who completed the Advanced Medical Directive
Time frame: 4 months
Number of patient who expressed interest to complete the Advanced Medical Directive
Time frame: 4 months
1 secondary outcome
Barriers to completion of the Advanced Medical Directive
Time frame: 4 months
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 24 Sep 2019.
- Background: PubMed 20625616Tay M, Chia SE, Sng J. Knowledge, attitudes and practices of the Advance Medical Directive in a residential estate in Singapore. Ann Acad Med Singap. 2010 Jun;39(6):424-8.
- Background: PubMed 17302667Ramsaroop SD, Reid MC, Adelman RD. Completing an advance directive in the primary care setting: what do we need for success? J Am Geriatr Soc. 2007 Feb;55(2):277-83. doi: 10.1111/j.1532-5415.2007.01065.x.
- Background: PubMed 15665319Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.
- Background: PubMed 22635278Foo AS, Lee TW, Soh CR. Discrepancies in end-of-life decisions between elderly patients and their named surrogates. Ann Acad Med Singap. 2012 Apr;41(4):141-53.
- Background: PubMed 24598477Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014 Jul;15(7):477-489. doi: 10.1016/j.jamda.2014.01.008. Epub 2014 Mar 2.
- Background: PubMed 19879090Tamayo-Velazquez MI, Simon-Lorda P, Villegas-Portero R, Higueras-Callejon C, Garcia-Gutierrez JF, Martinez-Pecino F, Barrio-Cantalejo IM. Interventions to promote the use of advance directives: an overview of systematic reviews. Patient Educ Couns. 2010 Jul;80(1):10-20. doi: 10.1016/j.pec.2009.09.027. Epub 2009 Oct 29.
- Derived from this study: PubMed 34144695Xu C, Yan S, Chee J, Lee EP, Lim HW, Lim SWC, Low LL. Increasing the completion rate of the advance directives in primary care setting - a randomized controlled trial. BMC Fam Pract. 2021 Jun 18;22(1):115. doi: 10.1186/s12875-021-01473-1.
- Singapore Ministry of Health - Advanced Medical Directives InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Lian Leng Low, MBBS principal investigator
low.lian.leng@singhealth.com.sg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardised face-to-face counselling session and advanced medical directive pamphlet in people with Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences, run by SingHealth Polyclinics at 4 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 2 inclusion and 4 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 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Number of patients who completed the Advanced Medical Directive (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT03499847, which also lists 7 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 24 Sep 2019.