Clinical trial NCT03499847: Increasing the Uptake of Advanced Directives in SingHealth Polyclinics
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Medical Directive, a Legal Document Signed in Advance to State Healthcare Preferences
Lead sponsor: SingHealth Polyclinics
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 189
Sex: ALL
Minimum age (years): 41
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age \> 40
* Patient who seeks medical consultation at Singhealth Polyclinics (Bedok, Marine Parade, Outram, Tampines)

Exclusion Criteria:

* History of dementia
* History of depression
* Known diagnosis of terminal illness
* Signed Advanced Medical Directive/Advanced Care Plan previously

Primary outcomes:
measure: Number of patients who completed the Advanced Medical Directive
timeFrame: 4 months
measure: Number of patient who expressed interest to complete the Advanced Medical Directive
timeFrame: 4 months
Secondary outcomes:
measure: Barriers to completion of the Advanced Medical Directive
timeFrame: 4 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Outram Polyclinic
city: Singapore
country: Singapore
facility: Marine Parade Polyclinic
city: Singapore
country: Singapore
facility: Bedok Polyclinic
city: Singapore
country: Singapore
facility: Tampines Polyclinic
Study officials:
affiliation: low.lian.leng@singhealth.com.sg
name: Lian Leng Low, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ramsaroop 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.
citation: Azoulay 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.
citation: Foo 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.
citation: Houben 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.
citation: Tamayo-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.
citation: Xu 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.