- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03499847
Increasing the Uptake of Advanced Directives in SingHealth Polyclinics
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Singapore, Singapore, 440080
- Marine Parade Polyclinic
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Singapore, Singapore, 469662
- Bedok Polyclinic
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Singapore, Singapore, 529203
- Tampines Polyclinic
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Singapore, Singapore, 168937
- Outram Polyclinic
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Styring
|
|
Aktiv komparator: Active Intervention
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
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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.
A standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore.
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Aktiv komparator: Passive Intervention
subjects will be given a pamphlet about the advanced medical directive
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A standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of patients who completed the Advanced Medical Directive
Tidsramme: 4 months
|
4 months
|
Number of patient who expressed interest to complete the Advanced Medical Directive
Tidsramme: 4 months
|
4 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Barriers to completion of the Advanced Medical Directive
Tidsramme: 4 months
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4 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lian Leng Low, MBBS, low.lian.leng@singhealth.com.sg
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Polyclinics AMD Intervention
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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