- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 440080
- Marine Parade Polyclinic
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Singapore, Singapur, 469662
- Bedok Polyclinic
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Singapore, Singapur, 529203
- Tampines Polyclinic
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Singapore, Singapur, 168937
- Outram Polyclinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Number of patients who completed the Advanced Medical Directive
Periodo de tiempo: 4 months
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4 months
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Number of patient who expressed interest to complete the Advanced Medical Directive
Periodo de tiempo: 4 months
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4 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Barriers to completion of the Advanced Medical Directive
Periodo de tiempo: 4 months
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4 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lian Leng Low, MBBS, low.lian.leng@singhealth.com.sg
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Polyclinics AMD Intervention
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre standardised face-to-face counselling session
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