Randomized Control Trial of Advance Care Planning in Primary Care
19 de febrero de 2020 actualizado por: McMaster University
A Randomized Control Trial of an Advance Care Planning Intervention to Engaged Substitute Decision-makers in Primary Care
Sometimes people with health conditions become ill suddenly and can no longer speak for themselves and another person (such as a family member) will make health care decisions for them.
This means it is important to think about your wishes and tell others about them.
This is called advance care planning.
When people have done advance care planning, if they become very sick and cannot speak for themselves they are more likely to get the kind of health care they want and it is easier for the people who make decisions for them.
There are tools such as brochures, questionnaires, and videos that can help people learn about these things.
This research is being to done to study whether using tools for advance care planning and goals of care discussions will improve how patients and their substitute decision makers do advance care planning.
This study is a randomized trial.
This means half of the people in this study will meet with someone at their family practice to talk about advance care planning and review some tools and half will get usual care (a Speak Up workbook).
The study will 1) evaluate if reviewing the tools, and having help to complete them, helps patients and their substitute decision maker do advance care planning 2) if this intervention will encourage patients to talk to their family doctor about these issues.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
In prospective and randomized trials, advance care planning (ACP) significantly improves outcomes including increased likelihood that clinicians and families understand and comply with a patient's wishes, reduces hospitalization at the end of life, results in less intensive treatments at the end of life (according to patients' wishes) and increases use of hospice services.
Trials have not been done in primary care.
In this project, we aim to determine the efficacy of a care pathway designed to increase the quality and quantity of ACP in patients and their substitute decision-makers in primary care.
The study is a multi-site, patient-based, unblinded, randomized trial conducted in family practices in Canada.
Participants will be patients who are determined by their physician to be able to benefit from ACP, and the patient's substitute decision-maker.
Participant pairs will be randomized to immediate intervention (care pathway) or delayed (8-12 weeks).
The intervention is guided use of tools and decision aids to clarify values and preferences for treatments in the event of serious illness or near end of life.
The outcomes will be substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
61
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ontario
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Dundas, Ontario, Canadá
- Dundas Family Health Team
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Dundas, Ontario, Canadá
- Michael West Doctor Office
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Hamilton, Ontario, Canadá, L8N 4A6
- St. Joseph's Healthcare Hamilton
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Hamilton, Ontario, Canadá, L7S 0A1
- Burlington Family Health Team
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Hamilton, Ontario, Canadá, L8P 1H6
- McMaster Family Health Team
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Hamilton, Ontario, Canadá, L8S 4K1
- McMaster University Medical Centre
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Hamilton, Ontario, Canadá, L8V 5C2
- Juravinski Cancer Centre Pain and Symptom Management Team
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients being treated for serious illness in outpatient settings or;
- Patients who could benefit from advance care planning self-assessed or assessed by their physician
- Patient able and willing to identify a substitute decision-maker who will participate in the study
- Patient cognitively able to participate
Exclusion Criteria:
- Patient or their substitute decision-maker does not speak English
- Patient unable to identify a substitute decision-maker who will consent to participation
- Patient does not consent to participation
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Advance care planning education session
Delivery of an advance care planning education session at the family doctor's office
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Administration of values clarification tool, elicitation of preference for treatment options, if preference for resuscitation, shown an educational video about cardiopulmonary resuscitation, summary document of values and preferences created by a facilitator to share with doctor
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Comparador falso: Wait list control
The intervention is not provided.
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No intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Advance care planning engagement of substitute decision-maker
Periodo de tiempo: 8 to 12 weeks (6 weeks for patients from cancer centre)
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A survey of the substitute decision-maker's engagement in advance care planning
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8 to 12 weeks (6 weeks for patients from cancer centre)
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Advance care planning engagement of patient
Periodo de tiempo: 8 to 12 weeks (6 weeks for patients from cancer centre)
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A survey of the patient's engagement in advance care planning
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8 to 12 weeks (6 weeks for patients from cancer centre)
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Substitute decision-maker self-efficacy survey
Periodo de tiempo: 8 to 12 weeks (6 weeks for patients from cancer centre)
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A survey of the substitute decision-maker's confidence to make future decisions
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8 to 12 weeks (6 weeks for patients from cancer centre)
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Decisional conflict
Periodo de tiempo: immediately after intervention
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A modified short decisional conflict survey
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immediately after intervention
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Satisfaction with intervention
Periodo de tiempo: immediately after intervention
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A satisfaction and endorsement survey on the process of the educational intervention
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immediately after intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Michelle Howard, PhD, McMaster University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- De Vleminck A, Houttekier D, Pardon K, Deschepper R, Van Audenhove C, Vander Stichele R, Deliens L. Barriers and facilitators for general practitioners to engage in advance care planning: a systematic review. Scand J Prim Health Care. 2013 Dec;31(4):215-26. doi: 10.3109/02813432.2013.854590.
- Teixeira AA, Hanvey L, Tayler C, Barwich D, Baxter S, Heyland DK; Canadian Researchers at End of Life Network (CARENET). What do Canadians think of advanced care planning? Findings from an online opinion poll. BMJ Support Palliat Care. 2015 Mar;5(1):40-7. doi: 10.1136/bmjspcare-2013-000473. Epub 2013 Oct 4.
- Howard M, Bernard C, Tan A, Slaven M, Klein D, Heyland DK. Advance care planning: Let's start sooner. Can Fam Physician. 2015 Aug;61(8):663-5. No abstract available.
- Rhee JJ, Zwar NA, Kemp LA. Advance care planning and interpersonal relationships: a two-way street. Fam Pract. 2013 Apr;30(2):219-26. doi: 10.1093/fampra/cms063. Epub 2012 Oct 1.
- Robinson C, Kolesar S, Boyko M, Berkowitz J, Calam B, Collins M. Awareness of do-not-resuscitate orders: what do patients know and want? Can Fam Physician. 2012 Apr;58(4):e229-33.
- Sudore RL, Lum HD, You JJ, Hanson LC, Meier DE, Pantilat SZ, Matlock DD, Rietjens JAC, Korfage IJ, Ritchie CS, Kutner JS, Teno JM, Thomas J, McMahan RD, Heyland DK. Defining Advance Care Planning for Adults: A Consensus Definition From a Multidisciplinary Delphi Panel. J Pain Symptom Manage. 2017 May;53(5):821-832.e1. doi: 10.1016/j.jpainsymman.2016.12.331. Epub 2017 Jan 3.
- 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.
- Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical care inconsistent with patients' treatment goals: association with 1-year Medicare resource use and survival. J Am Geriatr Soc. 2002 Mar;50(3):496-500. doi: 10.1046/j.1532-5415.2002.50116.x.
- Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345.
- Hammes BJ, Rooney BL. Death and end-of-life planning in one midwestern community. Arch Intern Med. 1998 Feb 23;158(4):383-90. doi: 10.1001/archinte.158.4.383.
- Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.
- Raymont V, Bingley W, Buchanan A, David AS, Hayward P, Wessely S, Hotopf M. Prevalence of mental incapacity in medical inpatients and associated risk factors: cross-sectional study. Lancet. 2004 Oct 16-22;364(9443):1421-7. doi: 10.1016/S0140-6736(04)17224-3.
- Fried TR, Redding CA, Robbins ML, O'Leary JR, Iannone L. Agreement between older persons and their surrogate decision-makers regarding participation in advance care planning. J Am Geriatr Soc. 2011 Jun;59(6):1105-9. doi: 10.1111/j.1532-5415.2011.03412.x. Epub 2011 Jun 7.
- Heyland DK, Ilan R, Jiang X, You JJ, Dodek P. The prevalence of medical error related to end-of-life communication in Canadian hospitals: results of a multicentre observational study. BMJ Qual Saf. 2016 Sep;25(9):671-9. doi: 10.1136/bmjqs-2015-004567. Epub 2015 Nov 9.
- You JJ, Dodek P, Lamontagne F, Downar J, Sinuff T, Jiang X, Day AG, Heyland DK; ACCEPT Study Team and the Canadian Researchers at the End of Life Network (CARENET). What really matters in end-of-life discussions? Perspectives of patients in hospital with serious illness and their families. CMAJ. 2014 Dec 9;186(18):E679-87. doi: 10.1503/cmaj.140673. Epub 2014 Nov 3.
- Heyland DK, Barwich D, Pichora D, Dodek P, Lamontagne F, You JJ, Tayler C, Porterfield P, Sinuff T, Simon J; ACCEPT (Advance Care Planning Evaluation in Elderly Patients) Study Team; Canadian Researchers at the End of Life Network (CARENET). Failure to engage hospitalized elderly patients and their families in advance care planning. JAMA Intern Med. 2013 May 13;173(9):778-87. doi: 10.1001/jamainternmed.2013.180.
- Cook D, Rocker G, Marshall J, Sjokvist P, Dodek P, Griffith L, Freitag A, Varon J, Bradley C, Levy M, Finfer S, Hamielec C, McMullin J, Weaver B, Walter S, Guyatt G; Level of Care Study Investigators and the Canadian Critical Care Trials Group. Withdrawal of mechanical ventilation in anticipation of death in the intensive care unit. N Engl J Med. 2003 Sep 18;349(12):1123-32. doi: 10.1056/NEJMoa030083.
- Gruneir A, Mor V, Weitzen S, Truchil R, Teno J, Roy J. Where people die: a multilevel approach to understanding influences on site of death in America. Med Care Res Rev. 2007 Aug;64(4):351-78. doi: 10.1177/1077558707301810.
- Heyland DK, Lavery JV, Tranmer JE, Shortt SE, Taylor SJ. Dying in Canada: is it an institutionalized, technologically supported experience? J Palliat Care. 2000 Oct;16 Suppl:S10-6.
- Ehlenbach WJ, Barnato AE, Curtis JR, Kreuter W, Koepsell TD, Deyo RA, Stapleton RD. Epidemiologic study of in-hospital cardiopulmonary resuscitation in the elderly. N Engl J Med. 2009 Jul 2;361(1):22-31. doi: 10.1056/NEJMoa0810245.
- Howard M, Elston D, Borhan S, Hafid A, Arora N, Forbes R, Bernard C, Heyland DK. Randomised trial of a serious illness decision aid (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning. BMJ Support Palliat Care. 2022 Mar;12(1):99-106. doi: 10.1136/bmjspcare-2021-003040. Epub 2021 Jun 30.
- Howard M, Slaven M, Bernard C, Borhan S, Elston D, Arora N, Tan A, Heyland DK. Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial. BMJ Open. 2019 Sep 20;9(9):e027897. doi: 10.1136/bmjopen-2018-027897.
Enlaces Útiles
- Metzger M, Song M-K, Ward S, Chang PP-Y, Hanson LC, Lin F-C. A randomized controlled pilot trial to improve advance care planning for LVAD patients and their surrogates. Hear Lung J Acute Crit Care. 2016 May;45(3):186-92
- Johnston SC, Pfeifer MP, McNutt R. The discussion about advance directives. Patient and physician opinions regarding when and how it should be conducted. End of Life Study Group. Arch Intern Med. 1995 May 22;155(10):1025-30
- Rhee JJ, Zwar NA, Kemp LA. Advance care planning and interpersonal relationships: a two-way street. Fam Pract. 2013 Apr 1;30(2):219-26
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
1 de marzo de 2018
Finalización primaria (Actual)
Finalización primaria
31 de diciembre de 2019
Finalización del estudio (Actual)
Finalización del estudio
31 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
2 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
2 de agosto de 2017
Publicado por primera vez (Actual)
Publicado por primera vez
4 de agosto de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
20 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
19 de febrero de 2020
Última verificación
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 3714
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Advance care planning education session
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NCT04424680Desconocido