- ICH GCP
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- Essai clinique NCT03434626
Advance Care Planning & Goals of Care Randomized Controlled Trial in Primary Care
17 juin 2019 mis à jour par: McMaster University
A Randomized Trial of ACP/GCD Care Pathway in Primary Care in Alberta
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 for people to think about their 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.
In Alberta, there is a form in the health care system that is used to indicate a person's wishes if participants are unable to speak for themselves.
There are tools such as brochures, questionnaires, and videos that can help participants learn about advance care planning and serious illness conversations.
This research is being done to study whether using tools for advance care planning will help improve goals of care designation completion rates in such a way that they better reflect patient values.
In this project, we aim to determine the efficacy of tools to increase the quality and quantity of advance care planning (ACP) and Goals of Care Determinations (GCD) in primary care settings in Alberta.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
The aim of this study is 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 presence of a goals of care form in the chart, substitute decision-maker engagement in ACP (including self-efficacy for enacting the role), patient engagement in ACP, and decisional conflict.
Type d'étude
Interventionnel
Inscription (Réel)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Alberta
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Lethbridge, Alberta, Canada, T1K 3M5
- Family Medical Centre
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Lethbridge, Alberta, Canada, T1K 5M5
- Chinook Primary Care Network
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- age 65 years or older
- have at least one chronic condition that may be life-limiting
Exclusion Criteria:
- Unable to communicate with an English-speaking research coordinator
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: ACP Education
Eligible patients in the experimental group will receive an educational intervention from an advance care planning navigator consisting of a 4-item values tool, a Goals of Care Designation form and, if applicable, watch a cardiopulmonary resuscitation video.
|
Decision aid and Goals of Care Designation form information administered by Navigator
Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician
|
Comparateur actif: Usual care
Patients in the usual care group will complete a Goals of Care Designation form with the family physician.
|
Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Presence of a completed goals of care designation form in the patient chart
Délai: 8-12 weeks
|
In Alberta there is a form in the health care system that is used to indicate a person's wishes if they are unable to speak for themselves.
The form is called a "Goal of Care Designation" form and is part of a package called the 'Greensleeve'.
Alberta Health Services requires that all patients in primary care and in hospital have a green sleeve and goal of care designation (RMC classification: R=resuscitative; M=medical; C=comfort care).
|
8-12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Agreement between patient's self-reported values and preferences for life sustaining treatment, and what is documented in the form in the chart
Délai: 8-12 weeks
|
Dichotomous variable of whether there is concordance between what the patient reports and what is in their chart (difference between groups)
|
8-12 weeks
|
Physician rating of decisional conflict
Délai: 8-12 weeks
|
The decisional conflict scale (DCS) measures personal perceptions of uncertainty in choosing options;modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making.
The outcome is the agreement between patient's self-reported preference for life sustaining treatment and decisional conflict using a 5-item decisional conflict scale pre- and post-intervention.
Each item is scored 0 to 4 (0=Yes; 1=Probably Yes; 2=Unsure; 3=Probably No; 4=No)
|
8-12 weeks
|
Patient-reported satisfaction with the intervention
Délai: 8-12 weeks
|
Do patients who participate in an ACP educational intervention experience greater satisfaction with decision-making than patients who get usual care?
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8-12 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michelle Howard, PhD, McMaster University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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. doi: 10.1001/archinte.155.10.1025.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 octobre 2017
Achèvement primaire (Réel)
26 septembre 2018
Achèvement de l'étude (Réel)
31 décembre 2018
Dates d'inscription aux études
Première soumission
1 août 2017
Première soumission répondant aux critères de contrôle qualité
13 février 2018
Première publication (Réel)
15 février 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 06-17
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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Étudie un produit d'appareil réglementé par la FDA américaine
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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