Evaluation of a Decision Aid About Life-sustaining Therapies
NCT ID: NCT04034979
Last Updated: 2019-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2017-05-23
2018-01-22
Brief Summary
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Methods: This study will have three phases. Phase I (May-June 2017) will be a baseline evaluation of the current goals-of-care decision making process with elderly patients in a single ICU setting (Levis, Quebec). Phase II (July-August 2017) will be an evaluation of the goals-of-care decision making process in the same ICU using a DA. Phase III (September-December 2017) will be the delivery of an online and in-person training session about the use of the DA and about how to conduct discussions about goals-of-care. The study will then evaluate the goals-of-care decision making process after completion of the training program and using the DA. The investigators will observe and audio- or video-record all eligible elderly-intensivist dyads discussing goals of care during each phase. Two investigators will analyse the recordings using the OPTION 12 scale (measuring the extent that clinicians engage patients in SDM) and the ACCEPT quality indicators (measuring the extent to which intensivists engage in best practice goals-of-care discussions). The investigators will conduct qualitative content analysis of the video and audio records to identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.
Deliverables: This study will produce evidence regarding the impact of a context-adapted DA and training program on clinicians' adoption of SDM and other best practice behaviors regarding goals-of-care decision making with the elderly, and evidence regarding the most frequent patients' incomprehension, concerns, questions and clinicians' opportunities to improve the goals-of-care decision-making skills.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Phase I-Baseline evaluation
The first two months of the investigator's project will be a baseline evaluation of the current decision making process about goals-of-care in a local ICU setting (Levis, Quebec). A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) dyads of physicians and newly admitted elderly patients discussing goals-of-care.
No interventions assigned to this group
Phase II-Impact of the decision aid
The two following months will be an evaluation of the decision making process about goals-of-care in the same local ICU setting using only the decision aid without any training. A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) new dyads of physicians and newly admitted elderly patients discussing goals-of-care, whether the physician chooses to use the context-adapted decision-aid or not.
decision aid
One hour online training about shared-decision making about goals-of-care and best practices regarding goals-of-care discussions and decision-making. One hour debriefing in presence.
Phase III- Impact of the decision aid and the
This phase will be an evaluation of the decision making process about goals-of-care in the same local ICU setting after intensivists complete the training program and using the DA. A PhD student will collect sociodemographic data (age, gender, education level, religion), observe and video record (or audio record) new dyads of physicians and newly admitted elderly patients discussing goals-of-care using the context-adapted decision aid and the new skills learned in the training program.
decision aid
One hour online training about shared-decision making about goals-of-care and best practices regarding goals-of-care discussions and decision-making. One hour debriefing in presence.
Interventions
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decision aid
One hour online training about shared-decision making about goals-of-care and best practices regarding goals-of-care discussions and decision-making. One hour debriefing in presence.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. capable of making their own healthcare decisions as determined by the attending intensivist's clinical judgment,
3. in need of a discussion about goals of care as determined by the attending intensivist's clinical judgment.
Exclusion Criteria
2. patients facing urgent decisions,
3. patients cared by the principal investigator,
4. patients who do not read or speak French.
65 Years
ALL
No
Sponsors
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Canadian Frailty Network
OTHER
Laval University
OTHER
Responsible Party
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Patrick Archambault
Assistant professor
Principal Investigators
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Patrick M Archambault, MD, MSc.
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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Centre de recherche de l'Hôtel-Dieu de Lévis
Lévis, Quebec, Canada
Countries
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References
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Sinuff T, Dodek P, You JJ, Barwich D, Tayler C, Downar J, Hartwick M, Frank C, Stelfox HT, Heyland DK. Improving End-of-Life Communication and Decision Making: The Development of a Conceptual Framework and Quality Indicators. J Pain Symptom Manage. 2015 Jun;49(6):1070-80. doi: 10.1016/j.jpainsymman.2014.12.007. Epub 2015 Jan 24.
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.
Heyland D, Cook D, Bagshaw SM, Garland A, Stelfox HT, Mehta S, Dodek P, Kutsogiannis J, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group; Canadian Researchers at the End of Life Network. The Very Elderly Admitted to ICU: A Quality Finish? Crit Care Med. 2015 Jul;43(7):1352-60. doi: 10.1097/CCM.0000000000001024.
Kon AA, Davidson JE, Morrison W, Danis M, White DB; American College of Critical Care Medicine; American Thoracic Society. Shared Decision Making in ICUs: An American College of Critical Care Medicine and American Thoracic Society Policy Statement. Crit Care Med. 2016 Jan;44(1):188-201. doi: 10.1097/CCM.0000000000001396.
Legare F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
Evans R, Edwards A, Brett J, Bradburn M, Watson E, Austoker J, Elwyn G. Reduction in uptake of PSA tests following decision aids: systematic review of current aids and their evaluations. Patient Educ Couns. 2005 Jul;58(1):13-26. doi: 10.1016/j.pec.2004.06.009.
White DB, Braddock CH 3rd, Bereknyei S, Curtis JR. Toward shared decision making at the end of life in intensive care units: opportunities for improvement. Arch Intern Med. 2007 Mar 12;167(5):461-7. doi: 10.1001/archinte.167.5.461.
Plaisance A, Turgeon J, Souza LG, Legare F, Turcotte S, Germain N, Jean T, Dionne M, Fortier FA, Plante P, Tapp D, Gelinas V, Belanger E, Ebell MH, Chabot C, van de Belt TH, Turgeon AF, Archambault PM. Exploring the Impact of a Context-Adapted Decision Aid and Online Training About Shared Decision Making About Goals of Care with Elderly Patients in the Intensive Care Unit: A Mixed-Methods Study. Patient. 2025 Sep 25. doi: 10.1007/s40271-025-00761-7. Online ahead of print.
Other Identifiers
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Catalyst-2017-001
Identifier Type: -
Identifier Source: org_study_id
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