Clinical trial NCT04034979: Evaluation of a Decision Aid About Life-sustaining Therapies
Official title: Evaluation of a Context-adapted Decision Aid Supporting Critically Ill Patients' Decisions About Life-sustaining Therapies - a Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Resuscitation
Intensive Care Unit
Goals-of-care
Shared-decision Making
Keywords: decision aid
ICU
goals-of-care
videotaping
shared-decision making
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Frailty Network
First posted: 2019-07-29
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 4 phases
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction: Clinical practice guidelines recommend shared decision making (SDM) to facilitate goals-of-care discussions. This study will train clinicians about how to use a context-adapted decision aid (DA) and SDM to conduct goals-of-care discussions with the elderly. The objectives of this study are to: 1) determine if the use of the DA and SDM training program: a) increase clinicians' engagement of patients in decision making regarding their goals of care; b) increase adoption of evidence-based behaviours regarding goals-of-care decision making; and 2) identify patients' most frequent incomprehension, concerns, questions and clinicians' opportunities to improve the skills in goals-of-care decision making.

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.


Eligibility criteria: Inclusion Criteria:

1. aged 65 and older,
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:

1. intubated patients,
2. patients facing urgent decisions,
3. patients cared by the principal investigator,
4. patients who do not read or speak French.

Primary outcomes:
measure: Observing Patient Involvement in Decision Making (OPTION) scale
timeFrame: The OPTION scale will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion).
measure: Score based on the quality indicators from the Audit of Communication, Care Planning, and Documentation (ACCEPT) study
timeFrame: The quality indicators will be measured at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion.
Secondary outcomes:
measure: Qualitative content analysis
timeFrame: The audio and video recordings will be done at the earliest possible time during the patients' intensive care stay (eg., first 24 hours after admission or whenever the patient is capable of engaging in a goals-of-care discussion.
Other outcomes:
Locations:
city: Lévis
country: Canada
facility: Centre de recherche de l'Hôtel-Dieu de Lévis
state: Quebec
Study officials:
affiliation: Laval University
name: Patrick M Archambault, MD, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.