Evaluation of a Decision Aid About Life-sustaining Therapies

NCT ID: NCT04034979

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2018-01-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decision Making Resuscitation Intensive Care Unit Goals-of-care Shared-decision Making

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

4 phases
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

decision aid

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

decision aid

Intervention Type BEHAVIORAL

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

training session

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Frailty Network

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Patrick Archambault

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick M Archambault, MD, MSc.

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de recherche de l'Hôtel-Dieu de Lévis

Lévis, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25623923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23545563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25901550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26509317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25222632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15950832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17353493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40999300 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Catalyst-2017-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Communication During Hospitalization About Resuscitation Trial
NCT02984124 ACTIVE_NOT_RECRUITING PHASE2/PHASE3
Data-driven SDM to Reduce Symptom Burden in AF
NCT04993807 ACTIVE_NOT_RECRUITING NA