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Completed

NCT Number: NCT04034979

Evaluation of a Decision Aid About Life-sustaining Therapies

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'Hôtel-Dieu de Lévis

Lévis, Quebec, G6V 3Z1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 65 and older,
  • capable of making their own healthcare decisions as determined by the attending intensivist's clinical judgment,
  • in need of a discussion about goals of care as determined by the attending intensivist's clinical judgment.

Exclusion criteria

  • intubated patients,
  • patients facing urgent decisions,
  • patients cared by the principal investigator,
  • patients who do not read or speak French.

Treatment and study plan

Decision aid

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.

Other names: training session

Primary outcomes

  1. Observing Patient Involvement in Decision Making (OPTION) scale

    Time frame: 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).

    The OPTION scale (12 items) measures the extent that clinicians engage patients in shared decision making. For each item, a score 0 (The behaviour is not observed) to 4 (The behaviour is observed and executed to a high standard) is given. Adding each item's score will arrive at a number between 0 (minimum) and 48 (maximum). The OPTION scale will be measured by two observers rating audio- or video-recordings of goals-of-care discussions conducted by intensivists with their patients at the earliest possible time during the patients intensive care stay. These discussions will be held at the discretion of the attending intensivist when deemed appropriate. Most often these discussions are held at the time of patient admission (first 24 hours) or whenever the patient is capable of engaging in a goals of care discussion (eg., after the patient is extubated and weaned off mechanical ventilation).

  2. Score based on the quality indicators from the Audit of Communication, Care Planning, and Documentation (ACCEPT) study

    Time frame: 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.

    This measure will be based on 7 of the 34 (ACCEPT) quality indicators that measure the quality of end-of-life communication and decision making: written information provided before discussion about goals of care, poor prognosis shared with patient during the discussion, verification with patient about prior discussions or written documents about the use of life-sustaining treatments, use of information by intensivist about about goals of care to support the decision, verification by the intensivist prior to the discussion of any written advanced directives in the patient's medical record, documentation of the goals of care discussed in medical record after discussion, goals of care documented in the medical chart after discussion consistent with patient's stated preferences. Indicators will be measured by two observers rating audio- or video-recordings. Score is the sum of the quality indicator items divided by the sum of highest possible values of these items on a scale 0% to 100%.

Secondary outcomes

  1. Qualitative content analysis

    Time frame: 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.

    Each audio or video recording will be content analysed by a doctoral student and a research assistant using the R language Qualitative Data Analysis (RQDA) package for Qualitative Data Analysis. The aim of this content analysis will be to identify: 1) patients' most frequent incomprehension, concerns, questions and 2) clinicians' opportunities to improve their skills in goals-of-care discussions and decision making.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Frailty Network

Registry information

Official study title

Evaluation of a Context-adapted Decision Aid Supporting Critically Ill Patients' Decisions About Life-sustaining Therapies - a Pilot Project

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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