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Completed

NCT Number: NCT03099746

Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)

Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have transient or persistent cognitive impairment that precludes them from making their own healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a family member. SDMs for the critically ill often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role.

The purpose of this study is to test the effectiveness of two decision support interventions for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

The investigators will conduct a three-arm unblinded clinical trial using pre- and post-tests to evaluate the efficacy of two electronic decision-support interventions, Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE) and Informational Support (IS), compared to each other and to usual care (UC) among 270 SDMs of cognitively impaired CCI patients. This design will allow the investigators to prospectively compare the efficacy of the experiential avatar-based decision support tool (INVOLVE) with both an information-only condition and UC. Subjects assigned to an experimental condition (INVOLVE or IS) will receive two doses of the intervention, at enrollment and 1 day later. After the second dose, these subjects will have access to their assigned condition for subsequent self-administered doses, which will be electronically captured until the patient's ICU discharge or death. Data will be collected at (T1) baseline (Day 3 or 4 of the patient's ICU stay), and then on Days 1, 3, 7 and 90 post-baseline

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The investigators aim to:

  • Identify the essential elements of the graphical user interface and educational content needed to revise the INVOLVE prototype for a set of common end-of-life decisions that occur in the ICU.
  • Evaluate if there are differences in the decision making readiness and decision making quality between subjects exposed to INVOLVE, IS, or UC on Days 1, 3, and 7 days post-baseline while accounting for covariates (prior SDM experience, SDM knowledge of the patient's preferences, and SDM's religious beliefs).
  • Determine if there are differences in the post-decision outcomes of SDMs and their CCI patient by study condition while accounting for covariates at 90 days post-baseline.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Eligibility criteria for CCI patients:

  • aged 18 years or older
  • required mechanical ventilation and ICU stay for greater than or equal to 3 days
  • not expected to be transferred out of the ICU within 48 hours
  • lacks cognitive capacity, as determined by a Glasgow Coma Scale eye score of less than 3 or the motor score less than 6 and verifying the status by asking the patients's attending physician or advanced practice nurse whether he or she would obtain consent from the patient or a family member
  • has an identified SDM (next-of-kin or legal representative for healthcare decision making).

Eligibility criteria for SDMs:

  • aged 18 years or older
  • identified by the healthcare team as the patient's next of kin or legal representative for healthcare decision making
  • able to speak and understand English
  • able to view images on an 10-inch computer screen and hear audio through a standard set of headphones.

Treatment and study plan

INVOLVE

Behavioral

Interactive content and decision coaching with tailored framing of messages to subject's informational processing style and stage of change to promote participatory decision making behavior. Consideration of options, consequences, values, and preferences to formulate an informed decision.

Informational Support

Behavioral

Passive, non-tailored informational support. Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit.

Usual Care

Behavioral

Routine decision support practices by the healthcare team. Family meetings, bedside updates, and access to printed or electronic decision aids.

Primary outcomes

  1. Repeated Measures

    Time frame: From (T1) baseline through (T5) 90 days post-baseline

    ANOVA Model (F-Statistic)

Secondary outcomes

  1. Change in Preparation for Decision Making Scale

    Time frame: (T1) baseline through (T4) 7 days post-baseline

    Measure of Decision Making Preparedness

  2. Change in Family Decision Making Self-Efficacy Scale

    Time frame: (T1) baseline through (T4) 7 days post-baseline

    Measure of Decision Making Self-Efficacy

  3. Change in Single item measure of Role Stress

    Time frame: (T1) baseline through (T4) 7 days post-baseline

    Measure of Decisional Role Stress

  4. Change in Decision Conflict Scale

    Time frame: (T1) baseline through (T4) 7 days post-baseline

    Measure of Decision Conflict

  5. Change in Modified Control Preferences Scale

    Time frame: (T1) baseline through (T4) 7 days post-baseline

    Measure of Behavioral Activation

  6. Change in Decision Regret Scale

    Time frame: (T1) baseline and (T5) 90 days post-baseline

    Measure of Decision Regret

  7. Change in Hospital Anxiety and Depression Scale

    Time frame: (T1) baseline and (T5) 90 days post-baseline

    Measure of Anxiety and Depressive Symptoms

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill

Acronym: INVOLVE

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2017
Registry last updated
Dec 16, 2021

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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