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

Summary

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.

Conditions

• Critical Illness

Interventions

BEHAVIORAL

INVOLVE

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.

BEHAVIORAL

Informational Support

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

BEHAVIORAL

Usual Care

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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Case Western Reserve University

  lead OTHER

Principal Investigators

• Ronald L. Hickman, PhD, RN · Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2020-06-30

Completion

2020-06-30

Countries

• United States

Study Locations