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

Critical Illness Clinical Trial

— INVOLVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099746
• Other study ID #: 08-16-25
• Secondary ID: 5R01NR015750-02
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2020

Study information

• Verified date: December 2021
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 . The investigators aim to: 1. 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. 2. 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). 3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeated Measures	ANOVA Model (F-Statistic)	From (T1) baseline through (T5) 90 days post-baseline
Secondary	Change in Preparation for Decision Making Scale	Measure of Decision Making Preparedness	(T1) baseline through (T4) 7 days post-baseline
Secondary	Change in Family Decision Making Self-Efficacy Scale	Measure of Decision Making Self-Efficacy	(T1) baseline through (T4) 7 days post-baseline
Secondary	Change in Single item measure of Role Stress	Measure of Decisional Role Stress	(T1) baseline through (T4) 7 days post-baseline
Secondary	Change in Decision Conflict Scale	Measure of Decision Conflict	(T1) baseline through (T4) 7 days post-baseline
Secondary	Change in Modified Control Preferences Scale	Measure of Behavioral Activation	(T1) baseline through (T4) 7 days post-baseline
Secondary	Change in Decision Regret Scale	Measure of Decision Regret	(T1) baseline and (T5) 90 days post-baseline
Secondary	Change in Hospital Anxiety and Depression Scale	Measure of Anxiety and Depressive Symptoms	(T1) baseline and (T5) 90 days post-baseline