Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/17/2019 |
| Start Date: | September 2015 |
| End Date: | June 2020 |
| Contact: | Ronald L. Hickman, PhD, RN |
| Email: | ronald.hickman@case.edu |
| Phone: | 216-368-2147 |
A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
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.
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.
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.
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.
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.
We found this trial at
1
site
Cleveland, Ohio 44194
Principal Investigator: Ronald L. Hickman, PhD, RN
Phone: 216-368-2147
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