University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
NCT Number: NCT03099746
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44106, United States
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligibility criteria for CCI patients:
Eligibility criteria for SDMs:
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.
Passive, non-tailored informational support. Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit.
Routine decision support practices by the healthcare team. Family meetings, bedside updates, and access to printed or electronic decision aids.
Time frame: From (T1) baseline through (T5) 90 days post-baseline
ANOVA Model (F-Statistic)
Time frame: (T1) baseline through (T4) 7 days post-baseline
Measure of Decision Making Preparedness
Time frame: (T1) baseline through (T4) 7 days post-baseline
Measure of Decision Making Self-Efficacy
Time frame: (T1) baseline through (T4) 7 days post-baseline
Measure of Decisional Role Stress
Time frame: (T1) baseline through (T4) 7 days post-baseline
Measure of Decision Conflict
Time frame: (T1) baseline through (T4) 7 days post-baseline
Measure of Behavioral Activation
Time frame: (T1) baseline and (T5) 90 days post-baseline
Measure of Decision Regret
Time frame: (T1) baseline and (T5) 90 days post-baseline
Measure of Anxiety and Depressive Symptoms
Case Western Reserve University
Other
A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
Acronym: INVOLVE
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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