Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR015750-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVOLVE | Experimental | The first study condition, called "Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE)" will consist of exposures to an avatar-based decision support technology that will be administered via tablet computer and allow SDMs opportunities to practice their communication and decision making skills through interactions with avatars that portray a decision coach and various healthcare providers. |
|
| Informational Support | Experimental | The second condition, called Informational Support (IS), will also be administered via tablet computers and expose SDMs to educational resources of INVOLVE without the experiential components. |
|
| Usual Care | Experimental | The third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Repeated Measures | ANOVA Model (F-Statistic) | From (T1) baseline through (T5) 90 days post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Preparation for Decision Making Scale | Measure of Decision Making Preparedness | (T1) baseline through (T4) 7 days post-baseline |
| Change in Family Decision Making Self-Efficacy Scale | Measure of Decision Making Self-Efficacy |
Not provided
Inclusion Criteria:
Eligibility criteria for CCI patients:
Eligibility criteria for SDMs:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald L. Hickman, PhD, RN | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40521758 | Derived | Pignatiello GA, Tuschman PJ, Griggs S, Schiltz NK, Hoffer A, Hickman RL Jr. Rethinking Regret: Reappraisal Tendencies Buffer Regret for ICU Surrogates Following Patient Death. West J Nurs Res. 2025 Sep;47(9):799-809. doi: 10.1177/01939459251344205. Epub 2025 Jun 16. | |
| 35802350 | Derived | Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| (T1) baseline through (T4) 7 days post-baseline |
| Change in Single item measure of Role Stress | Measure of Decisional Role Stress | (T1) baseline through (T4) 7 days post-baseline |
| Change in Decision Conflict Scale | Measure of Decision Conflict | (T1) baseline through (T4) 7 days post-baseline |
| Change in Modified Control Preferences Scale | Measure of Behavioral Activation | (T1) baseline through (T4) 7 days post-baseline |
| Change in Decision Regret Scale | Measure of Decision Regret | (T1) baseline and (T5) 90 days post-baseline |
| Change in Hospital Anxiety and Depression Scale | Measure of Anxiety and Depressive Symptoms | (T1) baseline and (T5) 90 days post-baseline |