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

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ClinicalTrials.gov Identifier: NCT03099746
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Ronald Hickman, Case Western Reserve University

Brief 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.


Condition or disease Intervention/treatment Phase
Critical Illness Behavioral: INVOLVE Behavioral: Informational Support Behavioral: Usual Care Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
Actual Study Start Date : September 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: INVOLVE
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.
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.

Experimental: Informational Support
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.
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.

Experimental: Usual Care
The third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team.
Behavioral: Usual Care
Routine decision support practices by the healthcare team. Family meetings, bedside updates, and access to printed or electronic decision aids.




Primary Outcome Measures :
  1. Repeated Measures [ Time Frame: From (T1) baseline through (T5) 90 days post-baseline ]
    ANOVA Model (F-Statistic)


Secondary Outcome Measures :
  1. Change in Preparation for Decision Making Scale [ Time Frame: (T1) baseline through (T4) 7 days post-baseline ]
    Measure of Decision Making Preparedness

  2. Change in Family Decision Making Self-Efficacy Scale [ Time Frame: (T1) baseline through (T4) 7 days post-baseline ]
    Measure of Decision Making Self-Efficacy

  3. Change in Single item measure of Role Stress [ Time Frame: (T1) baseline through (T4) 7 days post-baseline ]
    Measure of Decisional Role Stress

  4. Change in Decision Conflict Scale [ Time Frame: (T1) baseline through (T4) 7 days post-baseline ]
    Measure of Decision Conflict

  5. Change in Modified Control Preferences Scale [ Time Frame: (T1) baseline through (T4) 7 days post-baseline ]
    Measure of Behavioral Activation

  6. Change in Decision Regret Scale [ Time Frame: (T1) baseline and (T5) 90 days post-baseline ]
    Measure of Decision Regret

  7. Change in Hospital Anxiety and Depression Scale [ Time Frame: (T1) baseline and (T5) 90 days post-baseline ]
    Measure of Anxiety and Depressive Symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099746


Contacts
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Contact: Ronald L. Hickman, PhD, RN 216-368-2147 ronald.hickman@case.edu
Contact: Mary Leuchtag, MSSA,LISW-S 216-368-4417 mary.leuchtag@case.edu

Locations
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United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ronald L. Hickman, PhD, RN    216-368-2147    ronald.hickman@case.edu   
Principal Investigator: Ronald L. Hickman, PhD, RN         
Sponsors and Collaborators
Case Western Reserve University
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Ronald L. Hickman, PhD, RN Case Western Reserve University
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Responsible Party: Ronald Hickman, Associate Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03099746    
Other Study ID Numbers: 08-16-25
5R01NR015750-02 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ronald Hickman, Case Western Reserve University:
chronically critically ill
surrogate decision maker
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes