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

NCT ID: NCT03099746

Last Updated: 2021-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Critical Illness

Keywords

chronically critically ill; surrogate decision maker

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

INVOLVE

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Informational Support

Intervention Type: 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

The third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team.

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Ronald Hickman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald L. Hickman, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40521758 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35802350 (View on PubMed)

Other Identifiers

5R01NR015750-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-16-25

Identifier Type: -

Identifier Source: org_study_id