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

NCT03099746 | Completed DMC

• 2 other identifiers: 08-16-255R01NR015750-02
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

chronically critically ill; surrogate decision maker

Outcome Measures

Primary Outcomes (1)

• Repeated Measures

  ANOVA Model (F-Statistic)

  From (T1) baseline through (T5) 90 days post-baseline

Secondary Outcomes (7)

• Change in Preparation for Decision Making Scale

  (T1) baseline through (T4) 7 days post-baseline

• Change in Family Decision Making Self-Efficacy Scale

  (T1) baseline through (T4) 7 days post-baseline

• Change in Single item measure of Role Stress

  (T1) baseline through (T4) 7 days post-baseline

• Change in Decision Conflict Scale

  (T1) baseline through (T4) 7 days post-baseline

• Change in Modified Control Preferences Scale

  (T1) baseline through (T4) 7 days post-baseline

Study Arms (3)

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.

Behavioral: INVOLVE

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.

Behavioral: Informational Support

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.

Behavioral: Usual Care

Interventions

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.

INVOLVE

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.

Informational Support

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• 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.

  PMID: 40521758 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.

  PMID: 35802350 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald L. Hickman, PhD, RN

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 4, 2017
• Study Start: September 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)