Clinical trial NCT03099746: Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE)
Official title: A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: chronically critically ill
surrogate decision maker
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2017-04-04
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Repeated Measures
timeFrame: From (T1) baseline through (T5) 90 days post-baseline
Secondary outcomes:
measure: Change in Preparation for Decision Making Scale
timeFrame: (T1) baseline through (T4) 7 days post-baseline
measure: Change in Family Decision Making Self-Efficacy Scale
timeFrame: (T1) baseline through (T4) 7 days post-baseline
measure: Change in Single item measure of Role Stress
timeFrame: (T1) baseline through (T4) 7 days post-baseline
measure: Change in Decision Conflict Scale
timeFrame: (T1) baseline through (T4) 7 days post-baseline
measure: Change in Modified Control Preferences Scale
timeFrame: (T1) baseline through (T4) 7 days post-baseline
measure: Change in Decision Regret Scale
timeFrame: (T1) baseline and (T5) 90 days post-baseline
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: (T1) baseline and (T5) 90 days post-baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Ronald L. Hickman, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.