Multi-component Family Support Tool Intervention (FST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2026-04-30

Brief Summary

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The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that.

Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs.

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Detailed Description

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The Family Support Tool intervention is designed to help families navigate the emotional, psychological, and cognitive complexities of being a surrogate for an incapacitated critically ill patient and also to enhance the timeliness and quality of clinician-family communication. The intervention consists of three components:

1. Proactive clinician-family meetings within 48 hours of enrollment and every 5-7 days thereafter.
2. Family members complete sections of an interactive web-based tool upon study enrollment, before family meetings, and any other time they wish. Family members can access the tool anywhere via computer, tablet, or mobile phone. The first section of the tool is completed on the first day of study enrollment and contains: video messages supporting families including stories from other families and their experiences and coping strategies, tips on self-care and links to hospital resources. The second and third sections of the FST are completed before scheduled clinician-family meetings on study day 2-3 and again 5-7 days later. These sections of the tool contain: videos detailing what to expect during family meetings, interactive exercises and prompts about patient values, prognosis, care expectations and treatment leanings to help prepare for family meetings. The study team will provide families a printed summary sheet of their main questions for the ICU team that they are encouraged to bring to the family meeting.
3. Before each scheduled family meeting the ICU team receives a written report that summarizes the family's main questions and concerns, information about the patient's values and preferences, surrogates' prognostic expectations, and a visual display of their unmet PC needs.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Multi-component Family Support Intervention

Group Type EXPERIMENTAL

Multi-component Family Support Intervention

Intervention Type OTHER

The multi-component intervention is designed to enhance the quality of clinician-family communication and help families manage the emotional and cognitive complexities of surrogate decision-making. It involves: 1) proactive clinician-family meetings; 2) use by surrogates of an interactive web-based tool throughout the ICU stay which is narrated by family members of ICU patients and includes stories and experiences from other families, self-care strategies, brief videos explaining what to expect during family meetings, a question prompt list, an interactive values clarification exercise, and an explanation of different treatment pathways for critically ill patients. 3. Prior to the proactive family meetings, the ICU team is provided with a summary of the family's main questions/concerns, their prognostic expectations, a summary of the patient's values and preferences, and surrogates' current ratings of the extent to which their psychosocial needs are being addressed in the ICU.

Control

Usual ICU care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Multi-component Family Support Intervention

The multi-component intervention is designed to enhance the quality of clinician-family communication and help families manage the emotional and cognitive complexities of surrogate decision-making. It involves: 1) proactive clinician-family meetings; 2) use by surrogates of an interactive web-based tool throughout the ICU stay which is narrated by family members of ICU patients and includes stories and experiences from other families, self-care strategies, brief videos explaining what to expect during family meetings, a question prompt list, an interactive values clarification exercise, and an explanation of different treatment pathways for critically ill patients. 3. Prior to the proactive family meetings, the ICU team is provided with a summary of the family's main questions/concerns, their prognostic expectations, a summary of the patient's values and preferences, and surrogates' current ratings of the extent to which their psychosocial needs are being addressed in the ICU.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patient

1. Age ≥18
2. Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
3. Clinical indication of at least 40% risk of death or ≥40% chance of new, severe long-term functional impairment (needs assistance with ≥ 2 ADLs), as judged by the patient's attending physician or designee

Surrogate

1. The primary surrogate is determined by the patient's advance directive or, if no directive exists, by following the hierarchy of surrogates codified in state law.
2. Up to 3 additional surrogates

Clinician

1\. Patient's primary attending (or their designee)

EXCLUSION

Patient

1. Lack of a surrogate decision maker
2. Family not available for study
3. Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made
4. Currently participating in a competing research study that does not allow co-enrollment
5. Incarcerated or on an involuntary hold
6. Died prior to enrollment
7. Discharged prior to enrollment
8. Regained capacity prior to enrollment
9. Physician declined patient's participation
10. Physician and designee declined own participation
12. MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
13. Greater than 5 ICU days during the current hospitalization

Surrogate

1. Age \<18 years
2. Cannot read or understand English
3. Cannot complete questionnaires due to physical or cognitive limitations
4. Has no access to or cannot travel to access the internet

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes