Multi-component Family Support Tool Intervention (FST)

Last updated: October 2, 2024
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Multi-component Family Support Intervention

Clinical Study ID

NCT05019261
STUDY20110367
R01AG066731-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

INCLUSION

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

  11. Patient does not meet inclusion criteria within 5 days of ICU admission

  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

Study Design

Total Participants: 1163
Treatment Group(s): 1
Primary Treatment: Multi-component Family Support Intervention
Phase:
Study Start date:
November 11, 2021
Estimated Completion Date:
April 30, 2026

Study Description

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.

Connect with a study center

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Active - Recruiting

  • NYC Health + Hospitals/Lincoln Hospital

    New York, New York 10451
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Pittsburgh VA Medical Center

    Pittsburgh, Pennsylvania 15240
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.