Multi-component Family Support Tool Intervention (FST)

NCT05019261 | Completed DMC

• 2 other identifiers: STUDY20110367R01AG066731-01
• Study Type: interventional
• Target: 1,039
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Critical Illness

Keywords

Patient centeredness of care; Psychological Distress; End of Life Care; Critical Illness; Surrogate Decision Making; Goal Concordant Care

Outcome Measures

Primary Outcomes (1)

• Patient and family centeredness of care

  12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.

  3 months after hospital discharge

Secondary Outcomes (17)

• Composite measure of goal-concordant care

  3 months after hospital discharge

• Satisfaction with ICU care

  3 months after hospital discharge

• Unmet palliative care needs

  Measured at day 5 post-randomization

• Surrogates' prognostic awareness

  Measured at day 5 post-randomization

• Surrogates' clarity about patient values and preferences

  Measured at day 5 post-randomization

Other Outcomes (4)

• Patient hospital survival

  6 months after hospital discharge

• Duration of survival from hospital discharge through 6-month follow-up

  6 months after hospital discharge

• Days alive outside healthcare facilities

  6 months after hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Multi-component Family Support Intervention

Other: Multi-component Family Support Intervention

Control

NO INTERVENTION

Usual ICU care

Interventions

Multi-component Family Support Intervention 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.

Intervention

Eligibility Criteria

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

You may qualify if:

• Patient
• Age ≥18
• Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
• 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
• 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.
• Up to 3 additional surrogates
• Clinician
• \. Patient's primary attending (or their designee)

You may not qualify if:

• Patient
• Lack of a surrogate decision maker
• Family not available for study
• Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made
• Currently participating in a competing research study that does not allow co-enrollment
• Incarcerated or on an involuntary hold
• Died prior to enrollment
• Discharged prior to enrollment
• Regained capacity prior to enrollment
• Physician declined patient's participation
• Physician and designee declined own participation
• MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
• Greater than 5 ICU days during the current hospitalization
• Surrogate
• Age \<18 years

Sponsors & Collaborators

• University of Pittsburgh: lead
• Duke University: collaborator
• Baystate Medical Center: collaborator
• Oregon Health and Science University: collaborator
• National Institute on Aging (NIA): collaborator
• New York City Health and Hospitals Corporation: collaborator
• VA Pittsburgh Healthcare System: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (7)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

NYC Health + Hospitals/Lincoln Hospital

New York, New York, 10451, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Pittsburgh VA Medical Center

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Douglas B White, MD, MAS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Critical Care Medicine

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 24, 2021
• Study Start: November 11, 2021
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)