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Completed

NCT Number: NCT05019261

Multi-component Family Support Tool Intervention (FST)

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Medical Center, Springfield, Massachusetts, United States

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About this study

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:

  • Proactive clinician-family meetings within 48 hours of enrollment and every 5-7 days thereafter.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

INCLUSION

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)

EXCLUSION

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
  • Patient does not meet inclusion criteria within 5 days of ICU admission
  • 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
  • Cannot read or understand English
  • Cannot complete questionnaires due to physical or cognitive limitations
  • Has no access to or cannot travel to access the internet

Treatment and study plan

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.

Primary outcomes

  1. Patient and family centeredness of care

    Time frame: 3 months after hospital discharge

    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.

Secondary outcomes

  1. Composite measure of goal-concordant care

    Time frame: 3 months after hospital discharge

    Assessed by surrogates at 3-month telephone follow-up using an 8-item composite measure of goal-concordant care.

  2. Satisfaction with ICU care

    Time frame: 3 months after hospital discharge

    Assessed using the Family Satisfaction in the ICU (FS-ICU) instrument at 3-month telephone follow-up of surrogates. The FS-ICU is a 24-item scale concerning satisfaction with care, communication, and decision-making in the ICU.

  3. Unmet palliative care needs

    Time frame: Measured at day 5 post-randomization

    Measured using the adapted Needs of Social Nature, Existential Concerns, Symptoms, and Therapeutic Interaction (NEST) scale administered to surrogates on day 5 post-randomization. The adapted NEST scale is designed for ICU use; it is a 13-item instrument developed to identify unmet social, emotional, physical, and care-system needs in serious illness.

  4. Surrogates' prognostic awareness

    Time frame: Measured at day 5 post-randomization

    Assessed on study day 5 using the validated Clinician-Surrogate Concordance Scale (CSCS), which our research team developed. The single item CSCS has excellent test-retest reliability (r =0.91). It has established criterion validity and responsiveness to change.

  5. Surrogates' clarity about patient values and preferences

    Time frame: Measured at day 5 post-randomization

    Assessed by surrogates after family meetings on study day 5 using the "informed" and "values clarity" subscales, 6 items out of the 16-item Decisional Conflict Scale (DCS). The scale has established responsiveness to change, test-retest reliability (r=0.81), internal consistency (α=0.92), and discriminant validity.

  6. Clinician-family conflict

    Time frame: Measured at day 5 post-randomization

    A brief survey (measured by both surrogates and ICU clinicians) to determine the level of family-clinician conflict during index hospitalization

  7. Perceived effectiveness of Family Support Tool

    Time frame: Measured at day 5 post-randomization

    A brief survey asking (intervention only) surrogate participants perceived effectiveness of the FST intervention

  8. Risk of post-traumatic stress disorder

    Time frame: 6 months after hospital discharge

    Assessed using the Impact of Events Scale-revised (IES-R) at 6 months. The IES-R is a valid, reliable, and responsive 22 -item instrument measuring symptoms of avoidance and intrusive thoughts. A score 33 indicates a high risk of PTSD. It has been used successfully among ICU surrogates.

  9. Surrogates' symptoms of anxiety and depression

    Time frame: 6 months after hospital discharge

    The HADS is a 14-item, two-domain (anxiety, depression) instrument with established reliability and validity among ICU surrogates that is recommended by consensus guidelines for use among ICU surrogates. Assessed at 6-month telephone follow-up.

  10. Resource utilization

    Time frame: 3 months and 6 months after hospital discharge

    Among hospital survivors we will perform interviews with surrogates at 3-months and 6-months to identify patient's post-discharge healthcare utilization (e.g. hospital admissions, ED visits, skilled-nursing facility use, hospice use, etc.), assigning costs using validated methods.

  11. Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization

    Time frame: 6 months after hospital discharge

  12. Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care

    Time frame: 6 months after hospital discharge

  13. Proportion of patients enrolled in hospice during index hospitalization

    Time frame: 6 months after hospital discharge

  14. ICU and hospital length of stay

    Time frame: 6 months after hospital discharge

    Duration of time patient spent in ICU and hospital

  15. Duration of mechanical ventilation

    Time frame: 6 months after hospital discharge

    Duration of time patient spent on mechanical ventilation during index hospitalization

  16. Cost of index hospitalization

    Time frame: 6 months after hospital discharge

    Assigning costs using validated methods, the cost of index hospitalization will be calculated

  17. Time to hospice

    Time frame: 6 months after hospital discharge

    time in days from enrollment to hospice

Other outcomes

  1. Patient hospital survival

    Time frame: 6 months after hospital discharge

    The vital status of the patient will be assessed at the conclusion of index hospitalization

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

    Time frame: 6 months after hospital discharge

    This will be measured as a time-to-event variable, with time 0 being the date of hospital discharge. All death dates will be confirmed by querying the SSDMF or institutional death indices at the completion of the trial.

  3. Days alive outside healthcare facilities

    Time frame: 6 months after hospital discharge

    We will calculate the number of days a patient was alive from discharge to 6 months, then subtract that from the number of days the patient was in a hospital, LTAC, SNF, rehab facility, or hospice.

  4. Patients' functional status

    Time frame: 6 months after hospital discharge

    Assessed using the Katz Index of Independence in Activities of Daily Living, a validated and widely-used scale to quantify patients' functional status. Katz is a 6-item (1 or 0 point) scale measuring independency in older adults. Lower scores indicate a greater level of dependence for measured skills.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

Randomized Trial of a Scalable, Interactive Tool to Support Surrogate Decision-makers of Critically Ill Older Adults

Acronym: FST

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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